[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes-t1d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes-t1d":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,67,0,25,[9,50,81,108,134,167,196,218,244,272,314,340,368,389,416,438,450,477,510,534,553,577,612,646,684],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054307","phase-2-metabolic-modulation-to-enhance-insulin-sensitivity-and-mitochondrial-function-in-type-1-diabetes-metmod-t1d-100054307",false,"NCT07699380","METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)","MetMod-T1D","Inclusion Criteria:\n\n1. Adults ≥18 years to \\\u003C70 years of age with established T1D (duration ≥1 year)\n2. Currently on insulin therapy (multiple daily injections or insulin pump)\n3. HbA1c \\\u003C9.5%\n4. BMI 18.5-40 kg\u002Fm2\n5. On stable dose of RASB or statin, if indicated\n6. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. History of pancreatic disease (including pancreatitis) or pancreatic surgery\n2. History of cardiovascular disease or stroke within the past 6 months\n3. History of heart failure per New York Heart Association criteria\n4. History of severe edema or salt restriction requirement\n5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids\n6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²\n7. Liver disease (ALT\u002FAST \\>3x upper limit of normal \\[ULN\\])\n8. Pregnancy, breastfeeding, or planning pregnancy during the study period\n9. Known hypersensitivity to study drug components\n10. Abnormal baseline ECG\n11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)\n12. Chronic use of anticoagulants\n13. Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3\n14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein\n15. History of severe hypoglycemia requiring assistance within the past 3 months\n16. History of diabetic ketoacidosis (DKA) within the past 3 months\n17. Personal or family history of breast cancer or ovarian cancer\n18. Current participation in another clinical trial\n19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate","ALL","18 Years","69 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center\u002FDiabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.",[28,29,30,31,32,33,34,35,36],"Type 1 Diabetes (T1D)","Metabolic Diseases","Glucose Metabolism Disorders","Endocrine System Diseases","Autoimmune Diseases","Immune System Diseases","Diabetes Melletus, Type 1","Nutritional and Metabolic Diseases","Combination Therapy","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":22},"2026-06",{"date":45,"type":22},"2029-12",{"name":47,"class":48},"University of Washington","OTHER",2,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100053652","automated-insulin-for-management-of-intrapartum-glycemia-100053652","NCT06883344","Automated Insulin for Management of Intrapartum Glycemia","Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial","AIMING","Inclusion Criteria:\n\n* Currently pregnant at ≥ 34 weeks\n* Known diagnosis of type 1 diabetes ≥ 1 year\n* Use of commercially available AID system since at least 28 weeks gestation\n* Singleton pregnancy\n* English- or Spanish-speaking\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Planned cesarean delivery\n* Use of medications known to interfere with glucose metabolism\n* Intrauterine fetal demise\n* Physical or psychological disease likely to interfere with the conduct of the study and\u002For the ability to participate in own healthcare","FEMALE","55 Years",{"count":61,"type":22},150,[63],"NA","The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor\u002Fdelivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are\n\n* What are the neonatal glycemic outcomes with use of AID systems during labor\u002Fdelivery?\n* Do patients report higher birth satisfaction with use of AID systems during labor\u002Fdelivery?\n* Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor\u002Fdelivery?\n\nResearchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor\u002Fdelivery) by randomly assigning participants to one or the other.",[28,66,67],"Pregnancy","Pre-Gestational Diabetes",[66,69,70,71,72],"Intrapartum glycemic management","Neonatal hypoglycemia","Perinatal care","Diabetes in pregnancy",{"date":40,"type":41},{"date":75,"type":41},"2025-12-05",{"date":77,"type":22},"2028-12-31",{"name":79,"class":48},"University of California, San Francisco",3,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100644549","phase-3-prise-personalized-response-and-immunologic-surveillance-of-endogenous-c-peptide-preservation-in-new-recent-and-established-onset-type-1-diabetes-treated-with-human-anti-thymocyte-globulin-h-atg-study-100644549","NCT07670650","PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset T1D, Recent Onset T1D, and Established T1D","PRISE-hATG","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian for participants below the legal age of consent must have given written informed consent and\u002For assent according to local, regional and\u002For country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.\n2. Males and females 5-40 years old\\*, inclusive, at the time of randomisation.\n\n   \\* Note: Age step-down rules apply, as described in protocol Section 6.1.\n3. Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) between 16 to 32 (inclusive).\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria (refer Section 22.1) as following:\n\n   * For Cohort 2: within \\>100 days but \\\u003C1 year (365 days) of randomisation;\n   * For Cohort 3: within ≥1 year (365 days) but \\\u003C2 years (730 days) of randomisation. For participants who were initially misdiagnosed with Type 2 diabetes (T2D), time from misdiagnosis with T2D to randomisation is up to 1 and 2 years.\n\n   Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy the time of randomisation.\n5. Participant has random C-peptide levels of \\>0.2 nmol\u002FL, measured during Screening. One random C-peptide retest during screening period is allowed.\n6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.\n7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:\n\n   * Glutamic acid decarboxylase 65 (GAD65)\n   * Islet antigen 2 (IA-2)\n   * Zinc transporter 8 (ZnT8)\n   * Insulin autoantibodies (if testing within the first 14 days of insulin treatment)\n8. Female participants:\n\n   1. Must be of nonchildbearing potential, i.e., pre-pubertal\\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle -stimulating hormone \\[FSH\\] level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i.Have a negative result on a serum (beta human chorionic gonadotropin \\[β-hCG\\]) at screening and a negative urine β-hCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.\n\n   ii.Agree not to become pregnant or donate ova from the time of signing the consent form until the end of the study visit.\n\n   iii.If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception \\[Section 11.3.1\\]) from the time of signing the consent and for the duration of the study.\n\n   \\* Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)\u002Fguardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.\n9. Male participants, if not biologically or surgically sterilised, must:\n\n   1. Agree not to donate sperm from the time of signing the consent form until End of Study (EOS).\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception \\[refer to Section 11.3.1\\]) from the time of signing the consent form until EOS.\n   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from the time of signing the consent form until EOS.\n10. Prior to receiving study drug, participant must agree to receive locally, regionally and\u002For country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and\u002For country-specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.\n11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and\u002For stimulate pancreatic β cell regeneration or insulin secretion.\n12. Participant has suitable venous access for blood sampling.\n13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications). This includes participants with Hereditary Fructose Intolerance.\n2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.\n3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.\n4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.\n5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and\u002For efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.\n6. Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematosis) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.\n7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.\n8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.\n9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalisation or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active CMV, EBV as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative (defined as PCR \\\u003C1000 copies\u002FmL or its equivalent in plasma or serum based on the site-specific PCR assay) test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I\u002FE are met. Participants who have an active infection and\u002For fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.\n11. Participant has a diagnosis of significant liver disease or at screening ALT and\u002For AST \\>2× or total bilirubin of \\>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the site laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant may be eligible for randomisation. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and\u002For indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.\n12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:\n\n    * Lymphocyte count: \\\u003C1000\u002FμL\n    * Neutrophil count: \\\u003C1500\u002FμL\n    * Platelet count: \\\u003C100 000 platelets\u002FμL\n    * Haemoglobin: \\\u003C10 g\u002FdL\n\n    Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and\u002For is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the references ranges.\n13. Current or prior (within 5× half-lives before SV2) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.\n14. Current or prior (within 5× half-lives before SV2) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \\[glucagon-like peptide-1\\], dipeptidyl peptidase-4 \\[DPP-IV\\] inhibitors, or amylin).\n15. Current or prior (within 5× half-lives before SV2) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).\n16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact on the investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    Countries within the EU member states only:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): from 30 days before dosing through 6 months following administration of SAB-142 for each TP;\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: from 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of each TP.\n18. Female is lactating and\u002For plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.\n19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and\u002For country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit\u002Fhyperactivity disorder (ADHD) or others are allowed to participate in the study.\n20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.\n21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site. Note: Investigators should ensure that all study inclusion criteria and no study exclusion criteria have been met at screening. If a participant's clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study drug is given such that he or she no longer meets all eligibility criteria, then the participant should be excluded from participation in the study.\n22. An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI or if participation in the study may place the participant at risk.\n23. An individual who has been placed in an institution by official or court order.","5 Years","40 Years",{"count":92,"type":22},108,[94],"PHASE3","This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). The study will enroll participants with recent-onset T1D (\\>100 days to \\\u003C1 year from diagnosis) and established-onset T1D (≥1 year to ≤2 years from diagnosis) who retain residual beta-cell function as demonstrated by stimulated C-peptide levels \\>0.2 nmol\u002FL. Participants will be randomized in a 2:1 ratio to receive SAB-142 or placebo in addition to standard diabetes care. The primary objective is to determine whether SAB-142 preserves beta-cell function over 12 months as measured by stimulated C-peptide response during a mixed meal tolerance test (MMTT). External data from the SAB-142-201 SAFEGUARD study will be incorporated to include participants with new-onset T1D (\\\u003C100 days from diagnosis) in the primary efficacy analysis.",[28],"NOT_YET_RECRUITING","2026-06-25",{"date":100,"type":41},"2026-06-26",{"date":102,"type":22},"2026-09-01",{"date":104,"type":22},"2030-09-01",{"name":106,"class":48},"University of Florida",4,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100564044","circadian-mechanisms-glucose-and-cv-risks-in-t1d-100564044","NCT06624046","Circadian Mechanisms, Glucose, and CV Risks in T1D","Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Adults 18-50 years with a clinical diagnosis of T1D for at least one year\n* Report habitual sleep irregularity ≥1 hour\u002Fweek\n* Desire to improve sleep, and own a smartphone (Android or iPhone)\n\nExclusion Criteria:\n\n* Self-reported A1C within the past 6 months ≥10%\n* insomnia symptoms defined as Insomnia Severity Index score ≥15\n* history of restless leg syndrome\n* history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months\n* rotating shift or night work or routinely sleeping after 3 AM.\n* use of sleep medications\u002Faids, significant medical comorbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, on renal replacement therapy \\[dialysis\\])\n* depression (Patient Health Questionnaire 8 \\[PHQ-8\\] score ≥15)\n* history of stroke with neurological deficits\n* pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding.\n* Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC","50 Years",{"count":117,"type":22},100,[63],"People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.",[28],[122,123,124],"sleep","cardiovascular disease risk","glycemic control",{"date":126,"type":41},"2026-06-30",{"date":128,"type":41},"2025-03-13",{"date":130,"type":22},"2029-08-31",{"name":132,"class":48},"University of Illinois at Chicago",1,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":154,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":133},"100628559","integrating-new-skills-into-diabetes-education-with-cgm-100628559","NCT07463209","Integrating New Skills Into Diabetes Education With CGM","Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes","INSIDE-CGM","Participant Inclusion Criteria:\n\n* Adults 65 years and older at time of consent\n* Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as residing within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.\n* Using any insulin\n* No continuous glucose monitor (CGM) use within the previous 365 days\n* Willing to use a smartphone to access glucose readings using CGM phone app\n* Fluent in English\n\nParticipant Exclusion Criteria:\n\n* Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)\n* Currently receiving dialysis, assessed through chart review and self-report on screening visit\n* Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit\n* The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of \\\u003C1 year, assessed at screening visit\n* Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures\n* Not fluent in English\n* Unable to consent to recording of sessions\n\nCare Partner Inclusion Criteria:\n\n* Live in the same household as the study participant\n* Age 18 years or older\n* Fluent in English\n* Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes\n* Consent to recording of sessions","65 Years",{"count":144,"type":22},144,[63],"This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program (\"intervention\") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches (\"comparators\").\n\nFollowing a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator A) will receive a one-time clinic-based CGM training. The second comparator (Comparator B) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks.\n\nThe study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.\n\nLastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.",[148,149,150,151,152,28,153],"Insulin Dependent Diabetes","Diabetes (DM)","Diabetes (Insulin-requiring, Type 1 or Type 2)","Diabetes Education","Diabetes Care","Type 2 Diabetes Mellitus (T2DM)",[155,156,157,158,159,151],"Continuous Glucose Monitor","Diabetes","Insulin Dependent","Older Adults (65 years and older)","CGM","2026-06-23",{"date":100,"type":41},{"date":43,"type":22},{"date":164,"type":22},"2028-06",{"name":166,"class":48},"University of North Carolina, Chapel Hill",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":133},"100644212","efficacy-of-islet-re-transplantation-after-failure-of-beta-cell-replacement-100644212","NCT07666789","Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement","Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement","MULT-ILOT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of type 1 diabetes\n* Prior beta-cell replacement therapy : islet transplantation or pancreas transplantation\n* Islet re-transplantation performed after 2005\n* Islet re-transplantation performed after documented beta cell graft failure, defined by undetectable C-peptide and\u002For recurrence of severe hypoglycemia on insulin therapy\n* Availability of clinical and biological data required for assessment of study outcomes\n\nExclusion Criteria:\n\n* Missing or incomplete data preventing assessment of the primary outcome\n* Patients who did not meet inclusion criteria",{"count":176,"type":22},20,"OBSERVATIONAL","Islet transplantation and pancreas transplantation are established therapeutic options for selected individuals with type 1 diabetes experiencing severe glycemic instability and recurrent hypoglycemia. Although these approaches significantly improve glycemic management and quality of life, long-term graft survival remains limited, with a progressive decline in beta-cell function over time.\n\nThe clinical benefit-risk profile of islet re-transplantation after graft failure remains poorly defined, and outcomes following repeat islet transplantation after prior islet graft failure have not been specifically evaluated.\n\nRepeated exposure to multiple donors may increase the risk of alloimmunization, including the development of donor-specific antibodies , which may adversely affect graft survival and limit access to future transplantation.\n\nThis multicenter retrospective cohort study aims to evaluate the efficacy and safety of islet re-transplantation in adults with type 1 diabetes after failure of initial beta-cell replacement (islet or pancreas transplantation), with outcomes assessed at 3 months, 1 year, and 5 years.",[28,180],"Islets of Langerhans Transplantation",[182,183,184,185,186,124],"islet transplantation","pancreas transplantation","type 1 diabetes","beta cell replacement","graft survival","2026-06-21",{"date":189,"type":41},"2026-06-24",{"date":191,"type":41},"2025-07-31",{"date":193,"type":22},"2026-09-30",{"name":195,"class":48},"University Hospital, Montpellier",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":133},"100644045","dietary-approaches-for-the-management-of-overweight-and-obesity-in-type-1-diabetes-100644045","NCT07667504","Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes","Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study","D1ANA","Inclusion Criteria:\n\n* T1D treated with intensive insulin therapy (multiple daily insulin injections or continuous subcutaneous insulin infusion systems)\n* HbA1c 6.5-9%\n* BMI ≥ 25 and ≤ 45 kg\u002Fm2\n* Active prescription and use of CGM\n* Active prescription for glucagon\n\nExclusion Criteria:\n\n* Pregnancy, pregnancy planning, or breastfeeding\n* Forms of diabetes other than T1D, or T1D duration \\\u003C 1 year\n* Previous cardiovascular events (acute myocardial infarction or stroke), heart failure, unstable coronary artery disease, chronic kidney disease with estimated glomerular filtration rate ≤ 30 mL\u002Fmin\u002Fm², cirrhosis, or presence of active cancer\n* Unstable diabetes, episodes of glycemic decompensation (diabetic ketoacidosis) or severe hypoglycemia (level 3) within the past year.\n* Planned change in treatment during the study (switching from multiple daily insulin injections to continuous insulin infusion, or vice versa)\n* Use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1\u002FGIP agonists, or other medications that may influence weight loss\n* Having experienced a change in body weight greater than 5% within the 3 months before screening\n* Following any form of diet prior to inclusion, carbohydrate restriction, or intermittent fasting\n* History of eating disorders or alcohol abuse\n* Inability to follow the dietary recommendations\n* Presence of other conditions that, in the investigator's judgment, may compromise participation in the study.",{"count":205,"type":22},75,[63],"Although type 1 diabetes (T1D) has traditionally been considered a disease associated with a lean phenotype, it is estimated that up to 2 out of 3 people living with T1D are overweight or obese, factors linked to an increased risk of complications in these patients. The available evidence regarding nutritional strategies for weight loss in T1D is very limited, and clinical trials are needed to determine how to effectively and safely promote weight loss in this population. In recent years, low-carbohydrate diets and several intermittent fasting protocols have demonstrated efficacy in promoting weight loss both in patients with type 2 diabetes and in patients with obesity without diabetes. In this study, we will evaluate the efficacy of moderate carbohydrate restriction, time-restricted eating, and standard calorie restriction for weight loss in adults with T1D and overweight\u002Fobesity.",[28,209],"Obesity & Overweight","2026-06-18",{"date":98,"type":41},{"date":213,"type":22},"2026-07",{"date":215,"type":22},"2028-07",{"name":217,"class":48},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":226,"sex":17,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":133},"100644409","finding-immune-nascent-type-1-diabetes-100644409","NCT07663136","Finding Immune Nascent Type 1 Diabetes","Finding Immune Nascent Type 1 Diabetes (FIND T1D)","FIND T1D","Inclusion Criteria:\n\n* Participant must be in Indiana Biobank\n* Participant must be able to provide consent\n* Ages 1-99 including pregnant women\n\nExclusion Criteria:\n\n* Refusal to sign informed consent for home screening is exclusionary for the home screening portion of the study\n* While other medical conditions are allowable prior diabetes diagnosis is exclusionary for home autoantibody screening",true,"1 Year","99 Years",{"count":230,"type":22},3800,[63],"The goal of this clinical trial is to understand how many individuals who previously participated in the Indiana Biobank will return a type 1 diabetes home screening kit based upon different methods of recruitment communication. The main question it aims to answer is:\n\nWhat form of recruitment communication is most effective for completing a type 1diabetes home screening kit?\n\nResearchers will compare two types of recruitment contact: email and mail based communication (low-touch) versus phone contact and follow-up by a research team member (high-touch).\n\nParticipants will be contacted either via email\u002Fmail or by phone and asked if they want to complete a type 1 diabetes home screening kit.",[234,28],"Healthy Adult",[236,184],"type 1 diabetes home screening kit","2026-06-17",{"date":160,"type":41},{"date":43,"type":22},{"date":241,"type":22},"2029-06",{"name":243,"class":48},"Indiana University",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":133},"100631978","insulin-delivery-with-self-adjusting-closed-loop-and-behavioral-glycemic-control-enhanced-by-prediction-100631978","NCT07507708","Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction","Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)","INSIGHT","Participant Inclusion Criteria\n\n1. Age ≥18.0 years old at time of consent\n2. Clinical diagnosis, based on investigator assessment, of T1D for \\> 1 year.\n3. Having used an FDA approved AID system within the last 6 months (can be intermittent use).\n4. Currently using insulin for \\>6 months.\n5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.\n6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.\n7. Participant not currently known to be pregnant or breastfeeding.\n8. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.\n9. Willingness to wear a Dexcom CGM during each of the study phases.\n10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.\n11. Willingness not to start any new non-insulin glucose-lowering agent during the trial.\n12. Willingness to participate in all study procedures including in person training.\n13. Access to internet at home and willingness to upload data during the study as needed.\n14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.\n15. Participant is proficient in reading and verbal communication in English.\n\nParticipant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.\n\n1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.\n2. Current use of sulfonylurea medications.\n3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.\n4. Current use of an SGLT-2 or SGLT-1\u002F2 inhibitor due to risk of euglycemic DKA.\n5. Hemophilia or any other bleeding disorder.\n6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.\n7. History of DKA event in the last 12 months.\n8. Currently on peritoneal or hemodialysis.\n9. Currently being treated for adrenal insufficiency.\n10. Currently being treated for a seizure disorder.\n11. Hypothyroidism or hyperthyroidism that is not adequately treated.\n12. Use of oral or injectable steroids at the time of enrollment.\n13. Known ongoing adhesive intolerance that is not well managed.\n14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.\n15. Participation in another interventional trial at the time of enrollment.\n16. Participant with a direct supervisor at work\u002Fschool who is involved in the conduct of the trial.",{"count":176,"type":22},[63],"This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.",[28],[257,258,259,260,261,262,263],"Automated insulin delivery as Adaptive Network (AIDANET)","Fully automated Closed Loop (FCL)","Hybrid Closed Loop (HCL)","Continuous subcutaneous insulin infusion (CSII)","Insulin Pump","Tandem Mobi system","Anticipatory Closed Loop (ACL)",{"date":265,"type":41},"2026-06-22",{"date":267,"type":41},"2026-05-14",{"date":269,"type":22},"2026-12-31",{"name":271,"class":48},"Sue Brown",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":294,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":49},"100593800","primary-care-pragmatic-real-world-experience-for-automated-insulin-delivery-100593800","NCT07011147","Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery","PREPARE 4 AID","Inclusion Criteria:\n\n1. Age at time of consent \\>18 and \\\u003C89 years\n2. Either 2.a. or 2.b.:\n\n   1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year\n   2. Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)\n3. Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1\u002FGIP RA agents\n4. Stable doses of weight loss medications (including GLP-1 RA and GLP-1\u002FGIP RA agents) over the preceding 4 weeks as determined by the investigator.\n5. For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and\u002For indirectly, except for a dose reduction or discontinuation.\n6. Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study\n7. Willing to comply with all study procedures for the duration of the study\n8. Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP\n9. Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)\n10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol\n11. Willing and able to sign and date the Informed Consent Form (ICF)\n12. If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period\n\n    a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).\n\n    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).\n\n    iii. Placement of an intrauterine device or intrauterine hormone-releasing system.\n\n    iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository).\n\n    v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.\n\n    vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study.\n13. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration\n14. Have hardware and internet access capable of 2-way video and audio communication\n\nExclusion Criteria:\n\n1. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)\n2. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only\n3. Diagnosis of maturity-onset diabetes of the young (MODY)\n4. Plan to change usual diabetes regimen between screening and study randomization\n\n   1. This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1\u002FGIP RA medication\n   2. This would NOT include changes to any insulin doses, including pump settings, short- and\u002For long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1\u002FGIP RA); or changing type of type 2 diabetes medication within the same class\n5. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface\n6. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation\n7. Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. \"DIY Loop\", \"AAPS\", \"iAPS\" or \"Open APS\")\n8. Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy\n9. Planned use of hydroxyurea at any dose and\u002For of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.\n10. Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment\n11. Current participation in another diabetes-related clinical trial\n12. History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy\n13. Have a history of intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)\n14. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the 6 months prior to screening, unrelated to an intercurrent illness or to a kinked, dislodged, or occluded cannula\n15. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n16. Treated currently or within the past 30 days prior to enrollment, or plan to begin treatment, with sulfonylurea, pramlintide, or SGLT-2 inhibitor medication\n17. Any planned surgery during the study that would be considered major in the opinion of the investigator\n18. Pregnant or lactating, or planning to become pregnant in the next 6 months\n19. Renal failure on dialysis or chronic renal disease with a GFR or eGFR \\\u003C30mL\u002Fmin (values within the last two years will be accepted; if none available or \\>2 years prior, participant will be instructed to obtain GFR or eGFR through their usual care provider and to make copy of result available to study team)\n20. Any condition or circumstance that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study or which could compromise the results of the study c. Conditions to be considered by the investigator may include, but are not limited to, the following: i. Active clinical diagnosis of substance use disorder ii. Chronic use of opiates and\u002For benzodiazepines which, in the opinion of the investigator, might make it difficult for the participant to follow study procedures iii. Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening, a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting iv. Known history of prolonged QTc interval, malignant arrhythmia, or severe congenital heart disease v. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV vi. History of TIA or stroke in the last 12 months vii. Untreated or inadequately treated mental illness viii. History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia, or omission of insulin to manipulate weight ix. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n21. Plans to travel outside of the US and its territories for more than four weeks consecutively\n22. Plans not to have internet\u002Fvideo\u002Fphone access for more than one week consecutively\n23. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial\n24. Previous use of the iLet for more than four weeks (including use of the commercially available iLet or prior participation in a study involving wearing the iLet for more than four weeks)","89 Years",{"count":281,"type":22},240,[63],"The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:\n\nCan the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?\n\nResearchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.\n\nParticipants will:\n\nUse the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks",[28,285,286,287,288,289,290,156,291,292,293],"Type 2 Diabetes","Diabetes, Autoimmune","Diabetes Mellitus","Diabetes Mellitus Type 2","Diabetes Mellitus, Type I","Diabetes, Type II","Diabetes Mellitus, Insulin-Dependent","Diabetes Mellitus Type II","Diabetes Type 2 on Insulin",[295,184,296,297,298,299,300,301,302,303,304],"automated insulin delivery","type 2 diabetes","bionic pancreas","closed loop","pancreas, artificial","t1d","t2d","diabetes","insulin","primary care","2026-06-10",{"date":307,"type":41},"2026-06-11",{"date":309,"type":41},"2026-01-16",{"date":311,"type":22},"2029-04-01",{"name":313,"class":48},"University of Colorado, Denver",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":133},"100640346","phase-1-a-research-study-investigating-the-effect-of-nnc0497-0040-in-healthy-participants-participants-with-overweight-or-obesity-and-participants-with-type-1-diabetes-with-overweight-or-obesity-100640346","NCT07578584","A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or Obesity","Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Weekly Doses of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and in Participants With Type 1 Diabetes With Overweight or Obesity","For SAD cohorts\n\nInclusion Criteria:\n\n* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.\n* Body mass index between 18.5 kilogram per m\\^2 and 29.9 kilogram per m\\^2 (both inclusive) at screening.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.\n* Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.\n\nFor MAD1-3 cohorts\n\nInclusion Criteria:\n\n* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.\n* Body mass index between 27.0 kilogram per m\\^2 and 39.9 kilogram per m\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.\n* HbA1c above or equal to 6.5 percentage (48 millimoles per mole) at screening.\n* Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.\n\nFor MAD4 cohorts\n\nInclusion Criteria:\n\n* Male aged 18-55 years (both inclusive) at screening.\n* Body mass index between 27.0 kilogram per m\\^2 and 34.9 kilogram per m\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Diagnosed with type 1 diabetes mellitus above or equal to 1 year before screening.\n* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) more than 90 days prior to the day of screening.\n* Use of continuous glucose monitoring (CGM) device more than 90 consecutive days prior to the day of screening.\n* HbA1c in the range of 7.2percentage - 9.5percentage (both inclusive).\n\nExclusion Criteria:\n\n* Any disorder, unwillingness or inability, except for mild conditions under stable treatment associated with type 1 diabetes (T1D), which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).\n* Use of any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening or in the period between screening and randomisation.\n* Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers or growth hormone.\n* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).\n* Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.",{"count":322,"type":22},146,[324],"PHASE1","The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.",[28,327,328,329],"Overweight","Obesity","Healthy Volunteers","2026-06-01",{"date":332,"type":41},"2026-06-04",{"date":334,"type":41},"2026-05-07",{"date":336,"type":22},"2028-02-18",{"name":338,"class":339},"Novo Nordisk A\u002FS","INDUSTRY",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":80},"100640229","safety-evaluation-of-modi-an-insulin-titration-algorithm-in-adults-with-diabetes-100640229","NCT07599982","Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes","MODIUS","Inclusion Criteria:\n\n1. Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent\n2. Insulin therapy as follows:\n\n   1. If T1D, using MDI insulin therapy for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) meal-size-based dosing (small, normal, large); and taking\n\n      1 basal insulin injection per day for at least 1 week prior to screening\n   2. If T2D, either:\n\n   i. not using insulin in the 3 months prior to screening, but require initiation of a basal-only insulin regimen based on investigator assessment ii. using only basal insulin for at least 3 months prior to screening and taking 1 basal insulin injection per day for at least 1 week prior to screening iii. using MDI for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either\n\n   (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) mealsize-based dosing (small, normal, large); and taking 1 basal insulin injection per day for at least 1 week prior to screening\n3. Age at time of consent 18-80 years\n4. HbA1c \\>7.5% and \\\u003C12% as measured by point-of-care device or local lab at the time of screening\n5. Using only injected insulin types that are specified in the MODI Instructions for Use materials\n6. Stable doses of non-insulin glucose lowering medications over the 4 weeks preceding screening as determined by Investigator and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons\n7. Stable doses of weight loss medications that may have a meaningful effect on glycemic control over the 4 weeks preceding screening and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons\n8. Weight between 80 - 440 lb at the time of screening\n9. Willing to use FSL 3 System according to manufacturer instructions and to avoid use of any other personal CGM system during the period of study participation\n10. Willing to document insulin delivery, meals, and daily activities in the Diary mobile app\n11. Has a smartphone compatible with study requirements: either iOS version 17.0 or higher, or Android version 10.0 or higher, and willing to install required apps and use them as instructed during the period of study participation, with internet connectivity for a data upload at least once per day.\n12. Is deemed an appropriate candidate for automatic insulin guidance therapy per Investigator assessment\n13. Investigator has confidence that the participant has the cognitive ability necessary for study participation, can successfully operate all study devices, and can adhere to the protocol\n14. Has a sufficient understanding of written\u002Fspoken English for legally effective informed consent and successful use of the study mobile apps\n15. If woman of childbearing potential, is willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n1. Use of an insulin pump within 3 months prior to informed consent\n2. Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening\n3. Taking more than 128 units of daily basal insulin or more than 79 units in a single bolus insulin injection in the 7 days prior to screening\n4. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and\u002For eating disorders (i.e. anorexia\u002Fbulimia)\n5. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening\n6. Any planned surgery during the study which could be considered major in the judgment of the investigator\n7. History of more than 1 severe hypoglycemic event in the 6 months prior to screening\n8. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening\n9. Blood disorder or dyscrasia within 3 months prior to screening which in the investigator's opinion could interfere with determination of HbA1c\n10. Any condition or intervention that may affect red blood cell turnover, in the 3 months prior to the study and during the study, such as blood transfusion or donation\n11. Has taken oral or injectable corticosteroids within 2 weeks prior to screening or plans to take oral or injectable corticosteroids during the study\n12. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n13. Is an employee of DreaMed Diabetes, is a study Investigator or a member of the Investigator's study team, or is immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned\n14. Participation in another clinical study using an investigational drug or device in the 90 days prior to screening or intends to participate during the study period\n15. Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral\u002Finjectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months postmenopausal)\n16. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact the CGM sensor","80 Years",{"count":349,"type":22},102,[63],"A 13-week multi-center single-arm trial, preceded by a 2-week standard therapy phase, will be conducted to assess the safety of MODI, an insulin titration algorithm, in adults with type 1 diabetes (T1D) who use multiple daily insulin injections (MDI), or with type 2 diabetes (T2D) who use MDI, basal insulin only, or who are candidates to initiate basal insulin, in conjunction with continuous glucose monitoring (CGM).",[28,353],"Type 2 Diabetes (T2D)",[184,303,355,356,357,358,359,296],"titration","algorithm","adults","continuous glucose monitoring","multiple daily injections",{"date":361,"type":41},"2026-06-03",{"date":363,"type":41},"2026-05-25",{"date":365,"type":22},"2027-01",{"name":367,"class":339},"DreaMed Diabetes",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":376,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":133},"100564309","type-1-diabetes-rest-for-metabolic-health-100564309","NCT06627504","Type 1 Diabetes REst for Metabolic Health","Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes","T1DREaM","Inclusion Criteria:\n\n* High school students between the ages of 14-19 years;\n* Diagnosed with T1D for ≥1 year;\n* Using an insulin pump or other automated insulin delivery system;\n* Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);\n* With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg\u002Fm2);\n* Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.\n\nExclusion Criteria:\n\n* Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure\n* Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);\n* Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);\n* HbA1c ≥12%;\n* Severe illness or DKA within 60 days;\n* IQ\\\u003C70 or severe mental illness impacting sleep or ability to participate in the study;\n* Night-shift employment or other obligations that would preclude adherence to the intervention.","14 Years","19 Years",{"count":379,"type":22},50,[63],"Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \\<7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).",[28,383],"Sleep Health",{"date":361,"type":41},{"date":386,"type":41},"2025-08-12",{"date":130,"type":22},{"name":313,"class":48},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":227,"maxAge":18,"enrollmentInfo":396,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":4},"100640000","type-1-diabetes-screening-100640000","NCT07612475","Type 1 Diabetes Screening","Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics","Inclusion Criteria:\n\nChildren\n\n* All children presenting for the 2-4, 6-8, and 11-15 year well-child visit at participating clinics, or otherwise eligible for T1D screening, or otherwise receiving blood test recommendations from clinicians that happen outside of these recommended age buckets or routine visits, will be eligible to have their data extracted from the electronic health record (EHR)\n\nParents\u002FCaregivers\n\n\\- All parents\u002Fcaregivers who attended the well-child visit, who are eligible to have their child's data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.\n\nClinicians and Clinical Staff\n\n* All pediatric physicians and non-physician primary care providers (MD, DO, APP) employed at participating clinics will be eligible to complete the post-visit interview.\n* All clinic staff at participating clinics, including members of the care team (e.g., medical assistants, nurses) as well as clinic leaders, administrative staff, and other staff (e.g., front-desk triage), will be eligible to complete the post-visit interview.\n\nExclusion Criteria:\n\n* Parents\u002Fcaregivers and children who have opted-out of participating in research at their clinic.",{"count":397,"type":22},3500,"This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test and how often families complete it when integrated into existing workflows. Insights from parents, clinicians, and organizational leaders will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.",[28],[401,402,403,404,405,406],"Implementation Science","Pediatrics","Type 1 Diabetes","Universal Screening","Islet Autoantibodies","Population-based Screening","2026-05-27",{"date":409,"type":41},"2026-05-28",{"date":411,"type":22},"2026-07-15",{"date":413,"type":22},"2028-11-15",{"name":415,"class":48},"Northwestern University",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":429,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":434,"leadSponsor":436,"locationsCount":133},"100637915","phase-2-cadisegliatin-as-adjunctive-therapy-to-insulin-in-participants-with-type-1-diabetes-who-are-using-hybrid-closed-loop-hcl-systems-100637915","NCT07616206","Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems","Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study","Hybrid CATT1","Key Inclusion Criteria:\n\n* Participants \\>= 18 years of age\n* Fasting plasma C-peptide levels \\\u003C0.6 ng\u002Fml\n* Average TIR \\\u003C 70% at the end of the screening period\n* Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration\n* Willing to wear a study provided CGM for study duration\n* Capable of participating in a 30-minute lasting exercise test\n\nKey Exclusion Criteria:\n\n* Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.\n* Have been hospitalized for DKA within 3 months\n* Have uncontrolled hypothyroidism or hyperthyroidism\n* Have QTcF interval \\> 450 msec for males or \\> 470 msec for females\n* Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias\n* Have persistent, uncontrolled hypertension\n* Have clinically significant cardiovascular or cerebrovascular disease\n* Have proliferative retinopathy or maculopathy requiring acute treatment\n* Have a serious concomitant systemic disorder incliuding but not limited to HIV or active Hep B or Hep C\n* Diagnosed and\u002For treated for malignancy within 3 years\n* Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,",{"count":425,"type":22},40,[25],"TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes. Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.",[28],[430],"Hybrid Closed Loop","2026-05-22",{"date":330,"type":41},{"date":213,"type":22},{"date":435,"type":22},"2027-05",{"name":437,"class":339},"vTv Therapeutics",{"id":439,"slug":4,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":18,"maxAge":59,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":64,"conditions":442,"keywords":443,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":448,"leadSponsor":449,"locationsCount":49},"100583977",{"count":61,"type":22},[63],[28,66,67],[66,69,70,71,72],"2026-05-13",{"date":446,"type":41},"2026-05-18",{"date":75,"type":41},{"date":77,"type":22},{"name":79,"class":48},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":133},"100637719","pilot-of-food-is-medicine-interventions-to-reduce-cardiovascular-disease-risk-in-children-with-food-insecurity-and-diabetes-100637719","NCT07590817","Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes","Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes","Inclusion Criteria:\n\n* Families of school-age children (ages 5-12 years) with T1DM and food insecurity\n* fluent in English or Spanish.\n* child uses a continuous glucose monitor (CGM)\n* willing to provide consent for the research team to access CGM data\n\nExclusion Criteria:\n\n* recent diagnosis of T1DM (\\\u003C6 months)","12 Years",{"count":459,"type":22},12,[63],"Study Design: This two-arm parallel trial will randomize 12 families to receive 6-weeks of medically tailored meals or produce prescriptions. Both groups will receive nutrition coaching, weekly during the intervention. The hypothesis is that both interventions to have a positive impact on food security and fruit and vegetable intake. However, medically tailored meals also reduce the logistic barriers of planning, preparing, and calculating the carbohydrate content of nutritionally balanced meals essential for DM management. Therefore, the medically tailored meal intervention will result in greater improvements in the co-primary outcomes of diet quality and glucose stability after the intervention.",[28,463],"Food Insecurity",[403,463,465,466,467,468],"Food is Medicine","Medically Tailored Meals","Produce Prescriptions","Nutrition Education","2026-05-12",{"date":471,"type":41},"2026-05-15",{"date":473,"type":22},"2026-05-30",{"date":126,"type":22},{"name":476,"class":48},"Katelyn Fox",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":226,"sex":17,"minAge":18,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":493,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":133},"100610361","using-a-personalized-decision-support-tool-to-help-people-with-type-1-diabetes-manage-exercise-100610361","NCT07226583","Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise","Net-IOB & Exercise Toolkit Pilot Trial: Randomized, Crossover Evaluation of a Behavioral Decision Support Advisor to Improve Glycemic Safety During and After Exercise in Adults With Type 1 Diabetes (NEXT)","NEXT","Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups)\n\n* Adults between the age of 18-60 years\n* Able to perform moderate intensity walking for 60 minutes (target 40-60% age-predicted maximal heart rate).\n* Willing and able to comply with study procedures, including supervised exercise visits and device wear\n* Able to provide written informed consent\n\nInclusion Criteria: Type 1 Diabetes Group Only\n\n* Clinical diagnosis of type 1 diabetes for \\>1 year, based on the investigator's clinical judgement\n* Current use of continuous subcutaneous insulin infusion with Tandem Control-IQ and a compatible continuous glucose monitor (CGM) for \\>1 month prior to enrollment\n* Stable insulin delivery regimen, with no planned changes to insulin pump settings or insulin dosing strategy during the study period\n* Consistent CGM use during the month prior to enrollment (\\>80% data availability)\n\nInclusion Criteria: Health Control Group Only\n\n* No diagnosis of diabetes or other disorders of glucose metabolism\n* Not using insulin or glucose-lowering medications\n\nExclusion Criteria Exclusion Criteria: All Participants\n\n* Intercurrent illness or medical condition that precludes safe participation in moderate-intensity exercise (e.g., unstable cardiopulmonary disease, uncontrolled arrhythmia, or uncontrolled hypertension), as previously assessed by the participant's primary care physician\n* Known coronary artery disease with symptoms limiting moderate physical activity, or history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the past 12 months\n* Pregnancy, lactation, or plans to become pregnant during the study period\n* Renal insufficiency with estimated GFR \\\u003C45 mL\u002Fmin\u002F1.73 m², dialysis dependence, or adrenal insufficiency\n* Concurrent participation in another interventional drug or device study within 30 days prior to enrollment\n* Inability to comply with study procedures or safety requirements (e.g., inability to achieve target heart-rate zone, attend scheduled visits, or enable required device data access), or otherwise deemed unsuitable by the investigator\n\nExclusion Criteria: Type 1 Diabetes Group Only\n\n* Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period\n* Use of medications with potential to substantially affect glycemia (e.g., SGLT-2 inhibitors, GLP-1 receptor agonists, or GIP agonists), unless on a stable regimen with no planned changes during the study\n* Use of systemic corticosteroids within 4 weeks prior to participation\n* History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis within the prior 6 months","60 Years",{"count":176,"type":22},[63],"This study evaluates a clinician-facing decision-support toolkit designed to assist adults with type 1 diabetes in preparing for moderate-intensity exercise. The netIOB \\& Exercise Toolkit (NEXT) integrates recent glucose data and insulin delivery history to provide individualized suggestions regarding exercise timing, insulin adjustments, and carbohydrate intake.\n\nAdults with type 1 diabetes will complete three supervised exercise sessions under different pre-exercise guidance approaches:\n\n(A) published consensus-based standard-of-care guidance, (B) usual personal care routines, and (C) guidance informed by the NEXT Toolkit.\n\nA healthy adult control group will complete a single supervised exercise session to provide comparative physiologic data.",[490,28,491,492],"Type 1 Diabetes Mellitis","Type 1 Diabetes Mellitus (T1DM)","Exercise Physiology",[403,494,495,496,497,159,261,498,499,500,501],"T1D","T1DM","Continuous Glucose Monitoring","Insulin Dosing","Exercise","carbohydrate Intake","closed-loop system","hybrid closed-loop","2026-05-11",{"date":267,"type":41},{"date":505,"type":22},"2026-04",{"date":507,"type":22},"2026-08",{"name":509,"class":48},"Stanford University",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":533},"100586744","phase-1-a-study-of-gnti-122-in-adults-recently-diagnosed-with-t1d-100586744","NCT06919354","A Study of GNTI-122 in Adults Recently Diagnosed With T1D","POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)","POLARIS","Inclusion Criteria:\n\n1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.\n2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol\u002FL.\n3. Positive for at least one T1D-associated autoantibody.\n4. Able and willing to provide written, informed consent as approved by the IRB.\n5. Is confirmed positive for the HLA-DRB1\\*04:01 allele.\n6. Has adequate vascular access to undergo leukapheresis with no known contraindications.\n\n8\\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.\n\n9\\. Male participants of childbearing potential must agree to protocol specified contraception.\n\n10\\. Other than T1D, participant is in good general health.\n\nExclusion Criteria:\n\n1. Type 2 diabetes.\n2. Experienced DKA within 4 weeks prior to or during Screening.\n3. Unwilling or unable to comply with study procedures or schedule.\n4. Chronic or uncontrolled medical condition.\n5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.\n6. Participation in another clinical study or active follow-up in a prior study.",{"count":519,"type":22},16,[324],"This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https:\u002F\u002Fwww.polarisstudy.com to learn more!",[28,523],"Type 1 Diabetes Mellitus","2026-04-30",{"date":526,"type":41},"2026-05-04",{"date":528,"type":41},"2025-09-03",{"date":530,"type":22},"2028-02",{"name":532,"class":339},"GentiBio, Inc",10,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":551,"locationsCount":133},"100591223","feasibility-study-of-a-continuous-glucose-ketone-monitoring-device-in-people-with-type-1-diabetes-100591223","NCT06977633","Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes","A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM","Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes for at least 1 year without significant endogenous insulin production\n* Currently using insulin pump\n* Understanding and willingness to follow the protocol and sign informed consent.\n* Willingness to sign a consent for release of medical information at the time of enrollment\n* Ability to speak, read and write in the language of the investigators.\n\nExclusion Criteria:\n\n* History of DKA or severe hypoglycemia within the past 6 months\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2 or other significant renal impairment\n* Pregnancy or breastfeeding\n* Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors\n* Active skin infections or conditions affecting sensor application sites\n* Known skin allergies to tapes or adhesives\n* Current use of any long-acting insulin analogs\n* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol",{"count":533,"type":22},[63],"The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School. The CGM-CKM device will be applied to the upper arm area of patients and baseline ketone and glucose measurement will be performed for one hour prior to suspending or disconnecting the pump. Upon baseline measurement, the pump will be disconnected for 3 hours while the electrochemical signals are collected from the CGM-CKM device. During the 3 hours of pump disconnection, blood samples will be collected every 5 minutes from participants for analyzing their insulin and glucagon using conventional ELISA kits and glucose and ketone using standard meters.",[28],"2026-04-29",{"date":547,"type":41},"2026-05-05",{"date":126,"type":22},{"date":550,"type":22},"2027-09-30",{"name":552,"class":48},"Mahla Poudineh",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":576},"100623843","evaluation-of-the-safety-and-effectiveness-of-the-novel-medtronic-experimental-automated-insulin-delivery-system-nmx8-in-adults-living-with-type-1-diabetes-100623843","NCT07401901","Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes","ELEVATE","Inclusion Criteria:\n\n1. Is aged ≥ 18 years old at time of screening.\n2. Has a clinical diagnosis of Type 1 diabetes for ≥6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.\n3. Is on commercially approved AID therapy (e.g. MiniMed 780G, Control IQ, OmniPod 5, CamAPS FX) for at least 3 months before screening.\n4. Has a glycosylated hemoglobin (HbA1c) above ≥7.5 % (59 mmol\u002Fmol), therefore is not achieving therapy goal, at time of screening visit (as processed by a Central Lab).\n5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units.\n6. Has shown good compliance (≥70%) with sensor wear over the previous month prior to enrollment (based on sensor usage from the download summary report over the 30 days prior to enrollment).\n7. Is willing to switch to an approved insulin per insulin pump labeling.\n8. Is willing to participate in all training sessions as directed by study staff.\n9. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol.\n10. Subject is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.\n2. Is using any anti-diabetic medication other than insulin at the time of the screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists\u002Fmimetics, metformin, SGLT2 inhibitors).\n3. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take chronically any oral, injectable, or IV glucocorticoids during the course of the study.\n4. Has had renal failure defined by creatinine clearance \\\u003C30 ml\u002Fmin, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.\n5. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n6. Has active or severe retinopathy in the last 6 months before the screening.\n7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.\n8. Has a positive pregnancy test at screening or plan to become pregnant during the course of the study or is breast feeding at the time of the enrollment.\n\n   Note: Different effective contraception methods may be used such as contraceptive pills, condoms, intra-uterine device, patches, rings, or long-active reversible contraceptive methods, as per routine practice.\n9. History of 2 or more DKA events in the last 3 months before screening.\n10. Is on \"DIY\" therapy at the time of the screening or at least 3 months before the screening.\n11. Is planning to change AID therapy during the course of the study. Note: subjects randomized in the Control Arm should remain on their current therapy during the course of the study.\n12. Is actively participating in an investigational study (drug or device) wherein he\u002Fshe has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.\n13. Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.\n14. Is part of the research staff involved with the study.\n15. Is legally incompetent, illiterate or vulnerable person.",{"count":561,"type":22},230,[63],"The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.",[28],[566],"Automated insulin delivery (AID); Diabetes","2026-04-27",{"date":569,"type":41},"2026-04-28",{"date":571,"type":22},"2026-10-15",{"date":573,"type":22},"2028-03-29",{"name":575,"class":339},"Medtronic MiniMed, Inc.",21,{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":611},"100388202","kidney-precision-medicine-project-100388202","NCT04334707","Kidney Precision Medicine Project","KPMP","Chronic Kidney Disease Subjects Inclusion Criteria Diabetic kidney disease (DKD)\n\n* Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria:\n\n  o Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year\n\n  o Fasting blood sugar greater than or equal to 126 mg\u002FdL, confirmed with a repeat test within the past year\n  * Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)\n  * International Classification of Diseases (ICD) 9\u002F10 diagnostic code for diabetes\n* Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding people with acute medical illnesses and changing kidney function:\n\n  * Estimated glomerular filtration rate 30-59 mL\u002Fmin\u002F1.73m2 or\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine albumin excretion greater than or equal to 30 mg\u002Fg creatinine (or mg\u002Fday) or\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine protein excretion greater than or equal to 150 mg\u002Fg creatinine (or mg\u002Fday)\n\n    * Most recent eGFR must be within the past year and be ≥30 mL\u002Fmin\u002F1.73m\\^2.\n\nHypertension-associated Chronic Kidney Disease (H-CKD)\n\n* Diagnosis of hypertension (HTN) established by at least one of the following criteria:\n\n  * BP greater than 140\u002F90 mmHg measured on three occasions over at least 1 month\n  * Taking antihypertensive medication for blood pressure (BP) control\n  * International Classification of Diseases (ICD) 9\u002F10 diagnostic code for hypertension\n* Evidence of persistent kidney damage, manifested as any of the following present on at least two assessments at least 3 months apart and excluding people with acute medical illnesses and changing kidney function: Estimated glomerular filtration rate 30-59 mL\u002Fmin\u002F1.73m2 on two assessments at least 3 months apart with albuminuria less than or equal to 2000 mg\u002Fg creatinine (or mg\u002Fday), or proteinuria less than or equal to 3000 mg\u002Fg creatinine (or mg\u002Fday), or ≤1+ proteinuria on urinalysis, or\n\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine albumin excretion 30-2000 mg\u002Fg creatinine (or mg\u002Fday) or\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine protein excretion 150-3000 mg\u002Fg creatinine (or mg\u002Fday)\n* Most recent eGFR must be within the past year and be ≥30 mL\u002Fmin\u002F1.73m2\n\nAcute Kidney Injury Inclusion Criteria Baseline estimated glomerular filtration rate greater than 45 mL\u002Fmin\u002F1.73m2. Baseline defined by the median of the last three outpatient serum creatinine measurements from day 7 to 365 prior to enrollment.\n\n* If only two measurements are obtained within this window, the two results will be averaged.\n* If only one measurement was obtained within this window, this result will be used\n* If baseline is missing, the potential participant can be enrolled with an estimated baseline, but only if there is no past medical history of chronic kidney disease.\n* If the AKI RS PI believes that the baseline serum creatinine under or over-estimates baseline, a unanimous vote of AKI site PIs can confirm eligibility based on a review of deidentified serum creatinine values provided by the site PI.\n\nAND ONE of the following criteria must be met:\n\n* Drop in urine output (\\\u003C500 ml\u002F24 hours)\n* Any rise in serum creatinine ≥0.3 mg\u002Fdl over the baseline serum creatinine\n* A rise in serum creatinine \\>0.1 mg\u002Fdl in a patient with high risk of AKI and at least one of the following:\n* Positive kidney injury urine biomarker, as defined by any of the following:\n\n  ▪ NGAL level greater than or equal to 150 ng\u002FmL by ELISA or clinical analyzer\n  * KIM1 level greater than or equal to 2.8 ng\u002FmL by ELISA\n  * TIMP2 x IGFBP7 greater than or equal to 2.0 by NephroCheck®\n* Urine microscopy suggestive of acute tubular necrosis defined as a urine microscopy score of greater than or equal to 2. \\[25\\] ▪ greater than or equal to 1 Renal Tubular Epithelial cells (RTE) per high powered field (HPF) AND greater than or equal to 1 granular cast\u002F low powered field (LPF); or\n\n  * greater than or equal to 5 Renal Tubular Epithelial cells (RTE) per high powered field (HPF); or\n  * greater than or equal to 5 granular cast\u002F low powered field (LPF)\n\nType 1 Diabetes Inclusion Criteria Clinical diagnosis of T1D without evidence of other diabetes types (monogenic, secondary to pancreas disease, etc.), reviewed and approved by KPMP site endocrinologist, and supported by at least one of the following: One or more positive antibodies associated with T1D • Low C-peptide, defined as at least one of the following:\n\n* Prior\u002Fhistorical test undetectable (below lower limit of assay)\n* C peptide \\\u003C0.6 ng\u002Fml if estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin per 1.73m2 and use of multiple daily insulin injections or insulin pump use for \\>1 year\n* C peptide \\\u003C2.0 ng\u002Fml if eGFR \\\u003C60 mL\u002Fmin per 1.73m2\n\nand use of multiple daily insulin\n\ninjections or insulin pump use for \\>1 year\n\n• Diabetes mellitus diagnosis for 5 years and complex insulin defined by multiple daily insulin injections ( 3 or more) or basal insulin injection plus inhaled insulin for meals or insulin pump therapy \\> 1 year continuously\n\nAND one of the following (CKD, at risk of CKD, or DM-R):\n\n* CKD: Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding people with acute medical illnesses and changing kidney function: o eGFR 30-59 mL\u002Fmin per 1.73m2 or\n\n  o eGFR greater than or equal to 30 mL\u002Fmin per 1.73m2 with urine albumin excretion greater than or equal to 30 mg\u002Fg creatinine (or mg\u002Fday)\n  * eGFR greater than or equal to 30 mL\u002Fmin per 1.73m2 with urine protein excretion greater than or equal to 150 mg\u002Fg creatinine (or mg\u002Fday)\n  * Note: Most recent eGFR must be within the past year and be ≥30 mL\u002Fmin per 1.73m2 .\n  * Note: Most recent urine albumin\u002Fcreatinine or urine protein\u002Fcreatinine must be within the past year.\n* At risk of CKD: defined by any one or more of the following:\n\n  * Age \\\u003C40 years and eGFR 60-75 mL\u002Fmin per 1.73m2\n\n(persistent eGFR \\\u003C75 mL\u002Fmin per 1.73m2\n\n* at least 3 months apart and including the most recent measurement prior to screening, but not persistently \\\u003C60 mL\u002Fmin per 1.73m2 )\n\n  o eGFR slope \\\u003C-5 mL\u002Fmin\u002F1.73m2 per year, calculated using all available outpatient serum creatinine values over ≥3 years prior to screening, excluding those obtained during acute illness, and including ≥1 creatinine measurement ≥3 years prior to screening\n\n  o HbA1c ≥8% on 2 occasions and T1D duration ≥5 years\n\n  o Hypertension as defined by KPMP protocol (for hypertension and CKD cohort)\n\n  o UACR ≥10 mg\u002Fg (twice, at least 3 months apart)\n  * BMI ≥30 kg\u002Fm2 with dyslipidemia (defined as triglycerides (TG) ≥150 mg\u002FdL, high-density lipoprotein (HDL) \\\u003C40\u002F50 mg\u002FdL for men\u002Fwomen, or TG\u002FHDL ratio \\>3) or lipid lowering treatment\n  * sTNFR1 \\>870 pg\u002FmL\n\n    * DM-R: defined by all of the following:\n  * T1D for over 25 years\n  * Estimated glomerular filtration rate greater than or equal to 60 mL\u002Fmin per 1.73m2\n  * Urine albumin excretion less than 30 mg\u002Fg creatinine (or mg\u002Fday)\n\nDM-R Inclusion Criteria A special population of people with long-standing type 1 diabetes (\\>25 years) who remain free of clinically-evident DKD (i.e. DKD \"resilient\" or \"DM-R\" individuals) will also be included. Study of the DKD resilient population using KPMP protocols offers a unique opportunity to identify protective factors against complications of diabetes mellitus. Diabetic Kidney Disease Resilient individuals are defined as individuals with diabetes for more than 25 years that are free from clinical nephropathy\n\n* Type 1 diabetes for over 25 years\n* Estimated glomerular filtration rate greater than or equal to 60 mL\u002Fmin\u002F1.73m2\n* Urine albumin excretion less than 30 mg\u002Fd (or mg\u002Fg creatinine)\n\nGeneral Exclusion Criteria\n\n* Under 18 years of age\n* Severe allergy to iodinated contrast\n* Pregnancy\n* Transplant recipient (includes solid transplant and bone marrow)\n* Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)\n* Inability to provide informed consent\n* Clinical diagnosis of kidney disease from an autoimmune disease, dysproteinemia, viral disease or glomerular disease other than DKD or H-CKD\n* Unwilling to receive blood transfusion (if needed)\n\nSafety Exclusion Criteria:\n\nPotential participants will be excluded if the risk of kidney biopsy is considered too high by either the clinicians caring for the potential participant or the investigators at the RS.\n\nAnatomic or Imaging Exclusion Criteria Kidney depth more than 13 cm (percutaneous biopsies only)\n\n* Kidney size less than 8 cm (percutaneous biopsies only)\n* Solitary or single functioning kidney\n* Evidence of urinary tract obstruction or hydronephrosis\n* Multiple bilateral kidney cysts that will interfere with the safe performance of the biopsy\n* Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney (percutaneous biopsies only)\n* Any other imaging abnormality, which in the judgement of the operator, prevents biopsy being performed safely.\n\nBleeding Risk Exclusion Criteria\n\n* International Normalized Ratios (INR) greater than 1.4\n* Platelet count less than 100,000\u002FuL\n* Hemoglobin less than 8.5 g\u002FdL\n* Chronic anticoagulation\n* Inability to withdraw aspirin, clopidogrel, cilostazol, or similar anti-platelet agents for at least 7 days prior to biopsy (unless bleeding time is normal before open surgical biopsy); clinical judgement will be used in the case of nonsteroidal anti-inflammatory drugs (NSAID) exposure occurring less than 7 days before percutaneous biopsy.\n* Blood pressure of more than 160 mmHg systolic or 100 mmHg diastolic.\n\n  ○ Peri-procedure blood pressure fluctuations between 140-160 mmHg systolic and 90-100 mmHg diastolic require management, ideally to target, based on clinician\u002Finvestigator judgment.\n* Ventilator-dependent patient (does not apply to open biopsies)\n* Hypotension or pressor support requirement (does not apply to open biopsies)\n* Any other condition where in the judgement of the operator, biopsy cannot be performed safely.",{"count":585,"type":22},1000,"Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD.\n\nDespite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by:\n\nNon-predictive animal models The inability to identify and prioritize human targets The limited availability of human kidney biopsy tissue A poor understanding of AKI and CKD heterogeneity Historically, AKI and CKD have been described as single, uniform diseases. However, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs).\n\nAccess to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD.\n\nA number of research centers across the United States are collaborating to bring state-of-the-art technologies together to:\n\n* Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD\n* Define disease subgroups\n* Create a kidney tissue atlas\n* Identify critical cells, pathways, and targets for novel therapies\n\nThe KPMP is made up of three distinct, but highly interactive, activity groups:\n\n* Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy.\n* Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue.\n* Central Hub: The central hub is responsible for aggregating, analyzing, and visualizing the generated data and providing scientific, infrastructure, and administrative support for the KPMP consortium.",[588,589,590,591,592,593,594,595,596,597,598,599,600,601,28],"Acute Kidney Failure","Acute Kidney Insufficiency","Acute Renal Failure","Acute Renal Injury","Acute Renal Insufficiency","Kidney Failure, Acute","Kidney Insufficiency, Acute","Renal Failure, Acute","Renal Insufficiency, Acute","Chronic Kidney Diseases","Chronic Kidney Insufficiency","Chronic Renal Diseases","Chronic Renal Insufficiency","Kidney Insufficiency, Chronic","2026-04-09",{"date":604,"type":41},"2026-04-14",{"date":606,"type":41},"2019-09-01",{"date":608,"type":22},"2027-06-30",{"name":610,"class":48},"Icahn School of Medicine at Mount Sinai",13,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":226,"sex":17,"minAge":4,"maxAge":620,"enrollmentInfo":621,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":107},"100578729","capillary-ogtt-study-100578729","NCT06815081","Capillary OGTT Study","A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test","CapOGTT","Inclusion criteria:\n\nCohort 1\n\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n* Undergoing an OGTT, or consent to have one\n\nCohort 2\n\n* Positive for two or more islet autoantibodies at any time\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n\nCGM sub-study\n\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n* Confirmed to have stage 1, 2 or 3 T1D\n* Participation in Cohort 1\n\nQualitative sub-study\n\n* Willing and able to give informed consent for participation, or assent with parental consent Then EITHER\n* A young person positive for two or more islet autoantibodies (15 years old and above) at any time, or parent of a young person who has experienced a metabolic test e.g. OGTT OR\n* A healthcare professional involved in delivering metabolic testing\n\nCohort 3\n\n* Prediabetes diagnosis as above\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n\nExclusion Criteria:\n\nCohort 1\n\n* Any known haemoglobinopathy\n* Cystic fibrosis related diabetes\n* Non-English speaker\n\nCohort 2\n\n* Any known haemoglobinopathy\n* Known clinical diabetes and on treatment\n* Non-English speaker\n* No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement\n\nCGM sub-study\n\n* Any known haemoglobinopathy\n* Cystic fibrosis related diabetes\n* Non-English speaker\n* Any active skin issue which would prevent the use of a CGM device\n\nQualitative sub-study\n\n• Non-English speaker\n\nCohort 3\n\n* Known clinical diabetes and on treatment\n* Non-English speaker\n* No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement","17 Years",{"count":622,"type":22},135,"Type 1 diabetes (T1D) is a chronic condition, affecting 1 in 490 children under the age of 15 years. It is caused by the immune system damaging the pancreas, the organ which makes insulin. T1D has recognised stages before symptoms develop, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms.\n\nType 2 diabetes (T2D) is also a chronic condition where the body cannot make enough insulin, or cannot respond to the insulin properly. It is usually related to obesity, rather than an immune problem. It is more common in adults, but the early stages often start in childhood (up to 1 in 4 children in some clinics). Like T1D, early detection can delay onset of T2D, or even prevent it altogether.\n\nEarly diagnosis of T1D or T2D often relies on a test called the oral glucose tolerance test (OGTT), which is commonly used but not well tolerated, possibly because it requires a drip inserted into the vein, and several blood samples taken over 2-3 hours in a healthcare setting.\n\nOur study aims to test whether we can do an OGTT using a finger-prick to test glucose, at home. We call this the 'GTT@home'. The finger-prick creates a drop of blood, which is done before and two hours after drinking a sugary drink. We will also explore whether a continuous glucose monitor (CGM), which reads glucose levels through the skin could be an alternative. We plan to recruit 90 children and young people, across two groups to assess the GTT@home.\n\nTo understand the experiences of those involved in monitoring, we will invite young people, parents and healthcare workers to take part in an interview, to understand the impact of testing to predict clinical T1D.\n\nGroup 1 will assess the accuracy of measuring glucose from a finger-prick blood test when compared to a blood test from the vein. We will recruit individuals who are having an OGTT as part of a research study, for clinical care or if they have agreed to have an OGTT for this study. Those with T1D will be invited to wear a CGM to explore its use as an additional, practical alternative.\n\nGroups 2 and 3 will assess how well the GTT@home test works when done at home and how acceptable it is. This will only be offered to those known to be at risk of T1D.\n\nThese studies will help us to understand if the GTT@home can be used in routine care.",[28,285],[626,627,628,629,630,631,632,633,634,635,636],"Capillary","Glucose","Oral glucose tolerance test","Method Comparison","Feasibility","Acceptability","Type 1 diabetes","Monitoring","Follow-up","Screening","Type 2 diabetes","2026-04-07",{"date":639,"type":41},"2026-04-13",{"date":641,"type":41},"2024-02-29",{"date":643,"type":22},"2027-08-31",{"name":645,"class":48},"University of Oxford",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":656,"conditions":657,"keywords":661,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":683},"100631644","standardized-italian-network-enrolling-individuals-with-islet-autoantibodies-100631644","NCT07503366","Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies","Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)","SIRENA","Inclusion Criteria:\n\n* Individuals of any age who test positive for at least one islet autoantibody.\n* Absence of clinical symptoms of diabetes.\n* Do not meet ADA diagnostic criteria for diabetes (no overt hyperglycemia).\n* Ability to comply with follow-up procedures according to clinical practice.\n* Written informed consent obtained from the participant or, for minors, from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Prior diagnosis of type 1 or type 2 diabetes.\n* Fasting plasma glucose ≥126 mg\u002FdL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg\u002FdL.\n* Presence of symptoms suggestive of diabetes (e.g., polyuria, polydipsia, unexplained weight loss, fatigue, visual disturbances, acetone breath, Kussmaul respiration).\n* Any medical or psychological condition judged by the investigator to interfere with study participation or data reliability.\n* Inability or unwillingness to provide informed consent.",{"count":655,"type":22},300,"This project characterizes the longitudinal progression of children and adults who have tested positive for one or more islet cell autoantibodies across the early stages of type 1 diabetes (T1D). Despite advances in screening, limited evidence exists on how clinical, metabolic, and immunological markers evolve over time and predict progression to symptomatic disease. Using a screened cohort, participants are followed for up to 10 years with repeated standardized assessments. The study evaluates whether population-based screening can reduce diabetic ketoacidosis (DKA) at diagnosis and identify early predictors of progression to clinical T1D. Results are expected to improve risk stratification, inform surveillance strategies, and guide the timing of preventive interventions, with implications for clinical practice and health policy.",[28,658,659,660],"Autoantibodies","Hyperglycemia","Impaired Glucose Tolerance (Prediabetes)",[662,658,663,32,659,664,665,666,496,667,668,669,670,671,672,673],"Diabetes Mellitus, Type 1","Islets of Langerhans","Impaired Glucose Tolerance","C-Peptide","Oral Glucose Tolerance Test","Psychological Stress","Early Diagnosis","Disease Progression","Presymptomatic Type 1 Diabetes","Type 1 Diabetes Stage 1","Type 1 Diabetes Stage 2","Type 1 Diabetes Stage 3","2026-04-02",{"date":676,"type":41},"2026-04-08",{"date":678,"type":22},"2026-05",{"date":680,"type":22},"2036-04",{"name":682,"class":48},"Società Italiana di Endocrinologia e Diabetologia Pediatrica",24,{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":691,"enrollmentInfo":692,"targetDuration":4,"studyType":23,"phases":694,"briefSummary":695,"conditions":696,"keywords":698,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":703,"completionDateStruct":704,"leadSponsor":706,"locationsCount":4},"100630857","phase-1-study-of-imc-s118ai-in-type-1-diabetes-100630857","NCT07493122","Study of IMC-S118AI in Type 1 Diabetes","A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes","Inclusion Criteria:\n\n* Body mass index (BMI): 18 to 25 kg\u002Fm2\n* History of a diagnosis of T1D\n* HLA type: HLA-A\\*02:01\n* Shows signs of remaining beta-cell function\n\nExclusion Criteria:\n\n* Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)\n* History of recurrent hypoglycaemia due to non-compliance with insulin regimens\n* Prior treatment with immunomodulating therapy for T1D\n* Have a history of cardiovascular disease or impaired cardiac function\n* Current diagnosis of a malignancy or any history of malignancy","45 Years",{"count":693,"type":22},154,[324],"This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens. This study will potentially also explore the effects of multiple-dosing regimens on preservation of beta-cell function in Stage 3 Type 1 diabetes.",[403,28,697],"Diabetes Type 1",[302,699],"type 1","2026-03-19",{"date":702,"type":41},"2026-03-25",{"date":505,"type":22},{"date":705,"type":22},"2030-11",{"name":707,"class":339},"Immunocore Ltd"]