[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-i-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-i-diabetes":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100634116","food-is-medicine-in-pediatric-patients-with-diabetes-100634116",false,"NCT07535502","Food is Medicine in Pediatric Patients With Diabetes","The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Current patients of the UMMMC Pediatric Endocrinology Clinic\n* Children and Adolescents less than or equal to 17 years of age at the time of enrollment\n* Diagnosed with Type 1 Diabetes at least 3 months ago\n* Public (MassHealth or Medicaid) Health Insurance\n\nExclusion Criteria:\n\n* Celiac disease or severe gluten allergy\n* Congenital, genetic, or chronic comorbidities\n* DCF Custody\n* Pregnant women\n* Prisoners\n* Non-English speaking subjects","ALL","5 Years","17 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.",[27,28,29],"Type I Diabetes","Pediatrics","Food Insecurity",[31,27,28,29,32,33],"Food is Medicine","Continuous Glucose Monitoring","Medically-tailored Meals","NOT_YET_RECRUITING","2026-04-14",{"date":37,"type":38},"2026-04-17","ACTUAL",{"date":40,"type":21},"2026-05-20",{"date":42,"type":21},"2029-12-31",{"name":44,"class":45},"University of Massachusetts, Worcester","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100590182","phase-2-pharmacokinetic-and-early-efficacy-of-opt101-in-patients-with-type-1-diabetes-mellitus-100590182","NCT06964087","Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus","A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n* 1\\. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).\n\n  2\\. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).\n\n  3\\. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4. Diagnosis of T1DM within the last 20 years for Part A, within 1 to 10 years \\[N=15 at \\>5 to 10, N=12 at 1 to 5 yrs\\] for Part B, within less than or equal to 1 year for Part C.\n\n  5\\. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).\n\n  6\\. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.\n\n  7\\. Women of childbearing potential (WOCBP) must have a negative highly sensitive serum test (beta- human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.\n\n  8\\. WOCBP must agree to use one of the following methods of birth control for the duration of the clinical trial: Systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.\n\nExclusion Criteria:\n\n* 1\\. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.\n\n  2\\. Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia.\n\n  3\\. Has chronic kidney disease of Stage 2 or higher with eGFR of \\\u003C90 mL\u002Fmin\u002F1.73m2.\n\n  4\\. Is currently receiving an immuno-modulatory treatment. 5. Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following:\n  1. Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.\n  2. Patients with recent immobilization or recent surgery.\n  3. Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome.\n\n     6\\. Has an active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus, cytomegalovirus, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii pneumonia, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer.\n\n     7\\. Has recent or active hepatitis A infection, current\u002Fchronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection, defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody \\[anti-HBs\\] or vaccination \\[defined as negative HBsAg, negative anti-HBc, and positive anti-HBs\\] are eligible to participate.\n\n     8\\. Has a history of latent or active tuberculosis. 9. Has received a live attenuated vaccine within the last 60 days including patients who plan to receive live attenuated vaccines during the study or within 60 days after the final dose of study treatment.\n\n     10\\. Patients with the following should be excluded:\n\n  \u003C!-- -->\n\n  1. Abnormal coagulation test at screening: prothrombin time (PT; \\>14 sec), activated partial thromboplastin time (aPTT; \\>32 sec) or fibrinogen level (\\\u003C190 or \\>450 mg\u002FdL).\n  2. Abnormal liver function tests (except in the case of known Gilbert's syndrome):\n\n  i. AST or ALT ≥3x ULN and total bilirubin ≥2x ULN ii. AST or ALT ≥5x ULN iii. Abnormal platelet counts (\\\u003C150 or \\> 450 x10 to the third\u002FuL) iv. Abnormal white blood cell counts (\\\u003C 3.0 or \\>11.0 x10 to the third\u002FuL ) v. Abnormal eGFR (\\\u003C 90 mL\u002Fmin) vi. Abnormal Factor VIII (\\\u003C50% or \\>150% of normal) vii. Abnormal D-Dimer (\\> 500 ng\u002FmL of fibrinogen equivalent units (FEU)) 11. Patients planning to undergo elective procedures or surgeries at any time after signing the ICF through the follow-up visit.\n\n  12\\. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.\n\n  13\\. Recent history of bleeding or bleeding disorders or any condition whereby in the opinion of the treating investigator giving anti-coagulation during treatment would be contraindicated.\n\n  14\\. History of hypersensitivity to antihistamines. 15. Body mass index \\\u003C20 or \\>35 kg\u002FM2 16. Patients with active drug or alcohol abuse within one year prior to screening or patients who test positive for required drug testing during screening (refer to §8.4).\n\n  17\\. Patient is participating in a clinical trial of another investigational drug or device, including patients who have participated in another study for duration of 5 half-lives of the investigational agent.\n\n  18\\. Patient is a prisoner. 19. Patients with any medical condition, including, but not limited to, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or a psychiatric condition that, in the opinion of the Investigator, could compromise their ability to participate in this study.","18 Years","50 Years",{"count":57,"type":21},72,[59],"PHASE2","This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.",[27],"RECRUITING","2026-04-02",{"date":65,"type":38},"2026-04-06",{"date":67,"type":21},"2026-04-10",{"date":69,"type":21},"2028-08-19",{"name":71,"class":72},"Op-T LLC","INDUSTRY",5,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100572941","clinical-evaluation-of-the-medtronic-implantable-insulin-pump-system-miips-2020-in-adult-subjects-with-type-1-diabetes-cip347-100572941","NCT06739811","Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)","Phoenix: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes","Phoenix CIP347","Inclusion Criteria:\n\n1. Subject is aged ≥ 18 years old.\n2. Subject has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior to screening as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.\n3. Subject with type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), presenting with frequent, otherwise unexplained severe hyper-and\u002For hypoglycaemia.\n4. Subject has access to a reliable support person, defined as an individual who has daily contact with the subject and knows who to contact in the event of an emergency (i.e., caregiver).\n5. Subject has the physical and intellectual ability (in the opinion of the study investigator) to operate the MIIP system and to comply with the data reporting requirements of the study.\n6. Subject is willing and able to sign and date informed consent, comply with all study procedures as required during the study.\n\nExclusion Criteria:\n\n1. Subject is actively participating in an investigational study (drug or device) wherein he\u002Fshe has received treatment from an investigational study drug or device before enrollment into this study, that could impact the outcomes of this study; as per investigator and sponsor judgment.\n2. Subject has any other disease or condition that may increase risks during the implant procedure or may preclude the subject from participating in the study, as determined by a physician who is not the principal investigator.\n3. Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician.\n4. Subject is a woman who is pregnant, of childbearing potential or lactating, and who is neither surgically sterile nor using contraceptives (devices, oral, implanted or other physician-approved contraceptive) at the time of enrollment.\n5. Subject is vulnerable, legally incompetent or illiterate.\n6. Residence or planned non-pressurized travel at elevations above 10000 feet\u002F3048 meters (commercial airline travel is acceptable).\n7. Planning to engage in activities requiring a descent greater than or equal to 10 feet\u002F3 meters below sea level.\n8. Subject has an active infection requiring antibiotic treatment.\n9. Subject is a person whose body size is not sufficient to accept implantable pump bulk and weight.\n10. Subject has a life expectancy of less than 9 months.\n11. Subject has diagnosis of illicit drugs abuse disorder.\n12. Subject has diagnosis of marijuana abuse disorder.\n13. Subject has diagnosis of prescription drugs abuse disorder.\n14. Subject has diagnosis of alcohol abuse disorder.\n15. Subject who is unwilling or unable to monitor their glucose level or wear a personal continuous glucose monitor.\n16. Subject who is unwilling or unable to make programming modifications to the pump based on glucose level readings.",{"count":83,"type":21},40,[24],"The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), and presenting with frequent, otherwise unexplained severe hyper- and\u002For hypoglycemia.",[27],"2026-03-20",{"date":89,"type":38},"2026-03-23",{"date":91,"type":38},"2025-03-21",{"date":93,"type":21},"2026-12",{"name":95,"class":72},"Medtronic MiniMed, Inc.",6]