[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-insulin-requiring-type-1-or-type-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-insulin-requiring-type-1-or-type-2":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,79,100,128,155,179,204],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100645041","minimed-fit-payload-wear-pediatric-study-100645041",false,"NCT07675161","MiniMed Fit Payload Wear Pediatric Study","CIP361: MiniMed Fit Payload Wear Pediatric Study","Inclusion Criteria:\n\n* Participants with insulin-requiring diabetes\n* Participants 7-17 years of age\n* Participant and parent\u002Fguardian\u002Flegally authorized representative are able and willing to sign informed consent\u002Fassent\n\nExclusion Criteria:\n\n* Participants who report known skin sensitivity or allergy to polycarbonate or pressure-sensitive adhesives, e.g., medical device adhesives, band-aids, other acrylic-containing adhesives.\n* Participants with any skin condition in the area where device placement (e.g., irritation, rash, infection) could occur, per participant report.\n* Participants who are pregnant (per self-report) at initial screening. If a participant becomes pregnant during the study, the site will follow procedures for study withdrawal.","ALL","7 Years","17 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.",[25,26,27,28],"Diabetes (DM)","Diabetes (Insulin-requiring, Type 1 or Type 2)","Diabetes in Children","Diabetes in Adolescence","NOT_YET_RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":21},"2026-07",{"date":37,"type":21},"2026-12",{"name":39,"class":40},"Medtronic MiniMed, Inc.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"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":51,"type":21},144,"INTERVENTIONAL",[54],"NA","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.",[57,25,26,58,59,60,61],"Insulin Dependent Diabetes","Diabetes Education","Diabetes Care","Type 1 Diabetes (T1D)","Type 2 Diabetes Mellitus (T2DM)",[63,64,65,66,67,58],"Continuous Glucose Monitor","Diabetes","Insulin Dependent","Older Adults (65 years and older)","CGM","2026-06-23",{"date":70,"type":33},"2026-06-26",{"date":72,"type":21},"2026-06",{"date":74,"type":21},"2028-06",{"name":76,"class":77},"University of North Carolina, Chapel Hill","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100637211","study-on-influencing-factors-of-skin-complications-related-to-insulin-injection-in-children-with-type-1-diabetes-mellitus-100637211","NCT07615803","Study on Influencing Factors of Skin Complications Related to Insulin Injection in Children With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n* Patient meets the diagnostic criteria for T1DM recommended by WHO and is diagnosed with T1DM.\n* Patient was diagnosed with T1DM for \\>= 6 months.\n* Patient has no cognitive or awareness disorders and has the ability to read.\n* Patient agrees to participate in this study.\n* Patient's family caregiver has a certain level of comprehension ability, is conscious and clear-minded during the survey, and can answer freely.\n* Patient's family caregiver voluntarily participates in the survey.\n* Patient's family caregiver provides an average daily care time for the child of \\>= 6 hours.\n\nExclusion Criteria:\n\n* Patient has acute or chronic complications of diabetes and is unable to cooperate, requiring urgent treatment.\n* Patient is in a state of disease stress, such as acute infection, surgery, trauma, etc., and is difficult to cooperate with the research.\n* Patient's family caregiver has unconsciousness or abnormal mental state.\n* Patient's family caregiver has hearing or language disorders.\n* Patient or patient's family caregiver has already participated in this survey.",true,{"count":87,"type":21},199,"This study was a cross-sectional, observational design without involving random grouping or intervention. From July 2026 to June 2027, 199 children with type 1 diabetes who had received insulin treatment for at least 6 months and their main family caregivers were recruited by a continuous enrollment method from the endocrinology department of a tertiary children's hospital in Zhejiang Province. Qualified investigators conducted on-site distribution and collection of structured questionnaires, collecting general information of the children, the occurrence of skin complications, and the insulin injection behaviors of the caregivers. At the same time, personnel with ultrasound qualifications used a wireless handheld ultrasound combined with a skin lipid caliper to uniformly measure the subcutaneous fat thickness at 8 sites including the abdomen, buttocks, arms, and thighs.",[26,90],"Skin Abnormalities","2026-05-28",{"date":93,"type":33},"2026-05-29",{"date":95,"type":21},"2026-12-01",{"date":97,"type":21},"2027-12-01",{"name":99,"class":77},"The Children's Hospital of Zhejiang University School of Medicine",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":52,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":78},"100637848","evaluate-the-performance-of-the-dexcom-g7-continuous-glucose-monitoring-cgm-system-in-critically-ill-patients-undergoing-major-abdominal-surgery-and-solid-organ-transplantation-which-require-blood-glucose-monitoring-for-intensive-insulin-therapy-100637848","NCT07611721","Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.","Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU","DREAM-ICU","Inclusion Criteria:\n\n* Age 18 years or over\n* Intensive care unit admission\n* Requiring blood glucose monitoring for insulin therapy\n\nExclusion Criteria:\n\n* High-dose ascorbic acid or acetaminophen \\> 4g\u002Fday\n* Physical or mental health condition precluding continuous wear of the continuous glucose monitor, as judged by the physician","18 Years",{"count":110,"type":21},62,[54],"Main objective:\n\nThe goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit.\n\nOn admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position.\n\nSensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels.\n\nSensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose.\n\nPatients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows.\n\nCalibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter.\n\nCalibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol\u002FL).\n\nCalibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol\u002FL) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol\u002FL).\n\nHypothesis:\n\n* Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors.\n* Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%).\n\nFurther objectives:\n\nTo evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety.\n\nTo identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.",[67,114,115,116,117,26],"Intensive Care (ICU)","Liver Transplant Surgery","Solid Organ Transplantation","Major Abdominal Surgeries","RECRUITING","2026-05-20",{"date":91,"type":33},{"date":122,"type":33},"2026-01-14",{"date":124,"type":21},"2027-04",{"name":126,"class":127},"Institute for Clinical and Experimental Medicine","OTHER_GOV",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":135,"minAge":108,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":52,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100625310","pilot-study-of-intrapartum-insulin-pump-100625310","NCT07420972","Pilot Study of Intrapartum Insulin Pump","Pilot Study of Intrapartum Insulin Pump Use: Feasibility, Efficacy and Safety","Inclusion Criteria:\n\n* Singleton gestation\n* Established Type 1 or 2 diabetes mellitus\n* Use of continuous subcutaneous insulin infusion for ≥2 months prior to delivery, -Demonstrated cognitive ability to self-manage insulin, familiarity with pump technology, availability of necessary supplies, stable clinical status\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Planned cesarean delivery without labor\n* Significant comorbidities affecting insulin requirements (e.g., steroid therapy)\n* Stillbirth prior to presenting for delivery\n* Known severe fetal anomalies.","FEMALE",{"count":137,"type":21},30,[54],"People with type 1 or type 2 diabetes often use insulin pumps to manage their blood sugar during pregnancy. These pumps can help keep blood sugar in a healthy range. However, when people come to the hospital to give birth, they are often asked to stop using their insulin pump and switch to insulin given through an IV. This change can be stressful and may make blood sugar harder to control during labor. There is not enough research to know if it is safe and practical for people to keep using their insulin pump while in labor.\n\nThe goal of this study is to learn whether it is safe, practical, and acceptable for pregnant people with diabetes to continue using their insulin pump during labor. The study will also look at how this approach compares to standard care, which uses IV insulin.\n\nThis is a small pilot study. About 30 pregnant people with type 1 or type 2 diabetes will take part. All participants already use an insulin pump and receive care through the MedStar Diabetes in Pregnancy Program. Participants will be allowed to continue using their own insulin pump during labor, following a hospital safety plan. Their outcomes will be compared to similar patients from the past who used IV insulin during labor.\n\nThe main focus of the study is to see how often people can safely stay on their insulin pump during labor and how well this approach fits into hospital care. The study will also collect information about blood sugar levels during labor and health outcomes for newborns, such as low blood sugar, breathing problems, or need for care in the neonatal intensive care unit. These outcomes are being studied to help plan future research.\n\nAfter delivery, participants will be asked to share their experience. This includes how satisfied they were with their diabetes care during labor, how much control they felt over their care, and how difficult or easy the treatment was to manage. Nurses and doctors will also provide feedback about caring for patients who use insulin pumps during labor.\n\nParticipants will continue to check their blood sugar using continuous glucose monitoring, with fingerstick checks when needed. If any safety concerns arise, such as blood sugar levels that are too high or too low, participants will switch to standard IV insulin.\n\nThis study is not meant to prove that one method is better than another. Instead, it will help researchers decide whether a larger study should be done in the future. The long-term goal is to improve diabetes care during labor and support safe, patient-centered options for people with diabetes and their babies.",[64,26,141],"Pregnancy",[143,64,144,145,141],"Insulin pump","Type 1 diabetes","Labor","2026-02-11",{"date":148,"type":33},"2026-02-19",{"date":150,"type":21},"2026-04",{"date":152,"type":21},"2028-04",{"name":154,"class":77},"Medstar Health Research Institute",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":52,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":78},"100623147","investigation-of-the-effectiveness-of-prophylactic-npwt-cinpwt-in-high-risk-diabetic-patients-with-acute-laparotomy-wounds-100623147","NCT07392853","Investigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds","Investigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds - A Randomized, Prospective Clinical Trial","Inclusion Criteria:a (all criteria must apply simultaneously):\n\n* Age ≥18 years,\n* Undergoing urgent abdominal surgery,\n* Diagnosis of diabetes mellitus either already present or newly diagnosed at admission\n* High SSI risk. We consider a patient to be at high SSI risk if the operating surgeon categorizes the patient as high risk, and the patient is classified in the III-IV cleanliness category with an open abdominal surgical procedure (laparotomy). \"High SSI risk\" may also be assessed individually based on existing severe risk factors or using an SSI risk calculator (patients with a normal laparotomy SSI risk more than 3 times the baseline are eligible).\n\nExclusion Criteria: (any of the following):\n\n* Pregnancy,\n* Disseminated cancer (irresectable distant metastasis, peritoneal carcinomatosis),\n* Life expectancy of less than 30 days,\n* Refusal to participate in the study.",{"count":163,"type":21},110,[54],"The aim of this study is to evaluate the effectiveness of prophylactic Negative Pressure Wound Therapy (NPWT) in patients with diabetes mellitus undergoing laparotomy who are at high risk for Surgical Site Infections (SSI). In addition to clinical efficacy, the investigators also plan a cost effectiveness analysis to assess the applicability of this relatively high-cost intervention in a domestic healthcare setting.",[26],[168,169],"abdominal surgery, SSI, diabetes, emergency surgery","ciNPWT","2026-01-30",{"date":172,"type":33},"2026-02-06",{"date":174,"type":21},"2026-02-22",{"date":176,"type":21},"2026-03-22",{"name":178,"class":77},"Semmelweis University",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":49,"enrollmentInfo":186,"targetDuration":4,"studyType":52,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100616374","evaluation-of-a-mobile-ai-powered-decision-support-system-for-insulin-dosing-and-glucose-prediction-in-type-1-diabetes-the-glucmodel-clinical-trial-protocol-100616374","NCT07304778","Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol","glUCModel-1","Inclusion Criteria:\n\n* HbA1c \\\u003C 9%\n* Currently following an MDI Bolus-Basal therapy.\n\n  * Wearing CGMs connected to a mobile phone.\n  * Spanish language proficiency.\n  * Willingness to participate in the trial.\n  * At least one year since the time of diabetes diagnosis.\n  * Ability to use a mobile application like glUCModel.\n  * Own a mobile phone running Android or iOS operating system.\n  * Ability to follow a Portion-controlled diet for diabetes.\n  * Educated to do an active management of insulin dosing\n\nExclusion Criteria:\n\n* HbA1c \\\u003C 9%.\n* Not wearing CGMs.\n* Non-Spanish language proficiency.\n* Less than one year since the time of diabetes diagnosis\n* Unable to use a mobile application like glUCModel\n* Unable to follow a Portion-controlled diet for diabetes\n* Unable to do an active management of insulin dosing.\n* Diagnosed with a significant psychiatric disorder.\n* Subjects in treatment with corticoids\n* Patients who have required hospitalization or surgery in the last six months.\n* Pregnancy or planning a pregnancy",{"count":187,"type":21},34,[54],"The goal of this clinical trial is to evaluate the safety and efficacy of integrating predictive models into insulin therapy management via the user-centered glUCModel mobile app in People with Type 1 Diabetes Mellitus following Multiple Insulin Dosing therapy. Participants will be aged 18 to 65 years. The main questions it aims to answer are:\n\nDoes using the app improve glycaemic control, as measured by time in range? Does using the app reduce the number of episodes of hyperglycaemia and hypoglycaemia? Are the app's design and functionality adequate?\n\nThe study will comprise four phases:ses}):\n\n* Screening phase: Informed consent, collection of sociodemographic and clinical data, and baseline Pittsburg, IFIS, and DTSQ questionnaires.\n* Run-in phase: 2 weeks of standard care with CGM. Data will be used to generate personalized predictive models in the intervention group.\n* Active treatment phase: Participants continue MDI therapy. The intervention group will additionally use the glUCModel mobile app. CGM data from the final 2 weeks will be analyzed.\n* Evaluation and analysis phase: Participants will complete the uMARS, Pittsburgh, and DTSQ questionnaires. Statistical analysis and correlations among outcomes will be processed.",[26],[64,192,193],"Bolus recomendation","Artificial Intelligence","2026-01-02",{"date":196,"type":33},"2026-01-06",{"date":198,"type":33},"2025-07-11",{"date":200,"type":21},"2026-06-01",{"name":202,"class":77},"Universidad Complutense de Madrid",2,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":52,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100610455","evaluation-of-the-safety-and-performance-of-the-novel-medtronic-experimental-automated-insulin-delivery-system-nmx8-in-people-living-with-diabetes-nexus-100610455","NCT07227805","Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)","Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes","NEXUS","Inclusion Criteria:\n\n1. Is aged ≥2 years old at time of screening.\n2. Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.\n3. Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.\n4. Has a glycosylated hemoglobin (HbA1c) \\\u003C11% (97 mmol\u002Fmol) at time of screening visit as processed at Point of Care (PoC) or local lab.\n5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units\n6. Willing to switch to approved insulin per insulin pump labeling.\n7. Investigator has confidence that the subject, parent(s)\u002Flegal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.\n8. Subject, Parent(s)\u002Flegal guardian(s) is willing to participate in all training sessions as directed by study staff.\n9. Subject, Parent(s)\u002Flegal guardian(s) is willing and able to provide written informed consent.\n10. For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists\u002Fmimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.\n11. For Israel only: Subject, Parents(s)\u002Flegal guardian(s) is fluent in English.\n\nExclusion Criteria:\n\n1. Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.\n2. For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before 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 any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement\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 active or severe retinopathy in the last 6 months before screening\n6. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.\n8. History of 2 or more DKA events in the last 3 months before screening.\n9. Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.\n10. Is using hydroxyurea at time of screening or plans to use it during the study\n11. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.\n12. Women who are breastfeeding.\n13. 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 screening, as per investigator judgment.\n14. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.\n15. Subject, Parent(s)\u002Flegal guardian(s) are part of research staff involved with the study.\n16. Subject, Parent(s)\u002Flegal guardian (s) are legally incompetent, illiterate, or vulnerable.","2 Years",{"count":214,"type":21},116,[54],"This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.",[26],"2025-11-11",{"date":220,"type":33},"2025-11-13",{"date":222,"type":21},"2026-06-15",{"date":224,"type":21},"2027-03-17",{"name":39,"class":40}]