[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-2-diabetes-treated-with-insulin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-2-diabetes-treated-with-insulin":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,72,103,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100500375","the-caring-study-creating-and-restoring-health-through-nutrition-guidance-100500375",false,"NCT05795439","The CARING Study: Creating and Restoring Health Through Nutrition Guidance","Inclusion Criteria:\n\n1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months\n2. Male or female\n3. Age at least 18 years\n4. Have a diagnosis of type 2 diabetes\n5. Ability and willingness to participate in all components of the study, including:\n\n   1. Following a plant-based diet for the initial 16 weeks of the study;\n   2. Attending weekly online classes for the initial 16 weeks of the study; and\n   3. Keeping physical activity level consistent throughout the initial 16 weeks of the study.\n\nExclusion Criteria:\n\n1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome\n2. Smoking during the past six months\n3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use\n4. Current or unresolved past drug abuse\n5. Recently gave birth, pregnant, or plans to become pregnant before or during the study period\n6. Unstable medical or psychiatric status\n7. Cancer diagnosis\n8. Chronic kidney disease, stage 4 or 5\n9. Evidence of an eating disorder\n10. Lack of English fluency\n11. Bariatric surgery in the last 6 months\n12. Dementia\n13. Institutional custodial care\n14. End of life\n15. Palliative Care\n16. Actively engaged in specific BCBSM diabetes programs and case management programs",true,"ALL","18 Years",{"count":19,"type":20},700,"ESTIMATED","INTERVENTIONAL",[23],"NA","The CARING study assesses the health benefits of nutrition education for Blue Cross Blue Shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.",[26,27],"Type2diabetes","Type 2 Diabetes Treated With Insulin",[29,30,31,32],"Diabetes","Type2","Insulin","A1C","RECRUITING","2026-04-06",{"date":36,"type":37},"2026-04-13","ACTUAL",{"date":39,"type":37},"2023-07-11",{"date":41,"type":20},"2028-12",{"name":43,"class":44},"Physicians Committee for Responsible Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100560611","closed-loop-in-adults-with-type-2-diabetes-100560611","NCT06579404","Closed-loop in Adults With Type 2 Diabetes","An Open-label, Multinational, Multicentre, Randomised, Single-period Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes","COYOTE","Inclusion Criteria:\n\n* Aged 18 years and older\n* Type 2 diabetes diagnosed for at least 12 months\n* Established on an SGLT2 inhibitor and\u002For GLP-1 receptor agonist for at least 3 months, or have been offered these therapies previously.\n* Treatment with insulin therapy for at least 6 months\n* HbA1c ≤ 15% (140 mmol\u002Fmol) analysis from local laboratory or equivalent\n* Willing to wear study devices and follow study instructions\n* Capacity to consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Current use of insulin pump\n* Current use of any closed-loop system\n* Any physical\u002Fpsychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician\n* Known or suspected allergy against insulin\n* Medically documented allergy towards the adhesive\n* Pregnancy, planned pregnancy, or breast feeding\n* Severe visual impairment\n* Severe hearing impairment\n* Medically documented allergy towards the adhesive (glue) of plasters\n* Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor\n* Illicit drugs abuse\n* Prescription drugs abuse\n* Alcohol abuse",{"count":55,"type":20},224,[23],"The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes.\n\nThis is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices.\n\nThe primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol\u002FL) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \\& closed-loop usage, questionnaires and semi-structured interviews.",[27],[60,61],"Closed-loop insulin delivery","Type 2 diabetes","2026-03-10",{"date":64,"type":37},"2026-03-13",{"date":66,"type":37},"2024-12-06",{"date":68,"type":20},"2027-07",{"name":70,"class":44},"University of Cambridge",12,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"100530324","the-intelligent-diabetes-telemonitoring-using-decision-support-to-treat-patients-on-insulin-therapy-100530324","NCT06185296","The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy","The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial","DiaTRUST","Inclusion Criteria:\n\n* Adults ≥ 18 years.\n* Diagnosis of T2D for at least 12 months prior to the day of screening.\n* Patients who are being treated with insulin or about to start insulin treatment (insulin naïve) willing to travel to trial site in North Denmark to attend in-person visits.\n* Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial\n* Signed informed consent.\n* Ability to understand and read Danish.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Major surgery is planned during the trial period.\n* Cancer diagnosis within five years prior to inclusion.\n* Participation in other interventional trials.\n* Limited literacy affecting the use of trial devices.\n* Patient who has worn a CGM monitor less than 6 months prior to the trial.\n* Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate.\n* Patients treated with mixed insulin.",{"count":81,"type":20},51,[23],"The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for three months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.",[27],[29,31,86,87,88,89,90,91,92,93],"Telemedicine","Telehealth","Telemonitoring","CGM","Wearable devices","Adherence","Decision support","Algorithms","2026-02-05",{"date":96,"type":37},"2026-02-09",{"date":98,"type":37},"2025-11-15",{"date":100,"type":20},"2026-09",{"name":102,"class":44},"Aalborg University Hospital",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":45},"100597817","patient-centered-multi-agent-decision-support-system-pcm-dss-for-healthcare-providers-100597817","NCT07063420","Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers","Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study","TREAT2D","Inclusion Criteria:\n\n1. Age ≥18.0 years old at time of consent.\n2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months.\n3. Hemoglobin A1c (HbA1c) ≥ 7.0%.\n4. Currently using an approved long-acting insulin for at least 3 months (e.g., insulin glargine, insulin degludec).\n5. Treated or about to be treated with multi-drug therapies for T2D.\n6. If using a CGM, willingness to wear an additional study CGM during the duration of the study.\n7. Access to the internet and willingness to upload data during the study as needed.\n8. If female and sexually active, 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 females who self-report that they are 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.\n\nExclusion Criteria:\n\n1. Currently using rapid insulin for at least three months (e.g., insulin aspart, insulin lispro, insulin regular).\n2. Currently being treated for a seizure disorder.\n3. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:\n\n   1. Seizure disease\n   2. Decompensated cardiac disease\n4. Inpatient psychiatric treatment in the past 6 months\n5. Presence of a known adrenal disorder\n6. Currently pregnant or intent to become pregnant during the trial.\n7. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.",{"count":112,"type":20},18,[23],"Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).",[27],[117,118,119],"Patient Centered Multi-Agent Decision Support System (PCM-DSS)","Continuous Glucose Monitor (CGM)","Insulin pen","2025-11-10",{"date":122,"type":37},"2025-11-13",{"date":124,"type":37},"2025-10-28",{"date":126,"type":20},"2026-07-31",{"name":128,"class":44},"Daniel Chernavvsky, MD",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":45},"100463660","continuous-glucose-monitor-use-in-pregnancy-100463660","NCT05317585","Continuous Glucose Monitor Use in Pregnancy","Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:\n\n* 1\\) age greater than or equal to 18 years old\n* 2\\) singleton gestation less than or equal to 14 weeks at initial obstetric visit\n* 3\\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg\u002FdL, or fasting plasma glucose ≥126 mg\u002FdL\n* 4\\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC\n* 5\\) able and willing to provide informed consent\n\nExclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:\n\n* 1\\) known diagnosis of type 1 diabetes or gestational diabetes\n* 2\\) plan to receive prenatal care or delivery outside of UMMHC\n* 3\\) inability to provide informed consent\n* 4\\) multifetal gestation","FEMALE",{"count":138,"type":20},180,[23],"The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.",[27,142],"Pregnancy, High Risk",[61,144],"Pregnancy","2025-09-29",{"date":147,"type":37},"2025-10-01",{"date":149,"type":37},"2024-05-23",{"date":151,"type":20},"2027-07-01",{"name":153,"class":44},"University of Massachusetts, Worcester"]