[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-2-diabetes-t2d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-2-diabetes-t2d":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100640229","safety-evaluation-of-modi-an-insulin-titration-algorithm-in-adults-with-diabetes-100640229",false,"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","ALL","18 Years","80 Years",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).",[27,28],"Type 1 Diabetes (T1D)","Type 2 Diabetes (T2D)",[30,31,32,33,34,35,36,37],"type 1 diabetes","insulin","titration","algorithm","adults","continuous glucose monitoring","multiple daily injections","type 2 diabetes","RECRUITING","2026-06-01",{"date":41,"type":42},"2026-06-03","ACTUAL",{"date":44,"type":42},"2026-05-25",{"date":46,"type":21},"2027-01",{"name":48,"class":49},"DreaMed Diabetes","INDUSTRY",3,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100567699","phase-4-iglarlixi-cgm-study-in-chinese-t2d-individuals-after-oads-100567699","NCT06671587","iGlarLixi CGM Study in Chinese T2D Individuals After OADs","A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics","China Soli-CGM","Inclusion Criteria:\n\n* Participants who are diagnosed as T2D of at least 1 year before screening visit\n* Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD\n* Inadequate control\n* Body mass index (BMI) within the range 20-40 kg\u002Fm2 (inclusive)\n* Is willing and able to wear the CGM device continuously\n* Is willing to discontinue daily (oral) SU, glinide, alpha-GI, and DPP-4i\n* Not using another CGM device during the study\n\nExclusion Criteria:\n\n* Participants with severe renal dysfunction\n* Participants with short life expectancy\n* Participants with conditions\u002Fconcomitant diseases making them non evaluable for the efficacy endpoints\n* Participants with conditions\u002Fconcomitant diseases precluding their safe participation in this study\n* An episode of severe hypoglycemia requiring the assistance of a third party within 3 months before screening visit\n* History of clinically significant pancreatitis or severe gastrointestinal disorders\n* Participants who have any history of severe multiple allergies or an allergy resulting in anaphylaxis, or contraindication\u002Fhypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study\n* Previous treatment with insulin\n* Use of any glucose-lowering agents other than metformin alone or in combination with a second OAD (can be a SU, a glinide, an alpha-GI, a DPP-4i, or a SGLT-2i)\n* Use of systemic glucocorticoids\n* Use of weight loss drugs\n* History of discontinuation of a previous treatment with GLP-1 RA for safety\u002Ftolerability reasons or lack of efficacy\n* Laboratory findings at the screening visit\n* Participants have any current or previous skin conditions\n* Participants unwilling or unable to do blood glucose monitoring using the Sponsor-provided blood glucometer at home\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":60,"type":21},678,[62],"PHASE4","This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (\\\u003C8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).\n\nStudy details include:\n\n* The study duration per participant will be approximately up to 24 weeks.\n* The treatment duration will be up to 20 weeks.\n* The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1\u002F+3 days) after the last dose of the treatment.\n* Health measurement\u002FObservation: change in TIR as the primary endpoint\n* Intervention name: iGlarLixi and Gla-100\n* Participant gender: male and female\n* Participant age range: adults at least 18 years of age\n* Condition\u002Fdisease: type 2 diabetes\n* Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.",[28],[66,67],"Glucagon-like peptide-1 receptor agonist (GLP-1 RA)","FRC (fixed ration combination)","2026-03-13",{"date":70,"type":42},"2026-03-17",{"date":72,"type":42},"2024-12-10",{"date":74,"type":21},"2026-09-18",{"name":76,"class":49},"Sanofi",1]