RecruitingType 1 Diabetes (T1D)Type 2 Diabetes (T2D)
Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
Eligible age
18–80 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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).
Sponsor: DreaMed Diabetes
You may qualify if…
- ✓ 1. Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent
- ✓ 2. Insulin therapy as follows:
- ✓ 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
- ✓ 1 basal insulin injection per day for at least 1 week prior to screening
- ✓ 2. If T2D, either:
- ✓ 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
- ✓ (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
- ✓ 3. Age at time of consent 18-80 years
You may not qualify if…
- ✕ 1. Use of an insulin pump within 3 months prior to informed consent
- ✕ 2. Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening
- ✕ 3. 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
- ✕ 4. 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/or eating disorders (i.e. anorexia/bulimia)
- ✕ 5. 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
- ✕ 6. Any planned surgery during the study which could be considered major in the judgment of the investigator
- ✕ 7. History of more than 1 severe hypoglycemic event in the 6 months prior to screening
- ✕ 8. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening
Where it's recruiting
Source: ClinicalTrials.gov · NCT07599982 · last updated 2026-06-03