Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
DreaMed Diabetes
Summary
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).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 t…
Interventions
- DeviceMODI Algorithm
All participants use MODI insulin titration algorithm. Includes Diary app used to view treatment plans shared by MODI and manually log events (insulin intake, meal, physical activity and others) by participants; also includes a bolus calculator.
Locations (3)
- SUNY Upstate Medical CenterAlbany, New York
- Texas Diabetes & EndocrinologyAustin, Texas
- Diabetes & Endocrine Treatment Specialisits (DETS)Sandy City, Utah