Safety Evaluation of MODI, an Insulin Titration Algorithm, i... | Clinical Trial | StuddyBuddy@endsection Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
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Recruiting NCT07599982

Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes

Conditions: Type 1 Diabetes (T1D), Type 2 Diabetes (T2D)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: DreaMed Diabetes

Location: SUNY Upstate Medical Center Albany New York

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 Criteria

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 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 4. HbA1c \>7.5% and \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07599982). StuddyBuddy aggregates publicly available trial information.