Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDreaMed Diabetes
About this trial
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
Qualifiers
Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent
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
Age at time of consent 18-80 years
HbA1c >7.5% and <12% as measured by point-of-care device or local lab at the time of screening
Disqualifiers
Use of an insulin pump within 3 months prior to informed consent
Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening
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
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)
Trial design
Treatments tested in this trial
- MODI Algorithm
Treatment groups
102 Participants
are divided into 1 treatment groupSponsors and collaborators
DreaMed Diabetes
Lead sponsor
Jaeb Center for Health Research
Collaborator
Abbott Diabetes Care
Collaborator
Source ClinicalTrials.gov