Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
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).
• Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent
• Insulin therapy as follows:
∙ 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
‣ 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
• 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
• Using only injected insulin types that are specified in the MODI Instructions for Use materials
• 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
• 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
• Weight between 80 - 440 lb at the time of screening
• 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
⁃ Willing to document insulin delivery, meals, and daily activities in the Diary mobile app
⁃ 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.
⁃ Is deemed an appropriate candidate for automatic insulin guidance therapy per Investigator assessment
⁃ 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
⁃ Has a sufficient understanding of written/spoken English for legally effective informed consent and successful use of the study mobile apps
⁃ If woman of childbearing potential, is willing and able to have pregnancy testing