Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia
      which can lead to severe acute and chronic complications. The burden and complexity of
      managing T1D results in the majority of people not reaching adequate glycemic control. Our
      team has developed a smartphone based application, DailyDose, that combines continuous
      glucose monitoring data and insulin data to provide decision support for subjects with type 1
      diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time
      dosing recommendations for insulin doses prior to meals and to correct hyperglycemia.
      DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on
      insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose
      will make weekly recommendations to change basal insulin. For subject safety, study
      investigators will set constraints on settings for short and long acting insulin during the
      onboarding process. DailyDose will not be able to recommend insulin dose changes above or
      below the set safety thresholds. DailyDose also provides recommendations on carbohydrate
      intake for exercise and includes hypoglycemia and hyperglycemia alarms.
    

Detailed description: 
      Subjects will be on study for 10 weeks. Subjects will begin the study with a training visit
      on the Dexcom G6 CGM system and the InPen and Clipsulin smart insulin pens. Subjects will use
      these devices for the next 14 days at home. Subjects will return to OHSU at the end of the 14
      days for a training on using the DailyDose system. Subjects will then return home to use the
      DailyDose system for 8 weeks. Sensor glucose, exercise, insulin and meal data will be
      collected during the DailyDose portion of the study in order to produce recommendations for
      insulin dosing. Subjects will receive up to 4 recommendations every 7 days. Subjects will
      also receive recommendations for exercise based on the PEAK exercise guidelines.

      Subjects will wear the Dexcom G6 and an Apple Watch physical activity monitor for the entire
      study. Insulin data will be collected using the InPen for aspart insulin and Clipsulin for
      the long acting insulin. Subjects will complete a 30 minute aerobic exercise video at home
      once per week. Subjects will also be asked to complete two additional exercise sessions on
      their own at home, one aerobic session and the other whatever type of exercise they would
      normally do (aerobic, resistance etc.). Subjects will use the bolus calculator within the
      DailyDose app. Subjects will be instructed to test capillary blood glucose (CBG) after
      exercise, for symptoms of hypoglycemia or hypoglycemia alerts and again 15 minutes after
      rescue carbohydrate treatment until CBG >70 mg/dl.
    

Intervention name(s): DailyDose Decision Support
Intervention type(s): Device
Intervention description(s): DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment