NCT04428645

Assessment of a Decision Support Tool in Participants With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	DailyDose Decision Support	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.

Timeline

• Start date: 2020-07-21
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2020-06-11
• Last updated: 2022-07-19
• Results posted: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study