Evaluation of the DailyDose Smartphone App for Diabetes Education and Management in People with Type 1 Diabetes Using Multiple Daily Insulin Injections

What This Trial Is About

Researchers are evaluating an investigational smartphone app called DailyDose, designed to help people living with type 1 diabetes T1D who use multiple daily insulin injections MDI. DailyDose aims to improve diabetes management by analyzing continuous glucose monitoring CGM data, insulin use, and exercise to provide personalized insulin dosing and carbohydrate intake recommendations. The study focuses on assessing changes in blood sugar control, particularly through hemoglobin A1c HbA1c levels. Participants will be involved in the study for a total of 38 weeks, starting with a 2-week run-in period where they will be trained to use the Dexcom G6 CGM system, an insulin dose capture system with Novalog InPens, and DailyDose in data-logging mode. Following this, they will use the DailyDose system actively for 12 weeks, including weekly aerobic exercise sessions at home. Based on glucose control during this period, some participants will receive additional diabetes self-management education and support DSMES and behavioral health counseling for 12 weeks. All participants will then continue using DailyDose alone for a final 12 weeks to assess sustained effects. Throughout the study, participants will wear the Dexcom G6 CGM continuously and use the insulin dose capture system. The study team will collect data on glucose levels, exercise, insulin doses, and meals to generate personalized recommendations. A variety of measures will be used to evaluate changes in blood sugar control, time spent in target glucose ranges, and diabetes distress. Participants will attend training and counseling visits as needed, and study devices like an iPhone and Apple Watch will be provided to support data collection and monitoring.

App-Based Certified Diabetes Education Therapy (AB-CDE)