NCT07282639

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

Development and Evaluation of App-Based Certified Diabetes Education (AB-CDE) Therapy for People Living With T1D Using MDI

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for insulin dosing and carbohydrate intake during exercise or low blood sugar events. We want to find out if DailyDose can help lower blood sugar levels as measured by the hemoglobin A1c (HbA1c) test.

Detailed description

Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention/control). Participants will begin the study with a training visit on the Dexcom G6 CGM system, the insulin dose capture system, and the Data-logging Mode of DailyDose. Participants will be provided with Humalog and Basaglar Tempo pens for use with the insulin dose capture system. Participants will also receive an iPhone and Apple smart watch for acquiring sleep metrics and exercise data. Participants will use these devices during the next 14 days at home (2-week run-in). At the end of the run-in, participants will be randomized to the intervention or control group. The intervention group will be trained at Visit 3 on using the DailyDose system. Participants will then use the DailyDose system for 12 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. Participants will wear the Dexcom G6 for the entire study. Insulin data will be collected using the insulin dose capture system (Tempo pens and Tempo button). Participants will be instructed to use the bolus calculator within the DailyDose app. Participants will be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period. After 12 weeks, time in range (70-180 mg/dL, TIR) and time in hypoglycemia (\<70 mg/dL) will be assessed from the prior 4 weeks based on the Dexcom G6. Participants that have TIR ≥ 60% and time in hypoglycemia \<4% will continue with use of DailyDose. Those that have TIR \< 60% and/or time in hypoglycemia ≥ 4% will receive DSMES and, if recommended, behavioral health based on the T1-Diabetes Distress Assessment System (T1-DDAS) for the next 12 weeks. Additionally, if the DSMES provider feels the participant would benefit from behavioral health intervention, they can refer the participant for this even if T1-DDAS scores do not meet the cut off. All participants will then be followed for a final 12-week period using DailyDose alone to assess sustainability of any improvements in glycemic outcomes. Participants in the control group will use the Dexcom G6 CGM, the insulin dose capture system (Tempo pens and Tempo button), and the Data-logging Mode of DailyDose for the entire study. They will also be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period.

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
DEVICE	DailyDose	Our team has developed a smartphone-based application, DailyDose Decision Support Tool (DailyDose), that combines continuous glucose monitoring data and insulin data to provide decision support for people living with T1D taking MDI. DailyDose is an iPhone application that is designed to support this population by 1) allowing for bolus calculation based on inputs including carbohydrate intake, CGM value and trend, and exercise information, 2) providing recommendations for carbohydrate intake based on exercise type, intensity, and duration, and 3) providing weekly recommendations for adjustments in insulin doses at specific times of day, including basal insulin dose, carbohydrate ratios or fixed mealtime doses, and correction factors .

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-05-15
• Completion: 2027-12-15
• First posted: 2025-12-15
• Last updated: 2025-12-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study