App-Based Certified Diabetes Education Therapy (AB-CDE)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Oregon Health and Science University
- Study ID
- NCT07282639
- Status
- Recruiting
Conditions
- Type 1 Diabetes (T1D)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- DailyDose — DEVICEOur 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 .
Study Details
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.
Key Dates
- First listed
- Dec 15, 2025
- Start date
- Jul 8, 2026
- Status verified
- Sep 2026
- Primary completion
- Jul 15, 2027
- Completion
- Dec 15, 2027
Study Design
- Enrollment
- 99 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention GroupAB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated
- No Intervention: Control GroupUsual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.
Primary Outcome Measure
Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks [ Time Frame: Enrollment and 24 weeks after randomization ]
Central Contacts
- Linda Lester, MD503-418-8478
- Samrita Thapa, MPH503-494-8421
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90022 | Valerie Ruelas |
| Barbara Davis Center | Aurora | Colorado | 80045 | |
| Indiana University | Indianapolis | Indiana | 46202 | |
| Joslin Diabetes Center, Harvard School of Medicine | Boston | Massachusetts | 02215 | Christine Slyne |
| Mount Sinai School of Medicine | New York | New York | 10029 | Sarah Rancic Camilla Levister (SUB_INVESTIGATOR) |
| Oregon Health & Science University , Portland | Portland | Oregon | 97239 | Peter Jacobs, PhD (PRINCIPAL_INVESTIGATOR) |
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