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

Part of paid clinical trials in La Jolla, California.

Sponsor
Oregon Health and Science University
Study ID
NCT07282639
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DailyDose — DEVICE
    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 .

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

Start date
Jan 15, 2026
Status verified
Dec 2025
Primary completion
May 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated
  • No Intervention: Control Group
    Usual 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 after randomization [ Time Frame: Enrollment and 24 weeks after randomization ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Jeremy Pettus, MD
858-246-2169
University of Southern CaliforniaLos AngelesCalifornia90022-
Barbara Davis CenterAuroraColorado80045
Halis Akturk, MD
303-724-0467
Emma Mason
303-724-5895
Joslin Diabetes Center, Harvard School of MedicineBostonMassachusetts02215
Joslin Toschi, MD
617-309-2440
Christine Slyne
Mount Sinai School of MedicineNew YorkNew York10029
Carol Levy, MD
212-241-0068
Shaziah Hassan
Oregon Health & Science University , PortlandPortlandOregon97239
Leah Wilson, MD
503-494-3273
Peter Jacobs, PhD (PRINCIPAL_INVESTIGATOR)

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