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

NCT07282639 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 257912207
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Type 1 Diabetes (T1D)

Keywords

AB-CDE; DailyDose

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks after randomization

  Hemoglobin A1c will be processed by a central lab. Lower values generally indicate better glucose control.

  Enrollment and 24 weeks after randomization

Secondary Outcomes (29)

• Change in hemoglobin A1c (HbA1c) from baseline to 36 weeks after randomization

  Enrollment and 36 weeks after randomization.

• Change in percent of time in range (70-180 mg/dL) from baseline to 24 weeks after randomization

  Week 24 after randomization compared with baseline

• Change in percent of time in range (70-180 mg/dL) from baseline to 36 weeks after randomization

  Week 36 after randomization compared with baseline

• Change in percent of time in tight range (70-140 mg/dL) from baseline to 24 weeks after randomization

  Week 24 after randomization compared with baseline

• Change in percent of time in tight range (70-140 mg/dL) from baseline to 36 weeks after randomization

  Week 36 after randomization compared with baseline

Other Outcomes (6)

• Change in mean number of low glucose events / week from baseline to 24 weeks after randomization

  Week 24 after randomization compared with baseline

• Change in mean number of low glucose events / week from baseline to 36 weeks after randomization

  Week 36 after randomization compared with baseline

• Change in total daily dose of insulin (units) from baseline to 24 weeks

  Week 24 after randomization compared with baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated

Device: DailyDose

Control Group

NO INTERVENTION

Usual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.

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 .

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Age 18 years and older.
• Able to read, write and understand spoken English
• HbA1c or GMI 7.5- 11.5% at screening. GMI (%) = 3.31 + 0.02392 × \[mean glucose in mg/dL\] based on prior 30 days of CGM data with at least 70% time CGM active\[6\]
• Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit.
• Willing to use the approved study insulin and devices while on study - Humalog and Basaglar Tempo pens, Dexcom G6 CGM, study iPhone, Apple watch
• Willingness and ability to independently follow all study procedures, including attending all clinic and DSMES and behavioral health visits.
• Total daily insulin requirements of less than 200 units

You may not qualify if:

• Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence.
• History of stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty.
• Renal insufficiency (GFR \< 60 ml/min, using either MDRD\*\* or CKD-EPI# equation as reported by the laboratory).
• Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• History of severe hypoglycemia during the 3 months prior to screening or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
• History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.
• History of psychiatric admission during the 6 months prior to screening.
• Adrenal insufficiency.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Uncontrolled seizure disorder.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Major surgical operation within 30 days prior to screening.
• Use of an investigational drug within 30 days prior to screening.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Leona M. & Harry B. Helmsley Charitable Trust: collaborator

Study Sites (6)

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of Southern California

Los Angeles, California, 90022, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Joslin Diabetes Center, Harvard School of Medicine

Boston, Massachusetts, 02215, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Oregon Health & Science University , Portland

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Leah Wilson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Wilson, MD

CONTACT

503-494-3273; wilsolea@ohsu.edu

Samrita Thapa

CONTACT

503-494-8421; thapasa@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)