Digital Exercise for Type 1 Diabetes

Overseen By Garrett Ash, PhD, NSCA-CSCS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Insulin

Disqualifiers: Severe hypoglycemia, High A1c, Hypertension, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently.

Eligibility Criteria

This trial is for adults with Type 1 Diabetes or similar conditions where the body doesn't produce insulin. Participants should be interested in increasing their exercise and willing to use a mobile app that tracks blood sugar, activity, mood, and sleep.

Inclusion Criteria

I've been using an insulin pump or pen and sharing the data for over 6 weeks.

Less than 1.0 exercise sessions per week

Smartphone ownership

Exclusion Criteria

I have an irregular heartbeat that is not under control.

More than 1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months

A1c greater than or equal to 10.0%

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a free Garmin smartwatch and a program membership providing exercise coaching and personalized feedback

20 weeks

Periodic interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Digital Exercise

Trial Overview The study tests a new mobile app designed to help people with Type 1 Diabetes exercise more by providing personalized motivation and insights based on their health data. It aims to see if this technology can improve exercise habits.

Participant Groups

Group I: Exercise program Experimental Treatment 1 Intervention

Participants will receive a free Garmin smartwatch and a free program membership providing exercise coaching + personalized feedback about the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar.

Group II: Self-Monitoring Active Control 1 Intervention

Wear a fitness watch and keep daily health diary

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+