60 Participants Needed

Digital Exercise for Type 1 Diabetes

GA
Overseen ByGarrett Ash, PhD, NSCA-CSCS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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
See 6 more

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%
See 11 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise programExperimental Treatment1 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-MonitoringActive Control1 Intervention
Wear a fitness watch and keep daily health diary

Find a Clinic Near You

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+
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