Digital Exercise for Type 1 Diabetes

Overseen By Garrett Ash, PhD, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with type 1 diabetes exercise more regularly and confidently by using a mobile app that provides personalized support and insights. Participants will either track their health using a fitness watch and diary or receive a Garmin smartwatch with exercise coaching and feedback on how their lifestyle affects their blood sugar. The trial seeks individuals diagnosed with type 1 diabetes or similar conditions who exercise less than once a week and use a continuous glucose monitor and insulin pump. Participants should own a smartphone and have internet access.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management through technology.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the focus is on exercise and monitoring blood sugar.

What prior data suggests that this mobile application is safe for people with type 1 diabetes?

Research has shown that using smartwatches for diabetes care is generally safe and easy. Studies suggest that smartwatches, such as the Garmin model used in this trial, can help people with type 1 diabetes monitor exercise and manage blood sugar levels safely. These devices provide information to help adjust insulin doses and reduce the risk of low blood sugar (hypoglycemia).

The available research has not reported any major side effects. However, more studies are needed to fully understand the long-term effects of this technology on health. Participants in similar studies have not reported any major safety concerns when using smartwatches for health tracking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Exercise program for Type 1 Diabetes because it combines technology with personalized coaching to help patients better understand the interactions between their insulin, diet, exercise, sleep, and blood sugar levels. Unlike standard treatments, which often focus on insulin management and carbohydrate counting alone, this program provides real-time feedback using a Garmin smartwatch, empowering patients to make informed lifestyle choices. By integrating digital tools and personalized insights, the program aims to enhance self-management and potentially improve overall health outcomes for those living with Type 1 Diabetes.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

Research has shown that exercise can significantly help people with type 1 diabetes manage their blood sugar levels. One study found that after exercising, participants maintained their blood sugar within a healthy range more frequently. Another study demonstrated that using insulin pumps and sensors during exercise improved blood sugar control over time. In this trial, participants in the "Exercise program" arm will receive a free Garmin smartwatch and a program membership, which provides exercise coaching and personalized feedback on the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar. Digital tools like exercise apps and smartwatches can also boost motivation and help individuals maintain their exercise routines, leading to better overall health and increased confidence in managing diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Garrett Ash, PhD, CSCS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12451840/

Physical Activity Is Associated With Improved Glycemic ... In the 24 h following physical activity as compared with sedentary days, TIR improved, TAR was lower, and TBR remained within clinical target recommendations.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0168822724007848

Findings from the type 1 diabetes exercise initiative (T1DEXI) AID systems have resulted in improved glucose outcomes when evaluated under free-living conditions with a typical reduction in HbA1c of between 2.2–5.5 mmol/mol ...

3. mdpi.com mdpi.com/2813-2084/4/3/32

Virtual Reality Versus Conventional Exercise in Patients ... For instance, VR-based exercise intervention programs can improve exercise outcomes by increasing motivation, engagement, and accessibility and potentially ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12159555/

An Exergames Program for Adolescents With Type 1 ... Improving compliance with exercise in adolescents with insulin-dependent diabetes mellitus: results of a self-motivated home exercise program.

5. pediatrics.jmir.org pediatrics.jmir.org/2024/1/e57198/PDF

Digital Gaming and Exercise Among Youth With Type 1 ... To date, the association between digital games and daily physical activity minutes among youth with T1D has received no attention. The Type 1 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11629918/

The Role of Smartwatch Technology in the Provision of Care ... This systematic review aims to explore the literature for evidence of smartwatch technology in type 1, 2, and gestational diabetes.

7. nature.com nature.com/articles/s41597-025-05695-1

A Longitudinal Multimodal Dataset of Type 1 Diabetes Activity data collection. Participant activity data was collected using the Garmin Forerunner 45 smartwatch. A custom API was developed for ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589750023001127

Articles Integrating metabolic expenditure information from ... AIDs can integrate exercise data from smartwatches to inform insulin dosing and limit hypoglycaemia while improving glucose outcomes.

9. eresearch.qmu.ac.uk eresearch.qmu.ac.uk/bitstreams/215ab9af-7537-4da1-8f80-8b8b64e85fd4/download

The Role of Smartwatch Technology in the Provision ... Further research is required to establish the role of integrated smartwatch technology in important outcomes such as glycemic control, exercise.

10. dl.acm.org dl.acm.org/doi/full/10.1145/3706598.3713247

Integrating Technology into Self-Management Ecosystems To understand the role that a smartwatch could play in T1D management and how to integrate new technology into existing self-management ...