Help adults with type 1 diabetes build and keep regular exercise habits
Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Pilot Efficacy Study
This project will try a smartphone app plus personalized coaching, fitness-watch data, and continuous glucose monitoring insights to help adults with type 1 diabetes exercise more often and more confidently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06967701 on ClinicalTrials.gov |
What this trial studies
This remote study will deliver a mobile application that combines personalized encouragement, health coaching, and data-driven feedback from continuous glucose monitors, activity trackers, mood, and sleep patterns to promote regular exercise. Participants who are 30–65 years old with insulin-deficient diabetes and currently exercise less than once per week will use the app and wearable devices while sharing device data with the research team. The intervention emphasizes self-monitoring and tailored messages to support safe, frequent activity and better glucose management around exercise. All study activities are conducted remotely, with no required in-person visits to the coordinating site at Yale School of Medicine.
Who should consider this trial
Good fit: Ideal candidates are adults 30–65 with type 1 diabetes (or LADA/diabetes after pancreatitis) who currently do fewer than one exercise session per week, own a smartphone and home internet or cell service, are English-literate, are under regular medical care, and already use and share CGM and insulin-device data with their medical record.
Not a fit: People with recent severe hypoglycemia or diabetic ketoacidosis, very high A1c (≥10%), recent heart attack/angina, uncontrolled high blood pressure, or those not using/able to share CGM or insulin-device data may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could help adults with insulin-deficient diabetes increase how often they exercise and improve confidence managing blood sugar around activity.
How similar studies have performed: Related programs combining CGM data, wearables, and digital coaching have shown promise for short-term behavior change, but sustained habit formation using this exact integrated, remote approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 30-65 years old inclusive * Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis) * Less than 1.0 exercise sessions per week * Smartphone ownership * English literacy * Under regular care by a healthcare provider (1+ appointments per year) * Home Broadband wireless Internet or cell phone network * Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks * Using insulin pump or pen and sharing data with medical record for at least 6 weeks Exclusion criteria: * Diabetic ketoacidosis not clearly related to pump site failure in past 6 months * \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months * A1c ≥10.0% * Resting blood pressure \>160mmHg systolic or \>100 mmHg diastolic. * Myocardial infarction or angina in past 12 months * Uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, ventricular tachycardia, escape rhythms) * Congestive heart failure (stage 3 or 4) * Exercise-induced asthma (not controlled on inhalers) * Chronic obstructive pulmonary disease (requiring home oxygen) * Renal failure * Pregnancy * Cognitive impairment * Severe retinopathy or neuropathy. * Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)
Where this trial is running
New Haven, Connecticut
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Garrett Ash, PhD, CSCS — Yale University
- Study coordinator: Yashvi Verma, BS
- Email: activity@yale.edu
- Phone: 203-444-0678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.