Clinical trial Recruiting at 1 site Interventional Ages 30 to 65

Help adults with type 1 diabetes build and keep regular exercise habits

Official title: 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

Run by Yale University · NCT06967701 · Data updated 2026-11-12

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

Study typeInterventional
Ages30 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorYale University
Academic / other
Locations1 site (New Haven, Connecticut)
StatusRecruiting
StartedJuly 10, 2025
Main results expectedOctober 2027
Study endsOctober 2027
Registry record updatedJuly 22, 2026
Trial IDNCT06967701 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Differentiating heart disease in autoimmune vs. type 2 diabetes

    This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.

    Recruiting University of Roma La Sapienza · Rome, Roma · NCT07911007

  • Benefits of Retained Insulin for Good Health in Diabetes

    This study tests whether preserving or restoring a person’s own insulin production can improve quality of life and blood sugar control for people who need insulin to manage diabetes.

    Recruiting at 4 sites Royal Devon and Exeter NHS Foundation Trust · Truro, Cornwall and 3 other locations · NCT07828626

  • Short-stay aggressive hydration to prevent post-ERCP pancreatitis

    This trial tests whether a short, high-volume IV hydration with Lactated Ringer's plus a rectal indomethacin can prevent post-ERCP pancreatitis in adults undergoing ERCP.

    Recruiting Westmead Hospital · Westmead, New South Wales · NCT07776561

  • Intermittent CGM Use in high-risk children and teens with Type 1 Diabetes in the Dominican Republic

    This study tests whether using the Dexcom G7 intermittently, along with pediatric care and support, can improve glucose control in 10–19 year-olds with high-risk Type 1 Diabetes in the Dominican Republic.

    Recruiting at 3 sites Life for a Child Program, Diabetes Australia · Santiago de los Caballeros and 2 other locations · NCT07742306

  • AI-assisted remote insulin pump optimization for people with type 1 diabetes

    This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.

    Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07732777

  • AMX0035 in adults with Type 1 Diabetes

    This study tests whether 24 weeks of the oral medication AMX0035 help improves metabolic health in adults with Type 1 Diabetes compared with a placebo.

    Recruiting Phase 2 University of Washington · Seattle, Washington and 1 other locations · NCT07699380

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.