Recruiting

Mobile App

Sponsor:

Yale University

Code:

NCT06967701

Conditions

Type 1 Diabetes (T1D)

Latent Autoimmune Diabetes in Adult (LADA)

Pancreatitis

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

Exercise program

Self-monitoring

Study Details

Brief summary:

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 remote participation-based 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. You do not need to live in Connecticut to participate, as there will be no required in-person visits during the study.

Conditions

Type 1 Diabetes (T1D)

Latent Autoimmune Diabetes in Adult (LADA)

Pancreatitis

Study ID

NCT06967701

Start date

Jul 10, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Self-Monitoring

Wear a fitness watch and keep daily health diary

experimental: Exercise program

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.

Interventions

Exercise program

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.

Self-monitoring

Wear a fitness watch and keep daily health diary

Primary outcome measure

  • Weekly exercise duration [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Yashvi Verma, BS

203-444-0678activity@yale.edu

Garrett Ash, PhD, CSCS

203-444-3079garrett.ash@yale.edu

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Garrett Ash, PhD, NSCA-CSCS

203-444-3079garrett.ash@yale.edu

Principal Investigator:

Garrett Ash, PhD, NSCA-CSCS

More Information

Sponsor

Yale University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • exercise
  • physical activity
  • mobile phone
  • health coaching
  • fitness watch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-22.