RecruitingNot ApplicableNCT06967701

Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

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


Sponsor

Yale University

Enrollment

60 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Inclusion Criteria9

  • 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 Criteria14

  • 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)

Interventions

BEHAVIORALExercise 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.

BEHAVIORALSelf-monitoring

Wear a fitness watch and keep daily health diary


Locations(1)

Yale School of Medicine

New Haven, Connecticut, United States

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NCT06967701


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