RECRUITING

Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-07-10
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06967701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 30-65 years old inclusive
  2. * Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
  3. * Less than 1.0 exercise sessions per week
  4. * Smartphone ownership
  5. * English literacy
  6. * Under regular care by a healthcare provider (1+ appointments per year)
  7. * Home Broadband wireless Internet or cell phone network
  8. * Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks
  9. * Using insulin pump or pen and sharing data with medical record for at least 6 weeks
  1. * Diabetic ketoacidosis not clearly related to pump site failure in past 6 months
  2. * \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months
  3. * A1c ≥10.0%
  4. * Resting blood pressure \>160mmHg systolic or \>100 mmHg diastolic.
  5. * Myocardial infarction or angina in past 12 months
  6. * Uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, ventricular tachycardia, escape rhythms)
  7. * Congestive heart failure (stage 3 or 4)
  8. * Exercise-induced asthma (not controlled on inhalers)
  9. * Chronic obstructive pulmonary disease (requiring home oxygen)
  10. * Renal failure
  11. * Pregnancy
  12. * Cognitive impairment
  13. * Severe retinopathy or neuropathy.
  14. * Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)

Contacts and Locations

Study Contact

Yashvi Verma, BS
CONTACT
203-444-0678
activity@yale.edu
Garrett Ash, PhD, CSCS
CONTACT
203-444-3079
garrett.ash@yale.edu

Principal Investigator

Garrett Ash, PhD, CSCS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale School of Medicine
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Garrett Ash, PhD, CSCS, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-10
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07-10
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Type 1 Diabetes (T1D)
  • Latent Autoimmune Diabetes in Adult (LADA)
  • Pancreatitis