Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

NCT06967701 | Recruiting

• 2 other identifiers: 2000039977K01DK129441
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Weekly exercise duration

  Minutes/week. Measured by blinded hip watch and periodic interviews. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

  20 weeks

Secondary Outcomes (13)

• Weekly exercise volume

  20 weeks

• Weekly exercise days

  20 weeks

• Glucose

  20 weeks

• Body mass index

  20 weeks

• Waist circumference

  20 weeks

Study Arms (2)

Self-Monitoring

ACTIVE COMPARATOR

Wear a fitness watch and keep daily health diary

Behavioral: Self-monitoring

Exercise program

EXPERIMENTAL

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.

Behavioral: Exercise program

Interventions

Exercise program BEHAVIORAL

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.

Exercise program

Self-monitoring BEHAVIORAL

Wear a fitness watch and keep daily health diary

Self-Monitoring

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pancreatitis; Motor Activity

Interventions

Resistance Training; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Investigative Techniques

Study Officials

• Garrett Ash, PhD, CSCS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yashvi Verma, BS

CONTACT

203-444-0678; activity@yale.edu

Garrett Ash, PhD, CSCS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Biomedical Informatics, and Data Science

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)