Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

Yale University

Status: Enrolling

Conditions: Latent Autoimmune Diabetes in Adult (LADA); Type 1 Diabetes (T1D); Pancreatitis

Treatments: Behavioral: Self-monitoring; Behavioral: Exercise program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06967701

2000039977

K01DK129441 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Self-Monitoring

Active Comparator group

Description:

Wear a fitness watch and keep daily health diary

Treatment:

Behavioral: Self-monitoring

Exercise program

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise program