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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 30-65 years old inclusive - Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune conditions (where your immune system attacks your own body) 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

BEHAVIORAL

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.

BEHAVIORAL

Self-monitoring

Wear a fitness watch and keep daily health diary

Locations (1)

Yale School of Medicine
New Haven, Connecticut, United States