NCT06967701 · Yale University
Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes
What this study is 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.
View original scientific 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.
Interventions
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
Primary outcome measures
Weekly exercise duration
Time frame: 20 weeks
Minutes/week. Measured by blinded hip watch and periodic interviews. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Cognitive impairment
- Severe retinopathy or neuropathy.
- Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)
Where
- New Haven, Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 6, 2025 · Source of record for eligibility and locations