Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise program, Self-monitoring.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Latent Autoimmune Diabetes in Adult (LADA), Pancreatitis. Basic parameters: 30 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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]
Secondary outcome measures (12)
- Weekly exercise volume [Time frame: 20 weeks]
- Weekly exercise days [Time frame: 20 weeks]
- Glucose [Time frame: 20 weeks]
- Body mass index [Time frame: 20 weeks]
- Waist circumference [Time frame: 20 weeks]
- Blood pressure [Time frame: 20 weeks]
- Sleep disturbance [Time frame: 20 weeks]
- Sleep-related impairment [Time frame: 20 weeks]
- Affective motivation states [Time frame: 20 weeks]
- Fear of hypoglycemia [Time frame: 20 weeks]
- Fear of hyperglycemia [Time frame: 20 weeks]
- Exercise self-efficacy [Time frame: 20 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Yale School of Medicine — New Haven
Identifiers
NCT: NCT06967701 · 2000039977 · K01DK129441