Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes
- Conditions
 - Type 1 DiabetesLatent Autoimmune Diabetes in AdultsPancreatitis
 
- Registration Number
 - NCT06098729
 
- Lead Sponsor
 - Yale University
 
- 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 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.
- Detailed Description
 Not available
Recruitment & Eligibility
- Status
 - COMPLETED
 
- Sex
 - All
 
- Target Recruitment
 - 24
 
- Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
 - Low exercise levels
 - Smartphone ownership
 - English literacy
 - Under regular care by a healthcare provider
 - Home Broadband wireless Internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads)
 
- 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 >145mmHg systolic or >90 mmHg diastolic
 - Myocardial infarction or angina in past 6 months
 - Renal failure
 - Pregnancy
 - Cognitive impairment
 - Severe retinopathy or neuropathy.
 - Other chronic disease or physical disability that would influence exercise intervention
 
Study & Design
- Study Type
 - INTERVENTIONAL
 
- Study Design
 - SINGLE_GROUP
 
- Primary Outcome Measures
 Name Time Method Feasibility of Usage 4 weeks Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Acceptability 4 weeks Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Accuracy 4 weeks Accuracy to predict lapses in exercise behavior ahead of time. 50% accuracy is the lowest possible value (ie, equivalent to random guessing), 80% accuracy is the goal of the study, and 100% accuracy would be the highest possible accuracy.
This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.
- Secondary Outcome Measures
 Name Time Method Motivation States for Physical Activity 6 weeks Scale name: Cravings for Rest and Volitional Energy Expenditure (CRAVE) Construct: Transient state motivation for physical activity Scale ranges: 0 (not at all) to 100 (more than ever). Higher values represent a better outcome.
Moderate to Vigorous Physical Activity 6 weeks Minutes of moderate to vigorous physical activity registered by hip accelerometer. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Interview Themes 6 weeks Qualitatively-identified determinants and sequalae of motivation states for physical activity
Trial Locations
- Locations (1)
 Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Yale School of Medicine🇺🇸New Haven, Connecticut, United States
