Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Yale University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Feasibility of Usage
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
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 \>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
Outcomes
Primary Outcomes
Feasibility of Usage
Time Frame: 4 weeks
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Acceptability
Time Frame: 4 weeks
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Accuracy
Time Frame: 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 Outcomes
- Motivation States for Physical Activity(6 weeks)
- Moderate to Vigorous Physical Activity(6 weeks)
- Interview Themes(6 weeks)