Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Latent Autoimmune Diabetes in Adults; Pancreatitis

• 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

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-24
• Study Start: 2023-11-02
• Primary Completion: 2024-10-11
• Study Completion: 2024-10-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
Acceptability	4 weeks	Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
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.

Secondary Outcome Measures

Name	Time	Method
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
Motivation states for physical activity	6 weeks	Cravings for Rest and Volitional Energy Expenditure (CRAVE) survey of motivation states for physical activity. Scores range from 0 (not at all) to 10 (more than ever).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States