Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes (T1D); Latent Autoimmune Diabetes in Adult (LADA); Pancreatitis

• Registration Number: NCT06967701
• 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

• Status Verified: 2025-05
• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-03
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-16
• Study Start: 2025-06
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Weekly exercise duration	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.

Secondary Outcome Measures

Name	Time	Method
Weekly exercise volume	20 weeks	Kilocalories, determined by minutes and intensity. Measured by blinded hip watch and periodic interviews. A person achieving 150 minutes per week will achieve around 1,200 - 2,000 kilocalories per week.
Weekly exercise days	20 weeks	Days/week. Measured by blinded hip watch and periodic interviews. 0 days/week is the lowest value, 3-7 days/week meets clinically recommended amounts.
Glucose	20 weeks	The measurable range is 20-400 mg/dL. It is quantified by average levels, time above/within/below the target range of 70-180 mg/dL, and coefficient of variation.
Body mass index	20 weeks	Calculated from body weight and height (kilograms per meters squared)
Sleep disturbance	20 weeks	NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance survey. Scores given in t-score reflecting value relative to population.
Sleep-related impairment	20 weeks	NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep-related impairment survey. Scores given in t-score reflecting value relative to population.
Affective motivation states	20 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).
Fear of hypoglycemia	20 weeks	Survey with subscales of fear-related behavior and worry respectively. Scores range from 0 (never) to 4 (almost always).
Fear of hyperglycemia	20 weeks	Survey with subscales of glucose decisions, lifestyle decisions, and worry. Scores range from 1 (never) to 5 (always).
Exercise self-regulation	20 weeks	Survey of reasons for motivation to exercise. Participants rate possible reasons with scores ranging from 1 (not at all true) to 7 (very true).
Waist circumference	20 weeks	Measured in centimeters at umbilicus
Blood pressure	20 weeks	Systolic and diastolic values in mmHg. Values above 130 / 85 are considered hypertensive range. Measured on home monitor in duplicate
Exercise self-efficacy	20 weeks	Asks about confidence to achieve exercise goals. Scores range from 0 (not confident) to 10 (very confident).

Trial Locations

Locations (1)

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