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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

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
NameTimeMethod
Feasibility of Usage4 weeks

Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

Acceptability4 weeks

Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)

Accuracy4 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
NameTimeMethod
Motivation States for Physical Activity6 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 Activity6 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 Themes6 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

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