Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digital Exercise
|
Behavioral: Digital Exercise
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
|
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- 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).
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
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Low exercise levels
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Smartphone ownership
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English literacy
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Under regular care by a healthcare provider
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Home Broadband wireless Internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads)
Exclusion Criteria:
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Diabetic ketoacidosis not clearly related to pump site failure in past 6 months
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1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months
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A1c ≥10.0%
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Resting blood pressure >145mmHg systolic or >90 mmHg diastolic
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Myocardial infarction or angina in past 6 months
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Renal failure
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Pregnancy
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Cognitive impairment
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Severe retinopathy or neuropathy.
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Other chronic disease or physical disability that would influence exercise intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale School of Medicine | New Haven | Connecticut | United States | 06510 |
Sponsors and Collaborators
- Yale University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Exerscrip LLC
Investigators
- Principal Investigator: Garrett Ash, PhD, Yale School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000035846
- K01DK129441