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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes, Latent Autoimmune Diabetes in Adults, Pancreatitis

Intervention / Treatment
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* Behavioral: Digital Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Exercise<br> | Behavioral: Digital Exercise<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of usage | Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts. | 4 weeks | 
| Acceptability | Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied) | 4 weeks | 
| Accuracy | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation states for physical activity | 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). | 6 weeks | 
| Moderate to vigorous physical activity | 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. | 6 weeks | 
| Interview themes | Qualitatively-identified determinants and sequalae of motivation states for physical activity | 6 weeks |