Back to resultsDigital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes
Primary Purpose
Type 1 Diabetes, Latent Autoimmune Diabetes in Adults, Pancreatitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Exercise
Sponsored by
About this trial
This is an interventional health services research trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- Yale School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Digital Exercise
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of usage
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Acceptability
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
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.
Secondary Outcome Measures
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).
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.
Interview themes
Qualitatively-identified determinants and sequalae of motivation states for physical activity
Full Information
NCT ID
NCT06098729
First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Exerscrip LLC
1. Study Identification
Unique Protocol Identification Number
NCT06098729
Brief Title
Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Exerscrip LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Latent Autoimmune Diabetes in Adults, Pancreatitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital Exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Digital Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of usage
Description
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Time Frame
4 weeks
Title
Acceptability
Description
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Time Frame
4 weeks
Title
Accuracy
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Motivation states for physical activity
Description
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).
Time Frame
6 weeks
Title
Moderate to vigorous physical activity
Description
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.
Time Frame
6 weeks
Title
Interview themes
Description
Qualitatively-identified determinants and sequalae of motivation states for physical activity
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garrett Ash, PhD
Phone
2034443079
Email
garrett.ash@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garrett Ash, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Ash, PhD
Phone
203-444-3079
Email
garrett.ash@yale.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes
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