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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098729
• Other study ID #: 2000035846
• Secondary ID: K01DK129441
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: Garrett Ash, PhD
• Phone: 2034443079
• Email: garrett.ash[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Latent Autoimmune Diabetes in Adults
• Pancreatitis
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Exerscrip LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability	Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)	4 weeks
Primary	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	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
Secondary	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
Secondary	Interview themes	Qualitatively-identified determinants and sequalae of motivation states for physical activity	6 weeks