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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Pancreatitis; Latent Autoimmune Diabetes in Adults
• Intervention / Treatment: Behavioral: Digital Exercise

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 >160mmHg systolic or >100 mmHg diastolic
• Myocardial infarction or angina in past 12 months
• Uncontrolled arrhythmia (e.g., Afib with RVR, new onset Afib, ventricular tachycardia, escape rhythms)
• Congestive heart failure (stage 3 or 4)
• Exercise-induced asthma (not controlled on inhalers)
• Chronic obstructive pulmonary disease (requiring home oxygen)
• Renal failure
• Pregnancy
• Cognitive impairment
• Severe retinopathy or neuropathy.
• Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)	4 weeks
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
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. This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation States for Physical Activity	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.	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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Exerscrip LLC
• Investigators: Principal Investigator: Garrett Ash, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pancreatic Diseases; Nutritional and Metabolic Diseases; Latent Autoimmune Diabetes in Adults; Pancreatitis; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2000035846; K01DK129441 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No