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

NCT06098729 | Completed Results

• 2 other identifiers: 2000035846K01DK129441
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Latent Autoimmune Diabetes in Adults; Pancreatitis

Outcome Measures

Primary Outcomes (3)

• 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. 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 Outcomes (3)

• Motivation States for Physical Activity

  6 weeks

• Moderate to Vigorous Physical Activity

  6 weeks

• Interview Themes

  6 weeks

Study Arms (1)

Digital Exercise

EXPERIMENTAL

Behavioral: Digital Exercise

Interventions

Digital Exercise BEHAVIORAL

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

Digital Exercise

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Exerscrip LLC: collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases

Limitations and Caveats

This was a pilot study focused on feasibility and acceptability, so efficacy cannot be determined.

Results Point of Contact

• Title: Garrett Ash
• Organization: Yale University

garrett.ash@yale.edu

2034443079

Study Officials

• Garrett Ash, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: November 2, 2023
• Primary Completion: October 11, 2024
• Study Completion: October 25, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)