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NCT Number: NCT06098729

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Latent Autoimmune Diabetes in Adults Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Feasibility of Usage

    Time frame: 4 weeks

    Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

  2. Acceptability

    Time frame: 4 weeks

    Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)

  3. Accuracy

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Motivation States for Physical Activity

    Time frame: 6 weeks

    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.

  2. Moderate to Vigorous Physical Activity

    Time frame: 6 weeks

    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.

  3. Interview Themes

    Time frame: 6 weeks

    Qualitatively-identified determinants and sequalae of motivation states for physical activity

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Exerscrip LLC
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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