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

Last updated: November 8, 2024
Sponsor: Yale University
Overall Status: Completed

Phase

N/A

Condition

Pancreatitis

Diabetes Prevention

Diabetes Mellitus, Type 1

Treatment

Digital Exercise

Clinical Study ID

NCT06098729
2000035846
K01DK129441
  • Ages 30-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latentautoimmune 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 mbpsuploads)

Exclusion

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 requiringassistance 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, ventriculartachycardia, 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 exerciseintervention (e.g., recent spinal surgery)

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Digital Exercise
Phase:
Study Start date:
November 02, 2023
Estimated Completion Date:
October 25, 2024

Connect with a study center

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

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