N/A
N=24
Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes
Type 1 Diabetes · Latent Autoimmune Diabetes in Adults · Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT06098729 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Feasibility of Usage — 168 minutes/week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digital Exercise (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Usage |
168 | — |
| PRIMARY Acceptability |
4.0 | — |
| PRIMARY Accuracy |
70 | — |
| SECONDARY Motivation States for Physical Activity |
60.1 | — |
| SECONDARY Moderate to Vigorous Physical Activity |
168 | — |
| SECONDARY Interview Themes |
4 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT06098729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.