Actively Recruiting
Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Pilot Efficacy Study
Led by Yale University · Updated on 2025-11-06
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to help adults aged 30 to 65 with type 1 diabetes or other insulin deficiency diabetes improve their exercise habits. The study recognizes the challenges people with these conditions face in exercising regularly and seeks to use continuous blood sugar monitoring and personalized support to encourage more frequent and confident exercise. It is a pilot efficacy study led by Yale University focusing on digital tools to promote safe exercise. Participants will receive a free Garmin smartwatch and access to an exercise program that offers coaching and personalized feedback. This feedback is based on patterns in their insulin use, carbohydrate intake, exercise, sleep, and blood sugar levels. The study includes two groups: one using self-monitoring with a fitness watch and health diary, and the other receiving the exercise program intervention. The study period lasts 20 weeks, during which data is collected and analyzed. During the study, participants will wear the fitness watch and complete daily health diaries. Researchers will track weekly exercise duration, volume, and frequency, along with glucose levels, body mass index, waist circumference, blood pressure, sleep quality, motivation, fear related to blood sugar levels, and confidence in exercising. This remote study requires no in-person visits, allowing participants to take part from anywhere. The study ends in July 2027, with ongoing monitoring throughout the 20-week intervention.
CONDITIONS
Brief Title
Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 65 years inclusive
- Diagnosed with type 1 diabetes or other insulin deficiency diabetes such as latent autoimmune diabetes of adulthood or diabetes secondary to pancreatitis
- Currently exercising less than 1.0 session per week
- Own a smartphone
- Able to read and understand English
- Under regular care by a healthcare provider with at least 1 appointment per year
- Have home broadband or cell phone network access
- Using a continuous glucose monitor and sharing data with medical records for at least 6 weeks
- Using insulin pump or pen and sharing data with medical records for at least 6 weeks
You will not qualify if you...
- Diabetic ketoacidosis unrelated to pump site failure within past 6 months
- More than 1 episode of severe hypoglycemia needing assistance in past 6 months
- Hemoglobin A1c level 10.0% or higher
- Resting blood pressure over 160 mmHg systolic or over 100 mmHg diastolic
- Heart attack or angina within past 12 months
- Uncontrolled arrhythmia such as atrial fibrillation with rapid response, new onset atrial fibrillation, ventricular tachycardia, or escape rhythms
- Congestive heart failure stage 3 or 4
- Exercise-induced asthma not controlled by inhalers
- Chronic obstructive pulmonary disease requiring home oxygen
- Renal failure
- Pregnancy
- Cognitive impairment
- Severe retinopathy or neuropathy
- Other chronic disease or physical disability affecting ability to exercise, such as recent spinal surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants engage in a behavioral intervention involving wearing a fitness watch, keeping a daily health diary, and receiving exercise coaching with personalized feedback on insulin, carbohydrates, exercise, sleep, and blood sugar.
Weekly visits for up to 20 weeks
Trial Site Locations
Total: 1 location
1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
Y
Yashvi Verma, BS
G
Garrett Ash, PhD, CSCS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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