Clinical trial NCT06967701: Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes (T1D)
Latent Autoimmune Diabetes in Adult (LADA)
Pancreatitis
Keywords: exercise
physical activity
mobile phone
health coaching
fitness watch
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion criteria:

* 30-65 years old inclusive
* Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
* Less than 1.0 exercise sessions per week
* Smartphone ownership
* English literacy
* Under regular care by a healthcare provider (1+ appointments per year)
* Home Broadband wireless Internet or cell phone network
* Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks
* Using insulin pump or pen and sharing data with medical record for at least 6 weeks

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., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, 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)

Primary outcomes:
measure: Weekly exercise duration
timeFrame: 20 weeks
Secondary outcomes:
measure: Weekly exercise volume
timeFrame: 20 weeks
measure: Weekly exercise days
timeFrame: 20 weeks
measure: Glucose
timeFrame: 20 weeks
measure: Body mass index
timeFrame: 20 weeks
measure: Waist circumference
timeFrame: 20 weeks
measure: Blood pressure
timeFrame: 20 weeks
measure: Sleep disturbance
timeFrame: 20 weeks
measure: Sleep-related impairment
timeFrame: 20 weeks
measure: Affective motivation states
timeFrame: 20 weeks
measure: Fear of hypoglycemia
timeFrame: 20 weeks
measure: Fear of hyperglycemia
timeFrame: 20 weeks
measure: Exercise self-efficacy
timeFrame: 20 weeks
measure: Exercise self-regulation
timeFrame: 20 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
References: