Actively Recruiting
Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes
Led by University of Illinois at Chicago · Updated on 2025-08-11
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with type 1 diabetes (T1D) face a higher risk of cardiovascular disease (CVD), which is a major cause of death in this group. Short and irregular sleep patterns have been linked to increased cardiovascular risks and poorer blood sugar control in T1D. This research aims to understand how improving sleep regularity affects blood sugar control and heart health by studying the underlying circadian mechanisms in adults with T1D. The study involves a 4-week behavioral sleep stability intervention designed to help participants improve their sleep regularity. This intervention includes self-monitoring with a wearable sleep tracker and accountability coaching through weekly check-ins and daily monitoring of sleep data. The study measures circadian regulation using melatonin levels, rest-activity rhythms, gene expression, and factors like light exposure and meal timing, alongside monitoring blood sugar levels, insulin sensitivity, and cardiovascular health indicators. Participants will be monitored before and after the intervention with various assessments including continuous glucose monitoring, blood pressure measurements, endothelial function tests, pulse wave velocity, carotid artery thickness, and heart ultrasound. Sleep quality and patterns will be recorded objectively. The main outcomes focus on blood sugar control, insulin sensitivity, and cardiovascular markers over a 12-week period from enrollment. This comprehensive evaluation aims to clarify how sleep improvements can influence metabolic and heart health in T1D adults.
CONDITIONS
Brief Title
Circadian Mechanisms, Glucose, and CV Risks in T1D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 50 years old with a clinical diagnosis of type 1 diabetes for at least one year
- Report habitual sleep irregularity of 1 hour or more per week
- Desire to improve sleep
- Own a smartphone (Android or iPhone)
You will not qualify if you...
- Self-reported A1C of 10% or higher within the past 6 months
- Insomnia symptoms with an Insomnia Severity Index score of 15 or higher
- History of restless leg syndrome
- History of severe hypoglycemia causing loss of consciousness, seizure, or emergency room visit within the past 6 months
- Rotating shift or night work or routinely sleeping after 3 AM
- Use of sleep medications or aids
- Significant medical conditions such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active cancer treatment, or dialysis
- Depression with a Patient Health Questionnaire 8 score of 15 or higher
- History of stroke with neurological deficits
- Pregnant, breastfeeding, or planning pregnancy
- Allergy to lidocaine
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 - 4 weeks
Participants undergo a 4-week behavioral sleep stability intervention designed to improve sleep regularity using a wearable sleep tracker and accountability coaching.
Weekly coaching check-ins and daily monitoring via wearable sleep tracker
Duration - Up to 8 weeks following intervention
Participants are assessed for glycemic control, circadian regulation, and cardiovascular outcomes up to 12 weeks from enrollment after the intervention.
Assessments at baseline and end of intervention with additional follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
P
Pamela Martyn-Nemeth, PhD
S
Sirimon Reutrakul, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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