Improving sleep regularity to reduce cardiovascular risks in type 1 diabetes
Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes
This study is trying to see if improving sleep patterns can help adults with type 1 diabetes lower their risk of heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06624046 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between sleep regularity and cardiovascular disease risk in adults with type 1 diabetes (T1D). It aims to understand how enhancing sleep stability through behavioral interventions can improve glycemic control and reduce cardiovascular risks. The study will involve a 4-week intervention targeting sleep stability in 80 participants, examining the mechanisms by which sleep impacts metabolic health. The findings could provide insights into effective strategies for managing T1D and associated cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-50 with a clinical diagnosis of type 1 diabetes for at least one year and who experience habitual sleep irregularity.
Not a fit: Patients with severe hypoglycemia history, significant medical comorbidities, or those using sleep medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and glycemic control for patients with type 1 diabetes.
How similar studies have performed: Previous studies have shown promising results in improving glycemic control through sleep interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18-50 years with a clinical diagnosis of T1D for at least one year * Report habitual sleep irregularity ≥1 hour/week * Desire to improve sleep, and own a smartphone (Android or iPhone) Exclusion Criteria: * Self-reported A1C within the past 6 months ≥10% * insomnia symptoms defined as Insomnia Severity Index score ≥15 * history of restless leg syndrome * history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months * rotating shift or night work or routinely sleeping after 3 AM. * use of sleep medications/aids, significant medical comorbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, on renal replacement therapy \[dialysis\]) * depression (Patient Health Questionnaire 8 \[PHQ-8\] score ≥15) * history of stroke with neurological deficits * pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding. * Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC
Where this trial is running
Chicago, Illinois
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Pamela Martyn-Nemeth, PhD
- Email: pmartyn@uic.edu
- Phone: 312-996-7903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.