RECRUITING

Circadian Mechanisms, Glucose, and CV Risks in T1D

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.

Official Title

Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes

Quick Facts

Study Start:2025-03-13
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06624046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18-50 years with a clinical diagnosis of T1D for at least one year
  2. * Report habitual sleep irregularity ≥1 hour/week
  3. * Desire to improve sleep, and own a smartphone (Android or iPhone)
  1. * Self-reported A1C within the past 6 months ≥10%
  2. * insomnia symptoms defined as Insomnia Severity Index score ≥15
  3. * history of restless leg syndrome
  4. * 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
  5. * rotating shift or night work or routinely sleeping after 3 AM.
  6. * 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 \[dialysis\])
  7. * depression (Patient Health Questionnaire 8 \[PHQ-8\] score ≥15)
  8. * history of stroke with neurological deficits
  9. * pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding.
  10. * Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC

Contacts and Locations

Study Contact

Pamela Martyn-Nemeth, PhD
CONTACT
312-996-7903
pmartyn@uic.edu
Sirimon Reutrakul, MD
CONTACT
312-996-6060
sreutrak@uic.edu

Study Locations (Sites)

University of Illinois Chicago
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-13
Study Completion Date2029-08

Study Record Updates

Study Start Date2025-03-13
Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

  • sleep
  • cardiovascular disease risk
  • glycemic control

Additional Relevant MeSH Terms

  • Type 1 Diabetes (T1D)