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NCT06624046Recruiting

Circadian Mechanisms, Glucose, and CV Risks in T1D

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

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
27 Sept 2024
Start date
13 Mar 2025
Primary completion date
28 Feb 2029
Lead sponsor
University of Illinois Chicago
NCT number
NCT06624046

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 13 Mar 2025 to the primary completion date, 28 Feb 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • 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 \[dialysis\])
  • history of stroke with neurological deficits
  • Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC

Lab values

  • pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding.

Other

  • Self-reported A1C within the past 6 months ≥10%
  • insomnia symptoms defined as Insomnia Severity Index score ≥15
  • rotating shift or night work or routinely sleeping after 3 AM.
  • depression (Patient Health Questionnaire 8 \[PHQ-8\] score ≥15)

Who the study is looking for

  • 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)

Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Illinois Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.