NCT06624046 Circadian Mechanisms, Glucose, and CV Risks in T1D
| NCT ID | NCT06624046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-03-13 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06624046 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06624046 currently recruiting?
Yes, NCT06624046 is actively recruiting participants. Contact the research team at pmartyn@uic.edu for enrollment information.
Where is the NCT06624046 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06624046 clinical trial?
NCT06624046 is sponsored by University of Illinois at Chicago. The trial plans to enroll 100 participants.
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