Recruiting

Circadian Mechanisms

Sponsor:

University of Illinois at Chicago

Code:

NCT06624046

Conditions

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Sleep stability intervention

Study Details

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.

Conditions

Type 1 Diabetes (T1D)

Study ID

NCT06624046

Start date

Mar 13, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Single arm

Sleep stability intervention

Interventions

Sleep stability intervention

The sleep stability intervention will consist of three theory-based intervention components our team has developed and used in prior interventions: 1) self-monitoring using a wearable sleep tracker (Fitbit). This is well-liked by participants and increases awareness of their sleep goals. 2) Accountability coaching via weekly check-ins and daily monitoring of participants' wearable sleep tracking data and a coaching protocol.

Primary outcome measure

  • Glycemic status [ Time Frame: From enrollment to week 12 ]
  • Glycemic control [ Time Frame: From enrollment to week 12 ]
  • Insulin sensitivity [ Time Frame: From enrollment to week 12 ]

Central Contacts and Locations

Central contacts

Pamela Martyn-Nemeth, PhD

312-996-7903pmartyn@uic.edu

Sirimon Reutrakul, MD

312-996-6060sreutrak@uic.edu

Locations

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Pamela Martyn-Nemeth, PhD

312-996-7903pmartyn@uic.edu

Sirimon Reutrakul, MD

312-413-3631sreutrak@uic.edu

Principal Investigator:

Pamela Martyn-Nemeth, PhD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • sleep
  • cardiovascular disease risk
  • glycemic control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-06-30.