Circadian Mechanisms, Glucose, and CV Risks in T1D

NCT06624046 | Recruiting DMC

• 2 other identifiers: 2024-0886R01HL174738
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Keywords

sleep; cardiovascular disease risk; glycemic control

Outcome Measures

Primary Outcomes (3)

• Glycemic status

  Continuous glucose monitor (CGM)

  From enrollment to week 12

• Glycemic control

  Hemoglobin A1C

  From enrollment to week 12

• Insulin sensitivity

  Insulin sensitivity

  From enrollment to week 12

Secondary Outcomes (11)

• Circadian regulation DLMO

  enrollment to week 12

• Circadian regulation Melatonin

  Enrollment to week 12

• Circadian regulation actigraphy

  enrollment to week 12

• Circadian regulation CLOCK gene

  enrollment to week 12

• Circadian regulation light

  enrollment to week 12

Study Arms (1)

Single arm

OTHER

Sleep stability intervention

Behavioral: Sleep stability intervention

Interventions

Sleep stability intervention BEHAVIORAL

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Pamela Martyn-Nemeth, PhD

CONTACT

312-996-7903; pmartyn@uic.edu

Sirimon Reutrakul, MD

CONTACT

312-996-6060; sreutrak@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single arm, pretest, post-test design using a sleep stability intervention

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 2, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Scientific data will be shared as soon as possible, and no later than the time of publication, or the end of the award period, whichever comes first. Deidentified data will be available in INDIGO in perpetuity and with open access to the scientific community.
• Access Criteria: The UIC institutional repository provides shared datasets and metadata only records with a persistent identifier DOI, allowing for discovery and attribution. The ClinicalTrials.gov database additionally provides unique identifiers for submitted studies.

Locations

US (1)