N/A
N=191
Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
PreDiabetes
Bottom Line
View on ClinicalTrials.gov: NCT03398902 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention — 0.38; -0.49 Percent time glucose >= 140mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep extension (Behavioral); Habitual sleep (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention |
0.38; -0.49 | — |
Summary
This study will use continuous glucose monitoring and actigraphy to examine whether a personalized, daily sleep extension intervention improves glucose regulation for community dwelling, sleep-restricted adults with pre-diabetes. The randomized controlled trial will include 150 adults with pre-diabetes. Sleep extension and habitual sleep groups will complete daily sleep diaries and participate in a weekly 15-minute telephone call or videoconference meeting with a member of the study team (8 sessions total). Data collection will be at 2 time points: pre-randomization and post-intervention (completion of the 8-week intervention). Changes in the percent time glucose is ≥ 140mg/dL at baseline and post-intervention will be established and compared across the sleep extension and habitual sleep arms.
Eligibility Criteria
Inclusion Criteria
- Glycated hemoglobin (Hemoglobin A1C) greater than or equal to 5.7% and less than 6.5%.
- Restricted sleep defined as less than 6.5 hours average work day sleep (actigraphy confirmed).
Exclusion Criteria
- type 2 diabetes (Hemoglobin A1C greater than or equal to 6.5%)
- pregnancy or lactation (self-report)
- hemophilia (self-report)
- moderate/severe or severe depression (PHRQ greater than or equal to 15))
- alcohol abuse/dependence (Alcohol Use Disorders Identification Test greater than or equal to 10).
- sleep promoting medications (self-report)
- hypoglycemic agents (except metformin) (self-report)
--current chemotherapy treatments (self-report)
- Shift work during the past 2 months or planned during intervention period (self-report).
- Trans-meridian travel in the past 4 weeks or planned during intervention period (self-report).
Data sourced from ClinicalTrials.gov (NCT03398902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.