MedTrace Logo

Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes

NCT03398902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2025-09-04

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BEHAVIORAL

Sleep extension

Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.

OTHER

Habitual sleep

The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • New York University

    lead OTHER

Principal Investigators

  • Susan K Malone, PhD · New York University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-09-18
Completion
2023-09-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398902 on ClinicalTrials.gov