NCT03398902

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

Completed NA Results posted Last updated 4 September 2025

What this trial tests

NA trial testing Sleep extension in PreDiabetes in 393 participants. Completed in 18 September 2023.

Timeline

15 March 2021

Primary endpoint
18 September 2023

18 September 2023

Quick facts

Lead sponsor	New York University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	393
Start date	15 March 2021
Primary completion	18 September 2023
Estimated completion	18 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Sleep extension
• Habitual sleep

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →

Sponsor

New York University

Who can join

Adults 21 to 64, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention Primary · pre-treatment at baseline and post-treatment at ~12 weeks

The primary outcome will be the change in the percent time glucose is ≥ 140mg/dL from pre- to post-intervention estimated from \~7 days of continuous glucose monitoring.

Group	Value	95% CI
Sleep Intervention	0.38	± 4.74
Control	-0.49	± 3.22

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sleep Intervention

Serious: 0/99 (0%)

Deaths: 0/99

Control

Serious: 0/92 (0%)

Deaths: 0/92

Other adverse events (2 terms — click to expand)

Reaction	System	Sleep Intervention	Control
compalints of "not feeling well"	General disorders	—	—
complaints of a head cold	General disorders	—	—

Data from ClinicalTrials.gov NCT03398902 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.