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

NCT03398902 | Completed Results

• 1 other identifier: R00NR017416
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes

Keywords

sleep; sleep extension; sleep patterns; type 2 diabetes; glucose regulation; behavioral intervention; adults

Outcome Measures

Primary Outcomes (1)

• Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention

  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.

  pre-treatment at baseline and post-treatment at ~12 weeks

Study Arms (2)

Sleep extension

EXPERIMENTAL

Participants in the sleep extension group will keep daily sleep diaries. Sleep diaries will be reviewed with the participant and an instructor trained in Cognitive Behavioral Therapy for Insomnia (CBTI) on a weekly basis. These weekly sessions will take place by telephone or videoconferencing.

Behavioral: Sleep extension

Habitual sleep

ACTIVE COMPARATOR

Participants in the habitual sleep group will be instructed to keep their habitual bedtimes and wake times. Participants will keep daily sleep diaries that will we reviewed by a study team member each week. These weekly sessions will take place by telephone or videoconferencing.

Other: Habitual sleep

Interventions

Sleep extension BEHAVIORAL

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

Sleep extension

Habitual sleep OTHER

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

Habitual sleep

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• New York University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

NYU Langone

New York, New York, 10010, United States

Location

Related Publications (16)

• Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Quantity and quality of sleep and incidence of type 2 diabetes: a systematic review and meta-analysis. Diabetes Care. 2010 Feb;33(2):414-20. doi: 10.2337/dc09-1124. Epub 2009 Nov 12.

  PMID: 19910503 BACKGROUND

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  PMID: 24282622 BACKGROUND

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  PMID: 19878986 BACKGROUND

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• Perreault L, Temprosa M, Mather KJ, Horton E, Kitabchi A, Larkin M, Montez MG, Thayer D, Orchard TJ, Hamman RF, Goldberg RB; Diabetes Prevention Program Research Group. Regression from prediabetes to normal glucose regulation is associated with reduction in cardiovascular risk: results from the Diabetes Prevention Program outcomes study. Diabetes Care. 2014 Sep;37(9):2622-31. doi: 10.2337/dc14-0656. Epub 2014 Jun 26.

  PMID: 24969574 BACKGROUND

• Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

  PMID: 11333990 BACKGROUND

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  PMID: 9096977 BACKGROUND

• Schellenberg ES, Dryden DM, Vandermeer B, Ha C, Korownyk C. Lifestyle interventions for patients with and at risk for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013 Oct 15;159(8):543-51. doi: 10.7326/0003-4819-159-8-201310150-00007.

  PMID: 24126648 BACKGROUND

• Yoon U, Kwok LL, Magkidis A. Efficacy of lifestyle interventions in reducing diabetes incidence in patients with impaired glucose tolerance: a systematic review of randomized controlled trials. Metabolism. 2013 Feb;62(2):303-14. doi: 10.1016/j.metabol.2012.07.009. Epub 2012 Sep 7.

  PMID: 22959500 BACKGROUND

• Linmans JJ, Spigt MG, Deneer L, Lucas AE, de Bakker M, Gidding LG, Linssen R, Knottnerus JA. Effect of lifestyle intervention for people with diabetes or prediabetes in real-world primary care: propensity score analysis. BMC Fam Pract. 2011 Sep 13;12:95. doi: 10.1186/1471-2296-12-95.

  PMID: 21914190 BACKGROUND

• Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015 Dec 15;10:172. doi: 10.1186/s13012-015-0354-6.

  PMID: 26670418 BACKGROUND

• Leproult R, Deliens G, Gilson M, Peigneux P. Beneficial impact of sleep extension on fasting insulin sensitivity in adults with habitual sleep restriction. Sleep. 2015 May 1;38(5):707-15. doi: 10.5665/sleep.4660.

  PMID: 25348128 BACKGROUND

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  PMID: 20307809 BACKGROUND

• Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.

  PMID: 16391903 BACKGROUND

• Dunkley AJ, Bodicoat DH, Greaves CJ, Russell C, Yates T, Davies MJ, Khunti K. Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis. Diabetes Care. 2014 Apr;37(4):922-33. doi: 10.2337/dc13-2195.

  PMID: 24652723 BACKGROUND

• Cardona-Morrell M, Rychetnik L, Morrell SL, Espinel PT, Bauman A. Reduction of diabetes risk in routine clinical practice: are physical activity and nutrition interventions feasible and are the outcomes from reference trials replicable? A systematic review and meta-analysis. BMC Public Health. 2010 Oct 29;10:653. doi: 10.1186/1471-2458-10-653.

  PMID: 21029469 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Susan Malone
• Organization: Rory Meyers College of Nursing, New York University

sm7760@nyu.edu

212-992-7047

Study Officials

• Susan K Malone, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 16, 2018
• Study Start: March 15, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The timeline for submission to an NIH-designated data repository will allow first for publication of findings related to the aims of the R00 study, as well as submission of findings as preliminary data for anticipated grant application(s).
• Access Criteria: After data collection is complete, the investigators plan to make the full dataset (redacted of all identifying information) available through the National Sleep Research Resource.

Locations

US (1)