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

Not Applicable

• Conditions: PreDiabetes
• Interventions: Other: Habitual sleep; Behavioral: Sleep extension

• Registration Number: NCT03398902
• Lead Sponsor: New York University

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.

Detailed Description

Diet and exercise interventions have made great strides in preventing and delaying type 2 diabetes (T2D) onset: benefits that surpass pharmacological interventions in some people. Disappointingly, only half the amount of weight loss and wide ranges in T2D risk reduction have been reported when translating these programs into community settings using less intense, more affordable interventions. Low program participation rates, underscored by reports that only 50% of Americans with prediabetes attempt lifestyle modifications, suggest that approaches focused on calorie restriction and physical activity are only effective for select, highly motivated individuals. Expanding success for heretofore resistant groups and optimizing long term maintenance requires novel approaches beyond diet and exercise. One novel approach is improving sleep.

Associations between sleep duration, sleep patterns, and glucose regulation in healthy adults suggest that interventions targeting these dimensions of sleep will improve glucose regulation. Improved insulin sensitivity has been reported in a small community based daily sleep extension study (N= 16), as well as in a 2-day lab based sleep extension study using a personalized "catch up" sleep intervention in healthy adults (N = 19,). Limited by small sample sizes, controlled lab conditions, and the exclusion of persons at greatest risk for T2D, the role of sleep in mitigating T2D risk remains uncertain. Moreover, sleep extension interventions have applied a generic approach to extending sleep despite variability in individual sleep need. The sleep extension intervention in this study will address how to extend sleep based on individual responses to the intervention.

This study will test the effects of a personalized daily sleep extension intervention versus habitual sleep patterns on the percentage of time glucose is 140 mg/dL in sleep restricted community-dwelling adults at high risk for T2D. Wearable sensor technologies (continuous glucose monitoring and accelerometry) will be used. This study will inform person-specific sleep interventions that improve glycemic responses, thus providing treatment for the pre-diabetic state.

Hypothesis: Personalized daily sleep extension will result in a lower % time glucose is ≥ 140 compared to habitual sleep after 8 weeks of treatment initiation.

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-16
• Study Start: 2020-09-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-14
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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).
• employed greater than or equal to 20 hours of work per week (self report).

Exclusion Criteria

• type 2 diabetes (Hemoglobin A1C greater than or equal to 6.5%)

• pregnancy or lactation (self-report)

• hemophilia (self-report)

• obstructive sleep apnea (Multivariable Apnea Prediction Index > 0.50 or Home sleep apnea test Apnea-Hypopnea Index >10 events/hour).

• insomnia (Insomnia Severity Index greater than 10)

• moderate/severe or severe depression (PROMIS-D-short form raw score greater than or equal to 27 or T-score greater than or equal to 64.7)

• 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)

• extended napping (greater than or equal to 2 naps per day or greater than 90 minutes naps per day on 3 or more days of the week) (actigraphy-confirmed).

• 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).

• No difference between work day and free day sleep duration (actigraphy confirmed).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Habitual sleep	Habitual sleep	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.
Sleep extension	Sleep extension	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.

Primary Outcome Measures

Name	Time	Method
Change in % time glucose is ≥ 140mg/dL	baseline and week 12	measured with continuous glucose monitoring

Trial Locations

Locations (1)

NYU Langone; 🇺🇸 New York, New York, United States