An interventional study of Sleep extension and Habitual sleep in PreDiabetes, sponsored by New York University. Completed at 1 site in United States. Open to participants aged 21 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by New York University · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
hypoglycemic agents (except metformin) (self-report)
--current chemotherapy treatments (self-report)
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
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
Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.
The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times.
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.
Time frame: pre-treatment at baseline and post-treatment at ~12 weeks
Participants were recruited from the community by 1) study flyers, 2) past study participants who agreed to be contacted for future research studies, 3) using Epic to identify and contact potential participants, 4) using research registries such as Research Match, and 5) using a peer recruitment strategy.The first participant enrolled in March 2021 and the last participant enrolled in April 2023.
| Milestone | Control | Sleep Intervention |
|---|---|---|
| Started | 92 | 99 |
| Completed | 43 | 75 |
| Not completed | 49 | 24 |
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.
| Percent time glucose >= 140mg/dL | Sleep Intervention | Control |
|---|---|---|
| Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention | 0.38 ± 4.74 | -0.49 ± 3.22 |
Collected over Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sleep Intervention | 0/99 (0%) | 0/99 (0%) | 13/99 (13.1%) |
| Control | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
| Event | Sleep Intervention | Control |
|---|---|---|
| compalints of "not feeling well"General disorders | 7/99 | 0/92 |
| complaints of a head coldGeneral disorders | 6/99 | 0/92 |
| Age, Continuous(years) | Sleep Intervention | Control | Total |
|---|---|---|---|
| Mean | 51.92 ± 9.03 | 52.80 ± 8.465 | 52.35 ± 8.46 |
| Sex: Female, Male(Participants) | Sleep Intervention | Control | Total |
|---|---|---|---|
| Female | 67 | 58 | 125 |
| Male | 32 | 34 | 66 |
| Ethnicity (NIH/OMB)(Participants) | Sleep Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 19 | 22 | 41 |
| Not Hispanic or Latino | 79 | 64 | 143 |
| Unknown or Not Reported | 1 | 6 | 7 |
| Race (NIH/OMB)(Participants) | Sleep Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 12 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 44 | 27 | 71 |
| White | 40 | 39 | 79 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 14 | 19 |
| Percent time Glucose >= 140mg/dL(percentage) | Sleep Intervention | Control | Total |
|---|---|---|---|
| Mean | 5.80 ± 8.13 | 6.82 ± 8.57 | 6.29 ± 8.34 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators are committed to the principles that NIH has articulated regarding the sharing of study results and resources. The Investigators will make unique research resources readily available for research purposes to individuals within the scientific community after publication. The privacy and rights of participants in the research study will be protected by redacting all identifiers and adopting strategies to minimize the risk of unauthorized disclosure of identifiers in accordance with the data security plan and the participant's Institutional Review Board (IRB)-approved informed consent. The consent language for the R00 study will be worded for possible broad data sharing. Sharing Model Organisms Not Applicable Genome Wide Association Studies Not Applicable
Supporting information: Study protocol, Sap, Icf, Analytic code
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New York University