PreDiabetes
Conditions
Keywords
sleep, sleep extension, sleep patterns, type 2 diabetes, glucose regulation, behavioral intervention, adults
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.
Interventions
BEHAVIORALSleep extension
Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.
OTHERHabitual 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
National Institute of Nursing Research (NINR)
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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).
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of 393 enrolled participants,191 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Sleep Intervention 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. | 99 |
| Control 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. | 92 |
| Total | 191 |
Baseline characteristics
| Characteristic | Sleep Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 51.92 years STANDARD_DEVIATION 9.03 | 52.80 years STANDARD_DEVIATION 8.465 | 52.35 years STANDARD_DEVIATION 8.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 22 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 64 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 7 Participants |
| Percent time Glucose >= 140mg/dL | 5.80 percentage STANDARD_DEVIATION 8.13 | 6.82 percentage STANDARD_DEVIATION 8.57 | 6.29 percentage STANDARD_DEVIATION 8.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 12 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 27 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 14 Participants | 19 Participants |
| Race (NIH/OMB) White | 40 Participants | 39 Participants | 79 Participants |
| Sex: Female, Male Female | 67 Participants | 58 Participants | 125 Participants |
| Sex: Female, Male Male | 32 Participants | 34 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 92 |
| other Total, other adverse events | 13 / 99 | 0 / 92 |
| serious Total, serious adverse events | 0 / 99 | 0 / 92 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Intervention | Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention | 0.38 Percent time glucose >= 140mg/dL | Standard Deviation 4.74 |
| Control | Change in the Percent Time Glucose is ≥ 140 mg/dL From Pre- to Post-intervention | -0.49 Percent time glucose >= 140mg/dL | Standard Deviation 3.22 |