Trial Outcomes & Findings for Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes (NCT NCT03398902)
NCT ID: NCT03398902
Last Updated: 2025-09-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
393 participants
Primary outcome timeframe
pre-treatment at baseline and post-treatment at ~12 weeks
Results posted on
2025-09-04
Participant Flow
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.
Of 393 enrolled participants,191 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Control
Participant received a modified Diabetes Prevention Program Curriculum.
|
Sleep Intervention
Participants received a modifed Diabetes Prevention Program curriculum plus a personalized sleep intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
99
|
|
Overall Study
COMPLETED
|
43
|
75
|
|
Overall Study
NOT COMPLETED
|
49
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Baseline characteristics by cohort
| Measure |
Sleep Intervention
n=99 Participants
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.
|
Control
n=92 Participants
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.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.92 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
52.80 years
STANDARD_DEVIATION 8.465 • n=7 Participants
|
52.35 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Percent time Glucose >= 140mg/dL
|
5.80 percentage
STANDARD_DEVIATION 8.13 • n=5 Participants
|
6.82 percentage
STANDARD_DEVIATION 8.57 • n=7 Participants
|
6.29 percentage
STANDARD_DEVIATION 8.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: pre-treatment at baseline and post-treatment at ~12 weeksThe 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.
Outcome measures
| Measure |
Sleep Intervention
n=99 Participants
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.
|
Control
n=92 Participants
Participants in the control 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.
|
|---|---|---|
|
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
|
-0.49 Percent time glucose >= 140mg/dL
Standard Deviation 3.22
|
Adverse Events
Sleep Intervention
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sleep Intervention
n=99 participants at risk
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.
Sleep extension: Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.
|
Control
n=92 participants at risk
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.
Habitual sleep: The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times.
|
|---|---|---|
|
General disorders
compalints of "not feeling well"
|
7.1%
7/99 • Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.
|
0.00%
0/92 • Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.
|
|
General disorders
complaints of a head cold
|
6.1%
6/99 • Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.
|
0.00%
0/92 • Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.
|
Additional Information
Dr. Susan Malone
Rory Meyers College of Nursing, New York University
Phone: 212-992-7047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place