Trial Outcomes & Findings for Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes (NCT NCT04506151)
NCT ID: NCT04506151
Last Updated: 2026-08-27
Results Overview
total sleep time minutes
COMPLETED
NA
144 participants
Weeks 6
2026-08-27
Participant Flow
Participants were recruited both locally and nationally. Local recruitment was achieved through the University of Illinois Chicago medical center/university, diabetes clinics in the Chicago metropolitan area, diabetes websites and organizations, using flyers, e-announcements, recruitment letters and listservs. Participants were recruited nationally through Research Match (www.researchmatch.org) and the T1D Exchange, and diabetes social media sites.
After those who met study criteria by initial phone screening and informed consent was obtained, participants completed a 1-week run-in period and a confirmation of inclusion criteria, which served as baseline (week 0) data collection.
Participant milestones
| Measure |
Sleep-Opt
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
Healthy Living
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
71
|
|
Overall Study
COMPLETED
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Sleep-Opt
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
Healthy Living
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Time constraint
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
data collection only
|
0
|
1
|
Baseline Characteristics
Missing complete data on 1 participant
Baseline characteristics by cohort
| Measure |
Sleep-Opt
n=73 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
Healthy Living
n=71 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=73 Participants
|
8 Participants
n=71 Participants
|
14 Participants
n=144 Participants
|
|
Age, Continuous
|
38.2 Years
STANDARD_DEVIATION 11.8 • n=73 Participants
|
38.2 Years
STANDARD_DEVIATION 11.3 • n=71 Participants
|
38.2 Years
STANDARD_DEVIATION 11.5 • n=144 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=73 Participants
|
45 Participants
n=71 Participants
|
94 Participants
n=144 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=73 Participants
|
26 Participants
n=71 Participants
|
50 Participants
n=144 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=73 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=73 Participants
|
2 Participants
n=71 Participants
|
5 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=73 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=73 Participants
|
5 Participants
n=71 Participants
|
14 Participants
n=144 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=73 Participants
|
60 Participants
n=71 Participants
|
117 Participants
n=144 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=73 Participants
|
4 Participants
n=71 Participants
|
8 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=73 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=73 Participants
|
63 Participants
n=71 Participants
|
130 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=73 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=144 Participants
|
|
Sleep Variability
|
75.2 minutes
STANDARD_DEVIATION 30.8 • n=73 Participants • Missing complete data on 1 participant
|
69.3 minutes
STANDARD_DEVIATION 31.3 • n=70 Participants • Missing complete data on 1 participant
|
72.3 minutes
STANDARD_DEVIATION 31.0 • n=143 Participants • Missing complete data on 1 participant
|
|
Sleep Duration
|
390.8 Minutes
STANDARD_DEVIATION 47.0 • n=73 Participants • Missing complete data on 1 participant
|
377.9 Minutes
STANDARD_DEVIATION 48.2 • n=70 Participants • Missing complete data on 1 participant
|
384 Minutes
STANDARD_DEVIATION 48 • n=143 Participants • Missing complete data on 1 participant
|
|
Hemoglobin A1C
|
6.72 percent
STANDARD_DEVIATION 0.85 • n=73 Participants • Missing A1C data on one participant.
|
6.63 percent
STANDARD_DEVIATION 0.82 • n=70 Participants • Missing A1C data on one participant.
|
6.70 percent
STANDARD_DEVIATION 0.83 • n=143 Participants • Missing A1C data on one participant.
|
|
Glucose variability (coefficient of variation -CV%)
|
37.3 Percent
STANDARD_DEVIATION 6.4 • n=69 Participants • Missing glucose data
|
36.8 Percent
STANDARD_DEVIATION 8.1 • n=67 Participants • Missing glucose data
|
37 Percent
STANDARD_DEVIATION 7.26 • n=136 Participants • Missing glucose data
|
|
Glucose time-in-range
|
66.62 percent
STANDARD_DEVIATION 15.94 • n=69 Participants • Missing data
|
70.87 percent
STANDARD_DEVIATION 15.3 • n=67 Participants • Missing data
|
68.7 percent
STANDARD_DEVIATION 15.7 • n=136 Participants • Missing data
|
|
Type 1 Diabetes Distress Scale measures diabetes distress
|
1.87 Scale score
STANDARD_DEVIATION 0.62 • n=72 Participants • Missing data one participant
|
1.99 Scale score
STANDARD_DEVIATION 0.93 • n=71 Participants • Missing data one participant
|
1.93 Scale score
STANDARD_DEVIATION 0.79 • n=143 Participants • Missing data one participant
|
|
Diabetes Self Management-Questionnaire R- measures diabetes self-management behavior
|
7.5 Scale score
STANDARD_DEVIATION 1.14 • n=72 Participants • Missing data one participant
|
7.78 Scale score
STANDARD_DEVIATION 1.28 • n=71 Participants • Missing data one participant
|
7.64 Scale score
STANDARD_DEVIATION 1.22 • n=143 Participants • Missing data one participant
|
|
Diabetes Quality of Life Scale was used to measure quality of life
|
69.68 Scale score
STANDARD_DEVIATION 10.84 • n=71 Participants • Missing data
|
67.94 Scale score
STANDARD_DEVIATION 12.63 • n=71 Participants • Missing data
|
68.61 Scale score
STANDARD_DEVIATION 11.76 • n=142 Participants • Missing data
|
|
PROMIS Fatigue Scale was used to measure fatigue
|
52.08 T-score
STANDARD_DEVIATION 7.87 • n=72 Participants • Missing data
|
53.5 T-score
STANDARD_DEVIATION 8.15 • n=71 Participants • Missing data
|
52.79 T-score
STANDARD_DEVIATION 8.02 • n=143 Participants • Missing data
|
|
Center for Epidemiological Studies Depression Scale was used to measure depressive mood
|
10.22 Scale score
STANDARD_DEVIATION 7.03 • n=72 Participants • Missing data
|
10.9 Scale score
STANDARD_DEVIATION 9.25 • n=71 Participants • Missing data
|
10.56 Scale score
STANDARD_DEVIATION 8.19 • n=143 Participants • Missing data
|
|
Pittsburgh Sleep Quality Index was used to measure subjective sleep quality
|
8.78 Scale score
STANDARD_DEVIATION 2.32 • n=72 Participants • missing data
|
9.06 Scale score
STANDARD_DEVIATION 2.38 • n=71 Participants • missing data
|
8.92 Scale score
STANDARD_DEVIATION 2.35 • n=143 Participants • missing data
|
PRIMARY outcome
Timeframe: Week 6Standard deviation total sleep time for one week
Outcome measures
| Measure |
Healthy Living
n=56 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=59 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Sleep Variability Week 6
|
63.74 minutes
Standard Deviation 34.81
|
65.92 minutes
Standard Deviation 31.11
|
PRIMARY outcome
Timeframe: Week 12Standard deviation total sleep time for one week
Outcome measures
| Measure |
Healthy Living
n=60 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=60 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Sleep Variability Week 12
|
64.06 minutes
Standard Deviation 29.39
|
65.27 minutes
Standard Deviation 39.45
|
PRIMARY outcome
Timeframe: Week 24Standard deviation total sleep time for one week
Outcome measures
| Measure |
Healthy Living
n=56 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=59 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Sleep Variability Week 24
|
71.04 Standard deviation total sleep time (min
Standard Deviation 34.27
|
69.41 Standard deviation total sleep time (min
Standard Deviation 29.66
|
PRIMARY outcome
Timeframe: Weeks 6total sleep time minutes
Outcome measures
| Measure |
Healthy Living
n=56 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=59 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Sleep Duration Week 6
|
385.29 Sleep duration, minutes
Standard Deviation 44.96
|
411.53 Sleep duration, minutes
Standard Deviation 47.31
|
PRIMARY outcome
Timeframe: Week 12total sleep time in minutes
Outcome measures
| Measure |
Healthy Living
n=60 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=60 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Sleep Duration Week 12
|
384.84 sleep duration, minutes
Standard Deviation 50.74
|
405.39 sleep duration, minutes
Standard Deviation 48.48
|
PRIMARY outcome
Timeframe: Week 24total sleep time in minutes
Outcome measures
| Measure |
Healthy Living
n=56 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=59 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Sleep Duration Week 24
|
394.94 sleep duration, minutes
Standard Deviation 51.59
|
392.21 sleep duration, minutes
Standard Deviation 49.66
|
PRIMARY outcome
Timeframe: Week 6Hemoglobin A1C week 6, %
Outcome measures
| Measure |
Healthy Living
n=60 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
HbA1C Week 6
|
6.61 A1C, %
Standard Deviation 0.85
|
6.8 A1C, %
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: Week 12HbA1c blood test
Outcome measures
| Measure |
Healthy Living
n=62 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
HbA1C Week 12
|
6.75 A1C, %
Standard Deviation 1.07
|
6.75 A1C, %
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: Week 24HbA1c blood test
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
HbA1C Week 24
|
6.66 A1C, %
Standard Deviation 0.97
|
6.67 A1C, %
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 6Type 1 Diabetes Distress Scale measures diabetes distress. Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=59 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Diabetes Distress Week 6
|
2.13 score
Standard Deviation 0.83
|
1.83 score
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Week 12Type 1 Diabetes Distress Scale measures diabetes distress. Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=63 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=64 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Diabetes Distress Week 12
|
2.01 score
Standard Deviation 0.89
|
1.88 score
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Week 24Type 1 Diabetes Distress Scale measures diabetes distress. Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Diabetes Distress Week 24
|
1.99 score
Standard Deviation 0.87
|
1.83 score
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Week 6Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items \* 10). Ranges from 0-10. Higher numbers indicate better self-management behavior Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Self-management Behavior Week 6
|
7.77 score
Standard Deviation 1.3
|
7.56 score
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Week 12Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items \* 10). Scores ranges from 0-10. Higher numbers indicate better self-management behavior Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=63 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=64 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Self Management Behavior Week 12
|
7.64 score
Standard Deviation 1.31
|
7.69 score
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Week 24Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items \* 10). Ranges from 0-10. Higher numbers indicate better self-management behavior Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Self Management Behavior Week 24
|
7.53 score
Standard Deviation 1.38
|
7.56 score
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Week 6Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range \* 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale
Outcome measures
| Measure |
Healthy Living
n=58 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=61 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Quality of Life Week 6
|
68.19 Score
Standard Deviation 11.83
|
70.77 Score
Standard Deviation 10.46
|
SECONDARY outcome
Timeframe: Week 12Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range \* 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=63 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=64 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Quality of Life Week 12
|
69.96 score
Standard Deviation 13.8
|
71.12 score
Standard Deviation 12.35
|
SECONDARY outcome
Timeframe: Week 24Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range \* 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Quality of Life Week 24
|
70.29 score
Standard Deviation 12.89
|
71.83 score
Standard Deviation 12.19
|
SECONDARY outcome
Timeframe: Week 6Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue.
Outcome measures
| Measure |
Healthy Living
n=59 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Fatigue Week 6
|
53.69 t- score
Standard Deviation 9.48
|
50.64 t- score
Standard Deviation 9.05
|
SECONDARY outcome
Timeframe: Week 12Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue.
Outcome measures
| Measure |
Healthy Living
n=63 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=64 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Fatigue Week 12
|
51.96 t-score
Standard Deviation 8.87
|
49.9 t-score
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: Week 24Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue.
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Fatigue Week 24
|
51.25 t- score
Standard Deviation 8.35
|
48.5 t- score
Standard Deviation 9.94
|
SECONDARY outcome
Timeframe: Week 6Center for Epidemiological Studies-Depression (CES-D) measures depressive mood. Total summed score ranges from 0-60. Higher scores indicate greater depressive mood. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=59 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Mood Week 6
|
11.88 score
Standard Deviation 7.88
|
12.19 score
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: Week 12Center for Epidemiological Studies-Depression (CES-D) measures depressive mood. Total summed score ranges from 0-60. Higher scores indicate greater depressive mood. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=63 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=64 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Mood Week 12
|
12.03 score
Standard Deviation 7.96
|
11.3 score
Standard Deviation 9.47
|
SECONDARY outcome
Timeframe: Week 24Center for Epidemiological Studies-Depression (CES-D) measures depressive mood. Total summed score ranges from 0-60. Higher scores indicate greater depressive mood. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Mood Week 24
|
11.72 score
Standard Deviation 8.9
|
9.87 score
Standard Deviation 8.83
|
SECONDARY outcome
Timeframe: Week 6Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. Total summed score ranges 0-21. Higher score reflects poorer sleep quality. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=60 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Subjective Sleep Quality Week 6
|
8.55 score
Standard Deviation 2.41
|
7.6 score
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Week 12Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. Total summed score ranges 0-21. Higher score reflects poorer sleep quality. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=63 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=64 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Subjective Sleep Quality Week 12
|
8.05 score
Standard Deviation 2.14
|
7.61 score
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Week 24Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. Total summed score ranges 0-21. Higher score reflects poorer sleep quality. Unit of measure = units on a scale.
Outcome measures
| Measure |
Healthy Living
n=61 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=63 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Subjective Sleep Quality Week 24
|
7.79 score
Standard Deviation 2.15
|
7.17 score
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Week 6Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Outcome measures
| Measure |
Healthy Living
n=58 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=58 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Glycemic Variability Week 6
|
36.4 percent
Standard Deviation 9.25
|
37.57 percent
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Week 12Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Outcome measures
| Measure |
Healthy Living
n=60 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=60 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Glycemic Variability Week 12
|
36.42 percent
Standard Deviation 7.94
|
37.91 percent
Standard Deviation 6.64
|
SECONDARY outcome
Timeframe: Week 24Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Outcome measures
| Measure |
Healthy Living
n=57 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=56 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Glycemic Variability Week 24
|
35.4 percent
Standard Deviation 7.35
|
37.44 percent
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: Week 6Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Outcome measures
| Measure |
Healthy Living
n=56 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=58 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Glucose Time-in-range Week 6
|
72.82 percent
Standard Deviation 16.96
|
67.53 percent
Standard Deviation 15.43
|
SECONDARY outcome
Timeframe: Week 12Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Outcome measures
| Measure |
Healthy Living
n=60 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=60 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Glucose Time-in-range Week 12
|
69.96 percent
Standard Deviation 17.76
|
66.98 percent
Standard Deviation 16.34
|
SECONDARY outcome
Timeframe: Week 24Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Outcome measures
| Measure |
Healthy Living
n=57 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=56 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Glucose Time-in-range Week 24
|
69.78 percent
Standard Deviation 17.28
|
69.1 percent
Standard Deviation 14.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 12Population: Results are not reported by treatment arm. The mediation effect is the change in A1C attributable to the intervention due to its effect on sleep duration.
Mediation tests of the sleep intervention effect on A1C that is due to the change in sleep duration. It is the product of parameter estimates testing the effect of the intervention on sleep duration and the mediating effect of the change in sleep duration on A1C. Markov chain Monte Carlo (MCMC) models were used.
Outcome measures
| Measure |
Healthy Living
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=124 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Duration
|
—
|
0.00 Parameter estimates of mediation effect
Interval -0.05 to 0.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Results are not reported by treatment arm. The mediation effect is the change in A1C attributable to the intervention due to its effect on sleep variability.
Results are not reported by treatment arm. This analysis tests the sleep intervention effect on A1C that is mediated by the change in sleep variability. The values reported are the product of parameter estimates testing the effect of the intervention on sleep variability and the effect of the change in sleep variability on A1C. Markov chain Monte Carlo (MCMC) models were used.
Outcome measures
| Measure |
Healthy Living
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=124 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Mediation Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Variability.
|
—
|
0.00 Parameter estimate of mediation effect
Interval -0.04 to 0.03
|
POST_HOC outcome
Timeframe: 12 weeksPopulation: analysis stratified based on A1C; there were 4 groups
Effect on Hemoglobin A1C% by subgroups defined as: below 7% or greater than or equal to 7%. Percent is the unit of measure of A1C
Outcome measures
| Measure |
Healthy Living
n=62 Participants
12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
|
Sleep-Opt
n=62 Participants
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
|---|---|---|
|
Treatment Effect Based on Baseline A1C Level
A1C >/= 7%
|
7.09 percent
Standard Error 0.13
|
6.76 percent
Standard Error 0.13
|
|
Treatment Effect Based on Baseline A1C Level
A1C < 7%
|
6.67 percent
Standard Error .09
|
6.77 percent
Standard Error 0.09
|
Adverse Events
Sleep-Opt
Healthy Living
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place