Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with negative health consequences including poor blood glucose control and greater diabetes complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes.
Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and insufficient sleep duration. The American Diabetes Association Standards of Medical Care in Diabetes incorporated sleep as an important component of the medical evaluation in persons with diabetes. However, no specific recommendation was given as to how to improve sleep. A significant gap of knowledge exists regarding the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability, time in range), diabetes distress, self-management behavior, QoL, and other patient reported outcomes in working-age adults with T1D and habitual increased sleep variability or short sleep duration. To achieve these aims, a randomized controlled trial is planned in 120 working age adults (18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (\> 1 hour/week) or insufficient sleep duration (\< 6.5 hours per night). Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention control group for twelve weeks. A one-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and time in range using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that this study team developed that leverages the rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). The behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. At midpoint (Week 6) completion (Week 12) and post-program (Week 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention.
12-week behavioral intervention
Healthy Living
University of Illinois Chicago
Chicago, Illinois, United States
Sleep Variability Week 6
Standard deviation total sleep time for one week
Time frame: Week 6
Sleep Variability Week 12
Standard deviation total sleep time for one week
Time frame: Week 12
Sleep Variability Week 24
Standard deviation total sleep time for one week
Time frame: Week 24
Sleep Duration Week 6
total sleep time minutes
Time frame: Weeks 6
Sleep Duration Week 12
total sleep time in minutes
Time frame: Week 12
Sleep Duration Week 24
total sleep time in minutes
Time frame: Week 24
HbA1C Week 6
Hemoglobin A1C week 6, %
Time frame: Week 6
HbA1C Week 12
HbA1c blood test
Time frame: Week 12
HbA1C Week 24
HbA1c blood test
Time frame: Week 24
Diabetes Distress Week 6
Type 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
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Time frame: Week 6
Diabetes Distress Week 12
Type 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
Time frame: Week 12
Diabetes Distress Week 24
Type 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
Time frame: Week 24
Self-management Behavior Week 6
Diabetes 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
Time frame: Week 6
Self Management Behavior Week 12
Diabetes 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
Time frame: Week 12
Self Management Behavior Week 24
Diabetes 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
Time frame: Week 24
Quality of Life Week 6
Diabetes 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
Time frame: Week 6
Quality of Life Week 12
Diabetes 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.
Time frame: Week 12
Quality of Life Week 24
Diabetes 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.
Time frame: Week 24
Fatigue Week 6
Patient 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.
Time frame: Week 6
Fatigue Week 12
Patient 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.
Time frame: Week 12
Fatigue Week 24
Patient 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.
Time frame: Week 24
Mood Week 6
Center 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.
Time frame: Week 6
Mood Week 12
Center 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.
Time frame: Week 12
Mood Week 24
Center 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.
Time frame: Week 24
Subjective Sleep Quality Week 6
Pittsburgh 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.
Time frame: Week 6
Subjective Sleep Quality Week 12
Pittsburgh 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.
Time frame: Week 12
Subjective Sleep Quality Week 24
Pittsburgh 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.
Time frame: Week 24
Glycemic Variability Week 6
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Time frame: Week 6
Glycemic Variability Week 12
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Time frame: Week 12
Glycemic Variability Week 24
Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
Time frame: Week 24
Glucose Time-in-range Week 6
Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Time frame: Week 6
Glucose Time-in-range Week 12
Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Time frame: Week 12
Glucose Time-in-range Week 24
Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
Time frame: Week 24