Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSleep-Opt
12-week behavioral intervention
BEHAVIORALHealthy Living
Healthy Living
Sponsors
University of Illinois at Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Sleep optimization intervention will be compared to an attention control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adults aged 18-65 years * clinical diagnosis of type 1 diabetes minimum of one year * reported habitual sleep variability (1 hour/week or more) or sleep duration less than 6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch) * a desire to improve sleep * own a smartphone
Exclusion criteria
* insomnia symptoms * at high risk for obstructive sleep apnea * severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness) * A1C greater than 10% * rotating shift or night shift work * use of sleep medications/aids * renal impairment (estimated glomerular filtration rate \< 45 ml/min) * significant current medical morbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, depression, history of stroke with neurological deficits * breast feeding, pregnant, or planning pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Variability Week 12 | Week 12 | Standard deviation total sleep time for one week |
| Sleep Variability Week 24 | Week 24 | Standard deviation total sleep time for one week |
| Sleep Duration Week 6 | Weeks 6 | total sleep time minutes |
| Sleep Duration Week 12 | Week 12 | total sleep time in minutes |
| Sleep Duration Week 24 | Week 24 | total sleep time in minutes |
| HbA1C Week 6 | Week 6 | Hemoglobin A1C week 6, % |
| HbA1C Week 12 | Week 12 | HbA1c blood test |
| HbA1C Week 24 | Week 24 | HbA1c blood test |
| Sleep Variability Week 6 | Week 6 | Standard deviation total sleep time for one week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Variability Week 24 | Week 24 | Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100. |
| Glucose Time-in-range Week 6 | Week 6 | Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL. |
| Glucose Time-in-range Week 12 | Week 12 | Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL. |
| Glucose Time-in-range Week 24 | Week 24 | Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL. |
| Fatigue Week 12 | 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. |
| Diabetes Distress Week 6 | 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 |
| Diabetes Distress Week 12 | 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 |
| Diabetes Distress Week 24 | 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 |
| Self-management Behavior Week 6 | 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 |
| Self Management Behavior Week 12 | 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 |
| Self Management Behavior Week 24 | 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 |
| Quality of Life Week 6 | 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 |
| Quality of Life Week 12 | 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. |
| Quality of Life Week 24 | 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. |
| Fatigue Week 24 | 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. |
| Fatigue Week 6 | 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. |
| Mood Week 6 | 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. |
| Mood Week 12 | 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. |
| Mood Week 24 | 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. |
| Subjective Sleep Quality Week 6 | 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. |
| Subjective Sleep Quality Week 12 | 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. |
| Subjective Sleep Quality Week 24 | 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. |
| Glycemic Variability Week 6 | Week 6 | Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100. |
| Glycemic Variability Week 12 | Week 12 | Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPamela Martyn-Nemeth, PhD
University of Illinois at Chicago
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.2 Years STANDARD_DEVIATION 11.5 |
| Center for Epidemiological Studies Depression Scale was used to measure depressive mood | 10.22 Scale score STANDARD_DEVIATION 7.03 |
| Diabetes Quality of Life Scale was used to measure quality of life | 69.68 Scale score STANDARD_DEVIATION 10.84 |
| Diabetes Self Management-Questionnaire R- measures diabetes self-management behavior | 7.5 Scale score STANDARD_DEVIATION 1.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Glucose time-in-range | 70.87 percent STANDARD_DEVIATION 15.3 |
| Glucose variability (coefficient of variation -CV%) | 37.3 Percent STANDARD_DEVIATION 6.4 |
| Hemoglobin A1C | 6.70 percent STANDARD_DEVIATION 0.83 |
| Pittsburgh Sleep Quality Index was used to measure subjective sleep quality | 9.06 Scale score STANDARD_DEVIATION 2.38 |
| PROMIS Fatigue Scale was used to measure fatigue | 52.08 T-score STANDARD_DEVIATION 7.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 24 Participants |
| Sleep Duration | 390.8 Minutes STANDARD_DEVIATION 47 |
| Sleep Variability | 69.3 minutes STANDARD_DEVIATION 31.3 |
| Type 1 Diabetes Distress Scale measures diabetes distress | 1.99 Scale score STANDARD_DEVIATION 0.93 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 71 |
| other Total, other adverse events | 0 / 73 | 0 / 71 |
| serious Total, serious adverse events | 0 / 73 | 0 / 71 |
Outcome results
None listed