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Completed

NCT Number: NCT04506151

Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep-Opt

Behavioral

12-week behavioral intervention

Healthy Living

Behavioral

Healthy Living

Primary outcomes

  1. Sleep Variability Week 6

    Time frame: Week 6

    Standard deviation total sleep time for one week

  2. Sleep Variability Week 12

    Time frame: Week 12

    Standard deviation total sleep time for one week

  3. Sleep Variability Week 24

    Time frame: Week 24

    Standard deviation total sleep time for one week

  4. Sleep Duration Week 6

    Time frame: Weeks 6

    total sleep time minutes

  5. Sleep Duration Week 12

    Time frame: Week 12

    total sleep time in minutes

  6. Sleep Duration Week 24

    Time frame: Week 24

    total sleep time in minutes

  7. HbA1C Week 6

    Time frame: Week 6

    Hemoglobin A1C week 6, %

  8. HbA1C Week 12

    Time frame: Week 12

    HbA1c blood test

  9. HbA1C Week 24

    Time frame: Week 24

    HbA1c blood test

Secondary outcomes

  1. Diabetes Distress Week 6

    Time frame: 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

  2. Diabetes Distress Week 12

    Time frame: 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

  3. Diabetes Distress Week 24

    Time frame: 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

  4. Self-management Behavior Week 6

    Time frame: 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

  5. Self Management Behavior Week 12

    Time frame: 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

  6. Self Management Behavior Week 24

    Time frame: 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

  7. Quality of Life Week 6

    Time frame: 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

  8. Quality of Life Week 12

    Time frame: 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.

  9. Quality of Life Week 24

    Time frame: 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.

  10. Fatigue Week 6

    Time frame: 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.

  11. Fatigue Week 12

    Time frame: 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.

  12. Fatigue Week 24

    Time frame: 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.

  13. Mood Week 6

    Time frame: 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.

  14. Mood Week 12

    Time frame: 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.

  15. Mood Week 24

    Time frame: 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.

  16. Subjective Sleep Quality Week 6

    Time frame: 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.

  17. Subjective Sleep Quality Week 12

    Time frame: 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.

  18. Subjective Sleep Quality Week 24

    Time frame: 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.

  19. Glycemic Variability Week 6

    Time frame: Week 6

    Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.

  20. Glycemic Variability Week 12

    Time frame: Week 12

    Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.

  21. Glycemic Variability Week 24

    Time frame: Week 24

    Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.

  22. Glucose Time-in-range Week 6

    Time frame: Week 6

    Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.

  23. Glucose Time-in-range Week 12

    Time frame: Week 12

    Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.

  24. Glucose Time-in-range Week 24

    Time frame: Week 24

    Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.

Other outcomes

  1. Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Duration

    Time frame: week 12

    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.

  2. Mediation Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Variability.

    Time frame: Week 12

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: SOPT

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 10, 2020
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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