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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Sleep-Opt; Behavioral: Healthy Living

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep-Opt; 12-week intervention that includes self-monitoring, goal setting, motivational enhancement.	Behavioral: Sleep-Opt; 12-week behavioral intervention
Active Comparator: Healthy Living; 12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.	Behavioral: Healthy Living; Healthy Living

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Variability Week 6	Standard deviation total sleep time for one week	Week 6
Sleep Variability Week 12	Standard deviation total sleep time for one week	Week 12
Sleep Variability Week 24	Standard deviation total sleep time for one week	Week 24
Sleep Duration Week 6	total sleep time minutes	Weeks 6
Sleep Duration Week 12	total sleep time in minutes	Week 12
Sleep Duration Week 24	total sleep time in minutes	Week 24
HbA1C Week 6	Hemoglobin A1C week 6, %	Week 6
HbA1C Week 12	HbA1c blood test	Week 12
HbA1C Week 24	HbA1c blood test	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Week 24
Glucose Time-in-range Week 6	Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.	Week 6
Glucose Time-in-range Week 12	Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.	Week 12
Glucose Time-in-range Week 24	Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tests of the Sleep Intervention Effect on A1C That is Due to the Change in 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.	week 12
Mediation Tests of the Sleep Intervention Effect on A1C That is Due to the Change in 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.	Week 12

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Pamela Martyn-Nemeth, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.
• Hong SJ, Pratuangtham S, Martyn-Nemeth P, Steffen AD, Park CG, Reutrakul S. Blue Light Exposure During Sleep in Type 1 Diabetes: Impacts on Glycemic Control and Psychosocial Health. J Sleep Res. 2026 Jun 5:e70380. doi: 10.1111/jsr.70380. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): December 21, 2024
• Study Completion (Actual): December 21, 2025

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2020-0374; 1R01DK121726 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No