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

Type 1 Diabetes Clinical Trial

— SOPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506151
• Other study ID #: 2020-0374
• Secondary ID: 1R01DK121726
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: University of Illinois at Chicago
• Contact: Pamela Martyn-Nemeth, PhD
• Phone: 312-996-7903
• Email: pmartyn[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Sleep-Opt
12-week behavioral intervention
• Healthy Living
Healthy Living

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep variability	Standard deviation total sleep time for one week	Change from week 0, 6, 12, 24
Primary	Sleep duration	total sleep time	Change from weeks 0. 6, 12, 24
Primary	Glycemic control	HbA1c blood test	Change from week 0. 6, 12, 24
Secondary	Diabetes distress	T1D Diabetes Distress Scale score- higher numbers indicate greater distress	Change from week 0. 6, 12, 24
Secondary	Self-management behavior	Self-Management Questionnaire score- higher numbers indicate better self-management	Change from week. 6, 12, 24
Secondary	Fatigue	Patient Reported Outcomes Measure (PROMIS) fatigue scale score - higher numbers greater fatigue	Change from week 0. 6, 12, 24
Secondary	Mood	Center for Epidemiological Studies - Depressed Mood score - Higher numbers more depressive mood	Change from week 0. 6, 12, 24