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

NCT ID: NCT04506151

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2026-04-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sleep-Opt

12-week intervention that includes self-monitoring, goal setting, motivational enhancement.

Group Type: EXPERIMENTAL

Sleep-Opt

Intervention Type: BEHAVIORAL

12-week behavioral intervention

Healthy Living

12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.

Group Type: ACTIVE_COMPARATOR

Healthy Living

Intervention Type: BEHAVIORAL

Healthy Living

Interventions

Sleep-Opt

12-week behavioral intervention

Intervention Type: BEHAVIORAL

Healthy Living

Healthy Living

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Pamela Martyn-Nemeth

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Martyn-Nemeth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35986415 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK121726

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0374

Identifier Type: -

Identifier Source: org_study_id