- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506151
Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes (SOPT)
March 4, 2024 updated by: Pamela Martyn-Nemeth, University of Illinois at Chicago
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
Recruiting
Conditions
Intervention / Treatment
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 (Estimated)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pamela Martyn-Nemeth, PhD
- Phone Number: 312-996-7903
- Email: pmartyn@uic.edu
Study Contact Backup
- Name: Sirimon Reutrakul, MD
- Email: sreutrak@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois Chicago
-
Contact:
- Pamela Martyn-Nemeth, PhD
- Phone Number: 312-996-7903
- Email: pmartyn@uic.edu
-
Contact:
- Sirimon Reutrakul, MD
- Phone Number: 3129966060
- Email: sreutrak@uic.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep-Opt
12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
|
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.
|
Healthy Living
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep variability
Time Frame: Change from week 0, 6, 12, 24
|
Standard deviation total sleep time for one week
|
Change from week 0, 6, 12, 24
|
Sleep duration
Time Frame: Change from weeks 0. 6, 12, 24
|
total sleep time
|
Change from weeks 0. 6, 12, 24
|
Glycemic control
Time Frame: Change from week 0. 6, 12, 24
|
HbA1c blood test
|
Change from week 0. 6, 12, 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes distress
Time Frame: Change from week 0. 6, 12, 24
|
T1D Diabetes Distress Scale score- higher numbers indicate greater distress
|
Change from week 0. 6, 12, 24
|
Self-management behavior
Time Frame: Change from week. 6, 12, 24
|
Self-Management Questionnaire score- higher numbers indicate better self-management
|
Change from week. 6, 12, 24
|
Fatigue
Time Frame: Change from week 0. 6, 12, 24
|
Patient Reported Outcomes Measure (PROMIS) fatigue scale score - higher numbers greater fatigue
|
Change from week 0. 6, 12, 24
|
Mood
Time Frame: Change from week 0. 6, 12, 24
|
Center for Epidemiological Studies - Depressed Mood score - Higher numbers more depressive mood
|
Change from week 0. 6, 12, 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pamela Martyn-Nemeth, PhD, University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2021
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
April 30, 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 (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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