- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617770
A Sleep Intervention in Type 1 Diabetes
March 4, 2024 updated by: Pamela Martyn-Nemeth, University of Illinois at Chicago
A Sleep Intervention to Improve Glycemic Control and Reduce Diabetes Distress in Working Adults With Type 1 Diabetes
Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glucose control and diabetes distress in type 1 diabetes (T1D).
Up to 40% of adults with T1D had a sleep duration less than 6-6.5 hours per night.
Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glucose control.
Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of strategies to improve sleep on diabetes distress, and glucose control is limited.
The purpose of this pilot study is to evaluate the effects of a sleep intervention on sleep duration, diabetes distress and glucose control in individuals with T1D and habitual short sleep.
A randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed.
Eligible participants will be randomly assigned to a sleep intervention group or a control group.
Differences between the two groups on the outcomes of sleep duration, diabetes distress and glucose control will be evaluated.
Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glucose control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glycemic control and diabetes distress in type 1 diabetes (T1D).
Up to 40% of adults with T1D had a sleep duration < 6-6.5 hours per night, either by self-report or objectively assessed actigraphy.
Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glycemic control.
Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of sleep optimization on sleep, diabetes distress, and glycemic control is limited.
The purpose of this pilot and feasibility trial is to evaluate the effects of a T1D-specific sleep optimization intervention (Sleep-Opt-In) on the outcomes of sleep, diabetes distress and glycemic control in individuals with T1D and habitual short sleep.
The specific aims are to determine if Sleep-Opt-In will: 1) be feasible and acceptable to the target population; 2) result in improved sleep duration and regularity; 3) result in improved glycemic control; and 4) lower diabetes distress.
To achieve these aims, a randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed.
Participants will be screened for habitual sleep duration < 6.5 hours per night.
Eligible subjects will be randomized to the T1D-Sleep-Opt-In group or attention control group.
A one-week run-in period is planned, with baseline measures of sleep (duration and regularity), glycemia (A1C, fructosamine, glycemic variability), and diabetes distress (Diabetes Distress Scale).
The T1D-Sleep-Opt-In will entail a novel technology-assisted behavioral sleep extension intervention developed to leverage rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years).
This technology employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling.
The intervention will be T1D-specific by addressing T1D-related sleep issues such as nocturnal hypoglycemia.
The attention control group will participate in a healthy living information program.
At completion (Week 8) and post-program (Weeks 12 and 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention.
Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glycemic control.
Study Type
Interventional
Enrollment (Actual)
14
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 Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
-
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:
- type 1 diabetes for one year or more
- self-reported habitual sleep duration less than 6.5 hours per night during work- or weekdays
- own a smartphone.
Exclusion Criteria:
- insomnia
- sleep apnea
- severe hypoglycemia within past 6 months
- treated with an insulin pump with hybrid closed-loop features
- rotating shift or night shift work
- estimated glomerular filtration rate less than 45 ml/min
- heart failure
- cirrhosis
- chronic obstructive pulmonary disease requiring oxygen
- actively treated for cancer or psychiatric problem
- history of stroke
- pregnant or planning pregnancy
- HbA1c 10% or higher.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep-Opt-In
Sleep optimization intervention
|
8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling
|
Active Comparator: Healthy Living
Health education
|
8-week intervention that includes weekly telephone counseling on healthy living.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Duration
Time Frame: Assessing change between two time points:Week 0 to week 8
|
change in minutes of sleep (actigraphy-derived)
|
Assessing change between two time points:Week 0 to week 8
|
Sleep Regularity
Time Frame: Assessing change between two time points: from week 0 to week 8
|
Change in sleep regularity (variability)
|
Assessing change between two time points: from week 0 to week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Change between two time points, week 0 to week 8
|
HbA1c (A1C%)
|
Change between two time points, week 0 to week 8
|
Glucose Variability
Time Frame: Assessing change between two time points: from week 0 to week 8
|
Change in glucose variability (CV%) (continuous glucose monitor derived)
|
Assessing change between two time points: from week 0 to week 8
|
Diabetes Distress
Time Frame: Assessing change between two time points: from week 0 to week 8
|
Change in Diabetes Distress Scale score, 6-point, 17-item Likert scale. The 17 items are summed. The sum score is divided by 17 to provide a mean item score. Higher scores indicate greater distress. Score interpretation: < 2.0 = little distress 2.0-2.9 = moderate distress 3.0 or greater = hah distress |
Assessing change between two time points: from week 0 to week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Pamela Martyn-Nemeth, PhD, University of Illinois at Chicago
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 9, 2019
Primary Completion (Actual)
November 20, 2019
Study Completion (Actual)
November 20, 2019
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
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
- 2018-0762
- P30DK092949 (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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