Diabetes Sleep Treatment Trial for Insomnia (DSTT-I)

February 9, 2021 updated by: Eileen R. Chasens, University of Pittsburgh

Self-Management, Insomnia, and Glucose Control in Adults With Diabetes

This study will test the effect of the an insomnia intervention with cognitive behavioral treatment delivered via web compared with an information control group on glucose control and self management behavioral in a sample of persons with type 2 diabetes (T2DM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Recent evidence supports that insomnia is a prevalent problem among persons with type 2 diabetes that may be associated with increased daytime sleepiness and fatigue, increased diabetes-related distress, decreased self-management behavior, and worse glycemic control. The main hypothesis of the current application is that a web-based cognitive behavioral treatment of insomnia (Sleep Health Using the Internet: SHUTi) in persons with T2DM will not only improve their nighttime sleep, but also improve their ability to integrate diabetes education into their daily behavior and positively affect their glucose control compared to a web-based Information Control (IC) group. The aims of this study are to 1) obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a randomized clinical trial to examine if treatment of insomnia results in participant's being better able to integrate diabetes education into their self-management behavior and result in improved glucose control, 2) explore the associations among changes in insomnia severity, fatigue, daytime sleepiness, sleep quality, A1C (a measure of glucose control over the last three months) and diabetes self-management (DSM) behaviors, 3) explore average pre-intervention to post-intervention changes in insomnia severity, daytime symptoms (fatigue, sleepiness, mood) and DSM behaviors (diet and physical activity) in subjects treated with SHUTi + DSM compared to IC + DSM subjects at 3 months, and 4) explore sleep fragmentation as a potential physiological mechanism linking impaired glucose control (A1C) and sleep in subjects with insomnia and T2DM at baseline and 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh School of Nursing

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) T2DM with suboptimal glucose control
  • (2) age 18 years or older;
  • (3) willing to be randomized to SHUTi or IC group;
  • (4) able to speak, read, and write in English, and
  • (5) insomnia symptoms with at least one daytime consequence [e.g. impaired mood, poor sleep quality, excessive daytime sleepiness, fatigue].

Exclusion Criteria:

  • Type 1 or gestational diabetes
  • Change in oral medications or > 10% change in insulin in last 3 months
  • Acute medical or psychiatric illness or hospitalization ≤ 3 months (such as angina, stroke, major surgery, major depression or serious psychiatric conditions)
  • AHI (apnea-hypopnea index; apnea [cessation of breathing] or hypopnea [reduction in breathing]) ≥ 10 episodes an hour on overnight sleep study
  • Non-ambulatory
  • Self-reported epilepsy, psychotic or bipolar disorder
  • History of near-miss or auto accident during last 12 months
  • Employed in safety sensitive job (e.g. truck driver or airline pilot)
  • Working nights or rotating shifts
  • Regular use of alerting (e.g., modafinil) medications
  • Consumption of alcohol: Men: > 4 drinks a day or > 14 drinks per week
  • Women: > 3 drinks a day or > 7 drinks per week
  • If using sleep medications, the drug and/or dose changed in the past month
  • Depression
  • Medications for psychotic or bipolar disorders
  • No internet access
  • Pregnant or intend to become pregnant in the next four months (postmenopausal or confirmed not pregnant by a urine pregnancy test)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Insomnia Intervention
Insomnia intervention delivered via web using Cognitive Behavior Treatment
Behavioral: Insomnia Intervention
The SHUTi intervention is based on a cognitive behavioral treatment for insomnia (CBT-I) and organized into six structured, weekly online sessions. Each week the participants will complete a 30-minute interactive learning module and to complete daily online sleep diaries will be used.
OTHER: Information Control
General health information website
Other: Information Control
Information on websites that are general health promoting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Glucose Control for Last 3 Months Assessed by A!C level
Time Frame: After 12 weeks of either the insomnia intervention or the information control intervention
A1C level
After 12 weeks of either the insomnia intervention or the information control intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: After 12 weeks of either the insomnia intervention or the information control intervention
Scores on the Pittsburgh Sleep Quality Index questionnaire
After 12 weeks of either the insomnia intervention or the information control intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insomnia Severity
Time Frame: After 12 weeks of either the insomnia intervention or the information control intervention
Scores on the Insomnia Severity Index questionnaire
After 12 weeks of either the insomnia intervention or the information control intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eileen R Chasens, University of Pittsburgh

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K24NR016685-01A1 (NIH)

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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