search
Back to results

Diabetes Sleep Treatment Trial for Insomnia (DSTT-I)

Primary Purpose

Insomnia, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insomnia Intervention
Information Control
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring cognitive behavioral treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Insomnia Intervention

Information Control

Arm Description

Insomnia intervention delivered via web using Cognitive Behavior Treatment

General health information website

Outcomes

Primary Outcome Measures

Average Glucose Control for Last 3 Months Assessed by A!C level
A1C level

Secondary Outcome Measures

Sleep Quality
Scores on the Pittsburgh Sleep Quality Index questionnaire

Full Information

First Posted
February 15, 2017
Last Updated
February 9, 2021
Sponsor
University of Pittsburgh
search

1. Study Identification

Unique Protocol Identification Number
NCT03064321
Brief Title
Diabetes Sleep Treatment Trial for Insomnia
Acronym
DSTT-I
Official Title
Self-Management, Insomnia, and Glucose Control in Adults With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Diabetes Mellitus, Type 2
Keywords
cognitive behavioral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insomnia Intervention
Arm Type
Experimental
Arm Description
Insomnia intervention delivered via web using Cognitive Behavior Treatment
Arm Title
Information Control
Arm Type
Other
Arm Description
General health information website
Intervention Type
Behavioral
Intervention Name(s)
Insomnia Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information Control
Intervention Description
Information on websites that are general health promoting
Primary Outcome Measure Information:
Title
Average Glucose Control for Last 3 Months Assessed by A!C level
Description
A1C level
Time Frame
After 12 weeks of either the insomnia intervention or the information control intervention
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Scores on the Pittsburgh Sleep Quality Index questionnaire
Time Frame
After 12 weeks of either the insomnia intervention or the information control intervention
Other Pre-specified Outcome Measures:
Title
Insomnia Severity
Description
Scores on the Insomnia Severity Index questionnaire
Time Frame
After 12 weeks of either the insomnia intervention or the information control intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen R Chasens
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh School of Nursing
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diabetes Sleep Treatment Trial for Insomnia

We'll reach out to this number within 24 hrs