Diabetes Sleep Treatment Trial for Insomnia (DSTT-I)

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: Completed
• Conditions: Diabetes Mellitus, Type 2; Insomnia
• Intervention / Treatment: Behavioral: Insomnia Intervention; Other: Information Control

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: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Average Glucose Control for Last 3 Months Assessed by A!C level	A1C level	After 12 weeks of either the insomnia intervention or the information control intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Scores on the Pittsburgh Sleep Quality Index questionnaire	After 12 weeks of either the insomnia intervention or the information control intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity	Scores on the Insomnia Severity Index questionnaire	After 12 weeks of either the insomnia intervention or the information control intervention

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Eileen R Chasens, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cognitive behavioral treatment
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders
• Other Study ID 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