Diabetes Sleep Treatment Trial for Insomnia

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Insomnia
• Interventions: Behavioral: Insomnia Intervention; Other: Information Control

• Registration Number: NCT03064321
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-27
• Study Start: 2017-11-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insomnia Intervention	Insomnia Intervention	Insomnia intervention delivered via web using Cognitive Behavior Treatment
Information Control	Information Control	General health information website

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	After 12 weeks of either the insomnia intervention or the information control intervention	Scores on the Pittsburgh Sleep Quality Index questionnaire

Trial Locations

Locations (1)

University of Pittsburgh School of Nursing; 🇺🇸 Pittsburgh, Pennsylvania, United States