NCT03064321

Diabetes Sleep Treatment Trial for Insomnia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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	Information on websites that are general health promoting

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2017-02-27
• Last updated: 2021-02-10

Locations

1 site across 1 country: United States