Clinical trial NCT03064321: Diabetes Sleep Treatment Trial for Insomnia
Official title: Self-Management, Insomnia, and Glucose Control in Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Diabetes Mellitus, Type 2
Keywords: cognitive behavioral treatment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group design
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Average Glucose Control for Last 3 Months Assessed by A!C level
timeFrame: After 12 weeks of either the insomnia intervention or the information control intervention
Secondary outcomes:
measure: Sleep Quality
timeFrame: After 12 weeks of either the insomnia intervention or the information control intervention
Other outcomes:
measure: Insomnia Severity
timeFrame: After 12 weeks of either the insomnia intervention or the information control intervention
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eileen R Chasens
role: PRINCIPAL_INVESTIGATOR
References: