Diabetes Sleep Treatment Trial for Insomnia

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.

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 [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)