Het effect van cognitieve gedragstherapie voor slapeloosheid op slaap- en glycemische uitkomsten bij mensen met diabetes type 2: een gerandomiseerde gecontroleerde studie

We established the following objectives: 1) investigate if improving sleep by internet-based cognitive behavioural therapy (CBT) can improve insomnia and glycaemic control in people with T2DM; 2) assess whether CBT also improves BMI, waist circumference, lipids, blood pressure, dietary intake, physical activity, mood and quality of life. We will therefore perform a randomized controlled trial to assess the effect of CBT (i-sleep) versus care as usual on insomnia and glycaemic control in 80 people with T2DM and insomnia. Randomization will take place at the individual level on a 1:1 ratio, using random sequence block randomisation (blocks of 2 or 4 or 6). Participants will receive the outcome of randomization by email. Due to the nature and design of the study, blinding of the researchers and participants is not possible. This multi-disciplinary and innovative project will provide information on the pathophysiology of sleep and T2DM progression as well as provide a ready-to-use, targeted intervention. Because would it not be great if we can improve glycaemic status in people with T2DM by improving sleep, rather than prescribing pills?

We hypothesize that improving sleep will improve glycaemic control in people with T2DM and insomnia.

Baseline, 3 months and 6 months

The I-Sleep intervention is a 5 week online CBT i-sleep program to be completed by the participant at home and consisting of psycho-education, sleep hygiene, sleep restriction, stimulus control, cognitive restructuring and relapse prevention. A research nurse will offer guidance and feedback to increase motivation and adherence. The control condition is care-as usual. The control group will gain access to the intervention six months after inclusion.