We hypothesize that improving sleep will improve glycaemic control in people with T2DM and insomnia.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Health condition
T2DM and insomnia.
Research involving
Sponsors and support
Intervention
- Psychosocial intervention
Outcome measures
Primary outcome
Primary study parameters/endpoints: at baseline, 3 months and 6 months, we will determine glycaemic control, measured by levels of HbA1c.
Secondary outcome
At baseline, 3 months and 6 months fasting glucose and diabetes medication use as well as sleep, measured by validated questionnaires, sleep diaries, accelerometers and sleep medication prescriptions. Additionally, at baseline, 3 months and 6 months cardiovascular risk factors, including BMI, waist circumference, lipid levels, cholesterol levels, dietary intake, physical activity, mood and quality of life are measured. These parameters are determined using anthropometrical measurements, blood pressure measurements, lipid levels by measuring triglycerides and cholesterol, while dietary intake is measured using a food frequency questionnaire, physical activity by wearing an accelerometers, while mood and quality of life are measured by validated questionnaires.
Background summary
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?
Study objective
We hypothesize that improving sleep will improve glycaemic control in people with T2DM and insomnia.
Study design
Baseline, 3 months and 6 months
Intervention
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.
Age
Inclusion criteria
We recruit people with T2DM and self-reported insomnia.
Exclusion criteria
We will exclude participants who self-report the following psychiatric problems depression, schizophrenia, psychosis or suicidality; as well as those on medication affecting sleep (i.e. anti-psychotics, anxiolytic), pregnant, working night shifts or reporting excessive alcohol use (>21 alcoholic consumptions per week). People who answer yes to the questions did you receive psychological treatment in the last six months for insomnia will also be excluded. Those suffering from additional sleep disorders will not be excluded, but their diagnosis will be accounted for in the analysis.
Design
Recruitment
IPD sharing statement
Plan description
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7665 |
| CCMO | NL68074.029.18 |
| OMON | NL-OMON48417 |