People who are at high risk of type 2 diabetes and have insomnia Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will also be fitted with a continuous glucose monitor (CGM) and asked to wear it and an actigraph watch for 7 days. This is the first of at least four face-to-face contacts with participa
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. HbA1c 6-6.4% within the past 12 months and/or a diagnosis of pre-diabetes 2. Insomnia disorder 3. Reliable access to the internet 4. Capable of attending visits at the OCDEM Clinical Research Unit (CRU) at Oxford 5. Capable of complying with the study procedures and intervention 6. Able to understand study instructions in English 7. Age =18 years
Exclusion criteria
Exclusion criteria: 1. Diagnosis of diabetes/prescribed diabetes medication 2. Prescribed sleep medication 3. Diagnosed or probable obstructive sleep apnea (OSA), narcolepsy, restless legs syndrome/periodic limb movement disorder, circadian sleep-wake rhythm disorder, parasomnia; 4. Psychosis (schizophrenia or bipolar disorder) 5. Shift worker 6. Dementia or mild cognitive impairment 7. Suicidal ideation with intent 8. Epilepsy 9. Pregnant/planning pregnancy 10. Previously accessed or used the Sleepio® programme or is a current user 11. Currently receiving psychological therapy for insomnia or enrolled in another sleep intervention trial 12. Allergy to hypoallergenic adhesive plasters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to recruit participants from primary care measured by site activity reports and recruitment rate during the planned study period (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Engagement with digital sleep treatment: Proportion of participants who complete = 4 out of 6 Sleepio® intervention sessions by week 12. 2.1. Insomnia measured with the Insomnia severity index (ISI) at baseline and week 12 2.2. Health status measured with the EuroQoL (EQ-5D) at baseline and week 12 2.3. Depressive symptoms measured with the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and week 12 2.4. Self-reported sleep measured with the consensus sleep diary (CSD) at baseline and week 12. 2.5. Working memory performance measured with the visual short term memory task (VSTM) at baseline and week 12. 2.6. Rest-activity rhythms measured with actigraphy at baseline and week 12. 2.7. Glucose metabolism recorded by the G6 continuous glucose monitor for 7 days at baseline and week 12 2.8. Fasting blood test (for HbA1c, FBC, C+E/lipids, glucose and biomarker) measured at baseline and week 12. 3. Participant acceptability of the trial ascertained via semi structured interview (performed within 4 weeks of conclusion of 12 week intervention phase). | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Sharman
Outcome results
None listed