Digital sleep treatment for metabolic health in people who are at high risk of type 2 diabetes and have insomnia

ISRCTN	ISRCTN19682964
DOI	https://doi.org/10.1186/ISRCTN19682964
IRAS number	266313
Secondary identifying numbers	IRAS 266313, CPMS 44649

Submission date: 31/01/2022
Registration date: 02/02/2022
Last edited: 09/04/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Frequent problems with falling asleep or staying asleep (insomnia) have been linked to the development of type 2 diabetes. Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high. We would like to test whether improving sleep, through an effective behavioural treatment called cognitive behavioural therapy, can help improve metabolic health in people who are at risk of type 2 diabetes. This is best tested in a randomised controlled trial (a large study with lots of participants undergoing different procedures to compare which is best) but before we test this idea in a large group, we will be conducting this small feasibility study (SleepTMH) to see how the study might work. The SleepTMH study will allow us to gather data to inform the design of a future randomised controlled trial.

Who can participate?
We are inviting 20 people who regularly struggle to fall asleep or stay asleep during the night and who may have a risk of developing diabetes in the future. This is determined by your recent blood glucose tests conducted by your GP or previous conversations you may have had with your GP. You may not necessarily develop diabetes but your records suggest you might be at risk in the future and you may be eligible for the study.

What does the study involve?
Participants will be identified at up to ten participating primary care sites in Oxfordshire. All potential participants will be asked to complete an eligibility assessment. Eligible participants will be invited to attend a Baseline appointment (Visit 1) at the Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM) Clinical Research Unit (CRU) at the Churchill Hospital where informed consent will be taken and baseline assessments completed.

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 participants. After 7 days (Week 1, Visit 2) the CGM and actigraph watch will be removed and the participant will be asked to begin using the Sleepio® digital CBT sleep intervention for the next 10 weeks. Participants will be invited back to the OCDEM CRU during week 11 (Visit 3) where post-intervention assessments will be carried out. Participants will again be fitted with a CGM and an actigraph watch and asked to wear these for the next 7 days. 7 days later (week 12, Visit 4) the CGM and actigraph will be removed, marking the end of study participation. Post- study, participants will be invited to a voluntary telephone call with a member of the research team to give feedback on the study. This is in addition to the formal study procedures and there will be no requirement on the participant to complete this additional task. Study Participation will last for approximately 12 weeks from the time consent is provided with an additional four weeks post participation to complete the optional trial feedback interview (a maximum duration of approximately 16 weeks).

What are the possible benefits and risks of participating?
The Sleepio programme has been found to improve sleep quality in the majority of users. There is therefore a good possibility that your sleep quality will improve as a result of completing the programme. If your sleep does improve we think this could also be beneficial to metabolic health, however this is what we hope to find out by conducting research and so we cannot guarantee you will see any such benefits. We hope that this work will inform the design of future research studies and may help other patients in the future.
You will receive a £25 Amazon voucher after returning the CGM and actigraph watch during visit 2 and visit 4. As such if you complete the study in full you will receive a total of £50 of Amazon vouchers over the course of the study

As part of the study you will be asked to provide some blood samples and wear a continuous glucose monitor (CGM). All blood samples will be taken by a qualified member of the research team to minimise the possibility of bruising. Some people can find the experience of blood being drawn as uncomfortable or they may feel lightheaded or faint. Equally, some people may find the experience of having a CGM fitted uncomfortable. The CGM may itch or become uncomfortable as you wear it. The Sleepio programme involves making changes to your sleep pattern that may cause a short-term increase in sleepiness. If you do feel sleepy during the study we advise that you avoid activities that require a high degree of vigilance, such as driving or operating heavy machinery. If you become concerned about your mental or physical health at any time during the study we recommend that you speak with your GP/doctor. You are free to stop the sleep improvement programme at any point. You will be asked questions about your mental health and how you are feeling. If you find this too distressing, you can take a break from answering questions. You can also decline to answer certain questions. You will have to attend two approximately hour/ hour and a half long clinic visits with two further (much shorter) visits to retrieve the study equipment and SleepTMH Sleep Diary.

Where is the study run from?
This study is organised by researchers based at the Departments of Clinical Neurosciences, and Primary Care Health Sciences at the University of Oxford (UK) alongside the Oxford Centre for Diabetes, Endocrinology and Metabolism, where the study procedures will take place.

When is the study starting and how long is it expected to run for?
August 2019 to March 2024

Who is funding the study?
NIHR Oxford Biomedical Research Centre (UK)

Who is the main contact?
Associate Professor Simon Kyle, simon.kyle@ndcn.ox.ac.uk

Contact information

Dr Simon Kyle
Principal Investigator

Sir Jules Thorn Sleep and Circadian Neuroscience Institute (SCNi)
Nuffield Department of Clinical Neurosciences
New Biochemistry Building
University of Oxford
South Parks Road
Oxford
OX1 3QU
United Kingdom

ORCID ID	0000-0002-9581-5311
Phone	+44 1865618675
Email	simon.kyle@ndcn.ox.ac.uk

Dr Rachel Sharman
Public

Phone	+44 1865618675
Email	rachel.sharman@ndcn.ox.ac.uk

Study information

Study design	Single-arm feasibility trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Sleep improvement for metabolic health: feasibility trial of a digital sleep treatment in people who are at high risk of type 2 diabetes and have insomnia
Study acronym	SleepTMH
Study objectives	This is a feasibility study to determine feasibility of recruiting participants with a high risk of type 2 diabetes who have insomnia from primary care
Ethics approval(s)	Approved 12/03/2020, East of England - Essex Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 2071048227; Essex.REC@hra.nhs.uk), ref: 20/EE/0046
Health condition(s) or problem(s) studied	People who are at high risk of type 2 diabetes and have insomnia
Intervention	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 participants. After 7 days (Week 1, Visit 2) the CGM and actigraph watch will be removed and the participant will be asked to begin using the Sleepio® digital CBT sleep intervention for the next 10 weeks. Participants will be invited back to the OCDEM CRU during week 11 (Visit 3) where post-intervention assessments will be carried out. Participants will again be fitted with a CGM and an actigraph watch and asked to wear these for the next 7 days. 7 days later (week 12, Visit 4) the CGM and actigraph will be removed, marking the end of study participation. Post- study, participants will be invited to a voluntary telephone call with a member of the research team to give feedback on the study. This is in addition to the formal study procedures and there will be no requirement on the participant to complete this additional task. Study Participation will last for approximately 12 weeks from the time consent is provided with an additional four weeks post participation to complete the optional trial feedback interview (a maximum duration of approximately 16 weeks).
Intervention type	Behavioural
Primary outcome measure	Ability to recruit participants from primary care measured by site activity reports and recruitment rate during the planned study period (12 months).
Secondary outcome measures	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).
Overall study start date	01/08/2019
Completion date	08/03/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Total final enrolment	24
Key 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
Key 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
Date of first enrolment	28/02/2022
Date of final enrolment	15/11/2023

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Sponsor information

University of Oxford
University/education

Research Governance, Ethics & Assurance Team (RGEA)
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom

Phone	+44 1865289886
Email	heather.house@admin.ox.ac.uk
Website	https://researchsupport.admin.ox.ac.uk/contacts/rgea#collapse3089471
"ROR"	https://ror.org/03h2bh287

Funders

Funder type

Government

NIHR Oxford Biomedical Research Centre
Private sector organisation / Research institutes and centers

Alternative name(s): NIHR Biomedical Research Centre, Oxford, OxBRC
Location: United Kingdom

Results and Publications

Intention to publish date	30/04/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Results will be published in peer-reviewed journals.
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

09/04/2024: The overall study end date was changed from 30/04/2024 to 08/03/2024.
11/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 15/11/2023.
2. The total final enrolment was added.
05/10/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2022 to 31/12/2023.
2. The overall trial end date was changed from 31/12/2022 to 30/04/2024.
3. The intention to publish date was changed from 31/12/2023 to 30/04/2025.
02/03/2022: Internal review.
01/02/2022: Trial's existence confirmed by East of England - Essex Research Ethics Committee.