Long term effects of COVID-19 in people with diabetes

Plain English Summary

Background and study aims
People with diabetes have suffered greater adverse consequences of COVID-19 in the acute phase of infection during the pandemic. Whether they also have increased susceptibility to longer term sequelae is unknown. Such knowledge is critical to public health approaches to management of the pandemic in these populations. We will build on the excellent available surveillance of the population of people with diabetes in Scotland using the existing sci-diabetes platform, used already to accurately detail short-term outcomes.
Current research during the COVID crisis has highlighted that to the end of July, 2,724 people with diabetes had covid-19 (positive test, admission, or death certificate) of whom 988 had unfortunately died. This means more than 1,736 people with diabetes in Scotland may be living with the consequences of Covid-19. Assessment of the long term holistic impact on people with diabetes cannot be approached using routine data collated from electronic health records and so we propose to use the resources of the Scottish Diabetes Research Network (SDRN) to collect information through questionnaires and clinical examination on a range of outcomes in people with diabetes compared to the general population of people with diabetes.

Who can participate?
People aged over 18 resident in Scotland and with prior diagnosis of type 1 or type 2 diabetes

What does the study involve?
All participants will complete 4 questionnaires online. A smaller group of these participants will also be asked for a blood sample and to take some physical tests during a hospital visit, and repeat these measures after one year.

What are the possible benefits and risks of participating?
The study will not benefit you directly, but your participation will help provide important information about the impact of COVID-19 infection on diabetes patients and provide a stronger evidence base to inform national guidance and policy.
A possible benefit to you might be that if you’ve had COVID without realising it, we will be able to inform you of this.
For some, blood sampling may cause momentary discomfort at the site of the blood draw, possible bruising, redness, and swelling around the site, bleeding at the site, feeling of light headedness when the blood is drawn, and rarely, an infection at the site of blood draw.
There are some risks from the walking test such as tripping, falling, exhaustion and fatigue. A research staff member will be present to offer one:one support and the walk test will be carried out in a wide corridor free of trip hazards and obstructions. You will be able to use a walking aid if you routinely use one.
Lung function tests (spirometry) require the use of a mouthpiece connected to the device which poses a risk of infection. To minimise risk, mouthpiece plastic is single use and you’ll be shown how to carry out the test correctly.

Where is the study run from?
University of Glasgow (UK)

When is the study starting and how long is it expected to run for?
November 2020 to October 2024

Who is funding the study?
Chief Scientist Office, Scottish Government Health and Social Care Directorate (UK)

Who is the main contact?
Dr Robert Lindsay, robert.lindsay@glasgow.ac.uk

Study website

Type

Scientific

Contact name

Dr Robert Lindsay

ORCID ID

https://orcid.org/0000-0002-9868-5217

Contact details

126 University Place
Glasgow
G12 8TA
United Kingdom
+44 (0)141 330 2750
robert.lindsay@glasgow.ac.uk

EudraCT/CTIS number

Nil known

IRAS number

297448

ClinicalTrials.gov number

Nil known

Secondary identifying numbers

Sponsor ID GN20DI579_313445, IRAS 297448

Scientific title

Longer term impact of COVID infection in people with diabetes

Acronym

Study hypothesis

To understand the proportion of people with diabetes who experience longer term symptoms or illness after covid-19 infection, the nature of these symptoms, and the potential health impact of that.

Ethics approval(s)

Approved 19/05/2021, South East Scotland Research Ethics Committee 1(2ndFloor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)7814 764 241; Sandra.Wyllie@nhslothian.scot.nhs.uk), ref: 21/SS/0040

Study design

Case cohort and nested case control studies

Primary study design

Observational

Secondary study design

Nested case-control study

Study setting(s)

Hospital

Study type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

COVID-19 (SARS-CoV-2 infection) in people with diabetes

Intervention

Observational study with current health measured by questionnaire, bioimpedance, pulmonary function, grip strength, walking test.

1. Case cohort study - conducted with questionnaire usually online. Time from enrolment to end of this part of study is 1 hour . For the majority of participants this will be their only participation.

2. Case control study - people are recruited from the case cohort study and involves :
2.1. For controls single CRF visit (time 1 hours) - no in person follow up after this
2.2. Cases 2 CRF visits separated by up to 64 weeks later but each visit only 1 hour: total follow up to 64 weeks

For all participants we will request permission to connect data to their electronic health record but no other in person follow up

Intervention type

Mixed

Primary outcome measure

COVID symptoms measured using Wellcome Trust COVID-19 questionnaire at baseline (all participants) and 1 year (cases only)

Secondary outcome measures

Measured at baseline (all participants in case cohort study) and 1 year (cases in case cohort study only)
1. Bioimpedance measured using bioelectrical impedance analysis
2. Pulmonary function measured using lung function test
3. Grip strength measured using dynamometer
4. Physical ability measured using walking test
5. Diabetes Related Quality of Life (DQOL)
6. Diabetes-Specific Emotional Distress (DDS-1)
7. Quality of life (EQ5D)
8. HbA1c, LFTs, lipids, U&Es, inflammatory (e.g. CRP), vascular (t-PA, vWF) and cardiac (hs troponin, NT proBNP) biomarkers measured using blood test

Overall study start date

01/11/2020

Overall study end date

31/10/2024

Reason abandoned (if study stopped)

Participant inclusion criteria

People aged over 18 resident in Scotland and with prior diagnosis of type 1 or type 2 diabetes

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

1,000 in case control part

Participant exclusion criteria

Not able to read and write in English

Recruitment start date

28/05/2021

Recruitment end date

28/02/2024

Countries of recruitment

Scotland, United Kingdom

Study participating centre

University of Glasgow
126 University Place
Glasgow
G12 8TA
United Kingdom

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

R&I Office
Ward 11
Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom
+44 (0)141 314 4012
Maureen.Travers@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nhsggc.org.uk/

ROR

https://ror.org/05kdz4d87

Funder type

Government

Funder name

Chief Scientist Office, Scottish Government Health and Social Care Directorate

Alternative name(s)

Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, CSO

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Publication and dissemination plan

The study report will be used for publication and presentation at scientific meetings. Investigators have the right to publish orally or in writing the results of the study.
Summaries of results will also be made available to Investigators for dissemination within their clinical areas (where appropriate and according to their discretion).

Intention to publish date

31/12/2024

Individual participant data (IPD) Intention to share

No

IPD sharing plan

The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository: the ENLIGHTEN database of the University of Glasgow. Data stripped of all personal identifiers will be stored for 10 years and made available to bona fide researchers after the end of the study and study data analysis . Details of this data storage and sharing are transmitted to participants on the PIS for each part of the study.

IPD sharing plan summary

Stored in repository

Study outputs

• ISRCTN14643181_PROTOCOL_v1.0_24Mar2021.pdf Uploaded 01/06/2021