Long term effects of COVID-19 in people with diabetes
| ISRCTN | ISRCTN14643181 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14643181 |
| IRAS number | 297448 |
| Secondary identifying numbers | Sponsor ID GN20DI579_313445, IRAS 297448 |
- Submission date
- 20/05/2021
- Registration date
- 24/05/2021
- Last edited
- 10/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
126 University Place
Glasgow
G12 8TA
United Kingdom
 ORCID ID |
0000-0002-9868-5217 |
|---|---|
| Phone | +44 (0)141 330 2750 |
| robert.lindsay@glasgow.ac.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Longer term impact of COVID infection in people with diabetes |
| 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 |
| 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 |
Eligibility
| 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 inclusion criteria | People aged over 18 resident in Scotland and with prior diagnosis of type 1 or type 2 diabetes |
| Participant exclusion criteria | Not able to read and write in English |
| Recruitment start date | 28/05/2021 |
| Recruitment end date | 28/02/2024 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow
G12 8TA
United Kingdom
Sponsor information
Hospital/treatment centre
R&I Office
Ward 11, Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 314 4012 |
|---|---|
| Maureen.Travers@ggc.scot.nhs.uk | |
| Website | http://www.nhsggc.org.uk/ |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Government organisation / Local government
- 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, The Chief Scientist Office, CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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). |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v1.0 | 24/03/2021 | 01/06/2021 | No | No |
Additional files
- ISRCTN14643181_PROTOCOL_v1.0_24Mar2021.pdf
- Uploaded 01/06/2021
Editorial Notes
10/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 28/02/2024.
2. The overall end date was changed from 31/10/2022 to 31/10/2024.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
4. The plain English summary was updated to reflect these changes.
01/06/2021: Uploaded protocol version 1.0, 24 March 2021 (not peer reviewed).
21/05/2021: Trial's existence confirmed by South East Scotland Research Ethics Committee 01.
