Development of a risk prediction model for people with diabetes and COVID-19 in Scotland

ISRCTN ISRCTN45562523
DOI https://doi.org/10.1186/ISRCTN45562523
Secondary identifying numbers PBPP ref. 1617- 0147
Submission date
16/10/2020
Registration date
19/10/2020
Last edited
05/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

There is very little known amount the risk factors among those with diabetes that contribute to risk of COVID-19. This study aims to understand the risks of and risk factors for COVID-19 in people with diabetes

Who can participate?
People living with or without diabetes in Scotland with COVID-19

What does the study involve?
Health records of people with COVID-19 will be compared to records of people with and without diabetes to find risk factors that contribute to death with COVID-19 in diabetes patients.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Public Health Scotland (UK)

When is the study starting and how long is it expected to run for?
April 2020 to July 2020

Who is funding the study?
Public Health Scotland (UK)

Who is the main contact?
Professor Helen Colhoun, helen.colhoun@igmm.ed.ac.uk

Contact information

Prof Helen Colhoun
Scientific

Institute of Genetics and Molecular Medicine
University of Edinburgh
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

ORCiD logoORCID ID 0000-0002-8345-3288
Phone +44 (0)7791652665
Email helen.colhoun@igmm.ed.ac.uk

Study information

Study designObservational cohort
Primary study designObservational
Secondary study designCohort study
Study setting(s)Community
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleRisk of and risk factors for fatal or critical care unit treated COVID-19 and development of a risk prediction model in people with diabetes in Scotland: A cohort study
Study objectivesObjectives:
1. Ascertain the cumulative risk of fatal or CCU treated COVID -19 in those with diabetes and compare it to those without diabetes
2. Among those with diabetes to investigate risk factors for, and build a cross-validated predictive model of, fatal or CCU treated COVID-19
Ethics approval(s)1. Approved 06/04/2020, Public Benefit Privacy Protection Panel Scotland (no address provided; no telephone number provided; phs.pbpp@nhs.net), PBPP ref. 1617- 0147
2. Approved 01/06/2011, Scotland A Research Ethics Committee (2nd Floor Waverly Gate
2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5680; Manx.Neill@nhslothian.scot.nhs.uk), ref: 11/AL/0225
Health condition(s) or problem(s) studiedCOVID-19 (SARS-CoV-2 infection), diabetes
InterventionIn the total population of Scotland (5.6 million) we will ascertain all persons who had developed fatal or critical care unit-treated COVID-19 (hereafter F/CCU-COVID-19) between 1st March and July 31st 2020 from the nationwide virology, critical care unit, hospital discharge and register of deaths databases. Among those with F/CCU-COVID-19, diabetes status will be ascertained by linkage to the national diabetes register. The cumulative incidence of F/CCU-COVID-19 in those with and without diabetes will be compared using logistic regression. Among those with diabetes, data on potential risk factors for F/CCU-COVID-19 will be obtained from diabetes register and other linked health administrative databases. Among those with diabetes we will test association of these factors with F/CCU-COVID-19 and construct a prediction model using stepwise regression and 20-fold cross-validation.
Intervention typeNot Specified
Primary outcome measureFatal of Critical care Unit COVID-19 defined with cases ascertained on the basis of positive rtPCR test, hospital admission and death certification and this level of severity defined using linkage to the national critical care unit database (SICSAG) and death certification data (types of information included laboratory test results, ICD10 codes for hospital discharge diagnoses, dates of entry into critical care units and cause of death on death certificates)
Secondary outcome measuresNone
Overall study start date06/04/2020
Completion date31/07/2020

Eligibility

Participant type(s)All
Age groupAll
SexBoth
Target number of participants5,782,649
Total final enrolment5782649
Key inclusion criteriaPeople of any age living with or without diabetes in Scotland
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/03/2020
Date of final enrolment31/07/2020

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Public Health Scotland
Meridian Court
5 Cadogan Street
Glasgow
G2 6QE
United Kingdom

Sponsor information

Health Protection Scotland
Other

Public Health Scotland
Meridian Court
5 Cadogan Street
Glasgow
G2 6QE
United Kingdom

Phone +44 (0)141 300 1100
Email NSS.HPSenquiries@nhs.net
Website https://www.publichealthscotland.scot/
ROR logo "ROR" https://ror.org/04zgkpa58

Funders

Funder type

Government

Public Health Scotland

No information available

Results and Publications

Intention to publish date01/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication at The Lancet - Diabetes & Endocrinology
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the Scottish Public Benefits and Privacy Protection Committee

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/02/2021 25/03/2021 Yes No
Protocol file 05/10/2022 No No

Additional files

ISRCTN45562523_PROTOCOL.pdf

Editorial Notes

05/10/2022: Uploaded protocol (not peer reviewed).
25/03/2021: Publication reference added.
16/10/2020: Trial’s existence confirmed by NHS Scotland.