Coronavirus disease 2019 (COVID-19) was first reported in Wuhan, China, in December 2019 and declared to be a pandemic by the World Health Organisation in March 2020. It has so far claimed millions of lives around the world, but also affected other diseases and patient groups in many different ways. Previous studies have shown that COVID-19 might impact the course of diabetes (sugar disease) and the need for glucose-lowering treatment. However, the relation between COVID-19 and utilisation of glucose-lowering drugs is not yet clear.
In this study we assess the effect of COVID-19 infection on use of glucose-lowering drugs for up to one year in patients with diabetes. This will include the use of both insulin and non-insulin glucose-lowering drugs. We will also study the effect of COVID-19 infection on pattern of use of glucose-lowering drugs (starting, stopping and switching drugs), and any change in the daily dose of various glucose-lowering drugs.
By answering to our research question, we will have a better understanding of the effects of COVID-19 infection on use of glucose-lowering drugs among patients with diabetes. This will be of interest for both patient care and policy making, at a time when COVID-19 pandemic has had a huge impact on the healthcare systems and our societies.
Coronavirus disease 2019 (COVID-19) might influence the course of type 2 diabetes mellitus (T2DM) and raise the need for antidiabetic treatment. However, this association remains unclear to date. We aim to investigate the effect of COVID-19 infection on antidiabetic drug utilisation for up to one year in patients with T2DM.
This will be a retrospective population-based cohort study with data from the Clinical Practice Research Datalink (CPRD) GOLD database. Patients over the age of 18 with T2DM will be included between 1 September 2020 and 31 March 2021 and followed up for a maximum of 12 months. Our exposure of interest will be a confirmed or (highly) suspected COVID-19 diagnosis, and T2DM patients with a COVID-19 diagnosis will be matched with up to 4 T2DM patients unexposed to COVID-19 ever before. We will define drug utilisation outcome categories of non-insulin antidiabetic drugs (NIADs) and insulin. Multinomial logistic regression models will estimate the odds ratio of using ≥2 NIADs, insulin +/- NIAD, or no antidiabetic treatment, compared with 1 NIAD, in T2DM patients with COVID-19 versus those without, during the short (0-3 months), medium (4-6 months) and long (7-12 months) terms after the index date (i.e., COVID-19 diagnosis date). Also, the pattern of antidiabetic drug use (i.e., initiating, stopping, or switching) will be assessed between the two exposure groups. In secondary analyses, the average daily dose of insulin and a select of common and important NIADs (metformin and most common sulphonylurea, dipeptidyl peptidase-4 inhibitor, and sodium-glucose cotransporter-2 inhibitor in use) will be compared between the exposure groups in short, medium- and long-terms after the index date. The regression models will be adjusted for relevant lifestyle factors, comorbidities and relevant other drug exposures.
We will define four drug utilisation outcome categories: 1) monotherapy with one non-insulin antidiabetic drugs (NIADs); 2) treatment with ≥2 NIADs; 3) treatment with insulin, with or without NIAD; and 4) no antidiabetic treatment, based on the National Institute for Health and Care Excellence (NICE) guideline for the management of T2DM in the UK.1
Olaf Klungel - Chief Investigator - Utrecht University
Shahab Abtahi - Corresponding Applicant - Utrecht University
Eveline de Waard - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University