Since the outbreak of Covid-19 in the UK in late January 2020, primary care has changed quite dramatically, with many general practices restricting physical consultations and instead providing virtual consultations. In addition to this, due to the pressure on NHS resources, we have already seen a major decline in GP referrals in the midst of this pandemic. This in turn could impact on patient morbidity and mortality.
There is an urgent need to establish the impact of the Covid-19 outbreak in people with diabetes (type 1 and type 2) who would ordinarily have their diabetes and associated comorbidities frequently monitored in primary care. We aim to examine frequency of monitoring and checks in relation to diabetes care processes, frequency and mode of consultations, frequency of referrals, prescribing for diabetes, and patient outcomes/diagnoses pre-, during, and post-Covid-19. We aim to examine the following outcomes; death, incident diabetes, degree of alcohol abuse, mental health disorders, diabetes-related complications, heart disease and blood clots, and lung disease.
Using linked hospital and mortality data, outcomes will be examined in secondary care including; cause-specific mortality, hospitalisation, ICU admission, diabetes-related complications, kidney disease (acute and chronic) and renal replacement therapy, heart disease, lung disease and blood clots.
Pre-Covid-19 will be defined as a 10-year interval from January 2010-February 2020. Current Covid-19 will begin from March 2020 (calendar month in which full UK lockdown started) to post-Covid-19. Post-Covid-19 will be determined at a later stage when 70% of the population have been successfully vaccinated based on government figures.
In this descriptive study we will explore the impact of Covid-19 in people with diabetes by comparing primary and secondary care interactions and outcomes in pre- (Jan 2010-Feb 2020), current (Mar 2020 [full UK lockdown] to post Covid-19), and post-Covid-19 (future date when 70% of the population have been successfully vaccinated) time periods.
In Phase 1 we will use primary care records (CPRD GOLD/Aurum) from 01/01/2010 until the latest available date in the most recent CPRD release for patients with >1 year of continuous registration prior to cohort entry.
In each calendar month we aim to estimate incidence and prevalence rates of consultations, referrals, diabetes care processes, prescriptions, alcohol abuse, diagnoses [diabetes, diabetes-related and cardiovascular complications, thromboembolic disease, lung disease, mental health disorders], and death. Person-time will be calculated from the total number of individuals at risk in each calendar month.
For Phase 2, patients identified in Phase 1 will be linked to patient- and practice-level IMD, HES APC, HES A&E, HES Outpatient and ONS death registration to estimate incidence, prevalence and mortality rates in secondary care. Within pre-Covid, current and post-Covid periods, we aim to compare rates of cause-specific mortality, hospitalisations, ICU admissions, kidney disease and renal replacement therapy, diabetes-related complications, cardiovascular events, thromboembolic disease and lung disease.
We aim to use negative binomial regression to model 10 years of pre-Covid rates to define expected rates. Forecasting predictions will determine differences between observed and expected rates. Rates will be stratified by age, gender, type 1 and type 2 diabetes, ethnicity, deprivation, UK regions, history of cardiovascular disease, kidney disease, clinical risk (defined by levels of pre-Covid risk factors including HbA1c, blood pressure and lipid levels) and Freestyle Libre use to help identify if particular groups of people may have been more severely affected.
Comparison of pre-, current, and post-Covid-19 time periods:
Phase 1: Primary care-related
? Frequency of consultations and mode of consultation (face-to-face, telephone, video call)
? Incidence of diabetes
? Frequency of referrals to secondary care
? Frequency of referrals to diabetes services
? Diabetes care processes; measurement of glycated haemoglobin (HbA1c), blood pressure (BP) and cholesterol levels, retinal screening, foot checks, urinary albumin and serum creatinine testing, weight check, smoking status check
? Prescriptions for the management of diabetes and cardiovascular risk factors
? Diagnoses of alcohol abuse
? Diagnoses of mental health disorders including; depression, anxiety and self-harm
? Diabetes-related complications including; diabetic foot ulcers, amputations, microvascular complications (retinopathy, neuropathy, nephropathy)
? Cardiovascular events including; myocardial infarction, stroke, heart failure, and revascularisation procedures
? Thromboembolic disease (pulmonary embolism, deep vein thrombosis) and prescriptions for anticoagulation drugs
? Interstitial lung disease and pulmonary fibrosis
? Brain natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) levels
? Death rate
Phase 2: Linked data, ONS and hospital-related
? All-cause mortality
? Cause-specific mortality
? Hospitalisation
? ICU admission
? Acute kidney injury
? Renal replacement therapy including; dialysis (haemodialysis, peritoneal dialysis) and transplantation
? Diabetes-related complications including; diabetic foot ulcers, amputations, microvascular complications (retinopathy, neuropathy, nephropathy)
? Cardiovascular events including; myocardial infarction, stroke, heart failure, acute cardiac injury and revascularisation procedures
? Thromboembolic disease (pulmonary embolism, deep vein thrombosis)
? Interstitial lung disease and pulmonary fibrosis
Darren Ashcroft - Chief Investigator - University of Manchester
Alison Wright - Corresponding Applicant - University of Manchester
Hood Thabit - Collaborator - Manchester University NHS Foundation Trust (MFT)
Lalantha Leelarathna - Collaborator - Manchester University NHS Foundation Trust (MFT)
Martin Rutter - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Naresh Kanumilli - Collaborator - NHS England
Nicola Milne - Collaborator - Manchester University NHS Foundation Trust (MFT)
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation