Chronic kidney disease (CKD) is a very common long-term complication of diabetes. An estimated 40 per cent of people with both Type 1 and Type 2 diabetes will develop CKD (Stages 1 to 5) during their lifetime a condition known as diabetic kidney disease (DKD). Management of diabetes includes many areas that may be influenced by the severity of a patient's kidney dysfunction. Additionally, management of other conditions, such as high blood pressure and conditions associated with CKD, such as anaemia, must also be considered in the care of patients with diabetes and CKD.
It is important to recognize the impact of this combination of diagnoses because the risk of events and death from cardiovascular disease is significantly increased compared to patients without the combination.
This study aims to determine the size of the population group with DKD in England and describe its profile and associated risk factors. Further, we shall determine the health care resource use and costs and clinical outcomes associated with this group of patients.
This study will be able to provide an in-depth understanding of combination of diagnosis in England considering the increased risk of adverse health outcomes among this group of patients. This will trigger further research and inform health policy, treatment and clinical management options, especially targeting patients with risk factors to enable better outcomes in turn reducing costs and healthcare resource usage associated with DKD.
Type 2 diabetes mellitus and chronic kidney disease frequently coexist, and each disease independently increases the risk of cardiovascular events and end-stage renal disease. Diabetes mellitus is currently the leading cause of chronic kidney disease (CKD). In fact, approximately 40% of patients with diabetes develop diabetic kidney disease (DKD) resulting in albuminuria, reduction of glomerular filtration rate (GFR), or both.
The typical natural history of diabetic nephropathy has been derived mainly from studies in patients with type 1 diabetes mellitus. In these patients, microalbuminuria is the first sign of renal damage and may eventually progress to macroalbuminuria, which predicts subsequent decline of GFR. In contrast, the natural history of CKD in type 2 diabetes mellitus appears to be heterogeneous and a result, there is still limited knowledge on the associated epidemiology, treatments pathway, clinical outcomes, co-morbidities and healthcare resource use and, costs of DKD linked with type 2 diabetes in England.
This will be a descriptive study which aims to determine which patients were diagnosed with a combination of Diabetes and subsequent CKD and determining the incidence and prevalence by CKD stage and Albuminuria category, demographic profile, co-morbidities, treatment pathway, clinical outcomes and health care resource use and costs. The study design has been chosen as this is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for prescriptions, comorbidities, procedures, demographics, costs, complications, and resource use
We shall describe the cohort in terms of patient demographic characteristics, prevalence of comorbidities, treatment pathway and clinical outcomes. Health care resource usage for the cohort will be calculated and reported for inpatient admissions, outpatient appointments, A&E attendances, and primary care appointments, tests and prescriptions. Outcomes will be described as total, means, medians, percentage or rates as appropriate.
Prevalence of DKD; Prevalence of DKD by CKD stage; Prevalence of co-morbidities and risk factors in the cohort (Genital infections, Volume depletion, Lower limb amputation, Diabetic ketoacidosis and Hypoglycaemia); Demographics (Mean and median age on inclusion, percent males, total, mean and median follow-up and geographical region); treatment pathway(prescriptions issued in primary care, number of patients needing renal replacement therapy receiving haemodialysis, peritoneal dialysis, hemodiafiltration and transplantation); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality, Major Adverse Cardiac Event, end stage kidney disease, dialysis, transplantation, heart failure, renal complications)
Jay Were - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Jay Were - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Archie Farrer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Dana Ogaz - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Eva Maria Fuchs - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulum Alamgir - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Yasir Hassan - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data