Measuring current practice and inequalities in type 2 diabetes treatment and intensification: a population-based cohort study

Study type
Protocol
Date of Approval
Study reference ID
23_003530
Lay Summary

This analysis will describe current practice in type 2 diabetes treatment in England, this is a common disease, where blood sugar is too high. We will select a group of patients with a diagnosis of diabetes in their primary care record, and describe this population by age, gender, ethnicity, and deprivation, as well as how many patients have specific other health conditions or have diagnosed diabetic complications.

We will describe how many people start treatment (uptake), which medications are prescribed first and which drugs are added to prevent complications associated with diabetes.

All the statistics will be produced separately for different groups of people with type 2 diabetes: patients with one of two additional heart conditions, with kidney disease, and with either a high or no additional risk of heart problems.

Results from this analysis will be entered into a health economic model. That model will simulate current practice in diabetes treatment. Treatment effect measures from published clinical trials will also be entered into the model and the potential impact of different treatment policies on patients’ health and the corresponding costs to the health system will be estimated.

These results will by considered by the type 2 diabetes committee at the National Institute for Health and Care Excellence (NICE) to determine the most cost-effective treatment recommendations, while accounting for potential health inequalities in treatment uptake. The subsequent publication of a guideline update will likely have a considerable impact on patient care and benefit this patient population.

Technical Summary

NICE recommendations from 2022 for the management of Type 2 diabetes mellitus with pharmacological interventions are being updated to consider additional treatment benefits including for non-cardiovascular outcomes (including, blood glucose, amputation, end-stage renal disease, retinopathy, ulceration). The new guideline model will evaluate treatment effects on both cardiovascular and non-cardiovascular effects.

Descriptive data from CPRD will be entered into an economic model alongside estimates of treatment effects, costs and quality of life measures (from published sources such as systematic reviews and published clinical trials). CPRD primary care and linked hospital episode statistics admitted patient care (HES APC) data will be used to provide a real-world context to this guideline update. A cohort of patients with prevalent type 2 diabetes will be selected and we will describe:

1. Baseline demographic characteristics: ethnicity, gender, age, diabetes duration, weight, height, BMI
2. Percentages of patients who have historical records of eight diabetes-related complications (myocardial infarction, angina, stroke, heart failure, amputation, renal failure, diabetic ulcer and blindness in one eye) and additional clinical risk factors.
3. The most frequent treatment or treatment combinations for each population as a proxy for ‘standard care’ in the model, and uptake (as a proportion) to the first-line and additional treatments by ethnicity and deprivation.

Separate estimates will be generated patients in each of five defined strata: patients with heart failure; with atherosclerotic cardiovascular disease (CVD); with chronic kidney disease, with high CVD risk; without high CVD risk. Additionally, results will be stratified by ethnicity and Index of Multiple Deprivation (IMD) quintiles based on patient-level IMD index. Analyses will be descriptive with rates, frequency counts, means, proportions or similar measures presented as relevant. This work will benefit patients by supporting the update of NICE recommendations for the management of Type 2 Diabetes within the NHS.

Health Outcomes to be Measured

Frequency (count) of medicines prescribed for treatment of diabetes; Frequency (count) of medicines prescribed to prevent complications associated with diabetes; Uptake (proportion of patients) initiating first line treatment following diabetes diagnosis, Uptake (proportion of patients) initiating additional treatment (intensification); time to first line treatment; time to intensification; Prevalence of : angina, heart failure, myocardial infarction, stroke, amputation, end-stage kidney disease, retinopathy, ulceration; Demographic characteristics: age, duration of diabetes, ethnicity, gender, weight and height, BMI, IMD quintile; clinical risk factors: albuminuria, atrial fibrillation, peripheral arterial disease, smoking status, estimated glomerular filtration rate, haemoglobin, HbA1c, heart rate, high-density lipoprotein, low-density lipoprotein, systolic blood pressure, white blood cell count; QRISK scores.

Collaborators

Patrick Muller - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Folashade Naku - Collaborator - National Institute for Health and Clinical Excellence - NICE
James Hawkins - Collaborator - National Institute for Health and Clinical Excellence - NICE
Jonathan Wray - Collaborator - National Institute for Health and Clinical Excellence - NICE

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation