Diabetes (where the body cannot use or produce insulin properly) represents one of the most common diseases worldwide with more than 500 million people affected. Of those people living with diabetes, about 90% have type 2 diabetes. Individuals living with uncontrolled diabetes, defined as having consistently high blood sugar, are at higher risk of negative health outcomes, including stroke and heart attacks, than those with controlled diabetes. The National Institute for Health and Care Excellence (NICE) recommends that people with uncontrolled type 2 diabetes should be offered additional treatment, including intensification/optimisation of drug treatment. The goal being to control blood sugar levels and therefore reduce the risk of adverse events or death.
This study will use data from medical records to explore if people with uncontrolled type 2 diabetes in the UK are receiving additional treatment or other changes to their medications. Data will be assessed using electronic health records from the Clinical Practice Research Datalink, where participants will be included in the study based on their type 2 diabetes diagnosis and evidence of uncontrolled blood sugar. The aim of this study is to observe whether patients receive changes in their glucose lowering medication in the first 12 months of being diagnosed with uncontrolled type 2 diabetes. We will also investigate if changing treatment is associated with changes in blood sugar and complications. The findings from this project will provide insights into whether people with uncontrolled type 2 diabetes are receiving guideline-recommended treatment when they present with uncontrolled blood sugar.
It is NICE guidance for people with uncontrolled type 2 diabetes mellitus (T2DM) to receive intensification of glucose lowering therapies until glycaemic targets are reached. Despite the established benefits of early intervention, little is known about the proportion of people with uncontrolled T2DM in the UK who do receive this guideline-recommended treatment. This retrospective cohort study aims to describe the degree of therapeutic inertia through treatment patterns in people diagnosed with uncontrolled T2DM despite use of glucose lowering therapies, using electronic health records in CPRD from 2012. Uncontrolled T2DM will be defined as a HbA1c measurement of ≥7.5% and individuals will need to be treated with ≥2 oral antidiabetic medications and/or a GLP-1 in the preceding 12-months to enter the study population, with date of raised HbA1c used as the index date (cohort entry date). The primary outcome is quantifying and characterising any vs. no treatment intensification in the 12-months after index, with evidence of treatment optimisation being a secondary outcome. Individual-level categorisation (any treatment intensification vs. no treatment intensification) will be subsequently used as an exposure for analysing secondary outcomes.
T2DM medications will be handled at the class-level with descriptive analysis used to report the proportion of individuals not receiving treatment intensification in the 12-months post index (Identification period). Following the 1 year Identification period, the association between the ‘any treatment intensification’ sub-group (study-group) and ‘no treatment intensification’ sub-group (comparator) will be quantified for change in HbA1c, healthcare resource utilisation, direct healthcare costs, and incident disease complications rates during a 2-year Outcome period (years 2 & 3 post index). Our study will provide insights on the extent to which therapeutic inertia is present in people with uncontrolled T2DM. Better understanding of the implementation of treatment guidelines can inform strategies for further improving care for people living with diabetes.
The study primary outcome will be:
1) Among people living with uncontrolled T2DM despite use of glucose lowering therapies, to describe the proportion who do not receive treatment intensification within 12 months of being defined as having uncontrolled diabetes (Identification period), and their clinical and demographic characteristics
Secondary outcomes will be:
2) The proportion of people living with uncontrolled T2DM despite use of glucose lowering therapies, who receive treatment optimisation during the Identification period;
3) Describing the treatment intensification patterns by T2DM medication class in those that receive treatment intensification during the Identification period
4) Associations during the Outcome period (12-36 months post index) between those who receive treatment intensification vs those who do not during the Identification period for the following:
• Healthcare resource utilisation and direct healthcare costs
• Change in HbA1c levels
• Incident rates for cerebrovascular events, acute coronary syndrome, peripheral vascular disease, retinopathy, neuropathy, nephropathy, end stage renal disease, hypoglycaemic emergencies.
• All-cause mortality
Nick fabrin Nielsen - Chief Investigator - Novo Nordisk A/S
Nick fabrin Nielsen - Corresponding Applicant - Novo Nordisk A/S
Ayush Srivastava - Collaborator - Novo Nordisk Service Centre India Pvt Ltd.
Elisabeth de Laguiche - Collaborator - Novo Nordisk A/S
Marisse Asong - Collaborator - Novo Nordisk A/S
Elisabeth de Laguiche - Collaborator - Novo Nordisk A/S
Niels Væver Hartvig - Collaborator - Novo Nordisk A/S
Ayush Srivastava - Collaborator - Novo Nordisk Service Centre India Pvt Ltd.
HES Accident and Emergency;HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation