Assessing the Management and Clinical Outcomes of Patients with Non-Diabetic Intermediate Hyperglycaemia in UK Primary Care

Study type
Protocol
Date of Approval
Study reference ID
15_250
Lay Summary

People with non-diabetic intermediate hyperglycaemia have elevated blood glucose levels just below the cut-point for a diagnosis of diabetes and are considered at increased risk of developing diabetes. In recent years the term ‘pre-diabetes’ has also been used to describe this condition. There is an increasing interest in diagnosing and managing intermediate hyperglycaemia in the UK through the NHS Health Check and Diabetes Prevention Programme. However, we know very little about whether patients who are identified with intermediate hyperglycaemia have better health outcomes than they would have without this diagnosis. There are also concerns that the undue focus on lowering glucose levels may result in an inadequate management of other cardiovascular risk factors, i.e. blood pressure and central obesity.
This research project aims to: 1) characterise screening/testing and detection of ‘pre-diabetes’ in primary care settings, highlighting possible sub-groups differences and 2) determine the impact of a diagnosis of ‘pre-diabetes’ on the management of cardiovascular disease risk factors and health outcomes. This project will inform policy makers about the current management of patients with `pre-diabetes’ in clinical practice and the impact of this management on patients’ health outcomes.

Technical Summary

Non-diabetic intermediate hyperglycaemia is increasingly being identified and managed in primary care settings in the UK through the NHS Health Check and Diabetes Prevention Programme. However, little is known about whether the identification of intermediate hyperglycaemia improves health outcomes in routine care settings. The study aims to characterise and assess current practice for diabetes screening and identification of intermediate hyperglycaemia in UK primary care. It also aims to determine the impact of the diagnosis of intermediate hyperglycaemia on testing and control of cardiovascular disease (CVD) risk factors (i.e. HbA1c, blood pressure, and total cholesterol), hospital admissions for specific CVD events and all-causes and CVD-specific mortality. The study will use Clinical Practice Research Datalink (CPRD) data to construct a retrospective open cohort of patients aged 40-74 years with intermediate hyperglycaemia. In order to match cases and controls we will generate propensity scores for having a diagnosis of intermediate hyperglycaemia using multiple logistic or probit regression method. Mixed-effect logistic regression will be used for binary outcomes, linear mixed model for linear outcomes and mixed-effect Poisson regression model for count outcomes. Cox proportional hazards models will be used for survival analyses. Difference in differences methods will be employed as additional robustness test.

Collaborators

Christopher Millett - Chief Investigator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Eszter P Vamos - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Raffaele Palladino - Collaborator - Imperial College London
Utz Pape - Collaborator - Imperial College London

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Patient Level Townsend Score;Practice Level Index of Multiple Deprivation