NHS Digital Data Release Register - reformatted

Royal Devon and Exeter NHS Foundation Trust

Project 1 — DARS-NIC-147863-CCGZN

Opt outs honoured: Y, No - consent provided by participants of research study (Reasonable Expectation, Consent (Reasonable Expectation))

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2020/07.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable


  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Flagging Current Status Report
  • Demographics
  • Civil Registration - Deaths


There is considerable evidence that genetic influences are in the development of diabetes. Evidence for this includes the clustering in families of disease, a high concordance rate in identical twins and migration studies. However the majority of Type 2 forms of diabetes are greatly influenced by environment as shown by the rapidly increasing prevalence in the last two decades. This does not represent an alteration in the population gene frequency but rather changes in the environment, specifically a reduction in physical activity and increased food consumption. Both major types of diabetes represents classical “complex disorders” with both gene and environment playing an important role. Diabetes is a major cause of morbidity and mortality and has been estimated to account for 10% of NHS spending and this is likely to increase. Therefore understanding how to prevent complications is a major health priority. Both genetic susceptibility and environment are involved in the development of complications involving the small blood vessels such as retinopathy and large vessels such as myocardial infarction and stroke. Each risk factor has its own genetic and environments determinants. It is therefore a priority to have a very large collection of patients with Type 2 diabetes and associate controls from a defined geographical region to enable this work into susceptibility to progress.

Yielded Benefits:

No further papers have been written since the last application (four months ago) but it is envisaged that there will be some in the future. Currently, the major benefit is as above in that the organisation can ensure that individuals who are deceased are not tried to be contacted. Outputs from the DARE Study have already made a valuable contribution to clinical care for Diabetes patients at the Royal Devon and Exeter NHS Foundation Trust. A Principal Clinical Scientist at the Royal Devon and Exeter Hospital and his colleagues from the University of Exeter have discovered that the use of a simple urine test, urinary C-peptide: creatinine ratio (UCPCR) offers a practical non-invasive alternative to a C-peptide blood test. A C-peptide test is used to measure if patients with diabetes are making their own insulin. It is often used to find out whether someone has Type 1 or Type 2 diabetes. However, this blood test has been shown to be less reliable in patients whose kidneys are not working properly. The UCPCR test was developed using clinical data and samples donated from DARE participants and the test better reflects the amount of insulin being produced than repeated C-peptide measurements in patients with diabetes and kidney damage. A study led by Dr Christopher Clark an Academic Clinician at the University of Exeter used mortality data provided by NHS Digital to investigate whether differences in blood pressure between arms are associated with vascular disease and increased mortality; as this had not been reported in diabetes. His research was published in Diabetes Care journal. Clark C E, Steele A M, Taylor R S, Shore A C, Ukoumunne O C, Campbell J C. Interarm Blood Pressure Difference in People With Diabetes: Measurement and Vascular and Mortality Implications. Diabetes Care 2014 Jun; 37(6): 1613-1620 There have already been some papers arising from the DARE study published in: - Diabetic Medicine, the official journal of Diabetes UK; The Review of Diabetic Studies; Diabetes Care; Nursing Times. Diabetic Medicine: - A small study with big ambitions: 10 year review examining the impact and achievements of the Diabetes alliance for Research in England (DARE) within the Exeter NIHR Clinical Research Facility, Exeter and beyond. The transcription factor 7-like 2 (TCF7L2) gene is associated with Type 2 diabetes in UK community-based cases, but the risk allele frequency is reduced compared with UK cases selected for genetic studies. Difference in phenotype of patients recruited for genetic studies on an epidemiological rather than a familial based recruitment criteria. Angiotensin-converting enzyme gene insertion/deletion polymorphism is not associated with severe hypoglycaemia in patients with type 2 diabetes. What is the best case collection for defining the role of Type 2 diabetes genes? A comparison of the Diabetes UK Warren 2 Cases (W2C) and The Exeter Research Alliance for Diabetes (EXTRA). The Review of Diabetic Studies: - The Impact of Angiotensin-converting enzyme insertion/deletion polymorphism on severe hypoglycaemia in Type 2 diabetes. Nursing Times: - Implementing a research project on the development of diabetes.

Expected Benefits:

Flagging of patients and controls records on the NHS register with the ONS will be necessary. This will enable information on when patients die and information on their death certificate to be used in this study. This flagging is crucial as the greatly increased death rate from ischaemic heart disease in patients with diabetes needs to be studies in depth.


The aim of the study is to establish an epidemiologically based sample of patients with diabetes within the Exeter region. The major objective will be to collect DNA from all consenting patients and controls. Genetic information will be combined with clinical information to identify genes and gene/environment interaction in the development of Type 1 and Type 2 diabetes and for diabetes related complications specifically retinopathy and ischaemic heart disease. The study has arisen from discussion at meeting held with patients with diabetes (through patients organisation Diabetes UK) who felt that further research into who developed diabetes and who developed diabetes complications is important. A patient is on the steering committee and has read and given suggestions on the protocol and patient information sheet.


This study will be a central resource to allow both cohort and nested case/control studies. It will take place in both primary and secondary care as long as the individual doctors give their permission. The study will involve an integration of clinical information on patients from variety of sources which will be collected on the patient after he/she has given their permission and been recruited into the study. Flagging of patients and controls records on the NHS register with the ONS will be necessary. This will enable information on when patients die and information on their death certificate to be used in this study. This flagging is crucial as the greatly increased death rate from ischaemic heart disease in patients with diabetes needs to be studies in depth.