Pilot of capillary blood glucose testing in screening for diabetes v1
Research type
Research Study
Full title
Inclusion of a random capillary blood glucose test in screening for diabetes. A pilot study.
IRAS ID
123316
Contact name
Patrick Sharp
Contact email
Sponsor organisation
University Hospital Southampton (UHS)
Research summary
A diagnosis of diabetes is recognised to be a major risk factor for development of circulatory disorders, including heart diasease, stroke and limb amputation. There is agreement that screening for diabetes is worthwhile as an early diagnosis is treatable and reduces future risk. NICE have recently published guidance on screening for diabetes in those over the age of 40 years and in those over 25 years who are at risk. The published screening strategy would categorise the top 50% of the population as needing further testing which will be expensive for the health budget. This project examines the value of including a simple finger prick blood glucose test to the risk stratification tests. The measured outcome would be whether the additional measure reduces the number who are considered at high risk of diabetes and therefore requiring further testing. Statistical advice suggests that it is not possible to calculate a sample size, and this application is therefore for a pilot project of 300 individuals. The study protocol uses a marker of diabetes and pre-diabetes which has only recently been agreed for use by the World Health Organisation and UK Societies. The use of HbA1c to diagnose diabetes or those at imminent risk of diabetes is therefore novel, and follow up of test positive subjects will be built into the protocol. Similarly, there are questions surrounding the use of the HbA1c test and the test subject’s haemoglobin (Hb) level, and we will examine this relationship as part of the protcol.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0477
Date of REC Opinion
20 Dec 2013
REC opinion
Favourable Opinion