Education - Glucose monitoring

The National Institute for Health Research Health Technology Assessment (NIHR HTA) programme has published two new studies to help expand the evidence base around monitoring glucose levels in the management of both type 1 and type 2 diabetes.

Self-monitoring of blood glucose (SMBG) is a technology that is frequently incorporated into self-management interventions for diabetes, but has only been separately evaluated in a limited number of trials. Despite this lack of evidence, clinical guidelines have differed in advice about the best way to use SMBG.

The Diabetes Glycaemic Education and Monitoring (DiGEM) study, led by Dr Andrew Farmer, University of Oxford, tested whether self-monitoring of blood glucose alone, or with training in incorporating the findings into self-care, compared with standardised usual care improved glycaemic control in non-insulin treated patients with type 2 diabetes. Four hundred and fifty-three participants were recruited from 48 general practises in Oxford and South Yorkshire.

The research team concluded that the routine use of SMBG, with or withoutadditional training, was associated with higher costs and lower quality of life inpatients with well controlled non-insulin treated type 2 diabetes.

“Our trial does not provide evidence to support the routine use of SMBG. However it does not negate the established benefits for SMBG in insulin treated patients, although there remains further work to optimise its use,” says Dr Farmer. “Our results did not rule out there could be a role for SMBG in the management of patients with less well controlled diabetes and further research into this area would be valuable.”

A further clinical trial, led by Dr Steven John Hurel, University College London Hospitals Foundation Trust suggests that continuous glucose monitors do not lead to improved clinical outcomes in individuals with poorly controlled, insulin-requiring diabetes. The study evaluated the effectiveness and acceptability to patients of two minimally invasive continuous glucose monitoring devices to help improve diabetes control. The machines had been developed to automatically record sugar levels every 5-10 minutes whilst worn and provide additional information, which could help improve glyceamic control in people with poorly controlled insulin-requiring diabetes.

Four hundred and four participants were randomised into four groups: group one were asked to wear the Glucowatch a minimum of four times per month and a maximum of four times per week for the first three months; group two had the MiniMed Continuous Glucose Monitoring System fitted three times over the first three months of the study; group three received standard treatment with three nurse feedback sessions during the first three months; and group four received standard treatment only.

The results showed no significant difference between any of the groups and indicated no advantage in having the additional information provided by a continuous glucose monitoring device. There was also a decline in participants using the devices but this was more noticeable in the Glucowatch group with only 20 per cent of participants continuing to use the device at 18 months. The GlucoWatch was also associated with more side effects, greater interference with daily activities and more difficulty in using the device compared to the MiniMed Continuous Glucose Monitoring System. From the findings the researchers suggest that the use of these devices should be targeted to specific groups of patients who are most likely to benefit from wearing them.

"The findings of our research emphasise the importance of examining acceptability, as devices may demonstrate clinical value but if potential users find them unacceptable or choose not to use them then it is unlikely that they could be introduced into routine care," says Dr Hurel. "This study was performed on early versions of these devices and the technology has somewhat improved. Nevertheless the study demonstrates that the use of these devices should be focussed on certain subgroups of patients and that patient acceptability and expectations are key factors in using them successfully. As new devices emerge further research will need to be conducted to assess the effectiveness and acceptability of these."

1. The HTA programme is a programme of the National Institute for Health Research (NIHR) and produces high quality research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest of the NIHR programmes and publishes the results of its research in the Health Technology Assessment journal, with over 470 issues published to date. The journal’s 2007 Impact Factor (3.87) ranked it in the top 10% of medical and health-related journals. All issues are available for download free of charge from the website, www.hta.ac.uk. The HTA programme is coordinated by the NETSCC, Health Technology Assessment, based at the University of Southampton.

2. The National Institute for Health Research provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility. The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients. www.nihr.ac.uk