Open Access Study protocol

Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

Helen M Dallosso1*, Helen C Eborall2, Heather Daly1, Lorraine Martin-Stacey1, Jane Speight3, Kathryn Realf1, Marian E Carey1, Michael J Campbell4, Simon Dixon5, Kamlesh Khunti2, Melanie J Davies6 and Simon Heller7

Author Affiliations

1 Diabetes Research Department, University Hospitals of Leicester NHS Trust, Leicester, UK

2 Department of Health Sciences, University of Leicester, Leicester, UK

3 AHP Research, Hornchurch, UK/The Australian Centre for Behavioural Research in Diabetes, Melbourne, Australia/Centre for Mental Health and Wellbeing Research, Deakin University, Burwood, Australia

4 School of Health and Related Research, University of Sheffield, Sheffield, UK

5 Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield, UK

6 Department of Cardiovascular Sciences, University of Leicester, Leicester, UK

7 Department of Human Metabolism, University of Sheffield Medical School, Sheffield, UK

For all author emails, please log on.

BMC Family Practice 2012, 13:18  doi:10.1186/1471-2296-13-18

Published: 14 March 2012

Abstract

Background

The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.

Methods/Design

The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.

The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.

Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.

Discussion

The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study.

Trial registration

ISRCTN: ISRCTN95696668.