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Does self monitoring of blood blucose 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

Dallosso, Helen M., Eborall, Helen C., Daly, Heather, Martin-Stacey, Lorraine, Speight, Jane, Realf, Kathryn, Carey, Marian E., Campbell, Michael J., Dixon, Simon, Khunti, Kamlesh, Davies, Melanie and Heller, Simon 2012, Does self monitoring of blood blucose 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, BMC family practice, vol. 13, no. 18, pp. 1-9.

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Title Does self monitoring of blood blucose 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
Author(s) Dallosso, Helen M.
Eborall, Helen C.
Daly, Heather
Martin-Stacey, Lorraine
Speight, Jane
Realf, Kathryn
Carey, Marian E.
Campbell, Michael J.
Dixon, Simon
Khunti, Kamlesh
Davies, Melanie
Heller, Simon
Journal name BMC family practice
Volume number 13
Issue number 18
Start page 1
End page 9
Total pages 9
Publisher BioMed Central
Place of publication London, England
Publication date 2012-03-14
ISSN 1471-2296
Keyword(s) blood glucose
blood glucose self-monitoring
cholesterol
cluster analysis
cost-benefit analysis
cross-sectional studies
type 2 diabetes mellitus
England
glycosylated hemoglobin A
Summary 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.
Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Language eng
Field of Research 170106 Health, Clinical and Counselling Psychology
Socio Economic Objective 970117 Expanding Knowledge in Psychology and Cognitive Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2012, Dallosso et al.
Persistent URL http://hdl.handle.net/10536/DRO/DU:30047383

Document type: Journal Article
Collections: School of Psychology
Open Access Collection
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Created: Tue, 28 Aug 2012, 15:37:39 EST by Jane Moschetti