Primary Care Diabetes
Volume 3, Issue 2 , Pages 117-121, May 2009

Individual patient data meta-analysis of trials of self-monitoring of blood glucose in non-insulin treated type 2 diabetes: Protocol for a systematic review

  • A.J. Farmer

      Affiliations

    • Department of Primary Health Care, NIHR School of Primary Care Research, University of Oxford, Oxford, UK
    • Corresponding Author InformationCorresponding author.
    • ,
  • C. Heneghan

      Affiliations

    • Department of Primary Health Care, NIHR School of Primary Care Research, University of Oxford, Oxford, UK
    • ,
  • A.H. Barnett

      Affiliations

    • Department of Medicine, University of Birmingham and Heart of England National Health Service Foundation Trust, Birmingham Heartlands Hospital, Birmingham, UK
    • ,
  • M.B. Davidson

      Affiliations

    • Clinical Center for Research Excellence, Charles Drew University, Los Angeles, CA, USA
    • ,
  • B. Guerci

      Affiliations

    • Diabetology, Metabolic diseases and Nutrition & CIC Inserm, Hospital Jeanne d’Arc, CHU & University of Nancy, 54201 Toul cedex BP 90303, France
    • ,
  • M. O’Kane

      Affiliations

    • Department of Clinical Chemistry, Altnagelvin Hospital, Western Health and Social Care Trust, Londonderry, Ireland
    • ,
  • U. Schwedes

      Affiliations

    • Diabetes Zentrum Hamburg City, Mönckebergstr.5 20095 Hamburg, Germany
    • ,
  • R. Perera

      Affiliations

    • Department of Primary Health Care, NIHR School of Primary Care Research, University of Oxford, Oxford, UK
    • ,
  • Self-monitoring of blood glucose trialists collaboration

Received 22 December 2008; received in revised form 4 March 2009; accepted 4 March 2009. published online 17 April 2009.

Abstract 

Background and aim of the study

Recent trials have provided differing estimates of the benefits of self-monitoring of blood glucose (SMBG) for non-insulin treated patients with type 2 diabetes. Designing and conducting randomised trials to demonstrate the efficacy of complex interventions is challenging. Variations in the components of the intervention delivered, target population selected, and reporting methods used have limited the conclusions drawn in recent systematic reviews. We will systematically examine these factors within the trials of SMBG to enable further investigation of the data through an individual patient data analysis (IPD).

Methods/design

The IPD analysis will include data from randomised trials comparing blood glucose self-monitoring and decisions about self-management versus a control group with standardised or routine care. The data requested for each trial will include outcomes (HbA1c, blood glucose and quality of life), potential moderators of effect (e.g. demographic variables, clinical data and psychosocial factors) and intervention descriptors. The primary outcome of interest will be HbA1c. Secondary outcomes include alternative measures of glycaemia, cardiovascular risk factors, persistence with monitoring, and measures of health status, quality of life and psychosocial factors. Analysis of patient sub-groups defined by age at randomisation, gender, prior use of monitoring and health status will be carried out. An intention to treat analysis will be performed and assessed for clinical and statistical heterogeneity.

Discussion

With current uncertainty about the extent of benefit from SMBG for non-insulin treated patients with type 2 diabetes, this study will provide the best estimates to date of overall effectiveness, effectiveness within potential target populations, and optimal components of the intervention.

Keywords: Study protocol, Individual patient data meta-analysis, Self-monitoring of blood glucose, Type 2 diabetes

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PII: S1751-9918(09)00026-6

doi:10.1016/j.pcd.2009.03.002

Refers to corrigendum:

  • Corrigendum to “Individual patient data meta-analysis of trials of self-monitoring of blood glucose in non-insulin treated type 2 diabetes: Protocol for a systematic review” [Primary Care Diabetes 3 (2009) 117–121] , 14 March 2011

    A.J. Farmer, C. Heneghan, A.H. Barnet, M.B. Davidson, B. Guerci, M. O’Kane, U. Schwedes, R. Perera, Self-monitoring of Blood Glucose Trialists Collaboration
    Primary Care Diabetes July 2011 (Vol. 5, Issue 2, Page 143)

Primary Care Diabetes
Volume 3, Issue 2 , Pages 117-121, May 2009

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