Abstract
BackgroundWe do not yet know how to use blood glucose self-monitoring (BGSM) most effectively in the self-management of type 2 diabetes treated with oral medication. Training in monitoring may be most effective in improving glycaemic control and well being when results are linked to behavioural change.Methods/designDiGEM is a three arm randomised parallel group trial set in UK general practices. A total of 450 patients with type 2 diabetes managed with lifestyle or oral glucose lowering medication are included. The trial compares effectiveness of three strategies for monitoring glycaemic control over 12 months (1) a control group with three monthly HbA1c measurements; interpreted with nurse-practitioner; (2) A self-testing of blood glucose group; interpreted with nurse- practitioner to inform adjustment of medication in addition to 1; (3) A self-monitoring of blood glucose group with personal use of results to interpret results in relation to lifestyle changes in addition to 1 and 2.The trial has an 80% power at a 5% level of significance to detect a difference in change in the primary outcome, HbA1c of 0.5% between groups, allowing for an attrition rate of 10%. Secondary outcome measures include health service costs, well-being, and the intervention effect in sub-groups defined by duration of diabetes, current management, health status at baseline and co-morbidity. A mediation analysis will explore the extent to which changes in beliefs about self-management of diabetes between experimental groups leads to changes in outcomes in accordance with the Common Sense Model of illness. The study is open and has recruited more than half the target sample. The trial is expected to report in 2007.DiscussionThe DiGEM intervention and trial design address weaknesses of previous research by use of a sample size with power to detect a clinically significant change in HbA1c, recruitment from a well-characterised primary care population, definition of feasible monitoring and behaviour change strategies based on psychological theory and evidence, and measures along the hypothesised causal path from cognitions to behaviours and disease and well being related outcomes. The trial will provide evidence to support, focus or discourage use of specific BGSM strategies.
Highlights
We do not yet know how to use blood glucose self-monitoring (BGSM) most effectively in the selfmanagement of type 2 diabetes treated with oral medication
The DiGEM intervention and trial design address weaknesses of previous research by use of a sample size with power to detect a clinically significant change in HbA1c, recruitment from a well-characterised primary care population, definition of feasible monitoring and behaviour change strategies based on psychological theory and evidence, and measures along the hypothesised causal path from cognitions to behaviours and disease and well being related outcomes
DiGEM Objectives Primary objective Our primary objective is to determine whether HbA1c is significantly lower in patients with type 2 diabetes allocated to each of two intervention groups compared to patients allocated to a control group
Summary
This study will make an important contribution to the evidence-base for the use of blood glucose self-monitoring in non-insulin using patients with type 2 diabetes It will provide a robust estimate of overall effect of use of the meters for self-testing alone and with a more intensive programme to support people in using their test results actively in self management of health related behaviours. The detailed information about beliefs and the pre-specified sub-group analyses will provide information to inform design of future studies in this area by allowing refinement of interventions and accurate estimates to inform sample size calculations The detailed information from blood glucose diaries and relation to outcomes will inform the refinement of training programmes and data interpretation This trial has features of both a pragmatic and an explanatory trial [29]. The results of this trial will be available in 2007
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