The DiGEM trial protocol - A randomised controlled trial to determine the effect on glycaemic control of different strategies of blood glucose self-monitoring in people with type 2 diabetes [ISRCTN47464659]

被引：25

作者：

Farmer A. ^{[1
,5
]}

Wade A. ^{[1
]}

French D.P. ^{[2
]}

Goyder E. ^{[3
]}

Kinmonth A.L. ^{[4
]}

Neil A. ^{[5
]}

机构：

[1] Department of Primary Health Care, University of Oxford, Old Road Campus, Oxford

[2] School of Sport and Exercise Sciences, University of Birmingham, Birmingham

[3] School of Health and Related Research, University of Sheffield, Sheffield, S1 4DA

[4] General Practice and Primary Care Research Unit, University of Cambridge, Cambridge, CB2 2SR, Robinson Way

[5] Oxford Centre for Diabetes, Endocrinology and Metebolism Churchill Hospital, Headington, Oxford

来源：

BMC Family Practice | / 6卷 / 1期

关键词：

Glycaemic Control; Assessment Visit; Tight Glycaemic Control; Parallel Group Trial; Common Sense Model;

D O I：

10.1186/1471-2296-6-25

中图分类号：

学科分类号：

摘要：

Background: 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. Training in monitoring may be most effective in improving glycaemic control and well being when results are linked to behavioural change. Methods/design: DiGEM 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 selfmanagement 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. Discussion: 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. The trial will provide evidence to support, focus or discourage use of specific BGSM strategies. © 2005 Farmer et al; licensee BioMed Central Ltd.

引用

共 29 条

[1] Wild S., Roglic G., Green A., Sicree R., King H., Global Prevalence of Diabetes: Estimates for the year 2000 and projections for 2030, Diabetes Care, 27, pp. 1047-1053, (2004)
[2] Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet, 352, pp. 837-853, (1998)
[3] Garfield S.A., Malozowski S., Chin M.H., Venkat Narayan K.M., Glasgow R.E., Green L.W., Hiss R.G., Krumholz H.M., Considerations for Diabetes Translational Research in Real-World Settings, Diabetes Care, 26, pp. 2670-2674, (2003)
[4] Norris S.L., Lau J., Smith S.J., Schmid C.H., Engelgau M.M., Self-Management Education for Adults with Type 2 Diabetes: A meta-analysis of the effect on glycemic control, Diabetes Care, 25, pp. 1159-1171, (2002)
[5] Blonde L., Ginsberg B.H., Horn S., Frequency of blood glucose monitoring in relation to glycaemic control in patients with type 2 diabetes, Diabetes Care, 25, pp. 245-246, (2002)
[6] A desktop guide to type 2 diabetes mellitus, Diabet Med, 16, pp. 716-730, (1999)
[7] Farmer A.J., Neil A., Variations in glucose self-monitoring during oral hypoglycaemic therapy in primary care, Diabet Med, (2004)
[8] Peel E., Parry O., Douglas M., Lawton J., Blood glucose self-monitoring in non-insulin-treated type 2 diabetes: A qualitative study of patients' perspectives, Br J Gen Pract, 54, pp. 183-188, (2004)
[9] Franciosi M., Pellegrini F., DeBeradis G., Belfiglio M., Cavaliere D., Di Nardo B., Greenfield S., Kaplan S.H., Sacco M., Tognoni G., Valentini M., Nicolucci A., The impact of blood glucose self-monitoring on metabolic control and quality of life in type 2 diabetic patients: An urgent need for better educational strategies, Diabetes Care, 24, pp. 1870-1877, (2001)
[10] Harris M.I., Frequency of blood glucose monitoring in relation to glycaemic control in patients with type 2 diabetes, Diabetes Care, 24, (2001)

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