Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trialBMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39247.447431.BE (Published 19 July 2007) Cite this as: BMJ 2007;335:132
- Andrew Farmer, lecturer1,
- Alisha Wade, resident2,
- Elizabeth Goyder, reader3,
- Patricia Yudkin, reader1,
- David French, reader4,
- Anthea Craven, trial manager1,
- Rury Holman, professor5,
- Ann-Louise Kinmonth, professor6,
- Andrew Neil, professor7
- 1Department of Primary Health Care, University of Oxford, Oxford OX2 7LF
- 2Johns Hopkins University School of Medicine, Baltimore
- 3School of Health and Related Research, University of Sheffield
- 4Applied Research Centre in Health and Lifestyle Interventions, University of Coventry
- 5Diabetes Trials Unit, University of Oxford
- 6Institute of Public Health, University of Cambridge
- 7Division of Public Health and Primary Care, University of Oxford
- Correspondence to: A Farmer
- Accepted 13 June 2007
Objective To determine whether self monitoring, alone or with instruction in incorporating the results into self care, is more effective than usual care in improving glycaemic control in non-insulin treated patients with type 2 diabetes.
Design Three arm, open, parallel group randomised trial.
Setting 48 general practices in Oxfordshire and South Yorkshire.
Participants 453 patients with non-insulin treated type 2 diabetes (mean age 65.7 years) for a median duration of three years and a mean haemoglobin A1c level of 7.5%.
Interventions Standardised usual care with measurements of HbA1c every three months as the control group (n=152), blood glucose self monitoring with advice for patients to contact their doctor for interpretation of results, in addition to usual care (n=150), and blood glucose self monitoring with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (n=151).
Main outcome measure HbA1c level measured at 12 months.
Results At 12 months the differences in HbA1c level between the three groups (adjusted for baseline HbA1c level) were not statistically significant (P=0.12). The difference in unadjusted mean change in HbA1c level from baseline to 12 months between the control and less intensive self monitoring groups was −0.14% (95% confidence interval −0.35% to 0.07%) and between the control and more intensive self monitoring groups was −0.17% (−0.37% to 0.03%).
Conclusions Evidence is not convincing of an effect of self monitoring blood glucose, with or without instruction in incorporating findings into self care, in improving glycaemic control compared with usual care in reasonably well controlled non-insulin treated patients with type 2 diabetes.
Trial registration Current Controlled Trials ISRCTN47464659.
We thank the patients who took part in this study and their doctors for support and help. W Hardeman and I Hobbis contributed to the development of the intervention protocols and prepared and led some of the training sessions for the nurses. M McKinnon and J Donnelly helped train the nurses and L Rosmovitz carried out external review of interventions.
Contributors: AF, A-LK, and AN had the original idea for the study and wrote the trial protocol with PY, DF, and RH. AF, AW, DF, and A-LK developed the trial measures and intervention. PY was trial statistician and analysed the data. AW, AF, AC, and EG managed the trial. AF wrote the first draft of the manuscript with AN and A-LK and all members of the writing group reviewed and commented on the final manuscript. AF is guarantor of this paper. The DiGEM Trial Group. Writing committee: AF, AW, EG, PY, DF, AC, RH, A-LK, and AN. Investigators: AF, AN, A-LK, D Mant, S Ziebland, DF, A Gray, PY, and RH. Steering committee: N Stott (chair), AF, AN (to 2005), S Sutton, H Tewson, D Chapman, H Hearnshaw, E Goyder (from 2005), P Glasziou (from 2005), M Jiwa (2004 to 2005), and M Gordon (from 2005). Intervention development: AW, AF, DF, A-LK, and MP Selwood. Coordinating Centres: (Oxford) AW (to 2005, trial coordinator), AC (trial manager), PY (trial statistician), J Simon (health economist), and A Fuller (data manager); (Sheffield) Vivienne Walker (local trial administrator). Data monitoring committee: C Baigent (chair), J Levy, and K Wheatley. Research nurses (Oxford) MP Selwood, H Kirlow, M Chapman, and S Turner; (Sheffield) A Casbolt, K Dobson, A Willert, A Roberts, and H Wood. Central laboratory: K Islam.
Funding: The trial was funded by the NHS and the National Insitute for Health Research health technology assessment programme. The opinions expressed in this report are not necessarily those of the Department of Health. Abbott Diabetes Care provided blood glucose meters (Optium). AF was supported by an NHS research and development career development award from 2001-5. AW was supported by a Rhodes scholarship.
Competing interests: None declared.
Ethical approval: This study was approved by the Oxfordshire Research Ethics Committee B (002.059).
- Accepted 13 June 2007