CHAPTER 1
Self-Monitoring of Blood Glucose
Satish K. Garg1 and Irl B. Hirsch2
1University of Colorado Health Sciences Center, Aurora, CO, USA
2University of Washington Medical Center, Seattle, WA, USA
INTRODUCTION
Diabetes prevalence is increasing globally especially in the Asian subcontinent. It is expected that by the year 2030 there may be close to 400 million people with diabetes. All of the research in the past 25 years has clearly documented the effectiveness of improving glucose control in reducing long-term complications of diabetes, both microvascular and macrovascular. The improvement in glucose control usually requires continuous intensive diabetes management, particularly in insulin-requiring patients, which must include home self-monitoring of blood glucose (SMBG). Despite the convincing evidence, the role of SMBG in diabetes management is still being debated even though its availability in the past 35 years has revolutionised diabetes care, especially at home.
The International Diabetes Federation (IDF) recently published guidelines for SMBG use in non-insulin-treated diabetic patients, recommending that SMBG should be used only when patients and/or their clinicians possess the ability, willingness and knowledge to incorporate SMBG and therapy adjustment into their diabetes care plan. The IDF also recommends that structured SMBG be performed with the choice of applying different defined blood glucose testing algorithms to patients' individual diabetes care plans. These defined blood glucose testing algorithms give SMBG a medically meaningful structure to collect high quality glucose information and are called structured SMBG. Former SMBG studies have demonstrated SMBG to be beneficial when patients receive feedback regarding the impact of their behaviours on SMBG results. Other studies which did not link SMBG results to these principal behaviours have shown no SMBG benefit. A new wave of clinical studies performed after the release of the IDF guideline have recently been published and have proved the success of the new application of SMBG.
The reasons for this ongoing debate may in part be due to rising healthcare costs globally, lack of convincing data in non-insulin-requiring patients with type 2 diabetes in randomised controlled clinical trials and multiple controversial meta-analyses performed on several studies. Sometimes the decisions are extended to insulin-requiring patients, even those with type 1 diabetes. For example, last year in the state of Washington in the USA, legislators were going to stop reimbursing glucose test strips for children with type 1 diabetes. After much debate with committee members (who were not diabetologists and or endocrinologists) and law makers, not only SMBG but even in some cases continuous glucose monitoring (CGM) is now reimbursed. The issue was simply educating non-understanding but well-meaning people whose main concern is saving money. In the end, no one, even those not familiar with paediatric type 1 diabetes, can disagree about the need for SMBG in this age group.
It seems to us that we should instead be spending our time and effort in advancing the field and improving diabetes management for patients through newer technologies like CGM and closed-loop systems. As discussed in the section on CGM (Chapter 2) there is ample data from both non-randomised and randomised clinical trials showing the efficacy in reducing time spent in hypoglycaemia and hyperglycaemia along with improvement in glucose control without introducing any additional medication. We hope that the future will be spent in advancing the care rather than useless meta-analyses or going back in time. It is worthwhile to review existing evidence about SMBG to learn, transfer and apply knowledge about the core requirement for good diabetes management, glucose information.
Non-coding glucometers among paediatric patients with diabetes: looking for the target population and an accuracy evaluation of no-coding personal glucometer
Fendler W, Hogendorf A, Szadkowska A, Młynarski W
Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz, Poland
Pediatr Endocrinol Diabetes Metab 2011; 17: 57–63
Background
SMBG is one of the major components of diabetes management.
Aims
To evaluate the potential for miscoding of a personal glucometer, to define a target population among paediatric patients with diabetes for a non-coding glucometer and to assess the accuracy of the Contour TS non-coding system.
Methods
Potential for miscoding during SMBG was evaluated by means of an anonymous questionnaire, with worst and best case scenarios evaluated depending on the response pattern. Testing of the Contour TS system was performed according to the national committee for clinical laboratory standards guidelines.
Results
The estimated frequency of individuals prone to non-coding ranged from 68.21% [95% confidence interval (CI) 60.70%–75.72%] to 7.95% (95% CI 3.86%–12.31%) for the worse and best case scenarios, respectively. Factors associated with increased likelihood of non-coding were a smaller number of tests per day, a greater number of individuals involved in testing and self-testing by the patient. The Contour TS device showed intra- and inter-assay accuracy of –95%, a linear association with laboratory measurements (R2 = 0.99, p < 0.0001) and small bias of –1.12% (95% CI –3.27% to 1.02%). Clarke error grid analysis showed 4% of values within the benign error zone (B) with the other measurements yielding an acceptably accurate result (zone A).
Conclusions
The Contour TS system showed sufficient accuracy to be safely used in the monitoring of paediatric patients with diabetes. Patients from families with a high throughput of test-strips or multiple individuals involved in SMBG using the same meter are candidates for clinical use of such devices due to an increased risk of calibration errors.
COMMENT
This study further highlights the role of making SMBG simpler and easier so that patients can monitor the glucose more effectively. The current study used the Contour TS system which does not require coding by the patient and thus removes the barrier of mis-coding of SMBG. We personally think that all meters going forward must be non-coding meters.
Effect of ambient temperature on analytical performance of self-monitoring blood glucose systems
Nerhus K1, Rustad P2, Sandberg S1,3
1Norwegian Centre for Quality Improvement of Primary Care Laboratories, Department of Public Health and Primary Health ...