Self-monitoring of blood glucose
Disclosures: SG received honoraria for Advisory board or for giving talks for Roche Diagnostics, DexCom and Sanofi-Aventis in the last year. SG has also received research funding from Medtronic/Minimed for Close-Loop studies through the University of Colorado.
IH received consulting fees from Roche, Bayer, Johnson & Johnson and Abbott Diabetes Care.
SG has also received research funding from Novo Nordisk, Sanofi-Aventis and Mannkind Corporation.
Endorsed by the International Conference on ATTD organized by Kenes International.
Satish K. Garg,
University of Colorado Health Science Center, Aurora, CO, USA
Many would argue that the introduction of modern-day diabetes management started 30 years ago with the introduction of self-monitoring of blood glucose (SMBG) at home. While that may be true, it is interesting that many of today’s fundamental questions have yet to be answered. Furthermore, the technology itself continues to change, to improve and to better exist with our non-diabetes technology. For example, the first SMBG ‘apps’ are available now for smart-phones (iPhone), and we can expect the phones themselves to participate more directly with SMBG and diabetes management. Still, both researchers (and payors) continue to ask some fundamental questions.
- 1 What is the efficacy of SMBG for patients not requiring insulin therapy?
- 2 What is the optimum frequency of SMBG for patients who do require insulin therapy?
- 3 What is the role of software to assist in data management for SMBG (for both patients and clinicians)?
- 4 What is the cost effectiveness of SMBG for all of the different patient populations with diabetes?
- 5 What is the ideal chemistry which results in the least amount of interfering substances with SMBG?
- 6 What is an acceptable accuracy for SMBG both at home and in the hospital? The accuracy question is more important than ever since all continuous glucose monitoring (CGM) for now are calibrated with SMBG results.
- 7 What is the best strategy for teaching patients how best to use their SMBG data?
- 8 What is the best way to integrate SMBG with insulin pump therapy?
- 9 What is the role of SMBG with today’s CGM devices?
- 10 What will the role of SMBG be 5–10 years from now with future CGM devices?
These are just some of the questions which need more thought and study as we move into 2011. In this chapter we have selected papers that appeared in the PubMed on this topic and chose those we thought were most influential in this area. We have then addressed many of these topics although answers are far from clear for many of them. Although SMBG is not ‘new’ technology, much research needs to be completed before we fully understand this tool’s full impact, particularly as CGM becomes more popular.
The prevalence of self-monitoring of blood glucose and costs of glucometer strips in a nationwide cohort
R. L. S. Kjome,1A. G. Granas,2K. Nerhus,3T. H. Roraas,3S. Sandberg3,4
1Section for General Practice, University of Bergen, Bergen, Norway,2Centre for Pharmacy, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway,3Norwegian Centre for Quality Improvement of Primary Care Laboratories, University of Bergen, Bergen, Norway, and4Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway
Diabetes Technol Ther 2010; 12: 701–5
Background: Nationwide data were used to determine the prevalence of SMBG in Norway and to estimate the frequency and cost of SMBG and the use of different glucometers among patients with diabetes.
Methods: This retrospective study was based on data of glucometer strips sales to non-institutionalised persons in Norway. The data included demographic details, type and cost of strips, and the number/time/place of packages dispensed. Additionally, details about insulin and oral antidiabetes medication sales were obtained from the Norwegian Prescription Database.
Results: A total of 96,999 persons (2%) purchased strips. Approximately 70% of diabetes patients practised SMBG, and less than 50% of patients performed daily SMBG. An average patient used 1.7 strips per day, and younger patients purchased more strips than older patients. Most patients used only one type of strips, but the number of strips purchased increased with the number of different strips.
Conclusions: In total 2% of all non-institutionalised population and an estimated 70% of patients using diabetes medication purchased SMBG strips. This, together with the fact that over 50% of the patients measure less than once per day, calls for more tight monitoring of diabetes patients.
- • Comment: This is an important nationwide (Norway) study that addresses the importance of SMBG in patients with diabetes. Even though more than 70% of patients with diabetes bought SMBG strips, there were still more than half of the patients that monitored their glucose less than once per day. The overall cost for SMBG strips for diabetes management only accounted for 8% of the total cost (446 euros/person). Unfortunately, this study does not address the relationship of utilisation of SMBG strips and the complications and long-term health outcomes of patients with diabetes. Such studies using national databases may be able to answer in the future the important question of cost–benefit of SMBG in insulin-requiring or non-insulin-taking patients with diabetes.
Evolution of data management tools for managing self-monitoring of blood glucose results: a survey of iPhone applications
A. Rao, P. Hou, T. Golnik, J. Flaherty, S. Vu
AgaMatrix Inc., Salem, NH, USA
J Diabetes Sci Technol 2010; 4: 949–57
Background: Feedback from the healthcare provider based on SMBG can help achieve target glycaemic control. Electronic SMBG data management and sharing tools for the PC and smart phones may help in reducing the effort to manage SMBG data.
Methods: Software and top-ranking applications (apps) for the iPhone platform were reviewed for useful features, and patients with diabetes were observed as they recorded and relayed sample SMBG results to their hypothetical healthcare provider using three apps.
Results: The WaveSense Diabetes Manager allowed the participants to complete preselected SMBG data entry and relay tasks faster than other apps. The survey revealed patient behaviour patterns that would be useful in future app development.
Conclusions: Being able to record, analyse and obtain feedback on the SMBG data using an iPhone/iTouch app might potentially benefit patients. Trends in SMBG data management and the possibility of having interoperability of SMBG and smart phones may open up new avenues of diabetes management.
- • Comment: This study uses WaveSense Diabetes Manager applications on iPhone. The results of the study are reported as primarily potential as no application of these data has been applied in clinical practice. However, the use of such technology might allow more effective use of SMBG and its interpretation with a possible impact on glucose control and long-term health outcomes. The only problem with this study is that, if iPhone application is used as a standalone entity along with a blood glucose (BG) meter as part of the iPhone, it is likely that regulatory agencies [Food and Drug Administration (FDA) and European Medicines Agency] may consider the iPhone as a new device and thus require Pre-Market Approval applications, which is a very lengthy process for approval of the devices.
ROSSO-in-praxi: a self-monitoring of blood glucose structured 12-week lifestyle intervention significantly improves glucometabolic control of patients with type 2 diabetes mellitus
K. Kempf1, J. Kruse2, S. Martin1
1West-German Centre of Diabetes and Health, Sana Hospital Gerresheim, Sana Clinics Düsseldorf GmbH, Düsseldorf, Germany, and2Department of Psychosomatic Medicine and Psychotherapy, Justus-Liebig-University Gießen, Gießen, Germany
Diabetes Technol Ther 2010; 12: 547–53
Background: Lifestyle changes with healthy diet and physical activity should be the basis for each therapy in patients with type 2 diabetes. The only tool to visualise immediate effects of these changes is SMBG. The aim of the 12-week lifestyle intervention ROSSO-in-praxi was to evaluate the impact of an SMBG-structured motivation and education programme on metabolic and health parameters in diabetes patients not treated with insulin.
Methods: Participants (n = 405) generated a seven-point SMBG diurnal profile every 4 weeks, including actual weight, waist circumference and steps per day. At baseline and the end of the study, HbA1c, blood pressure, cholesterol levels, lifestyle changes and well-being were assessed.
Results: In total 327 participants (81%) completed the programme and significantly improved their quality of diet and physical activity, accompanied by an increase of > 2300 steps/day. Patients significantly reduced body mass index, waist circumference, BG, blood pressure, low-density lipoprotein cholesterol and HbA1c (all p < 0.001), accompanied by increased physical and mental health and reduced depression measurements. Weight loss was significantly associated with overall improvements of metabolic and health parameters.
Conclusions: The evaluated SMBG-structured lifestyle intervention is applicable to motivate individuals with type 2 diabetes for lifestyle changes. Integration of this highly motivational low-cost intervention in patients without insulin therapy could strengthen patient empowerment and change lifestyle with improved general health.
- • Comment: This is a prospective non-randomised controlled trial where patients were followed for 12 weeks. The subjects were asked to do seven-point BG profiles every 4 weeks along with lifestyle intervention. The results clearly indicate that when lifestyle interventions are properly implemented they result in significant improvement of A1c and other glucose, metabolic and health parameters in patients with diabetes. We are not sure if the structured SMBG (seven-point glucose profile) done in this study reflects the improvement in A1c by 0.3%. This modest drop in A1c could easily have been related to the lifestyle modification rather than to the structured SMBG.
The value of episodic, intensive blood glucose monitoring in non-insulin-treated persons with type 2 diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial
W. Polonsky,1L. Fisher,2C. Schikman,3D. Hinnen,4C. Parkin,5Z. Jelsovsky,6L. Amstutz,7M. Schweitzer,7R. Wagner7
1University of California, San Diego, and Behavioral Diabetes Institute, San Diego, CA, USA,2University of California, San Francisco, CA, USA,3North Shore University Health System, Skokie, IL, USA,4Mid America Diabetes Associates, Wichita, KS, USA,5Health Management Resources Inc., Carmel, IN, USA,6Biostat International Inc., Tampa, FL, USA, and7Roche Diagnostics, Indianapolis, IN, USA
BMC Fam Pract 2010; 11: 37
Background: The Structured Testing Program is a 12-month, cluster-randomised, multicentre clinical trial that will try to evaluate whether poorly controlled (HbA1c ≥ 7.5%), non-insulin-treated type 2 diabetes mellitus patients benefit from an integrated physician/patient intervention using structured SMBG in US primary care practices.
Methods: A total of 504 patients will be enrolled from 34 clinics, and will be randomly assigned to an active control group that receives enhanced usual care or to an enhanced usual care group plus structured SMBG. Differences in timing and degree of treatment intensification, cost effectiveness, changes in patient self-management behaviours, and quality of life over time will be assessed. Change in HbA1c and other variables over time will be evaluated, and results will be available in 2010.
Conclusions: The intervention and trial design emphasise appropriate and collaborative use of SMBG by both patients and physicians, with assessment of the broader impact of intervention on multiple dependent variables.
- • Comment: This is a randomised control trial sponsored by Roche Diagnostics. The cluster randomisation was done by the practices and the active control group received enhanced usual care plus the structured SMBG. This paper only highlights the design of the study; however, the data were presented at the American Diabetes Association Conference (ADA) in Orlando, FL, 2010. The conclusion of the abstract presented at the ADA showed significantly better A1c improvement in the active control group that was maintained up to 1 year. We shall have to wait for the full paper to be published for further comments.
Evaluation of self-monitoring of blood glucose in non-insulin-treated diabetic patients by randomised controlled trials: little bang for the buck
M. B. Davidson
Charles Drew University, Los Angeles, CA, USA
Rev Recent Clin Trials 2010; 5: 138–42
Background: There are still controversial data about the benefit of SMBG in non-insulin-treated type 2 diabetes patients. Only randomised controlled trials can provide the answer.
Methods: A meta-analysis on 14 randomised controlled trials where SMBG was performed was done.
Results: Nine studies showed no benefit in lowering HbA1c levels. In four of five positive ones, the SMBG group received more intensive education and/or treatment than the control group. In the one in which patients in both groups were followed similarly, over 500 patients were required to produce a statistically significant difference of 0.2% favouring SMBG.
Conclusions: There is scant evidence that SMBG in non-insulin-treated type 2 diabetes patients is effective in improving glycaemic control.
- • Comment: The controversy on the role of SMBG in type 2 diabetes continues especially in patients not requiring insulin therapy. In this paper Mayer Davidson did a meta-analysis on 14 randomised controlled trials where SMBG was performed. There was an improvement of only 0.2% in A1c values in favour of SMBG and the clinical significance of that remains debatable. Davidson believes that SMBG is very expensive and may not be useful for non-insulin-requiring patients with type 2 diabetes. It is hoped that there will be a study done one day which will answer this question once and for all rather than continuing to debate based on meta-analysis.
Self-monitoring of blood glucose in type 2 diabetes: systematic review
C. Clar,1K. Barnard,2E. Cummins,3P. Royle,4N. Waugh5Aberdeen Health Technology
1Systematic Reviews, Berlin, Germany,2University of Southampton, Southampton, UK,3McMaster Development Consultants, Glasgow, UK,4University of Aberdeen, Aberdeen, UK, and5Department of Public Health, Medical School Buildings, Foresterhill, Aberdeen, UK
Health Technol Assess 2010; 14: 1–140
Background: A meta-analysis was done to examine whether SMBG is worthwhile in terms of glycaemic control, quality of life and cost per quality-adjusted life year (QALY) in adult patients with type 2 diabetes who were not treated with insulin or who were on basal insulin in combination with oral agents.
Methods: A literature search included English language systematic reviews published since 1996 and meta-analyses of randomised controlled trials along with review of qualitative and economic studies. Databases included the Cochrane Library, MEDLINE, EMBASE, PsycINFO, Web of Science (limited to meeting abstracts) and websites. The intervention was SMBG with a meter and test strips. Data were analysed by outcome and subgroups. The following analyses were carried out: SMBG compared to self-monitoring of urine glucose; SMBG vs. no SMBG; more intensive SMBG vs. less intensive SMBG; and more intensive SMBG vs. no SMBG.
Results: The review identified 30 randomised controlled trials. Ten trials comparing SMBG with no SMBG showed a reduction in HbA1c of 0.21%, which may not be considered clinically significant. A similar difference was shown where SMBG with education was compared with SMBG without education or feedback. Randomised controlled trials showed no consistent effect on hypoglycaemic episodes and no impact on medication changes. Costs of SMBG per year varied considerably. Diabetes Glycaemic Education and Monitoring analysis concluded that SMBG was not cost effective. Qualitative studies revealed that there was a lack of education in how to interpret and use the data from SMBG, with common failure to act on the results.
Conclusions: SMBG is of limited clinical effectiveness in improving glycaemic control in type 2 diabetes patients treated with oral agents or diet alone, and is therefore unlikely to be cost effective. SMBG may lead to improved glycaemic control only in the context of appropriate education for patients and healthcare professionals on how to respond to the data (lifestyle and treatment adjustment).
- • Comment: Here is another meta-analysis similar to the one presented above which further highlights that the cost–benefit ratio goes against SMBG. Similar to the previous study, this meta-analysis also showed a favourable drop in A1c of 0.21% in the SMBG group in the randomised, controlled trial. However, the authors continue to discuss whether this modest reduction in A1c justifies the cost increase to patients with diabetes. One wonders if a better return for the money might come from lifestyle modifications and other medical management in patients with type 2 diabetes not requiring insulin therapy.
System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197
G. Freckmann,1A. Baumstark,1N. Jendrike,1E. Zschornack,1S. Kocher,2J. Tshiananga,2F. Heister,2C. Haug1
1Institute for Diabetes-Technology at the University of Ulm, Ulm, Germany, and2Institute for Medical Informatics and Biostatistics, Basel, Switzerland
Diabetes Technol Ther 2010; 12: 221–31
Background: Blood glucose monitoring systems with a Conformité Européenne (CE) label should meet the standard DIN EN ISO 15197: 2003: ≥ 95% of the BG results shall fall within ±15 mg/dl of the reference method at BG concentrations < 75 mg/dl and within ±20% at BG concentrations ≥ 75 mg/dl. This study evaluated if BG monitoring systems with a CE label fulfil these minimum accuracy requirements.
Methods: Twenty-seven BG monitoring systems from 18 manufacturers were evaluated for system accuracy according to DIN EN ISO 15197: 2003. Twenty-four systems were compared with the glucose oxidase reaction (YSI 2300 glucose analyser, YSI Life Sciences, Yellow Springs, OH, USA) and three systems with the hexokinase reaction (Hitachi 917, Roche Diagnostics, Mannheim, Germany).
Results: Sixteen of the 27 BG monitoring systems fulfilled the minimum accuracy requirements of the standard, i.e. ≥ 95% of their results showed the minimum acceptable accuracy. Overall, the mean percentage of results showing the minimum acceptable accuracy was 95.2% ± 5.2%, ranging from 80.0% to 100.0%.
Conclusions: More than 40% of the evaluated BG monitoring systems did not fulfil the minimal accuracy requirements of DIN EN ISO 15197: 2003 with the risk of false treatment decisions by the diabetes patient and subsequent possible severe health injury. Thus, manufacturers should effectively check the quality of BG meters and test strips.
- • Comment: This is an important study that compares 27 different BG monitoring systems. The study concludes that more than 40% of the BG monitoring systems did not fulfil the ISO 15197: 2003 minimum criteria of ±20% of the BG concentrations more than 75 mg/dl. This is more important than ever as we calibrate continuous glucose monitoring systems with SMBG systems. Any error in calibration will result in a much larger mean absolute relative difference on the continuous glucose monitoring system. This is why the FDA is requesting all the meter companies to improve the accuracy of their meters to ±10%.
Cost effectiveness of self-monitoring of blood glucose in patients with type 2 diabetes mellitus managed without insulin
C. Cameron,1D. Coyle,2E. Ur3,5,6, S. Klarenbach4–6
1Canadian Optimal Medication Prescribing and Utilization Service,2Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Department of Epidemiology and Community Medicine,3University of Ottawa, Ottawa, ON, Division of Endocrinology,4St Paul’s Hospital and Vancouver General Hospital, University of British Columbia, Vancouver, BC, Department of Medicine,5University of Alberta, Calgary, AB, and6Canadian Optimal Medication Prescribing and Utilization Service Expert Review Committee
CMAJ 2010 12; 182: 28–34
Background: This study tried to determine the cost effectiveness of SMBG for patients with type 2 diabetes not using insulin.
Methods: A cost effectiveness analysis of the SMBG in adult patients with type 2 diabetes not taking insulin was performed using the UK Prospective Diabetes Study (UKPDS) model to forecast diabetes-related complications, corresponding QALYs and costs. Clinical data were obtained from a systematic review comparing self-monitoring with no self-monitoring.
Results: Based on a clinically modest reduction in HbA1c of 0.25% (estimated from the systematic review), the UKPDS model predicted that SMBG performed ≥ 7 times/week reduced the lifetime incidence of diabetes-related complications compared with no SMBG, albeit at a higher cost.
Conclusions: For most patients with type 2 diabetes not using insulin, use of BG test strips for frequent SMBG ≥7 times/week is unlikely to represent efficient use of finite healthcare resources, although periodic testing of once or twice a week may be cost effective.
- • Comment: Here is another study from Canada looking into cost effectiveness of SMBG in non-insulin-requiring patients with type 2 diabetes. A similar but modest reduction in A1c of 0.25% was reported in subjects using SMBG seven or more times per week. The authors conclude that SMBG is unlikely to represent efficient use of finite healthcare resources. There needs to be a proper study done for a longer duration addressing the cost–benefit ratio of SMBG.
Inpatient glucose control: a glycaemic survey of 126 US hospitals
C. B. Cook,1G. L. Kongable,2D. J. Potter,2V. J. Abad,2D. E. Leija,2M. Anderson3
1Mayo Clinic College of Medicine, Scottsdale, AZ, USA,2The Epsilon Group Virginia, LLC, Charlottesville, VA, USA, and3Medical Automation Systems, Charlottesville, VA, USA
J Hosp Med 2009; 4 (9): E7–E14
Background: There is a significant value of treating inpatient hyperglycaemia. However, little is known about glucose control in US hospitals.
Methods: The Remote Automated Laboratory System-Plus was used to extract inpatient point-of-care bedside glucose (POC-BG) tests from 126 hospitals between January and December 2007. Patient-day-weighted mean POC-BG and hypoglycaemia/hyperglycaemia rates were calculated for intensive care unit (ICU) and non-ICU areas, and the relationship of POC-BG levels and hospital characteristics was determined.
Results: A total of 12,559,305 POC-BG measurements were analysed (23.4% from the ICU and 76.6% from the non-ICU). Patient-day-weighted mean POC-BG was similar for ICU and for non-ICU (165 mg/dl and 166 mg/dl, respectively). Prevalence of hospital hyperglycaemia (> 180 mg/dl) was 46.0% and 31.7% and for hypoglycaemia (< 70 mg/dl) 10.1% and 3.5% for ICU and for non-ICU, respectively. Larger hospitals (≥ 400 beds) had significantly lower patient-day-weighted mean POC-BG per patient day than smaller hospitals (< 200 beds, p < 0.001). Rural hospitals had higher POC-BG levels than urban and academic hospitals (p < 0.05), and hospitals in the West had the lowest values.
Conclusions: POC-BG data can support hospital efforts to monitor the status of inpatient glycaemic control. Hospital hyperglycaemia was found to be common, whereas hypoglycaemia prevalence was low, and POC-BG levels varied by hospital characteristics.
- • Comment: This is an interesting study that addresses remote automated lab systems to evaluate inpatient POC-BG tests. The results were strikingly different in rural hospitals compared to academic or urban hospitals. Rural hospitals had much higher POC-BG levels than academic institutes. Such a system could possibly guide remote facilities electronically with better inpatient diabetes management. We are sure that in the future we will see many such applications available to many institutes worldwide.
Evaluation of a simple policy for pre- and post-prandial blood glucose self-monitoring in people with type 2 diabetes not on insulin
K. Bonomo, A. De Salve, E. Fiora, E. Mularoni, P. Massucco, P. Poy, A. Pomero, F. Cavalot, G. Anfossi, M. Trovati
San Luigi Gonzaga Faculty of Medicine of the Turin University, Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, Italy
Diabetes Res Clin Pract 2010; 87: 246–51
Background: This study evaluated the effects of the frequency of SMBG policy on glycaemic control, taking into account compliance in type 2 diabetes patients not treated with insulin.
Methods: A total of 273 patients with HbA1c > 7% already using SMBG were randomised as follows: group A, one BG profile per month with fasting and postprandial values; group B, one BG profile every 2 weeks with preprandial and postprandial values. Patients were followed by the same team with the same education and treatment policies every 3 months. At 3 and 6 months, SMBG profiles were evaluated and HbA1c measured.
Results: Self-monitoring of blood glucose was performed as recommended by 73% of group A and 44% of group B patients. In compliant patients, HbA1c and BG were unchanged in group A, whereas in group B fasting, preprandial and two out of three postprandial BG values were reduced and HbA1c was significantly decreased (p < 0.001).
Conclusions: The more intensive SMBG policy considered was associated with improved glycaemic control in compliant subjects.
- • Comment: This Italian study addresses the role of preprandial and postprandial BG monitoring in type 2 diabetes. This was a proper randomised control trial where half of the patients were randomised to one BG profile per month with fasting and postprandial glucose values and the second group was randomised to a frequency increase to every 2 weeks. The study concluded that frequent SMBG monitoring resulted in a better A1c drop. Unfortunately, this was only a 6-month clinical trial and no analysis was done for long-term health outcomes in these patients with type 2 diabetes not on insulin therapy; and thus the controversy continues.
Impact of self-measurement of blood glucose on complications of type 2 diabetes: economic analysis from a Czech perspective
C. Weber,1S. Kocher,1K. Neeser,1D. Bartaskova2
1Institute for Medical Informatics and Biostatistics, Basel, Switzerland, and2Motol University Hospital, Prague, Czech Republic
Curr Med Res Opin 2010; 26: 289–96
Background: The objective of this analysis was to determine the economic impact of SMBG by comparing the cost share of self-monitoring and the direct costs of diabetes-related complications in SMBG users and non-users.
Methods: A matched-pair analysis based on the cohorts of patients with type 2 diabetes (ROSSO) was conducted. The average annual costs of diabetes monitoring, treatment-related services, complications and follow-up costs of the disease for SMBG users vs. non-users were calculated. Analysis was performed to determine the main cost drivers.
Results: Total annual costs were higher in non-users compared with users in patients treated with oral antidiabetic drugs (OADs) only, and in those treated with OADs + insulin. The main cost drivers were stroke and myocardial infarction in patients treated with OADs only, and stroke, dialysis and myocardial infarction in patients treated with OADs + insulin.
Conclusions: Cost analysis indicated that SMBG provides a rapid return on initial investment.
- • Comment: A study from the Czech Republic addresses the impact of SMBG on long-term complications of type 2 diabetes. This was a large retrospective study and thus the conclusions deriving from it may need to be questioned. However, the main cost driver reported in the study was related to myocardial infarction, stroke and dialysis in patients on oral drugs and/or insulin therapy. The use of SMBG was reported to be beneficial as the major cost drivers were long-term complications of diabetes. Even though this study is retrospective in nature, we think it at least looks at a long-term health outcome in the Czech Republic.
Self-monitoring of blood glucose in patients with type 2 diabetes on oral anti-diabetes drugs: cost effectiveness in France, Germany, Italy and Spain
S. L. Tunis,1W. D. Willis,2V. Foos3
1IMS Health Inc., Falls Church, VA, USA,2LifeScan Inc., High Wycombe, Buckinghamshire, UK, and3IMS Health Inc., Basel, Switzerland
Curr Med Res Opin 2010; 26: 163–75
Background: This study used the IMS-CORE Diabetes Model to project the long-term (40-year) cost effectiveness of SMBG at once, twice or three times per day (vs. no SMBG) for patients with type 2 diabetes treated with OADs from national reimbursement system perspectives (in France, Germany, Italy and Spain).
Methods: Self-monitoring of blood glucose input costs (strips, lancets, meters, nurse training) were supplied by LifeScan and applied as appropriate for each country’s reimbursement policy. Cohort characteristics and assumed HbA1c effects came from a US longitudinal analysis of new SMBG users. Country-specific estimations for use of screening programmes, concomitant medications and mortality rates were used. Primary outcomes included total direct costs, gains in QALYs, and incremental cost effectiveness ratios (ICERs) over 40 years.
Results: Incremental cost effectiveness ratios were largest in France and in Italy. Five-year ICERs for SMBG twice per day were below 40,000 euros/QALY for all four countries, and those for SMBG three times per day were below 45,000 euros/QALY. With the SMBG dis-utility, ICERs increased modestly in all scenarios except SMBG once per day in France and Italy.
Conclusions: With cost assumptions reflecting current reimbursement levels in four European countries, SMBG was found to be cost effective across a 40-year time horizon, with all base case ICERs < 16,000/QALY. This study documented the country-specific, long-term value of SMBG for type 2 diabetes patients treated with OADs.
- • Comment: The use of SMBG in type 2 diabetes and its controversies continues; this work done in France, Germany and Italy reported cost effectiveness across a 40-year time horizon in favour of SMBG. This study is important as it was looking at ICERs and QALYs in patients with type 2 diabetes on OADs alone.
Self-monitoring of blood glucose for type 2 diabetes patients treated with oral antidiabetes drugs and with a recent history of monitoring: cost effectiveness in the USA
S. L. Tunis,1M. E. Minshall2
1IMS Health Inc., Falls Church, VA, USA, and2Formerly with IMS Health Inc.
Curr Med Res Opin 2010; 26: 151–62
Background: This study modelled the cost-effectiveness of SMBG at frequencies of once, twice or three times per day for patients with type 2 diabetes mellitus on OADs and included those who had used SMBG in the previous year.
Methods: A validated model was used to project 40-year clinical and economic outcomes for SMBG at once, twice or three times per day vs. no SMBG. Primary outcomes were differences in total costs, cumulative incidence of complications, QALYs and ICERs.
Results: For patients using SMBG once, twice or three times per day, relative risks over 40 years were lower for 14 of 16 complications. Compared to no SMBG, QALYs increased with SMBG frequency. Some increased costs with SMBG were offset by reductions in costs for several diabetes-related complications. Results were most sensitive to time horizon, with SMBG not cost effective over a 5-year simulation period.
Conclusions: Results showed that, compared with no SMBG, base case ICERs for each of the three SMBG frequencies examined were below $30,000, and that a portion of the increased costs associated with SMBG were offset by reductions in complication costs and by modest increases in QALYs.
- • Comment: The controversy on SMBG in type 2 diabetes continues; here is a study reported from the USA. This study also reports on subjects using SMBG once, twice or three times per day with type 2 diabetes not on insulin therapy. It concluded that the relative risks over 40 years were lower for 14 of the 16 complications in patients using SMBG, thus favouring the use of SMBG in non-insulin-requiring type 2 diabetes. This is an important study (not randomised) which addresses long-term health outcomes in type 2 diabetes not on insulin therapy and SMBG.
Self-monitoring of blood glucose in non-insulin-treated patients with type 2 diabetes: a systematic review and meta-analysis
S. Allemann,1,2C. Houriet,1P. Diem,1C. Stettler2,3
1Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital, and University of Bern, Bern, Switzerland,2Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland, and3Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital of Bern, Bern, Switzerland
Curr Med Res Opin 2009; 25: 2903–13
Background: To assess the effect of SMBG on glycaemic control in non-insulin-treated patients with type 2 diabetes.
Methods: This is a systematic review and meta-analysis based on MEDLINE and the Cochrane Controlled Trials Register data of randomised controlled trials comparing SMBG with non-SMBG (primary analysis) or more frequent SMBG with less intensive SMBG (secondary analysis). The primary endpoint was HbA1c; secondary outcomes included fasting glucose and the occurrence of hypoglycaemia.
Results: Fifteen trials (3270 patients) were included in the analyses. SMBG was associated with a larger reduction in HbA1c compared with non-SMBG. The beneficial effect associated with SMBG was not attenuated over longer follow-up. SMBG significantly increased the probability of detecting hypoglycaemia. Frequency of SMBG did not result in significant changes of HbA1c.
Conclusions: SMBG compared with non-SMBG is associated with a significantly improved glycaemic control in non-insulin-treated patients with type 2 diabetes. The added value of more frequent SMBG compared with less intensive SMBG remains uncertain.
- • Comment: As in the other analyses above, SMBG in type 2 patients not receiving insulin resulted in a small and clinically debatable reduction in A1c. This study, however, adds another dimension to the question: the frequency of SMBG which at least for the meta-analysis has not been able to be well characterised. Assessing frequent, less frequent, ‘structured’ or no SMBG in one randomised trial under usual conditions for this population would be welcomed.
Interference studies with two hospital-grade and two home-grade glucose meters
M. E. Lyon,1–4L. B. Baskin,4S. Braakman,5S. Presti,6J. Dubois,6T. Shirey6
1Department of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB, Canada,2Department of Pediatrics, University of Calgary, Calgary, AB, Canada,3Department of Pharmacology and Therapeutics, University of Calgary, Calgary, AB, Canada,4Calgary Laboratory Services, Calgary, AB, Canada,5Calgary Health Region, Calgary, AB, Canada, and6Nova Biomedical Corporation, Waltham, MA, USA
Diabetes Technol Ther 2009; 11: 641–7
Background: Interference studies of four glucose meters (Nova Biomedical StatStrip – hospital grade; Roche Diagnostics Accu-Chek Aviva – home grade; Abbott Diabetes Care Precision FreeStyle Freedom – home grade; and LifeScan SureStep Flexx – hospital grade) were evaluated and compared with the clinical laboratory plasma hexokinase reference method.
Methods: Within-run precision was determined using a freshly prepared whole blood sample spiked with concentrated glucose to give three glucose concentrations. Day-to-day precision was evaluated using aqueous control materials supplied by each vendor. Common interferences, including haematocrit, maltose and ascorbate, were tested alone and in combination with one another on each of the four glucose testing devices at three BG concentrations.
Results: Within-run precision for all glucose meters was < 5% except for the FreeStyle (up to 7.6%). Between-day precision was < 6% for all glucose meters. Ascorbate caused differences of > 5% with pyrroloquinolinequinone (PQQ)-glucose-dehydrogenase-based technologies (Aviva and Freestyle) and the glucose-oxidase-based Flexx meter. Maltose strongly affected the PQQ-glucose-dehydrogenase-based meter systems. When combinations of interferences were tested, the extent of the interference was up to 193% (Aviva), 179% (FreeStyle), 25.1% (Flexx) and 5.9% (StatStrip). The interference was most pronounced at low glucose (3.9–4.4 mmol/l).
Conclusions: All evaluated glucose meter systems demonstrated varying degrees of interference by haematocrit, ascorbate and maltose mixtures. Aviva and Freestyle showed greater susceptibility than glucose Flexx meter. However, the modified glucose-oxidase-based amperometric method (Nova StatStrip) was less affected in comparison with the glucose-oxidase-based photometric method (LifeScan SureStep Flexx).
- • Comment: Imprecision due to the various known interfering substances is well known, but quantification of the inaccuracies is not as well appreciated. The good news is that the PQQ-glucose-dehydrogenase meters will probably be replaced by other chemistries in the near future. The ultimate goal needs to be a minimisation of all interfering substances with SMBG.
Performance of a new interference-resistant glucose meter
S. Vanavanan,1P. Santanirand,2U. Chaichanajarernkul,1A. Chittamma,1J. A. Dubois,3T. Shirey,3M. Heinz3
1Faculty of Medicine, Division of Clinical Chemistry, Department of Pathology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand,2Faculty of Medicine, Microbiology Unit, Department of Pathology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, and3Nova Biomedical Corporation, 200 Prospect Street, Waltham, MA, USA
Clin Biochem 2010; 43: 186–92
Background: The study examined the analytical performance of the StatStrip glucose monitoring system.
Methods: Linearity, percentage recovery and within-run imprecision were studied using glucose-spiked whole blood. A total of 120 samples were used in method comparison using plasma hexokinase as the comparison method. Common interferences were tested on the StatStrip, Accu-Chek Advantage and the MediSense Optium glucose meters at different glucose levels.
Results: The StatStrip assay showed excellent linearity and recovery. The coefficients of variation for imprecision were < 5%. This meter correlated well with the comparison method. Of the three meters tested, only the StatStrip showed interference < 10% for all spiked levels of different interferences at different levels of glucose tested.
Conclusions: The StatStrip meter showed good performance and is suitable for point-of-care hospital glucose testing.
- • Comment: The initial announcement in 2009 of 13 deaths from meters using PQQ-glucose-dehydrogenase chemistry has resulted in the entire diabetes community assessing the importance of accuracy in general but especially in the inpatient setting. The Nova StatStrip® (Nova Biomedical Corporation, Waltham, MA, USA) appears to be an excellent example of a BG strip that could resolve many of the problems now noted with precision and interferences.
Frequency and motives of blood glucose self-monitoring in type 1 diabetes
M. V. Hansen,1U. Pedersen-Bjergaard,1S. R. Heller,2T. M. Wallace,3A. K. Rasmussen,4,5H. V. Jørgensen,4S. Pramming,6B. Thorsteinsson1
1Department of Cardiology and Endocrinology, Hillerød Hospital, Hillerød, Denmark,2Clinical Sciences Centre, Northern General Hospital, Sheffield, UK,3Endocrinology and Metabolism, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, UK,4 Steno Diabetes Center, Gentofte, Denmark,5Department of Endocrinology, Copenhagen University Hospital, Denmark, and6Oxford Health Alliance, London, UK
Diabetes Res Clin Pract 2009; 85: 183–8
Background: This study assessed the frequency of and motives for SMBG and compared SMBG behaviour with clinical, behavioural and demographic characteristics.
Methods: A cross-sectional Danish–British multicentre survey of patients with type 1 diabetes (n = 1076) completed a detailed questionnaire on SMBG test frequency and motive as well as related issues.
Results: SMBG was performed daily by 39% of the patients and less than weekly by 24%. Routine testing was reported by 67%, and the remaining patients only tested when hypoglycaemia or hyperglycaemia was suspected. Age, gender and level of diabetes-related concern were associated with test pattern. Lower HbA1c was associated with more frequent testing. Reported frequencies of mild and severe hypoglycaemia and hypoglycaemia awareness were independently associated with testing behaviour, whereas the presence of late diabetic complications was not.
Conclusions: Almost two-thirds of the patients do not perform daily SMBG and one-third does not perform routine tests.
- • Comment: This report underscores the challenges with diabetes therapy, particularly as it pertains to type 1 diabetes. Even though we have had the definitive proof for almost two decades that meticulous glycaemic control can improve long-term complications, the actual self-management of these patients is poor. For physicians who practise in specialised diabetes centres, the extent of the lack of self-management may be a surprise, but patients (at least in the USA) are clearly biased to where they obtain their care. Our speculation is that the general results from this report are likely to be applicable to most countries. The real issues are (i) what can be done to improve patient self-management practices; and (ii) would it be more efficient to instead use our resources to develop technologies that make successful control less dependent on patient actions? The latter point is obviously ideal but will probably be required to have more significant improvements in care.
The value of self-monitoring of blood glucose: a review of recent evidence
A. St John A,1W. A. Davis,2C. P. Price,3T. M. Davis2
1ARC Consulting, Perth, W Australia, Australia,2School of Medicine and Pharmacology, University of Western Australia, Fremantle, W Australia, Australia, and3Department of Clinical Biochemistry, University of Oxford, John Radcliffe Hospital, Headington, Oxford, UK
J Diabetes Complications 2010; 24: 129–41
Background: This study reviewed the recent literature relating to the role of SMBG and glycaemic control.
Methods: A meta-analysis searching the MEDLINE and EMBASE databases was performed on randomised controlled trials in type 2 diabetes with HbA1c as an outcome measure.
Results: There were 23 studies (13 non-experimental and 10 experimental) including six randomised controlled trials of type 2 diabetes. The results of five of these randomised controlled trials in non-insulin-treated type 2 diabetic patients were combined in a meta-analysis with two earlier randomised controlled trials which yielded a significant pooled SMBG-related decrease in HbA1c of −0.22.
Conclusions: The present meta-analysis showed an SMBG-related HbA1c reduction in non-insulin-treated type 2 diabetes patients. This finding is consistent with most observational studies of similarly treated patients.
- • Comment: This is another meta-analysis in non-insulin-requiring type 2 patients, and another finding of a small improvement of HbA1c of unclear significance. The consistency of these meta-analyses is noteworthy.
Predictors of glycaemic control in patients with type 1 diabetes commencing continuous subcutaneous insulin infusion therapy
S. Shalitin, M. Gil, R. Nimri, L. de Vries, M. Y. Gavan, M. Phillip
The Jesse Z and Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel
Diabet Med 2010; 27: 339–47
Background: This study aimed to identify variables that predict glycaemic control in type 1 diabetic patients switched to a continuous subcutaneous insulin infusion (CSII) regimen.
Methods: Medical files of type 1 diabetic patients (n = 421) aged 2.6–39.8 years who initiated CSII treatment and used it for ≥ 1 year (mean time use 4.1 ± 2.1 years) were reviewed. Details about their background and disease-related and treatment-related variables were recorded. At pump initiation, the mean age was 15.9 ± 7.2 years, mean diabetes duration 6.4 ± 5.8 years. Good glycaemic control was defined by HbA1c stratified by age (American Diabetes Association target levels). Improvement in glycaemic control was defined as a reduction of ≥ 0.5% in HbA1c from baseline, and change in the rate of severe hypoglycaemia or diabetic ketoacidosis.
Results: A significant sustained decrease in HbA1c with CSII for a long period without increased rates of hypoglycaemia was found. Achievement of target HbA1c was significantly associated with lower HbA1c (p < 0.001), younger age (< 12 years), shorter diabetes duration (p < 0.001) and more frequent daily SMBG (p < 0.01) at pump initiation. Improved glycaemic control was associated with longer CSII use (p = 0.032) and higher HbA1c at pump initiation (p < 0.001).
Conclusions: Switching patients to CSII resulted in a sustained decrease in HbA1c. Young age, frequent SMBG and lower HbA1c at pump initiation were identified as predictors of achieving glycaemic targets with CSII.
- • Comment: This study conveys a fundamental point about CSII: without frequent SMBG full benefit and long-term improvement of glycaemic control will be lacking.
Associations between features of glucose exposure and A1c: the A1c-Derived Average Glucose (ADAG) study
R. Borg,1J. C. Kuenen,2B. Carstensen,1H. Zheng,3D. M. Nathan,3R. J. Heine,2J. Nerup,1K. Borch-Johnsen,1D. R. Witte1on behalf of the ADAG Study Group
1Steno Diabetes Center, Copenhagen, Denmark,2Vrije Universiteit Medical Center, Vrije Universiteit, Amsterdam, The Netherlands, and3Diabetes Center and Biostatistics Department, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
Diabetes 2010; 59: 1585–90
Background: The objective of this study was to examine the relationship among common indexes of postprandial glycaemia, overall hyperglycaemia, glucose variability and HbA1c using detailed glucose measures, and to evaluate which BG values of the day provide the strongest prediction of HbA1c.
Methods: In the HbA1c -Derived Average Glucose (ADAG) study, glucose levels were monitored with continuous glucose monitoring (CGM) and frequent SMBG during 16 weeks in participants with type 1 diabetes (n = 268) and type 2 diabetes (n = 159) and in non-diabetic subjects (n = 80). Several indexes of glycaemia were calculated. The association between glucose measurements at different times of the day and HbA1c was analysed.
Results: Indexes derived with SMBG strongly correlated with those from CGM. The area under the glucose curve calculated from CGM 2 h after a meal correlated well with the 90-min SMBG postprandial measurements. Fasting BG levels were moderately correlated with indexes of hyperglycaemia and average or postprandial glucose levels. Preprandial glucose values had a stronger association with HbA1c than postprandial values for both diabetes types, but particularly for type 2 diabetes.
Conclusions: Indexes of glucose variability and average and postprandial glycaemia intercorrelate strongly within each category. Variability indexes are weakly correlated with the other categories, indicating that these measures convey different information. Preprandial glucose values have a larger impact on HbA1c levels than postprandial values.
- • Comment: Many of us recall how the only way diabetes was often assessed was with fasting plasma glucose measurements. It was certainly not appreciated how little this information provided. We also should not be surprised that preprandial glucose levels had better correlation with A1c than postprandial levels since, depending on the population (recall, this was in all patients studied), the postprandial glucose spikes will be short-lived. Much work is required to better understand all of the different measurements of glucose variability and it is not surprising that these metrics convey different information. The key for this in the future will be to best understand which of the measures are most dangerous as they pertain to hypoglycaemia and long-term complications.
Review of adverse events associated with false glucose readings measured by GDH-PQQ-based glucose test strips in the presence of interfering sugars
J. P. Frias, C. G. Lim, J. M. Ellison, C. M. Montandon
Departments of Clinical, Medical, and Regulatory Affairs, LifeScan, Milpitas, CA, USA
Diabetes Care 2010; 33: 728–9
Background: This study assessed the implications of falsely elevated glucose readings measured with glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) test strips.
Methods: A review of the FDA’s Manufacturer and User Facility Device Experience database and medical literature for adverse events associated with falsely elevated glucose readings with GDH-PQQ test strips in the presence of interfering sugars was conducted.
Results: Eighty-two reports were identified: 20% were associated with death, 56% with severe hypoglycaemia and 15% with non-severe hypoglycaemia. Although most events occurred in hospitalised patients, at least 17% occurred in outpatients. Agents most commonly associated with adverse events were icodextrin-containing peritoneal dialysate and maltose-containing intravenous immune globulin.
Conclusions: GDH-PQQ test strips pose a safety risk to patients treated with agents containing or metabolised to interfering sugars.
- • Comment: This report, coming after the FDA announcement, further emphasises the need to improve SMBG chemistries as they pertain to interferences, particularly in the hospital. It is not surprising that further review of database and literature resulted in the finding of more deaths and adverse events. Despite this report and the FDA announcement in August of 2009, there are still accidents ‘waiting to happen’ as not all providers are aware of the problem, particularly with the GDH-PQQ strips. Until new chemistry replaces this older technology, there will probably be more events.
Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes
R. Ziegler,1B. Heidtmann,2D. Hilgard,3S. Hofer,4J. Rosenbauer,5R. Holl6for the DPV-Wiss-Initiative
1Clinic for Pediatric and Adolescent Diabetes, Muenster, Germany,2Catholic Children’s Hospital, Wilhemstift, Hamburg, Germany,3Department of Paediatrics, Gemeinschaftskrankenhaus Herdecke, Herdecke, Germany,4Department of Pediatrics, Medical University of Innsbruck, Austria,5Institute of Biometrics and Epidemiology, German Diabetes Centre, Leibnitz Centre for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany, and6University of Ulm, Department of Epidemiology, Ulm, Germany
Pediatr Diabetes 2010 Mar 22 [Epub ahead of print]
Background: The aim of this study was to correlate the frequency of SMBG to the quality of metabolic control as measured by HbA1c, frequency of hypoglycaemia and ketoacidosis events, and to see whether the associations between SMBG and these outcomes are influenced by the patient’s age or treatment regimen.
Methods: Data from the DPV-Wiss database of 26,723 children and adolescents with type 1 diabetes were analysed. Background, disease-related and treatment-related variables were evaluated.
Results: The frequency of SMBG was higher in the youngest age group of children (<6 years) than in children aged 6–12 years or in children aged >12 years (p < 0.001). Frequency of SMBG differed significantly also in the different groups of treatment (p < 0.001), but only for the CSII group was the frequency considerably higher than with multiple daily injections or conventional therapy. Adjusted for age, gender, diabetes duration, insulin regimen, body mass index standard deviation score, and centre difference, SMBG frequency was significantly associated with better metabolic control (p < 0.001). Increasing the SMBG frequency above five times per day did not result in further improvement of metabolic control.
Conclusions: A higher frequency of SMBG measurements was related to better metabolic control. Among adolescents glycaemic control improved distinctly with two or more BG measurements.
- • Comment: This important report confirms what many have speculated for the paediatric population: the greatest SMBG frequency is in the younger groups (most probably due to greater parental involvement). In a non-randomised population, those who opt for CSII will test more frequently; and greater SMBG frequency will result in lower A1c levels.
The business of self-monitoring of blood glucose: a market profile
M. D. Hughes
Enterprise Analysis Corporation, Stamford, CT, USA
J Diabetes Sci Technol 2009; 3: 1219–23
SMBG meters and test strips are viewed by consumers and insurers as essentially generic products, with a dramatic growth in sales of SMBG products and declining glucose test strip prices. Thus, it will be challenging for new market entrants to displace well-entrenched existing competitors without a truly innovative technology. Market expansion can only occur through identification of more of the undiagnosed diabetes population and convincing existing diabetes patients to adopt glucose testing or to test more frequently. Ultimately, a combination of technology innovations, patient education and economic incentives may be needed to significantly expand the SMBG market.
- • Comment: Despite the growth of diabetes worldwide, given the lack of definitive data for SMBG in type 2 patients not receiving insulin it is probably unrealistic to think that glucose meter strips will continue to grow at the pace they have for the past 25 years. In many countries the marketing of test strips has changed since it is more difficult to differentiate meters and strips. More often the strips used for a given population are those that go to the cheapest bidder. It is clear that newer forms of glucose monitoring, particularly CGM, are more likely to achieve the type of growth seen previously with SMBG.
Glucose meters: a review of technical challenges to obtaining accurate results
K. Tonyushkina,1J. H. Nichols2
1Department of Pediatrics, Section of Endocrinology, Baystate Children’s Hospital, Tufts University School of Medicine, Springfield, MA, USA, and2Department of Pathology, Baystate Medical Center, Tufts University School of Medicine, Springfield, MA, USA
J Diabetes Sci Technol 2009; 3: 971–80
This paper reviews the challenges involved in obtaining accurate glucose meter results. Establishing the accuracy of glucose meters is challenging. Glucose meters can only analyse whole blood, in which glucose is unstable. Truth for whole blood has not been established, and cells must be separated from the whole blood before analysis by a method like isotope dilution mass spectrometry. Serum cannot be analysed by glucose meters, and isotope dilution mass spectrometry is not commonly available in most hospitals and diabetes clinics to evaluate glucose meter accuracy.
Consensus standards recommend comparing whole blood analysis on a glucose meter against plasma/serum centrifuged from a capillary specimen and analysed by a clinical laboratory comparative method.
Multiple complexities are involved in defining technical accuracy and there is no clear consensus among standards agencies and professional societies on accuracy criteria. Clinicians are more concerned with clinical agreement of the glucose meter with a serum/plasma laboratory result. Acceptance criteria for clinical agreement vary across the range of glucose concentrations and depend on how the result will be used in screening or management of the patient. A variety of factors can affect glucose meter results, including operator technique, environmental exposure and patient factors, such as medication, oxygen therapy, anaemia, hypotension and other disease states.
- • Comment: Issues pertaining to SMBG accuracy and precision are much more complex than most people appreciate. Many of the issues addressed in this paper do not include the problem of patient error, which further complicates the situation. The bottom line is that it may be more difficult than many expect to develop meters as accurate as desired.
Blood glucose test strips: options to reduce usage
T. Gomes,6D. N. Juurlink,1,3–6, B. R. Shah,1,3,5,6J. M. Paterson,6–8M. M. Mamdani2,3,5,6
1Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada,2St Michael’s Hospital, Toronto, ON, Canada,3Department of Medicine, University of Toronto, Toronto, ON, Canada,4Department of Pediatrics, University of Toronto, Toronto, ON, Canada,5Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada,6Institute for Clinical Evaluative Sciences, Toronto, ON, Canada,7Department of Family Medicine, McMaster University, Hamilton, ON, Canada, and8Centre for Evaluation of Medicines, St Joseph’s Healthcare, Hamilton, ON, Canada
CMAJ 2010; 182: 35–8
Background: The impact of more focused public-payor policies for the use of BG test strips was evaluated.
Methods: A cross-sectional analysis of annual prescription claims for test strips was conducted for adult patients (≥ 65 years old) with diabetes. Patients were stratified into one of four hierarchical groups according to the most intensive glucose-lowering treatment received during each calendar year. Test strip use was calculated annually for each group over the study period and the effects of five hypothetical policy scenarios of more selective test strip use were assessed.
Results: Test strip use increased by almost 250% during one decade; however, more focused policy scenarios could have reduced this number.
Conclusions: Many people who self-monitor their BG are at relatively low risk for drug-induced hypoglycaemia. The economic benefits associated with more selective testing could be redirected to more effective interventions for patients with diabetes.
- • Comment: The economic implications of SMBG continue to achieve much attention. Furthermore, as clinicians use more incretins and less sulfonylureas, rationale let alone data to support SMBG may become even more limited. We should all expect more resistance from payors of SMBG strips for patients with type 2 diabetes given the data currently available.