GlucoScreen

Summary Blood glucose meters and test strips for self-monitoring of blood glucose (SMBG) are often inaccessible to, and infrequently used by, people with diabetes in countries with limited resources for health care. Supplies for measuring blood glucose can also be scarce in health facilities, despite being needed in a myriad of clinical settings at all levels of the health system. Numerous studies and international guidelines emphasise the value of SMBG in diabetes care, particularly in people with type 1 diabetes. In this Review, we assess global access to blood glucose meters and test strips, collating published information on cost, availability, system accuracy, competitive bidding, technological trends, and non-financial barriers. We also provide new information on global market share data and prices, taxes and tariffs, and product availability. Blood glucose meters and test strips should be viewed similarly to essential medicines, with issues of access prioritised by relevant international agencies. Efforts are needed to reduce tariffs and taxes and to create unified global system accuracy requirements and accountable post-marketing evaluations. Preferential pricing arrangements, pooled procurement, and best-purchasing practices could help to lower direct costs. SMBG supplies should also be included in national health insurance schemes. Enhanced diabetes education of health professionals and patients is crucial to ensure effective use of SMBG. Finally, as technology advances for people who can afford new interstitial fluid glucose monitoring systems, blood glucose meters and test strips must remain available and become more affordable in low-resource settings.

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. 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. Nerhus K 1 , Rustad P 2 , Sandberg S 1,3 1 Norwegian Centre for Quality Improvement of Primary Care Laboratories, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway, 2 Norwegian Clinical Chemistry EQA-Program, Fürst Medical Laboratory, Oslo, Norway, 3 Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway Diabetes Technol Ther 2011; 13: 883–92 Background: Analytical quality of SMBG can be affected by environmental conditions. Aims: To determine the influence of a shift in the ambient temperature immediately before measurement and taking measurements in the lower and upper part of the operating temperature range. Methods: Different SMBG systems (n = 9) available on the Norwegian market were tested with heparinised venous blood (4.8 and 19.0 mmol/l). To test the effect of a shift in ambient temperature, the glucometer and strips were equilibrated for 1 h at 5 °C or 30 °C before the meter and strips were moved to room temperature, and measurements were performed after 0, 5, 10, 15 and 30 min. To test the lower and upper temperature range, measurements were performed at 10 °C and at 39 °C after 1 h for temperature equilibration of the glucometer and strips. All the measurements were compared with measurements performed simultaneously on a meter and strips kept the whole time at room temperature. Results: Six of nine SMBG systems overestimated and/or underestimated results by more than 5% after moving meters and strips from 5 °C or 30 °C to room temperature immediately before the measurements. Two systems underestimated the results at 10 °C. One system overestimated and another underestimated the results by more than 5% at 39 °C. Conclusions: A rapid shift in the ambient temperature affects analytical performance. Therefore patients need to wait at least 15 min for temperature equilibration of affected meters and strips before measuring blood glucose. Comment: This study highlights the importance of ambient temperature on analytical performance of SMBG. The study shows that rapid shift in ambient temperature may affect the accuracy and bias in SMBG measurement and highlights the need for 15 min temperature equilibration. In addition to what has been highlighted in the study, future studies also need to assess the accuracy of existing meters (especially the one using glucose oxidase) at higher altitudes (10,000 feet or higher). It is known that many of these meters do not perform well at high altitudes. McAndrew LM 1,2 , Horowitz CR 3 , Lancaster KJ 4 , Quigley KS 2,5,6 , Pogach LM 1,2 , Mora PA 7 , Leventhal H 8 1 War Related Illness and Injury Study Center and REAP Center for Healthcare Knowledge Management, Department of Veterans Affairs, New Jersey Health Care System, East Orange, NJ, USA, 2 University of Medicine and Dentistry of New Jersey, Newark, NJ, USA, 3 Department of Health Evidence and Policy, Mount Sinai School of Medicine,New York, NY, USA, 4 Department of Nutrition, Food Studies and Public Health, New York University, New York, NY, USA, 5 Department of Veterans Affairs, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, USA, 6 Department of Psychology, Northeastern University, Boston, MA, USA, 7 Psychology Department, University of Texas at Arlington, Arlington, TX, USA, and 8 Institute for Health, Health Care Policy and Research, Rutgers University, New Brunswick, NJ, USA J Diabetes 2011; 3 : 147–52; Comment in J Diabetes 2011; 3 : 93–4 Background: It is unknown whether SMBG can motivate adherence to dietary recommendations. Aims: To evaluate if patients who used more SMBG would also report lower fat and greater fruit and vegetable consumption. Methods: This was a cross-sectional study of primarily minority individuals living with diabetes in East Harlem, New York (n = 401). Fat intake and fruit and vegetable consumption were measured with the Block Fruit/Vegetable/Fiber and Fat Screeners. Results: Greater frequency of SMBG was associated with lower fat intake [r(s) = –0.15; p < 0.01], but not fruit and vegetable consumption. The effects of SMBG were not moderated by insulin use. A significant interaction was found between frequency of SMBG and changing one's diet in response to SMBG on total fat intake. Conclusions: The frequency of SMBG was associated with lower fat intake. The data suggest that participants who use SMBG to guide their diet do not have to monitor multiple times a day to benefit. Comment: This study further highlights the importance of SMBG in daily lifestyle changes. Subjects with higher frequency of SMBG consumed less fat, in part related to overall education and seeing the impact from making dietary changes on SMBG levels. Kuo CY 1,2 , Hsu CT 3 , Ho CS 3 , Su TE 3 , Wu MH 4 , Wang CJ 2,5 1 Department of Clinical Laboratory, Tai-An Hospital, Taichung, Taiwan, 2 Institute of Biochemistry and Biotechnology, Chung Shan Medical University, Taichung, Taiwan, 3 Department of Core Technical Research, Bionime Corporation, Taichung, Taiwan, 4 Department of Laboratory Medicine, Min-Sheng General Hospital, Taoyuan, Taiwan, 5 Department of Medical Research, Chung Shan Medical University Hospital, Taichung, Taiwan Diabetes Technol Ther 2011; 13 : 596–600 Background: SMBG systems should at least meet the minimal requirement of the World Health Organization's ISO 15197:2003. For tight glycaemic control, a tighter accuracy requirement is needed. Methods: Seven SMBG systems were evaluated for accuracy and precision: Bionime Rightest™ GM550 (Bionime Corp., Dali City, Taiwan), Accu-Chek® Performa (Roche Diagnostics, Indianapolis, IN, USA), OneTouch® Ultra®2 (LifeScan Inc., Milpitas, CA, USA), MediSense® Optium™ Xceed (Abbott Diabetes Care Inc., Alameda, CA, USA), Medisafe (TERUMO Corp., Tokyo, Japan), Fora® TD4227 (Taidac Technology Corp., Wugu Township, Taiwan) and Ascensia Contour® (Bayer HealthCare LLC, Mishawaka, IN, USA). The 107 participants were 23–91 years old. The analytical results of seven SMBG systems were compared with those of plasma analysed with the hexokinase method (Olympus AU640, Olympus America Inc., Center Valley, PA, USA). Results: The imprecision of the seven blood glucose meters ranged from 1.1% to 4.7%. Three of the seven blood glucose meters (42.9%) fulfilled the minimum accuracy criterion of ISO 15197:2003. The mean absolute relative error value for each blood glucose meter was calculated and ranged from 6.5% to 12.0%. Conclusions: More than 40% of evaluated SMBG systems meet the minimal accuracy criterion requirement of ISO 15197:2003. However, considering a tighter criterion for accuracy of ±15%, only the Bionime Rightest GM550 meets this requirement. Manufacturers have to try to improve accuracy and precision and to ensure the good quality of blood glucose meters and test strips. Comment: This study further highlights the need for more accurate SMBG systems. Their data concluded that more than 40% of the evaluated SMBG systems meet the minimum ISO criteria. Since patients use blood glucose information for adjusting their insulin dose and/or treating hypoglycaemia, the accuracy of the glucose meters has to be consistent and improved. Hortensius J 1 , Slingerland RJ 2 , Kleefstra N 1,3,4 , Logtenberg SJ 1 , Groenier KH 5 , Houweling ST 3,6 , Bilo HJ 1,4 1 Diabetes Centre, Isala Clinics, Zwolle, The Netherlands, 2 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 3 Medical Research Group, Langerhans, The Netherlands, 4 Department of Internal Medicine, University Medical Center, Groningen, The Netherlands, 5 Department of General Practice, University of Groningen, Groningen, The Netherlands, and 6 General Practice Sleeuwijk, Sleeuwijk, The Netherlands Diabetes Care 2011; 34 : 556–60 Background: There is no agreement regarding the use of the first or second drop of blood for glucose monitoring. Aims: To investigate whether capillary glucose concentrations, as measured in the first and second drops of blood, differed ≥10% compared with a control glucose concentration in different situations. Methods: Capillary glucose concentrations were measured in two consecutive drops of blood in 123 patients with diabetes in the following circumstances: without washing hands, after exposing the hands to fruit, after washing the fruit-exposed hands, and during application of different amounts of external pressure around the finger. The results were compared with control measurements. Results: Not washing hands led to a difference of ≥10% in glucose concentration in the first and in the second drops of blood in 11% and 4% of the participants, respectively. In fruit exposed fingers, these differences were found in 88% and 11% of the participants, respectively. Different external pressures led to ≥10% differences in glucose concentrations in 5%–13% of the participants. Conclusions: Washing hands with soap and water, drying them, and using the first drop of blood for SMBG is recommended. If washing hands is not possible, it is acceptable to use the second drop of blood after wiping away the first drop. External pressure may lead to unreliable readings. Comment: Over the years we have probably under-emphasised the importance of technique with SMBG. One has to wonder how much iatrogenic hypoglycaemia has occurred due to unintended exposure to glucose on the hands, and how often CGM devices are due to technique with SMBG use. 1,2 , 3 , 4 , 5 , 6 , 7 , 8 , 8 , 8 1 University of CA, USA, 2 Diabetes CA, USA, 3 University of CA, USA, 4 University Health System, USA, 5 America Diabetes USA, 6 Health IN, USA, 7 USA, and 8 Diagnostics, Indianapolis, IN, USA Diabetes Care 2011; 34 : To assess the effectiveness of structured blood glucose testing in controlled patients with type 2 diabetes without insulin Methods: A study patients with type 2 diabetes (n = and glycaemic control from 34 care in the were randomised to an control with care or a structured testing with care and at least use of structured SMBG. patients and were to use a to glucose consecutive The was measured at Results: The analysis = = showed greater in mean in the compared with the = p = analysis = = showed even greater mean in the compared with the p < more patients a at the first compared with patients, of the p < and patients significant < 0.0001) in Conclusions: use of structured SMBG glycaemic control and more changes in patients with type 2 diabetes without Comment: It is with an healthcare using a structured glucose testing can improve glucose control in non-insulin-treated Potential are of this can be in a with the more time in a care to be , 5 , 6 , 1,4 1 Department of and Laboratory Medicine, University of 2 Department of and University of 3 Department of Pediatrics, University of 4 Laboratory 5 Corporation, MA, USA, and 6 Department of Health University of J Diabetes Technol 4 : Aims: To analytical error in and glucose meters by in and Methods: The of and were tested and in with each glucose meter and with a plasma glucose method at glucose was by consecutive analysis (n = at glucose levels. analysis was used to the bias associated with the and in Results: Three meters demonstrated bias that was glucose bias on the and the of bias was on small significant on meters. of and of increased the bias and was by of total analytical the glucose meter devices of total analytical error in glucose measurement ranged from to the Conclusions: The of glucose meters to significant analytical is the analytical Comment: with to for SMBG and the research is it does not that many people the This has impact on as new guidelines for greater of are the impact on SMBG accuracy be particularly by the device should be a 1 , 1 , 2 , 3 1 Health and 2 Health, and 3 of and Department of Internal Medicine, : Aims: To evaluate the of SMBG in patients with type 2 diabetes with in Methods: In a study a of diabetes was used to from a published study of SMBG in patients with type 2 diabetes, with and with no of a time was from the of a healthcare and clinical were at Results: or times daily SMBG was associated with in which led to increased and and of diabetes complications compared with no SMBG in type 2 diabetes patients on costs increased by and in patients SMBG or times daily compared with those not using SMBG. were well at and per year respectively. Conclusions: SMBG is to be by standards in patients on in the Comment: This analysis is on a showing of and The concern of is that this analysis is not a randomised controlled and at best the data are about the efficacy of this population using this analysis is probably on controversial 1,2 , 3 , S 3 , 1 Health Research, University School of Medicine, Indianapolis, IN, USA, 2 Institute for Health Care, Indianapolis, IN, USA, 3 of University School of Medicine, Indianapolis, IN, USA, and 4 Diabetes and Center, University School of Medicine, Indianapolis, IN, USA Diabetes 2011; : To assess the and of a glucose monitoring system for with type 1 diabetes and their Methods: Patients with type 1 diabetes who been for at least 1 year in the used the system for 6 3 to and with the glucose monitoring as well as how use of the system affect quality of and diabetes management. Results: about the a number of significant that affected use of the all that the in monitoring testing was The use of the did not the quality of their of with their their of diabetes, or their glycaemic control within the time of the Conclusions: This that glucose monitoring can be used in an population to and in self-monitoring Comment: for both SMBG and CGM is clearly the future for with type 1 diabetes. The will be to how to best use this to improve in this To the is new to how best to use more studies will be to this P 1 , 2 , ST 3 , 2 , 2 , 4 , Bilo 5 , Bilo HJ 1 Department of Internal Medicine, Hospital, The Netherlands, 2 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 3 Department of Isala Clinics, Zwolle, The Netherlands, 4 Centre for The Netherlands, 5 Department of Internal Medicine, Isala Clinics, Zwolle, The Netherlands, and 6 Department of Internal Medicine, University Medical Centre, Groningen, The Netherlands One 5 : Background: Patients with diabetes part in and thus blood glucose meters are studies bias in blood glucose measurements using different at high To evaluate if glucose are more by the lower pressure at than glucose Methods: measurements at of nine glucose glucose were compared with glucose measurement on a at and with a laboratory glucose blood of different glucose were were at a bias from glucose and from glucose mmol/l). Results: significant difference was between measurements at and for glucose or glucose as a Two glucose did not meet performance criteria. Conclusions: high all tested glucose did not influence of All for two glucose performed within criteria. are glucose concentration at high high one glucose best precision and Comment: testing for SMBG meters may be In glucose test strips should be at high altitudes. not in this it should be that patients do not this into when or 1 , J 2 , 2 , 1 , 3 , 4 , J 3 , 5 , J 6 , 7 , 7 , 8 1 Department of Health University of Health Center, USA, 2 and Health Department of Medical and University of USA, 3 Department of and Health University of USA, 4 Diabetes Care Center, Medical USA, 5 Department of University of USA, 6 Medicine Technology Center USA, 7 Department of Medicine, University of USA, and 8 Health Research USA J Aims: To assess the and of using as part of an existing system for between patients with diabetes and a care Methods: In glucose meter and two to feedback on glycaemic control were Results: glucose meter with and data feedback were the system to an and feedback system for value in the system as an to the and Conclusions: diabetes management systems may one to improve the quality of diabetes Comment: best to in a care for type 2 diabetes is still It is that there will be different of that will for different patient the use of the as a means of that device like the of in diabetes management. the now seems to be how to is a It may be that will be the only for many the of time this population 1 , 2 1 Centre for Policy Research, of Health Health Policy and Research, University of and 2 Institute for Medicine, and Health University Medical Centre 2011; : Background: the of and in Patients with 2 Diabetes a in the risk of in patients with type 2 diabetes who performed SMBG. Aims: To evaluate if these are by a that time Methods: The bias in the study was and demonstrated that it is to the effect of SMBG on Results: In the study, patients were as exposed to SMBG for their whole time if performed SMBG for at least 1 year during the study the time between and the after 1 year of self-monitoring was performed is for patients with SMBG. Patients to at least 1 year to be as exposed to this and were from The total of in the SMBG is at least of at risk After of as the relative risk from to Conclusions: The effect of SMBG on in the study is by time Comment: The study is one of the trials in the of SMBG. Study is probably a major for between the studies. Kleefstra N 1,2 , Hortensius J 1 , Logtenberg SJ 1 , 3 , Groenier K 4 , Houweling ST 2,5 , 6 , 2 , Bilo HJ 1 Diabetes Centre, Isala Clinics, Zwolle, The Netherlands, 2 Medical Research Langerhans, Zwolle, The Netherlands, 3 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 4 Department of General Practice, University of Groningen, Groningen, The Netherlands, 5 General Practice Sleeuwijk, Sleeuwijk, The Netherlands, 6 Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands J : Background: It is not if SMBG glycaemic control in patients with type 2 diabetes. To investigate the effects of SMBG in patients with type 2 diabetes who were in glycaemic Methods: Patients years with an of using one to two blood glucose were in the Patients (n = were to receive SMBG to care or to with care for 1 A glucose value and glucose values were measured The efficacy was quality of and were using the Health the the Diabetes and the Results: in between was (95% CI to p = There were no significant changes between on the type or for the which was lower in the difference (95% CI to Conclusions: type 2 diabetes patients some of their the use of SMBG in these patients is and its use should be Comment: This is another SMBG study in non-insulin-treated type 2 the of not patients what to do with the information is one has to wonder if this at some to have some of the it is to that the in care is to more education and time than is in many of these studies. A 1 , 1 , 1 , S 2 , S 3 , A 1 , A 1 , 1 , 4 , 3 , 3 , 1 1 Department of and School of Medicine, 2 Department of School of Medicine, 3 Department of Biochemistry, School of Medicine, and 4 Department of School of Medicine, Diabetes Technol Ther : Background: glucose meters may not be accurate to Aims: of the accuracy and the capillary and venous of different Xceed (Abbott Diabetes Care, Alameda, CA, USA), Contour TS (Bayer Diabetes Care, (Roche Milpitas, CA, and Inc., in an Methods: The insulin hypoglycaemia test was performed for of mean age was measured from venous blood and capillary before and after of insulin were analysed in the laboratory by the hexokinase In tests for method and precision were also performed by the venous Results: All to hypoglycaemia to some was in error zone and was in the error zone Xceed and Contour TS and were than the other two according to error grid analysis or International for criteria. The in tests were consistent with the clinical The capillary and venous of and were than the other Not all are accurate in blood glucose levels. The patients and the should be of these of the and give more to the hypoglycaemia than the values with the These results that there is a need for the of accuracy standards of at blood glucose levels. Comment: We have the that meters are from especially at levels. patients can state a time when an The are not only for the of hypoglycaemia but also as we forward with CGM about how this about this the with the for use of the meters our clinical with patient error us that accuracy a for glucose meters at levels. has research from Inc., Corporation, Inc., and is a for Diagnostics, Diabetes Care and

We have compared the performance of the newly available blood glucose test strip, Visidex (Ames Division, Miles Laboratories Ltd., Stoke Poges, Slough, United Kingdom), designed for visual reading, with that of the already available BM-Test-Glycemie 20-800 [Boehringer Mannheim Corporation (London) Ltd., Lewes, East Sussex, United Kingdom]. The new test strip proved slightly less accurate over a wide range of blood glucose values and was less precise at normal and high glucose values. The color of the Visidex faded more rapidly on storage and errors in timing of the blood strip reaction caused greater inaccuracies. At present BM-Test-Glycemie 20-800 remains the visual glucose test strip of choice, although even with this strip there was a wide scatter of values when used by patients.

Glucose test strips vary slightly from batch to batch. These variations are accounted for by a batch-specific "code": a set of parameters defining the relationship between the signal change induced on the glucose test strip and the blood glucose concentration. We assessed the impact on accuracy of miscoding the ACCU-CHEK Aviva system across a wide range of glucose test strip batches and glucose levels, throughout the shelf life of the glucose test strips. The deviations in coding that we investigated had no effect on clinical action. Additionally, we showed, with mathematical modeling of a worst-case scenario, that the probability of an error altering clinical action is low. The batch-specific code of glucose test strips ensures the accuracy and safety of each blood glucose measurement. In addition to the parameters directly related to the blood glucose measurement, the electronic code chip contains the expiration date of the test strips and can deliver firmware updates for upgrades to the glucose meter. We eliminated the handling step of coding and retained all the advantages of coding. In Roche's newest all-in-one glucose meter, the ACCU-CHEK Compact Plus system, the batch-specific code is integrated into the drum that contains the glucose test strips. As a result, changing the drum containing the glucose test strips automatically changes the glucose test strip code. Patients with diabetes who use the ACCU-CHEK Compact Plus glucose meter do not have to be concerned with coding.

Recent evidence suggests that, despite widespread use, self-monitoring of blood glucose levels has little clinical benefit in many patients with diabetes. The impact of more focused public-payer policies for the use of blood glucose test strips may be substantial. We conducted a cross-sectional analysis of annual prescription claims for test strips between 1997 and 2008 for patients in Ontario aged 65 and older with diabetes. Patients were stratified into 1 of 4 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 5 hypothetical policy scenarios of more selective test strip use were assessed. Test strip use increased by almost 250% from 1997 to 2008, with 52.6% (n = 263,513) of included patients receiving a prescription during 2008. Almost half of these patients were at low risk for drug-induced hypoglycemia. In 2008, over 117 million test strips were dispensed in Ontario; however, more focused policy scenarios could have reduced this number by between 9.5 million and 74.5 million test strips. Many people who self-monitor their blood glucose are at relatively low risk for drug-induced hypoglycemia. The economic benefits associated with more selective testing could be redirected to more effective interventions for patients with diabetes.

PDB8: FACTORS ASSOCIATED WITH PRESCRIPTION CLAIMS FOR BLOOD GLUCOSE TEST STRIPS AMONG FEE-FOR-SERVICE NEW MEXICO MEDICAID PATIENTS

Utilization and Expenditure on Blood Glucose Test Strips in Canada

School nurses should participate in the care of children with type 1 diabetes mellitus. The aim of this study was to assess the level of knowledge of school nurses about the basic principles of self-control and the treatment of type 1 diabetes mellitus and to attempt to determine the factors that influence this level of knowledge. A cross-sectional survey was conducted among school nurses from October 2018 to November 2019 in the Pomeranian Voivodeship. The study was conducted using a self-constructed questionnaire. The survey included questions about the sociodemographic characteristics of the respondents, and a test of the knowledge and skills regarding the principles of self-control and the treatment of type 1 diabetes mellitus (16 test questions). This study included 168 Polish school nurses (mean age ± SD = 55.1 ± 8.9 years). Most of the nurses had a secondary education (81%), worked in a municipal educational institution (78.6%), and provided care to more than one student with type 1 diabetes mellitus at school (70.2%). The average level of knowledge of school nurses was 12.5 ± 2.0 points (maximum 16). The nurses working in a village school and those who worked only in one school had lower levels of knowledge. Only 85.7% of nurses reported that they could independently perform a blood glucose measurement with a glucometer, and as many as 56.5% were unable to determine the level of ketone bodies in the urine with Keto-Diastix test strips. Only 62.5% of nurses had a glucometer and glucometer strips in their nursing office. A total of 19.6% of nurses did not have glucagon (1 mg GlucaGen HypoKit®, Novo Nordisk A/S, Bagsværd, Denmark) or an ampoule with 20% glucose for an intravenous administration. The knowledge of school nurses about the principles of self-control and the treatment of type 1 diabetes mellitus is insufficient. Due to the strong increase in the incidence of type 1 diabetes mellitus among children and adolescents, it is important to organize permanent, continuous, and mandatory training on the principles of self-control and the treatment of type 1 diabetes mellitus for school nurses. The equipment in Polish school nurses’ offices should be supplemented with a working glucometer and blood glucose test strips, and the set of obligatory medications in the school nurse’s office should be supplemented with glucagon for students with type 1 diabetes mellitus.

Self-Monitoring of Blood Glucose: Impact of Quantity Limits in Public Drug Formularies on Provincial Costs Across Canada.

This paper presents a machine vision system for defect inspection disposable glucose test strips. The proposed system first lightened and captured image of flawless glucose test strip while offline training. The captured image was processed through image processing technology to establish standard projection data of silver paste and carbon rubber in flawless glucose test strips. Then the measured blood glucose test strips were processed with the same lighting and image processing procedures when online detection. The defects of the measured blood glucose test strips were inspected by the projection data comparison. Experiments show that the proposed system can effectively detect three main defects on glucose test strips, i.e., silver exposing, short circuit of carbon paste electrode and unglued carbon plastic electrode.

Chemical senses such as odor, taste and appearance are directly related with appetite. Understanding the relation between appetite and flavor is getting more important due to increasing number of obese patients worldwide. The literature on the studies investigating the change in olfactory abilities and gustatory sensitivity mostly performed using food-related odors and tastes rather than standardized tests were developed to study olfaction and gustation. Therefore, results are inconsistent and the relationship between olfactory and gustatory sensitivity with respect to the actual state of human satiety is still not completely understood. Here, for the first time in literature, we investigated the change in both olfactory abilities and gustatory sensitivity in hunger and in satiety using 123 subjects (37 men, 86 women; mean age 31.4years, age range 21-41years). The standardized Sniffin' Sticks Extended Test and Taste Strips were used for olfactory testing and gustatory sensitivity, respectively. TDI score (range 1-48) was calculated as the collective scores of odor threshold (T), odor discrimination (D) and odor identification (I). The evaluation was performed in two successive days where the hunger state of test subjects was confirmed by blood glucose test strips (mean blood glucose level 90.0±5.6mg/dl in hunger and 131.4±8.1mg/dl in satiety). The results indicated statistically significant decrease in olfaction in satiety compared to hunger (mean TDI 39.3±1.1 in hunger, 37.4±1.1 in satiety, p<0.001). The comparison of gustatory sensitivity indicated significantly higher sensitivity to sweet, sour and salty in hunger (p<0.001), but significantly higher sensitivity to bitter tastant in satiety (p<0.001). With this prospective study, we were able to show that both olfactory abilities and gustatory sensitivity were affected by hunger state.

The aim of the study was to determine the feasibility of conducting a case-finding programme for Type 2 diabetes mellitus in primary health care and to see whether random urinary glucose or random capillary blood glucose testing is the most suitable instrument for the early detection of Type 2 diabetes. Residents in the community of Låxa aged 35-64 years were subjected to testing during 1983-1987; those aged 65-79 were included from July 1985 and onwards. The urinary glucose testing was considered positive if a urinary dipstick was not unequivocally negative. The random blood glucose test was regarded as positive when > or = 8.0 mmol l-1. A diagnosis of Type 2 diabetes made within a follow-up period of 3 years from the initial examination was regarded as a positive outcome. Random blood glucose testing was performed on 3268 persons which was close to 85% of the eligible population. Urinary glucose tests were missing in 67 subjects. The random blood glucose test was positive in 220 persons and the urinalysis in 42 persons. A total of 234 individuals had a positive test, out of which 66 new diabetic cases were found. Sixty-four of these were detected by the random blood glucose testing and 20 by the urinalysis. The sensitivity for the random blood glucose and urinary glucose testing was 73 and 23%, the specificity was 95 and 99%, the positive predictive value 29 and 48%, and the negative predictive value 99 and 98%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Utilisation of blood glucose test strips in insulin-requiring people with diabetes mellitus using continuous glucose monitoring in Saxony-Anhalt – Analysis of health insurance data

The accuracy of glucose test strip in critically care has been questioned. We investigated the accuracy of glucose test strip in critically ill children. Patients, aged from 1 month to 18 years admitted in pediatric intensive care unit. Demographic data, hemodynamic parameters, and perfusion index (PI) were recorded. Glucose test strips were performed from finger stick blood [capillary blood glucose (CBG)] and from whole blood [whole blood glucose (WBG)] along with laboratory plasma blood glucose (PBG) from either arterial or venous blood samples. The accuracy of glucose test strips was defined according to ISO 15197 and Clarke error grid (CEG). One hundred and eighty one blood samplings including 117 arterial blood (CBG, WBGa, PBGa) and 64 venous blood (CBG, WBGv, PBGv) were obtained. The accuracy of WBGa was 98.3 and 95.2% when compared to the accuracy of CBG (88.7 and 83.3%. The accuracy of WBGv was 92.2% and 87.0 when compared to the accuracy of CBG which was 79.7 and 72.9% (ISO 15197: 2003 and 2013, respectively). Bland-Altman plot demonstrated bias and precision of 7.4±17.7 mg/dL in acceptable PI group compared to 30.2±23.4 mg/dL in low PI group (PI≤0.3). The CBG test strip must be interpreted carefully in critically ill children. A low PI was associated with poor CBG strip accuracy. WBG test strip from arterial blood was more appropriate for glucose monitoring in children with peripheral hypoperfusion.

Lack of knowledge and confusion exists regarding safe and appropriate use of blood glucose monitoring equipment. Increasing numbers of diabetics, and exponential growth in blood glucose monitoring presents increased opportunities for infection transmission between patients. Diabetics have increased exposure to blood and blood borne pathogens from frequent blood glucose monitoring.Risk factors have been identified in infectious outbreaks and by analysis of testing practice. Point of care blood glucose meters are frequently contaminated by blood. Bacterial and viral organisms survive on surfaces and in dried blood. Instrumentation is shared between patients, and is heavily utilized in institutional settings, so that serial testing is performed on multiple patients within a short timeframe. Hand hygiene, glove changes and meter disinfection between testing events has been found to be inconsistent. Time pressure for meter usage competes with proper cleaning and disinfection procedures. Meter storage areas are frequently contaminated by blood. Multi-use lancets, improperly used for serial patient blood sampling, are a source for infection transmission. Test strips in vials, frequently contaminated by bacterial organisms, present potential hazard. The responsibility of the clinical laboratory is to insure successful implementation of practices that insure patient safety.Risk reduction strategies include single-use auto-disabling skin puncture devices for blood sampling; hand hygiene and glove change for every testing event; effective meter cleaning and disinfection for every testing event; meter use restriction to a single patient; safe practices for glucose meter storage; infection control practices to reduce contamination of blood glucose test strips or changes in test strip packaging and test strip dispensing.