Blood Glucose Test Strips Research Articles

PDB66 - The Cost-Utility of Insulin Degludec Compared with Current Standard of Care in the Management of Type One and Type Two Diabetes Mellitus in Belgium

Insulin degludec (IDeg) is a basal insulin with an ultra-long duration of action for management of patients with type 1 (T1DM) and patients with type 2 (T2DM) diabetes. IDeg has demonstrated efficacious blood glucose control, with less hypoglycaemic events, and with an option for flexibility in dose time, compared with insulin glargine (IGlar). The objective was to assess the cost-effectiveness of IDeg in Belgium, compared with IGlar. The analysis focused on patients in three treatment regimens: T1DM, T2DM treated with basal insulin in combination with oral anti-diabetics (BOT) and T2DM treated with basal-bolus (BB). A one-year cost-utility model driven by differences in hypoglycaemia was used. Published dis-utilities for hypoglycaemic events were multiplied by the rate of hypoglycaemia to calculate quality-adjusted life years (QALYs). Costs and utilities were also calculated for potential use of less blood glucose test strips. A utility gain was attributed to the additional benefit of dosing flexibility. Unit costs pertained to public tariffs and reflected the payer perspective in Belgium. Baseline incidence rates of hypoglycaemic events and related resource utilization pertained to a Belgian patient-reported outcomes study. Hospitalization costs following severe hypoglycaemia were estimated using the IMS Hospital Disease Database. IDeg was associated with an incremental cost-effectiveness ratio of 14,677€/QALY in T1DM, 4,976€/QALY in T2DM BOT, and 12,930€/QALY in T2DM BB. Univariate and probabilistic sensitivity analyses confirmed robust results. Results were most sensitive to variations in number of IGlar doses per day, and number of glucose-monitoring tests. At a willingness to pay threshold of 30,000€/QALY, IDeg would be cost-effective in 54%, 100% and 93% of the cases in the T1DM, T2DM BOT or T2DM BB treatment regimens respectively. These analyses demonstrate that IDeg is cost-effective in Belgium, when used in patients with T1DM and T2DM currently treated with long-acting insulin analogues.

Histological changes and antidiabetic activities of Icacina trichantha tuber extract in beta–cells of alloxan induced diabetic rats

ObjectiveTo investigate the antidiabetic, hypolipidaemic activities and histopathological changes of Icacina trichantha (I. trichantha) tuber extract in alloxan induced diabetic rats. MethodsIn the present study, 80% methanol extract of I. trichantha tuber was tested on alloxan induced diabetic rats. They were randomly grouped into control (distilled water and glibenclamide) and experimental (200, 400 and 600 mg/kg body weight). Diabetes was induced by a single intraperitoneal injection of 160 mg/kg body weight of alloxan. Blood glucose levels were measured using blood glucose test strips with AccuCheck Advantage II glucometer at 1, 3, 6, and 24 h on the first day and 1 h after treatment on Day 7, 14 and 21. Blood samples were collected and centrifuged to separate serum for estimation of lipid profile and other biochemical parameters. Histopathological changes in diabetic rats pancreas were also studied after extract treatment. ResultsDaily oral administration of I. trichantha tuber extract (200, 400, and 600 mg/kg body weight) and glibenclamide (2 mg/kg) showed beneficial effects on blood glucose level (P<0.01) as well as improving liver, kidney functions and hyperlipidaemia due to diabetes. The extract had a favourable effect on the histopathological changes of the pancreas in alloxan induced diabetes. ConclusionsI. trichantha tuber extracts posses antidiabetic activities as well as improve liver and renal profile and total lipids levels. I. trichantha tuber extracts also have favourable effects to inhibit the histopathological changes of the pancreas in alloxan induced diabetes.

Prevalence of Bacterial Contamination of Glucose Test Strips in Individual Single-Use Packets versus Multi-Use Vials

Glucose measurement is the cornerstone of diabetes control. In the hospital setting, the same device and package of test strips (50 or 100 strips) can be used to monitor glucose in several patients, which can increase cross contamination. The objective of our study is to measure bacterial contamination in glucose test strips, comparing results in individual single-use packets (one hospital) versus multi-use vials (two hospitals) in Spain. Test strips were collected from five different wards. Each hospital also collected two unopened vials from a single ward as controls. They were sent to a reference laboratory for microbiologic study. A number equal or higher than two colony forming units per strip was considered as a positive result. Out of 423 glucose test strips collected and cultured, 146 were contaminated (34%); only 7% of individually packed strips were contaminated versus 45% of strips packed in multi-use vials, with a high statistical significance (p &lt; .001). In the strips from multi-use vials, a high contamination rate was found and highly pathogenic organisms were identified, such as methicillin-resistant Staphylococcus epidermidis or Staphylococcus hemolyticus. In contrast, in strips packed individually, there was a much lower contamination rate and no such pathogen organisms were found. Therefore, in the hospital setting, the use of blood glucose test strips in individual packages would be more advantageous (mainly from a clinical point of view, but also from a financial one) than those packed in multi-use vials.

Resource Consumption and Costs of Treatment in Patients with Type 1 Diabetes under Intensified Conventional Therapy under German Real-Life Conditions

The aim of this study was to compare, from the perspective of the statutory health insurance, resource consumption and the associated adjusted treatment costs of intensified conventional therapy (ICT) with long-acting insulins in patients with type 1 diabetes mellitus (T1DM). We identified patients with T1DM who started ICT with either insulin glargine or neutral protamine Hagedorn (NPH) insulin between July 2000 and February 2008 using a representative German database (IMS® Disease Analyzer). The variables age, gender, insurance status, diabetes duration, hemoglobin A1c level, body mass index, and geographic region and specialization of practice were collected. Resource consumption was evaluated over a time period of 12 months and included the quantities of applied basal and bolus insulin, blood glucose test strips, lancets and needles, physician visits (general practitioner, specialist), hospitalization, and antihypoglycemic therapy (intravenous glucose/glucagon). A total of 2297 patients with T1DM were included; 1079 received ICT with insulin glargine and 1218 with NPH insulin. After adjustment, annual cost savings in favor of insulin glargine amounted to €423.94 compared with NPH insulin (p = .3019). The adjusted results show that an ICT with insulin glargine results in lower annual costs than ICT with NPH insulin (this difference was not statistically significant). However, in the context of glucose-lowering effect and a lower hypoglycemia rate, insulin glargine is preferred to NPH insulin for patients with T1DM undergoing ICT.

Blood Glucose Meter Market: This World is Undergoing Drastic Changes

Blood Glucose Meter Market: This World is Undergoing Drastic Changes

Foundation Activities To Improve Health Around The World

Foundation Activities To Improve Health Around The World

Impact of Emerging Health Insurance Arrangements on Diabetes Outcomes and Disparities: Rationale and Study Design

Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre–post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes quality of care, outcomes, and disparities. We will use a 13-year rolling sample (2001–2013) of members of an HDHP and members of a control group. To reduce selection bias, we will limit participants to those whose employers mandate a single health insurance type. The study will measure rates of monthly hemoglobin A1c, lipid, and albuminuria testing; availability of blood glucose test strips; and rates of retinal examinations, high-severity emergency department visits, and preventable hospitalizations. Results could be used to design health plan features that promote high-quality care and better outcomes among people who have diabetes.

Performance of a New Algorithm for Sample Re-application During Blood Glucose Test Strip Underfill Conditions

Performance of a New Algorithm for Sample Re-application During Blood Glucose Test Strip Underfill Conditions

Performance of a New Blood Glucose Monitoring System in the Hands of Intended Users

This study assessed the performance of a blood glucose monitoring system (BGMS) in development that uses a new generation of blood glucose test strips with capillary and venous blood in the hands of its intended users, people with diabetes and healthcare professionals (HCPs). In total, 93 subjects ≥ 18 years old (median age, 33 years) with type 1 (78%) or type 2 (22%) diabetes participated. Untrained subjects performed self-test fingersticks using a Microlet(®)2 lancing device (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) followed by testing of their own capillary blood on the BGMS. HCPs performed fingersticks (using a Tenderlett(®) lancing device [International Technidyne Corp., Edison, NJ]) and venipunctures on subjects and tested both capillary and venous samples from subjects on the BGMS. All BGMS results were compared with Yellow Springs Instruments (YSI) (YSI Life Sciences, Inc., Yellow Springs, OH) laboratory results. Analytical accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., within ± 15 mg/dL or ± 20% of the YSI results for samples with glucose concentrations < 75 mg/dL and ≥ 75 mg/dL, respectively) and more stringent criteria (i.e., within ± 15 mg/dL or ± 15% of the YSI results for samples with glucose concentrations < 100 mg/dL and ≥ 100 mg/dL, respectively). Overall, 98.9% (180/182) of subject Microlet2 capillary fingerstick results, 99.5% (182/183) of HCP Tenderlett capillary fingerstick results, and 100% (186/186) of venous results met current ISO criteria and more stringent criteria. The average hematocrit was 44%, with values ranging from 32% to 52%. Test results from both capillary fingerstick and venous samples with a new BGMS in development met current accuracy guidelines as well as proposed tighter criteria.

Self-monitoring of blood glucose

Self-monitoring of blood glucose

Cost of self-monitoring of blood glucose in the United States among patients on an insulin regimen for diabetes.

People with diabetes are at an increased risk of developing numerous complications, resulting in increased health care expenditures, economic burden, and higher mortality. For patients using an insulin pump or multiple insulin injections, self-monitoring of blood glucose (SMBG) is recognized as a core component of effective diabetes self-management. However, little is known about the real-world frequency and true costs associated with SMBG as a percentage of an insulin regimen in the United States. To evaluate SMBG frequency, SMBG-related costs (including blood glucose test strips and testing supplies), and insulin therapy costs among insulin-dependent patients with diabetes and at least 1 pharmacy claim for blood glucose testing strips during a 12-month follow-up period. A retrospective database analysis was conducted using the IMS LifeLink Health Plan Claims database to capture the frequency and costs associated with SMBG in relation to a specific insulin regimen, and SMBG expenditure compared with other treatment costs. The study employed a retrospective cohort analysis of patients with 2 or more claims for insulin between January 1, 2007, and June 30, 2009, with the first such claim representing the index date. All patients were required to have 6 months of pre-index continuous enrollment (pre-index period) and 12 months of post-index continuous enrollment (follow-up period). Patients were also required to have a diagnosis of diabetes in the pre-index period and to have no gaps of more than 90 days between consecutive insulin claims during the 360-day follow-up period. Patients without at least 1 pharmacy claim for blood glucose testing strips during the 12-month follow-up period and patients with pharmacy claims with extreme values (greater than 1,500 strips) were excluded. Depending on the insulin types used within the 30 days immediately following their index date, patients were subcategorized into 1 of 4 insulin regimen groups (basal, bolus, premixed, or basal-bolus). Patients' frequency of blood glucose testing was measured throughout their 12-month post-index follow-up period through analysis of clinical codes found on pharmacy claims. Quantity supplied fields on pharmacy claims were used to calculate total tests utilized over the follow-up period (e.g., 50 test strips dispensed=50 tests assumed). Insulin-related costs were also evaluated for the 12-month follow-up period. Among an initial sample of 373,946 patients with at least 2 claims for insulin between January 1, 2007, and June 30, 2009, 45,555 patients (12.2%) formed the final overall cohort who met the inclusion and exclusion criteria. SMBG-related pharmacy costs accounted for 27% of the insulin-and SMBG-related treatment costs for insulin users with an average $772 per patient in prescription testing strips and supplies versus $2,078 for insulin prescriptions and supplies. With an overall mean utilization for pharmacy-based SMBG testing of 764.3 strips per year, the average cost per testing strip was $0.98. Annual SMBG costs were 24.5% of total insulin and SMBG-related pharmacy costs for the basal insulin group compared with 35.8% for bolus, 21.0% for premixed, and 26.4% for basal-bolus. For insulin users with at least 1 pharmacy claim for glucose test strips, SMBG-related costs accounted for about one-fourth of total insulin and SMBG-related pharmacy costs.

Use of antidepressants in diabetes patients not using drugs, but only monitoring blood glucose

Objective: Patients with diabetes have an increased Odds Ratio （OR） for depressive disor- der. We wanted to investigate if patients with metabolic syndrome and/or diabetes type 2 not treated with antidiabetic agents, have an OR for concurrent antidepressant use comparable to other types of diabetes. Methods: Drug delivery data from 25 pharmacies were analysed with respect to sale of antidepressants, oral antidiabetic agents, insulin and blood glucose test strips. Results: Total population of the area was 337,019, whereas 254,083 were 18 or older. Of these 20,139 were patients receiving insulin, oral antidiabetics, glucose test strips and/or antidepressants. Those receiving antidepressants were 5.8% of those 18 or older whereas 2.4% received any antidiabetic medication (including test strips for HBGM). For patients receiving no medications but test strips alone, the adjusted OR for use concurrent use of antidepressants was 1.62 (95% confidence interval: 1.19 - 2.23), p = 0.002. For insulin-only receiving patients, the adjusted OR was 1.65 (1.41 - 1.93), p = 0.000, whereas for patients receiving only oral antidiabetics, it was 1.53 (1.38 - 1.71), p = 0.000. Patients receiving both insulin and oral antidiabetics: 2.23 (1.75 - 2.85), p = 0.000. Conclusion: Patients receiving only blood glucose strips have an OR of concurrently receiving antidepressants, not different from those receiving insulin only or oral antidiabetics only.

Patent Atomic Bomb Defused

This article explains why an appeals court felt the need to reinterpret a disclosure rule that had caused an explosion of paperwork in patent-related cases. In May 2011, the Federal Circuit, in the case of Therasense Inc. v. Becton Dickinson &amp; Co. involving blood glucose test strip technology, changed the standards for proving inequitable conduct. Following this change, a withheld reference must invalidate the patent in order to be material and support a charge of inequitable conduct. A withheld reference that merely presents an argument for invalidity fails as grounds for a charge of inequitable conduct. So long as the non-cited article does not disclose or render obvious the patented invention, the article is not material. Even if the article is material, that alone is not enough. The accused patent violator must also prove that the reference was knowingly and deliberately withheld. The patentee does not have to provide an explanation for the missing information.

The Costs of Type 2 Diabetes Mellitus Outpatient Care in the Brazilian Public Health System

ObjectiveThe prevalence of type 2 diabetes has shown a significant increase in parallel with health care costs. The objective of the Brazilian Study on Diabetes Costs (ESCUDI study) was to estimate direct and indirect costs of type 2 diabetes outpatient care in the Brazilian Public Health Care System. MethodsData were collected from different levels of health care in eight Brazilian cities in 2007. A total of 1000 outpatients were interviewed and had their medical records data analyzed. Direct medical costs included expenses with medications, diagnostic tests, procedures, blood glucose test strips, and office visits. Nonmedical direct costs included expenses with diet products, transportation, and caregivers. Absenteeism, sick leave, and early retirement were classified as indirect costs. ResultsTotal annual cost for outpatient care was US$2108 per patient, out of which US$1335 per patient of direct costs (63.3%) and US$773 per patient of indirect costs (36.7%). Costs escalated as duration of diabetes and level of health care increased. Patients with both microvascular and macrovascular complications had higher costs (US$3199 per patient) compared to those with either microvascular (US$2062 per patient) or macrovascular (US$2517 per patient) complications only. The greatest portion of direct costs was attributed to medication (48.2%). ConclusionsDiabetes treatment leads to elevated costs both to Brazilian Public Health Care System and society. Costs increased along with duration of disease, level of care and presence of chronic complications, which suggested a need to reallocate health resources focusing on primary prevention of diabetes and its complications.

Lancing: Quo Vadis?

Today, lancing fingertips or alternative sites for obtaining a blood sample for self-monitoring of blood glucose (SMBG) is a standard procedure for most patients with diabetes. The need for frequent lancing and associated discomfort and pain can be seen as a key hurdle for patients to comply with SMBG regimens. This article provides an overview of the status quo and future of lancing, focusing on key areas for future developments driven by customer and market needs. We also review technical issues and provide a background for possible improvements. The act of puncturing the skin with a lancet to obtain a blood sample seems to remain the standard procedure for the foreseeable future, because alternate ways of providing a blood sample have not demonstrated overall superiority (e.g., with laser technology). Other methods, which avoid lancing entirely, have also not gained broad market acceptance (e.g., minimally invasive continuous glucose monitoring) or not shown technical viability (e.g., noninvasive glucose monitoring). In relation to blood glucose (BG) meters and test strips, lancing has been a "stepchild" with regards to commercial attention and development efforts. Nevertheless, significant technological improvements have been made in this field to address key customer needs, including better performance (regarding pain, wound healing, and long-term sensitivity), reduced cost, and higher integration with other components of BG monitoring (e.g., integration of the lancing device with the glucose monitor). From a technical perspective, it is apparent that highly comfortable lancing can be accomplished; however, this still requires fairly advanced and complex devices. New developments are necessary to achieve this level of sophistication and performance with less intricate and costly system designs. Manufacturers' motivation to pursue these developments is compromised by the fact that they might not recoup their development cost on commercial advanced lancing systems through direct profits, but only through its positive influence on adherence and increased more profitable sensor utilization. We believe that two main driving forces will continue to push the evolution of lancing and sampling technology: (1) the need for maximum lancing comfort and (2) the advent of fully integrated systems, realizing a device in which all steps for SMBG are incorporated, thus providing a "one-step" experience. Rendering lancing a "nonissue" will eliminate a key barrier to adherence with appropriate SMBG regimens. Providing sophisticated lancing devices that allow the highest level of comfort and/or seamless blood sampling is key to improving user acceptance. This may have a greater impact on metabolic control than many of the new and expensive antidiabetic drugs.

The Impact of Non-Severe Hypoglycemic Events on Work Productivity and Diabetes Management

ObjectivesHypoglycemia is a common complication of treatment with certain diabetes drugs. Non-severe hypoglycemic events (NSHEs) occur more frequently than severe events and account for the majority of total events. The objective of this multi-country study was to identify how NSHEs in a working population affect productivity, costs, and self-management behaviors. MethodsA 20-minute survey assessing the impact of NSHEs was administered via the Internet to individuals (≥ 18 years of age) with self-reported diabetes in the United States, United Kingdom, Germany, and France. The analysis sample consisted of all respondents who reported an NSHE in the past month. Topics included: reasons for, duration of, and impact of NSHE(s) on productivity and diabetes self-management. ResultsA total of 1404 respondents were included in this analysis. Lost productivity was estimated to range from $15.26 to $93.47 (USD) per NSHE, representing 8.3 to 15.9 hours of lost work time per month. Among individuals reporting an NSHE at work (n = 972), 18.3% missed work for an average of 9.9 hours (SD 8.4). Among respondents experiencing an NSHE outside working hours (including nocturnal), 22.7% arrived late for work or missed a full day. Productivity loss was highest for NSHEs occurring during sleep, with an average of 14.7 (SD 11.6) working hours lost. In the week following the NSHE, respondents required an average of 5.6 extra blood glucose test strips. Among respondents using insulin, 25% decreased their insulin dose following the NSHE. ConclusionsNSHEs are associated with substantial economic consequences for employers and patients. Greater attention to treatments that reduce NSHEs could have a major, positive impact on lost work productivity and overall diabetes management.

Community pharmacists' knowledge, attitude and practice towards diabetes care in Tripoli, Libya

Background: Significant benefit from involving community pharmacists in diabetes management has been demonstrated. This study was undertaken to evaluate the knowledge and attitudes of community pharmacists to diabetes care in Tripoli, Libya. Materials and Methods: One hundred and forty six conveniently selected community pharmacists were surveyed by 2 questionnaires. The first documented the available services and pharmacists' perceived role in diabetes care. The second evaluated the pharmacists' diabetes knowledge based on a validated 23 item questionnaire, the “Arabic Short Diabetes Knoledge Test” (ASDKT). Results: The survey demonstrated inconsistent supply of different diabetic medications. Insulin was not available throughout most of the pharmacies, whereas Sulphonylureas and Metformin were more readily available. Urine and blood glucose testing strips and glucose meters were available irregularly in about half of the pharmacies. The role of pharmacists in diabetes care was mainly viewed as supply and dispensing, dispensing and instruction and help and support. Diabetes educational activities offered by the pharmacists included providing information on availability of diabetes-related items, counseling on the use of drugs, instruction on use of glucose meters and answering general questions about diabetes. The information provided was rated as good and adequate by almost three quarters of the participants. The median ASDKT's overall score for all questions was 16/23. General diabetes information score was 9/15 and for insulin therapy-specific questions was 7/8. The sources of information used in diabetic education were books and journals, through learning from colleagues, product literature and attending lectures were thought to be helpful. Pharmacists were prepared to enhance their education by meetings and lectures, Journals and books, audiotapes and self-education. Conclusions: Community pharmacists offer a readily accessible potential resource for diabetes education. Our survey of practicing pharmacists, elucidated their readiness to participate in a multidisciplinary diabetes management team. Incorporation of community pharmacists in any national diabetes educational program is necessary.

Antidiabetic, hypolipidemic and histopathological analysis of Dillenia indica (L.) leaves extract on alloxan induced diabetic rats

Objective To investigate antidiabetic, hypolipidemic histopathological analysis of Dillenia indica ( D. indica) methanolic leaves (DIME) extract in alloxan induced diabetic rat by administering oral doses (250 and 500 mg/kg body weight). Methods Blood glucose levels were measured using blood glucose test strips with elegance glucometer on weekly intervals till the end of study ( i.e. 3 weeks). Other parameters e.g. liver profile, renal profile and total lipid levels were determined in normal and alloxan induced diabetic rats after oral administration of the extract for 21 days. Histopathological changes in diabetic rat organs (pancreas, liver and kidney) were also observed after extract treatment. Results Daily oral administration DIME (250 and 500 mg/kg body weight) and glibenclamide (10 mg/kg) showed beneficial effects on blood glucose level ( P < 0.001) as well as improving kidney, liver functions and hyperlipidaemia due to diabetes. The extract treatment also showed to enhanced serum insulin level and body weight of diabetic rats as compared to diabetic control group. Furthermore, the extract has a favorable effect on the histopathological changes of the pancreas, liver and kidney in alloxan induced diabetes. Conclusions D. indica possess antidiabetic property as well improve body weight, liver profile, renal profile and total lipid levels. DIME has also favorable effect to inhibit the histopathological changes of the pancreas and kidney in alloxan induced diabetes.

Accuracy and Precision Evaluation of Seven Self-Monitoring Blood Glucose Systems

Self-monitoring blood glucose (SMBG) systems play a critical role in management of diabetes. SMBG systems should at least meet the minimal requirement of the World Health Organization's ISO 15197:2003. For tight glycemic control, a tighter accuracy requirement is needed. Seven SMBG systems were evaluated for accuracy and precision: Bionime Rightest(™) GM550 (Bionime Corp., Dali City, Taiwan), Accu-Chek(®) Performa (Roche Diagnostics, Indianapolis, IN), OneTouch(®) Ultra(®)2 (LifeScan Inc., Milpitas, CA), MediSense(®) Optium(™) Xceed (Abbott Diabetes Care Inc., Alameda, CA), Medisafe (TERUMO Corp., Tokyo, Japan), Fora(®) TD4227 (Taidac Technology Corp., Wugu Township, Taiwan), and Ascensia Contour(®) (Bayer HealthCare LLC, Mishawaka, IN). The 107 participants (44 men and 63 women) were between 23 and 91 years old. The analytical results of seven SMBG systems were compared with those of plasma analyzed with the hexokinase method (Olympus AU640, Olympus America Inc., Center Valley, PA). 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 criteria 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%. More than 40% of evaluated SMBG systems meet the minimal accuracy criteria requirement of ISO 15197:2003. However, considering tighter criteria for accuracy of ±15%, only the Bionime Rightest GM550 meets this requirement. Because SMBG systems play a critical role in management of diabetes, manufacturers have to strive to improve accuracy and precision and to ensure the good quality of blood glucose meters and test strips.

Performance of a New Test Strip for FreeStyle Blood Glucose Monitoring Systems

a new strip, designed to enhance the ease of use and minimize interference of non-glucose sugars, has been developed to replace the current FreeStyle (Abbott Diabetes Care, Alameda, CA) blood glucose test strip. We evaluated the performance of this new strip. laboratory evaluation included precision, linearity, dynamic range, effects of operating temperature, humidity, altitude, hematocrit, interferents, and blood reapplication. System accuracy, lay user performance, and ease of use for finger capillary blood testing and accuracy for venous blood testing were evaluated at clinics. Lay users also compared the speed and ease of use between the new strip and the current FreeStyle strip. for glucose concentrations <75 mg/dL, 73%, 100%, and 100% of the individual capillary blood glucose results obtained by lay users fell within ± 5, 10, and 15 mg/dL, respectively, of the reference. For glucose concentrations ≥75 mg/dL, 68%, 95%, 99%, and 99% of the lay user results fell within ± 5%, 10%, 15%, and 20%, respectively, of the reference. Comparable accuracy was obtained in the venous blood study. Lay users found the new test strip easy to use and faster and easier to use than the current FreeStyle strip. The new strip maintained accuracy under various challenging conditions, including high concentrations of various interferents, sample reapplication up to 60 s, and extremes in hematocrit, altitude, and operating temperature and humidity. our results demonstrated excellent accuracy of the new FreeStyle test strip and validated the improvements in minimizing interference and enhancing ease of use.