Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters.

Background: Accuracy of blood glucose readings is (among other things) dependent on the test strip being completely filled with sufficient sample volume. The devices are supposed to display an error message in case of incomplete filling. This laboratory study was performed to test the performance of 31 commercially available devices in case of incomplete strip filling.

Technical aspects of the Parkes error grid.

Background: The Parkes error grid, which was developed in 1994, presented performance zones for blood glucose (BG) monitors with borders that were not mathematically specified at the time the grid was published.

Methods: In this article, we (1) review the history of the Parkes error grid, (2) present the never-before-published exact coordinates and specifications of the grid so that others may produce an exact replica of the original grid, and (3) discuss our suggestions how this metric should be applied.

Results: The new ISO15197:2013 guideline for system accuracy assessment of BG meters for patient self-measurement incorporates use of this metric for defining acceptable accuracy of BG monitors.

The precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors.

Objective: Self-monitoring of blood glucose is a key element in diabetes management. Accurate and precise performance of blood glucose monitors (BGMs) ensures that valid values are obtained to guide treatment decisions by patients and physicians. BGStar and iBGStar are hand-held BGMs that use dynamic electrochemistry to correct for potential interferences and thereby minimize system errors.

Hematocrit interference of blood glucose meters for patient self-measurement.

Background: Abnormal hematocrit levels may interfere with glucose readings of patient self-assessment blood glucose (BG) meters. The aim of this laboratory investigation was to assess the potential influence of hematocrit variations on a variety of BG meters applying different measurement technologies.

Methods: Venous heparinized blood was manipulated to contain three different BG concentrations (50-90, 120-180, and 280-350 mg/dl) and five different hematocrit levels (25%, 35%, 45%, 55%, and 65%).

Determination of hematocrit interference in blood samples derived from patients with different blood glucose concentrations.

Background: We performed a blood glucose meter hematocrit (HCT) interference test with lower sample manipulation requirements by using blood samples from patients with different blood glucose (BG) levels.

Methods: Blood from five patients with different BG levels (2.8, 5.

Variability of blood glucose meters for patient self-testing: analysis of the article by Brazg and coauthors.

The article by Brzag and coauthors in this issue of Journal of Diabetes Science and Technology reports a competitive accuracy performance study for a branded meter in comparison with six low-cost meters currently available in the United States. It highlights several important topics: (1) the need for more stringent post-marketing requirements for blood glucose meters after launch and (2) low-cost meters use older technologies and their manufacturers do not usually seriously invest in new technology or constant quality assurance efforts. This may explain the study results, which show superior performance of the branded meter.

Comparison of patient preference for two insulin injection pen devices in relation to patient dexterity skills.

Background: Impaired dexterity has been reported to be prevalent in diabetes patients independent from the existence of diabetic neuropathy. This study was performed to investigate the impact of dexterity impairment on patient preference for two insulin pen injection devices (InnoLet and FlexTouch).

Methods: Ninety patients [54 male/36 female; age (mean ± standard deviation), 62 ± 8 years; disease duration, 18 ± 11 years; hemoglobin A1c, 7.

Patient device assessment evaluation of two insulin injection devices in a mixed cohort of insulin-treated patients with type 1 or type 2 diabetes mellitus.

Objective: FT (FlexTouch*) is a new disposable insulin injection pen device for use in insulin-treated patients with diabetes mellitus. The aim of this study was to evaluate patient perception of FT versus IL (InnoLet†) with respect to the ease of use and patient preference in a mixed patient cohort with different kinds and degrees of visual or dexterity impairments.

Methods: Ninety patients were included into this investigation (54 male/36 female, age [mean ± SD]: 62 ± 8 yrs, disease duration: 18 ± 11 yrs, HbA1c: 7.

Clinical assessment of the accuracy of blood glucose measurement devices.

Objectives: Blood glucose meters for patient self-measurement need to comply with the accuracy standards of the ISO 15197 guideline. We investigated the accuracy of the two new blood glucose meters BG*Star and iBG*Star (Sanofi-Aventis) in comparison to four other competitive devices (Accu-Chek Aviva, Roche Diagnostics; FreeStyle Freedom Lite, Abbott Medisense; Contour, Bayer; OneTouch Ultra 2, Lifescan) at different blood glucose ranges in a clinical setting with healthy subjects and patients with type 1 and type 2 diabetes. BGStar and iBGStar are employ dynamic electrochemistry, which is supposed to result in highly accurate results.

Self-assessment and objective determination of dexterity in patients with type 1 or type 2 diabetes mellitus.

Objective: Insulin-treated patients perform complex treatment activities during daily routine, such as blood glucose measurements and insulin injections. We aimed to identify suitable dexterity and cognitive function tests for diabetes patients, and to compare the patient self-assessment of their dexterity skills with the test results (Jebsen-Taylor hand function test, (JHFT), motoric performance test (MLS), number connection test).

Method: We enrolled 90 diabetes patients (36 females, 54 males): 15 type 1 with clinically suspected dexterity impairment (A: age: 60 ± 9 years), 30 type 2 with clinically suspected dexterity impairment (B: 61 ± 10 years), 30 type 1 or type 2 patients with visual impairment (C: 64 ± 6 years), and 15 type 1 or type 2 patients without obvious impairment (control group: D: 64 ± 5 years).

Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices.

Background: It has been demonstrated that dynamic electrochemistry can be used to correct blood glucose measurement results for potentially interfering conditions, such as humidity, hematocrit (HCT) variations, and ascorbic acid. The purpose of this laboratory investigation was to assess the potential influence of hematocrit variations on a variety of blood glucose meters applying different measurement technologies.

Methods: Venous heparinized whole blood was drawn, immediately aliquoted, and manipulated to contain three different blood glucose concentrations (80, 155, and 310 mg/dl) and five different hematocrit levels (25%, 37%, 45%, 52%, and 60%).

Effect of pioglitazone and ramipril on biomarkers of low-grade inflammation and vascular function in nondiabetic patients with increased cardiovascular risk and an activated inflammation: results from the PIOace study.

Aims: This study investigated the effects of pioglitazone (PIO), ramipril (RAM), or their combination (PIRA) on low-grade inflammation in nondiabetic hypertensive patients with increased cardiovascular risk.

Methods And Results: Patients enrolled in this placebo-controlled, double-blind, randomized, parallel trial (72 male, 77 female, aged 60 ± 9 years, body mass index 30.4 ± 4.

Downregulation of the proinflammatory state of circulating mononuclear cells by short-term treatment with pioglitazone in patients with type 2 diabetes mellitus and coronary artery disease.

Background. This study was performed to investigate the influence of a short-term treatment with pioglitazone versus placebo on inflammatory activation of mononuclear cells (mRNA expression/protein secretion of inflammatory markers). Methods and Results.

Review of approved pioglitazone combinations for type 2 diabetes.

Introduction: Pioglitazone is approved in combination with several other blood-glucose-lowering drugs for the treatment of type 2 diabetes mellitus (T2DM). Beyond lowering blood glucose levels, each combination of different blood-glucose-lowering drugs for the treatment of T2DM evolves specific pleiotropic effects, which might be considered on an individual basis in a certain patient.

Areas Covered: The objective of this article is to provide a short review of the pathophysiology of T2DM and to provide a rationale for the combination of pioglitazone with other antidiabetic drugs, based on a pathophysiological understanding of T2DM.

Prevalence of CYP450 gene variations in patients with type 2 diabetes.

Background: Drug degradation in the human organism is driven by detoxification mechanisms that can be affected in their efficiency by genetic mutations. The purpose of this pilot investigation was to investigate whether Type 2 diabetes is associated with mutations in prominent members of the CYP 450 isoenzyme family.

Methods: Genomic DNA was isolated from EDTA blood samples of 203 Caucasian subjects (101 patients with Type 2 diabetes and 102 non-diabetic subjects, age (mean +/- STD): 49 +/- 16 years) was analyzed.

Laboratory evaluation of a new lateral-flow-based point-of-care rapid test for assessment of chronic systemic inflammation.

The determination of C-reactive protein (CRP) by means of a highly sensitive laboratory method as an independent biomarker for assessment of chronic systemic vascular inflammation and cardiovascular risk is recommended by therapeutic guidelines for diabetes and cardiovascular disease in the United States and in Europe. The purpose of this investigation was to investigate the specificity and sensitivity of a newly developed lateral-flow-based point-of-care (POC) rapid test with semi-quantitative visual reading in comparison with a laboratory reference standard method. The high-sensitivity CRP concentrations of 66 samples were determined by means of turbidimetry and the POC test (5 microl serum/10 microl capillary whole blood, 10 minutes) was independently performed by three investigators blinded to each other's results.

Comparison of the dose accuracy of prefilled insulin pens.

Background: Prefilled insulin pens have become a convenient and accurate way for diabetes patients to inject insulin. Their ease of use has helped to reduce the resistance of patients with type 1 diabetes and type 2 diabetes in the United States and Europe toward initiation of insulin therapy. This study compared the dosing accuracy of two prefilled insulin pens (the SoloStar((R)) from Sanofi Aventis, Berlin, Germany, and the Next Generation [NG] FlexPen((R)) from Novo Nordisk, Mainz, Germany).

Differences in the results and interpretation of oxidized LDL cholesterol by two ELISA assays--an evaluation with samples from the PIOstat study.

Background: The oxidized LDL-particles (oxLDL) are considered to be an important driving factor in the pathophysiology of arteriosclerosis. Few methods exist today to directly determine oxLDL in human plasma. We evaluated the plausibility of results derived from a new ELISA (Immundiagnostik, Bensheim, Germany) in comparison to a different ELISA test (Mercodia, Uppsala, Sweden).

Intensification with prandial insulin.

Aims: Many patients with type 2 diabetes will ultimately need insulin therapy to maintain their target for glycaemic control. This review considers how best to achieve the target for glycaemic control in primary care.

Methods: Literature review and workshop discussions among participants at the Insulin Intensification Summit.

A biomarker concept for assessment of insulin resistance, beta-cell function and chronic systemic inflammation in type 2 diabetes mellitus.

The classification of patients with type 2 diabetes by means of the classical clinical and laboratory markers (HbA1c, glucose, lipids, BMI and blood pressure) is a classification by symptoms and does not provide an insight into the underlying pathophysiological disorders, insulin resistance, beta-cell dysfunction and adipogenesis. However, a better understanding of these disorders may be helpful for the selection of appropriate and successful therapeutic interventions. The assessment of beta-cell dysfunction has become of special interest as more drugs have been developed that are supposed to protect these cells or preserve their functional capacity, such as GLP-1 analogs or DPPIV-inhibitors.

Impact of rosiglitazone on visfatin and adiponectin plasma concentrations in patients with type 2 diabetes and coronary artery disease.

Visfatin is a recently described new adipokine that is considered to bind to the insulin receptor and induce insulin action via signal transduction pathways distinct from those of insulin. This study investigated whether circulating plasma visfatin levels may be influenced by PPARy activation, as shown for adiponectin and other adipokines. Samples from a prospective single-blinded placebo-controlled three-month intervention study with rosiglitazone were retrospectively analysed.

Pioglitazone: update on an oral antidiabetic drug with antiatherosclerotic effects.

Pioglitazone, a member of the PPAR-gamma agonist drug family, has been demonstrated to improve both metabolic and vascular insulin resistance when applied to patients with Type 2 diabetes mellitus. The drug is well tolerated with fluid retention and weight gain being the most frequently described side effects. The observed effects (e.

Rosiglitazone and glimeperide: review of clinical results supporting a fixed dose combination.

Type 2 diabetes has become a major burden to the health care systems worldwide. Among the drugs approved for this indication, glimepiride and rosiglitazone have gained substantial importance in routine use. While glimepiride stimulates beta-cell secretion and leads to reduction of blood glucose values, rosiglitazone activates PPARgamma and improves insulin resistance, at the vascular and metabolically active cells.

Performance of the continuous glucose monitoring system (CGMS) during development of ketosis in patients on insulin pump therapy.

Aims: Ketoacidosis is one of the most severe complications of Type 1 diabetes. Development of ketosis leads to substantial shifts in electrolyte and ion concentrations in the different fluid compartments of the body. This study was performed to investigate the performance of the continuous glucose monitoring device (CGMS) during ketoacidosis.

Pioglitazone: an antidiabetic drug with cardiovascular therapeutic effects.

The antidiabetic compound pioglitazone, an activator of the intracellular peroxisome proliferator-activated receptor-gamma, and decreases metabolic and vascular insulin resistance. The drug is well tolerated, and its metabolic effects include improvements in blood glucose and lipid control. Vascular effects consist of improvements in endothelial function and hypertension, and a reduction in surrogate markers of artherosclerosis.