Glucose monitoring systems (GMS) are routinely used by patients with diabetes to monitor glycemic control and modify treatment as needed. In this respect, the analytical performance of GMS is of course of crucial importance. The accuracy of GMS is usually assessed according to the Guidelines of the International Organization for Standardization (ISO). A new standard has recently been published with more stringent criteria than in the previous edition.1,2 Minimum acceptable system accuracy requirements for GMS now specify that ≥95% of the glucose meter results may not differ more than ±15 mg/dl from the reference method at glucose concentrations < 100 mg/dl (previously < 75 mg/dl) and ±15% (previously ±20%) at glucose concentrations ≥ 100 mg/dl.1 Furthermore, concerning prevalence and range of outliers, it is now specified that >99% of measured glucose values must fall in zones A and B of the consensus error grid.During the consultation process of the new criteria it has been suggested that the analytical performance of GMS is highly dependent on its intended use.3-6 For example, insulin-dependent patients under intensified glycemic control require highly accurate devices for adequate insulin dosing, whereas patients with Type 2 diabetes who are treated with medication with no or little risk of hypoglycemia could use less accurate GMS. It has, therefore, been suggested that the analytical accuracy of GMS should be tested not only in relation to BG level ranges below and above 100 mg/dL but also in relation to different glycemic ranges, as already previously proposed for continuous glucose monitoring systems. The aim of the present study was to analyze test results from 27 GMS obtained in a clinical setting, with regard to (1) analytical accuracy according to the new ISO accuracy limits as well as after stratification into 5 different BG level ranges and (2) frequency and extent of outliers. AbstractWe investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between...

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Background: Glycated albumin (GA) represents a better marker of glycemic control than HbA1c in patients with renal failure. Studies on the clinical impact of GA in patients with normal or moderately impaired renal function (CKD stages 1-3) are sparse. The present study investigates the relationship between GA and HbA1c in this patient group and the ability of both biomarkers to predict vascular complications. Methods: A total of 380 type 2 diabetic patients were followed-up during a median time of 4.7 years in a prospective, monocentric cohort study. Following parameters were measured at 6-12 month intervals : GA, HbA1c, NT-pro-BNP and further routine laboratory parameters; clinical status regarding treatment modality and onset of cardiovascular, cerebrovascular, peripheral vascular, renal, and ophthalmological events as well as death by any cause. Results: GA showed a strong positive correlation with HbA1c (r=0.71, 95% CI 0.61 to 0.75), with little dependence on patient gender, age, renal function and anemia. No association was found between the two biomarkers and risk of cardiovascular and cerebrovascular events. The risk of peripheral vascular events significantly increased with increasing HbA1c (Pval=0.002, HR=1.45) and showed a borderline association with increasing GA (Pval=0.06, HR=1.09). A strong association was found between GA and onset of renal events (Pval=0.01, HR=1.15). Conclusions: GA and HbA1c measurements are correlated in diabetic patients with CKD stages 1-3. The association with macroangiopathic complications is stronger for HbA1c than for GA values. GA levels predict particularly well renal events.

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Verschiedene Faktoren k?nnen die Blutzuckerkontrolle mit Handmessger?ten bei einer nachlassenden Nierenfunktion bzw. Niereninsuffizienz beeintr?chtigen. Interferierende Substanzen und ?nderungen des H?matokrits k?nnen zu Fehlern bei der Glukosemessung f?hren, die m?glicherweise fatale Konsequenzen im Hinblick auf die Insulindosis nach sich ziehen. Die vor Kurzem durchgef?hrte Umstellung der Handmessger?te von Vollblut- auf Plasmakalibration erscheint in der praktischen Umsetzung nicht unproblematisch. So zeigte sich, dass bei der Verwendung plasmakalibrierter Teststreifen nicht von einer ?einheitlichen Erh?hung? der ausgegebenen Blutzuckerwerte um circa 11?% bei Plasmakalibration ausgegangen werden kann. Auch dies kann zu Fehlern bei der zu spritzenden Insulindosis f?hren. Schlie?lich kann eine bei der Niereninsuffizienz h?ufig bestehende Komorbidit?t (fortgeschrittene Retinopathie und Neuropathie) das Handling der Blutzuckerselbstkontrolle beeintr?chtigen. Diese Fehlerm?glichkeiten bei der Blutzuckerkontrolle mit Handmessger?ten zu kennen und zu ber?cksichtigen ist wesentlich, um Fehleinsch?tzungen insbesondere bei der Insulindosierung zu vermeiden.