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Kerner W.,Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH and Co. KG | Freckmann G.,Institute For Diabetes Technology | Muller U.A.,Friedrich - Schiller University of Jena | Roth J.,Friedrich - Schiller University of Jena | And 5 more authors.
Diabetologie und Stoffwechsel | Year: 2015

Aim of thisosition statement is to highlight critical aspects of the measurement of HbA1c and to indicate steps towards and improvement in quality and comparability of the measurement of this importantarameter. The focus of this statement is on methodological/analytical aspects and not on interpretation and the clinical importance of thisarameter. © Georg Thieme Verlag KG Stuttgart New York. Source


As an integral part of therapy many patients with diabetes regularly measure their blood sugar levels. The recently introduced classification of the measurement systems (device plus test strips) into A and B systems solely based on the cost introduced a considerable degree of uncertainty among patients and physicians. With the following comments the Working Group Diabetes Technology (AGDT) of the German Diabetes Association would like to initiate a more objective debate on this topic and contribute to an effective and safe therapy for people with diabetes. The agreement for classification of A and B systems for blood glucose measurement between the Pharmacists Association (DAV) and the Association of Sick Funds (vdek) has the primary aim of reducing costs. However, the two groups of people that are mainly affected by the agreement were not heard: the patients, whose prognosis and quality of life is determined by a qualified therapy and the treating physicians who work with the patients in order to individualize treatment goals and to establish a qualified and cost-conscious therapy. The AGDT regard it as essential that patients and physicians have the opportunity to select the optimal measurement system according to individual needs but bearing costs aspects clearly in mind. © 2014 Springer-Verlag Berlin Heidelberg. Source


Hessel F.,SRH University of Applied Sciences Berlin | Freckmann G.,Institute For Diabetes Technology | Resch A.,Abbott Laboratories
Diabetologe | Year: 2014

Background: Despite quality standards for accuracy there are performance differences among commercially available blood glucose monitoring (BGM) systems. Aim: The objective of this analysis was to assess the potential clinical and economic impact of differences in measurement accuracy of various BGM systems using a modeling approach for patients with diabetes who carry out an intensified insulin therapy. Material and methods: An international simulation model was adapted to the German healthcare setting and additional risks of hypoglycemia due to blood glucose (BG) measurement errors of five different BGM systems were simulated based on results of a real-world accuracy study. Using data from published literature an annual additional number of required medical interventions as a result of hypoglycemia was estimated. The calculations were based on patients with type 1 (T1DM) and type 2 (T2DM) diabetes mellitus requiring multiple daily injections (MDIs) of insulin in the German healthcare setting. The additional costs attributable to treatment of severe hypoglycemic episodes resulting from BG measurement errors were calculated. Results: The results of the model simulation predicted an annual difference of approximately 63,000 severe hypoglycemic episodes from BG measurement errors for T1DM and 56,000 for T2DM MDI patients for the estimated German population of T1DM and T2DM MDI patients using the least accurate BGM system compared to patients using the most accurate system. This resulted in additional direct medical costs of approximately 27.8 million Euros for T1DM and approximately 30.0 million Euros for T2DM MDI patients per year. Conclusion: The results of the analysis show that error patterns over the operating range of BGM systems can lead to relevant clinical and economic outcome consequences for the routine care of diabetes patients in Germany treated with insulin. © 2014 Springer-Verlag Berlin Heidelberg. Source


Zisser H.,Sansum Diabetes Research Institute | Wagner R.,Roche Holding AG | Pleus S.,Institute For Diabetes Technology | Haug C.,Institute For Diabetes Technology | And 4 more authors.
Diabetes Technology and Therapeutics | Year: 2010

Background: Insulin pump systems now provide automated bolus calculators (ABCs) that electronically calculate insulin boluses to address carbohydrate intake and out-of-range blood glucose (bG) levels. We compared the efficacy of three ABCs (Accu-Chek® Combo [Roche Insulin Delivery Systems (IDS), Inc., Fishers, IN, a member of the Roche Group], Animas® 2020 [Animas Corp., West Chester, PA, a Johnson and Johnson company], and MiniMed Paradigm Bolus Wizard® [Medtronic MiniMed, Northridge, CA]) to safely reduce postprandial hyperglycemia in type 1 diabetes mellitus (T1DM). Methods: T1DM subjects (n = 24) were recruited at a single center for a prospective, triple crossover study. ABCs with the programmed target range (80-140 mg/dL) were used in random order. Postprandial hyperglycemia was induced by reducing the calculated bolus by 25%. Two hours after test meals, the ABCs were allowed to determine whether a correction bolus was needed. Differences between 6-h bG values after test meals that achieved 2-h postprandial hyperglycemia and the mean of the target range (110 mg/dL) were determined. Results: The mean difference between 6-h bG levels following test meals and the 110 mg/dL bG target with the MiniMed device (47.4 ± 31.8 mg/dL) was significantly higher than the Animas (17.3 ± 30.9 mg/dL) and Roche IDS (18.8 ± 33.8 mg/dL) devices (P = 0.0022 and P = 0.0049, respectively). The number of meals with 2-h postprandial hyperglycemia and bG levels at 2 h was similar. Roche IDS and Animas devices recommended correction boluses significantly (P = 0.0001 and P = 0.0002, respectively) more frequently than the MiniMed device. ABC use was not associated with severe hypoglycemia. There was no significant difference in the rate of mild hypoglycemia (bG <60 mg/dL not requiring assistance) among the three groups (Roche IDS and Animas, n = 2; MiniMed, n = 0). Conclusions: In this study, the Roche IDS and Animas devices were more efficacious in controlling postprandial hyperglycemia than the MiniMed device. This may be due, in part, to differences in ABC setup protocols and algorithms. Use of ABCs can assist in controlling postprandial glycemia without significant hypoglycemia. Copyright 2010, Mary Ann Liebert, Inc. Source


Liebl A.,Fachklinik Bad Heilbrunn | Henrichs H.R.,Arbeitsgemeinschaft Diabetologische Technology e.V. | Heinemann L.,Science and Co. | Freckmann G.,Institute For Diabetes Technology | And 2 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2012

Continuous glucose monitoring (CGM) has become an increasingly important part of modern diabetes therapy. Recent randomized controlled studies have provided evidence that sufficiently frequent CGM can improve HbA 1c results in patients with type 1 diabetes and elevated baseline HbA 1c levels, while lowering the rate and duration of hypoglycaemic events in patients with good baseline HbA 1c levels. The CGM group in German Diabetes Association (DDG)'s diabetes technology working group (AGDT) has defined evidence-based indications for the clinical CGM application in a consensus statement; these indications are hypoglycaemia (frequent, severe, or nocturnal) and hypoglycaemia unawareness, insufficient metabolic control despite full use of every possible therapeutic option and good patient compliance, pregnancy with unsatisfactory blood glucose results, and the need for more than ten blood glucose measurements per day. Contraindications and defined preconditions for the successful use of CGM should be considered. Source

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