Mainz, Germany
Mainz, Germany
Time filter
Source Type

Tack C.,Radboud University Nijmegen | Pohlmeier H.,Zentrum fur Diabetes und Gefasserkrankungen | Behnke T.,Diabetes Zentrum Neuwied | Schmid V.,IKFE CRO GmbH | And 3 more authors.
Diabetes Technology and Therapeutics | Year: 2012

Background: This multicenter study was conducted to evaluate the performance of five recently introduced blood glucose (BG) monitoring (BGM) devices under daily routine conditions in comparison with the YSI (Yellow Springs, OH) 2300 Stat Plus glucose analyzer. Methods: Five hundred one diabetes patients with experience in self-monitoring of BG were randomized to use three of five different BGM devices (FreeStyle Lite ® [Abbott Diabetes Care Inc., Alameda, CA], FreeStyle Freedom Lite [Abbott Diabetes Care], OneTouch ® UltraEasy ® [LifeScan Inc., Milpitas, CA], Accu-Chek ® Aviva [Roche Diagnostics, Mannheim, Germany], and Contour ® [Bayer Vital GmbH, Leverkusen, Germany]) in a daily routine setting. All devices and strips were purchased from local regular distribution sources (pharmacies, four strip lots per device). The patients performed the finger prick and the glucose measurement on their own. In parallel, a healthcare professional performed the glucose assessment with the reference method (YSI 2300 Stat Plus). The primary objective was the comparison of the mean absolute relative differences (MARD). Secondary objectives were compliance with the International Organization for Standardization (ISO) accuracy criteria under these routine conditions and Clarke and Parkes Error Grid analyses. Results: MARD ranged from 4.9% (FreeStyle Lite) to 9.7% (OneTouch UltraEasy). The ISO 15197:2003 requirements were fulfilled by the FreeStyle Lite (98.8%), FreeStyle Freedom Lite (97.5%), and Accu-Chek Aviva (97.0%), but not by the Contour (92.4%) and OneTouch UltraEasy (91.1%). The number of values in Zone A of the Clarke Error Grid analysis was highest for the FreeStyle Lite (98.8%) and lowest for the OneTouch Ultra Easy (90.4%). Conclusions: FreeStyle Lite, FreeStyle Freedom Lite, and Accu-Chek Aviva performed very well in this study with devices and strips purchased through regular distribution channels, with the FreeStyle Lite achieving the lowest MARD in this investigation. © Copyright 2012, Mary Ann Liebert, Inc. 2012.

Schipper C.,IKFE | Musholt P.B.,IKFE | Ramljak S.,IKFE | Knesovic M.,IKFE | And 3 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2012

The aim of this study was to evaluate accuracy and intra-assay precision in low-cost blood glucose meters with electrochemical sensors compared to BG*Star and iBG*Star. Blood samples were drawn from five patients with varying blood glucose concentrations (50-400 mg/dl). The samples were tested ten times with ten devices from each type. Devices tested were: GlucoCheck Comfort, GlucoTest TD, FineTouch, BeurerGL40, MediTouch, OmniTest3, MyLife GM300, IME iDia, GlucoCheck plus, BG*Star and iBG*Star. Mean intra-assay CV/MARD results were as follows: BG*Star 5.61%/6.43%, iBG*Star 5.24%/3.48%, GlucoCheck Comfort 5.62%/11.24%, GlucoTestTD 4.49%/13.10%, FineTouch 6.10%/8.67%, Beurer GL40 3.86%/10.60%, MediTouch 4.16%/17.46%, OmniTest3 7.45%/20.93%, MyLife GM300 3.70%/12.23%, IME iDia 6.55%/22.92%, GlucoCheck plus 5.32%/16.50%. BG*Star and iBG*Star were significantly more accurate than any other device (p < 0.001 vs. all other meters). With few exceptions, intra-assay precision was comparable between the devices, ranging between 3% and 6% in most cases. This laboratory study demonstrates that BG*Star and iBG*Star are more accurate than low-cost meters. CV was similar in across the devices, indicating that intra-assay precision may not present a quality issue in low-cost meter technologies.

Schoffski O.,Friedrich - Alexander - University, Erlangen - Nuremberg | Mentrup S.,Novo Nordisk AS | Lund N.,Novo Nordisk AS | Pfutzner A.,IKFE
Diabetes, Stoffwechsel und Herz | Year: 2010

The carrying out of cost-benefit analyses of innovative drugs is a complex venture accompanied by various methodological challenges. The German Institute for Quality and Efficiency in Health Care (IQWiG) uses the response rate to indicate benefit, i.e., the number of patients reaching the therapeutic target of any given intervention. We attempted to demonstrate the cost-effectiveness of the GLP-1 analogue, liraglutide, by using data from the LEAD study and applying this to a treatment efficacy parameter for type 2 diabetes mellitus which we had derived from actual treatment guidelines: HbA1c <6.5%; no hypoglycaemic events; no weight gain. The LEAD study data was used to calculate an efficacy threshold for liraglutide, glimepiride, rosiglitazone, insulin glargine and exenatide. In addition, a cost-of-control index was determined, indicating the association between the cost-benefit ratios of each drug vs. liraglutide. Liraglutide demonstrated a significantly better cost-benefit profile compared to all the other therapies tested. The addition of further parameters to the efficacy endpoint had no effect on the results. Calculation of the cost-of-control indices, using the same cost-benefit parameters, revealed better results for both dosages of liraglutide vs. rosiglitazone, insulin glargine and exenatide.

Loading IKFE collaborators
Loading IKFE collaborators