A5029102634- Diabetes Management and Research
- Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Diabetes and associated disorders
- Pancreatic function and diabetes
- Spectroscopy Techniques in Biomedical and Chemical Research
- Electrochemical sensors and biosensors
- Diabetes Treatment and Management
- Non-Invasive Vital Sign Monitoring
- ECG Monitoring and Analysis
- Spectroscopy and Chemometric Analyses
- Clinical Laboratory Practices and Quality Control
- Analytical Chemistry and Sensors
- Metabolism, Diabetes, and Cancer
- Wireless Body Area Networks
- Diabetic Foot Ulcer Assessment and Management
- Clinical Nutrition and Gastroenterology
- Intravenous Infusion Technology and Safety
- Artificial Intelligence in Healthcare
- Microfluidic and Capillary Electrophoresis Applications
- Diabetes Management and Education
- Diabetes, Cardiovascular Risks, and Lipoproteins
- Mobile Health and mHealth Applications
- Blood donation and transfusion practices
- Diet and metabolism studies
- Cardiovascular and exercise physiology
Universität Ulm
2016-2025
European School of Molecular Medicine
2024
German Center for Diabetes Research
2010-2012
Background: The accuracy of systems for self-monitoring blood glucose is important, as reliable measurement results are a prerequisite therapeutic decisions. Methods: This system evaluation study was performed according to DIN EN ISO 15197:2003 43 Conformité Européenne (CE)-labeled (BG) monitoring systems. Measurement each were compared with the designated comparison method (manufacturer's procedure): oxidase (YSI 2300 analyzer) or hexokinase (Hitachi 917/ cobas 501). Results: Complete...
Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to lack comprehensive guidelines for clinical study design. In particular, absence concise requirements distribution comparator (reference) blood (BG) concentrations and their rate change (RoC) that are used evaluate CGM performance, impairs comparability. For this article, several experts in field testing have collaborated propose characteristics measurements should be collected during...
Background: The performance of continuous glucose monitoring (CGM) systems is difficult to compare due different study designs and a lack head-to-head studies. This evaluated the FreeStyle Libre 3 (FL3), Dexcom G7 (DG7), Medtronic Simplera (MSP) against comparator methods during clinically relevant glycemic scenarios. Method: Twenty-four adult participants with type 1 diabetes mellitus wore one sensor each CGM system in parallel for up 15 days. Sensors DG7 MSP were exchanged on days 5 8,...
An error grid compares measured versus reference glucose concentrations to assign clinical risk values observed errors. Widely used grids for blood monitors (BGMs) have limited value because they do not also reflect accuracy of continuous (CGMs).
Accurate and reliable blood glucose (BG) measurements require that different test strip lots of the same BG monitoring system provide comparable measurement results. Only a small number studies addressing this question have been published.In study, four for each five systems [Accu-Chek® Aviva (system A), FreeStyle Lite® B), GlucoCheck XL C), Pura™/mylife™ Pura D), OneTouch® Verio™ Pro E)] were evaluated with procedures according to DIN EN ISO 15197:2003. The results compared manufacturer's...
Background: Systems for self-monitoring of blood glucose (SMBG) have to provide accurate and reproducible (BG) values in order ensure adequate therapeutic decisions by people with diabetes. Materials Methods: Twelve SMBG systems were compared a standardized manner under controlled laboratory conditions: nine available on the German market purchased from local pharmacy, three obtained manufacturer (two U.S. market, one system was not yet introduced market). System accuracy evaluated following...
Background: This study is aimed at comparing the performance of three continuous glucose monitoring (CGM) systems following Clinical and Laboratory Standards Institute's POCT05-A guideline, which provides recommendations for evaluation CGM systems. Methods: A total 12 subjects with type 1 diabetes were enrolled in this study. Each subject wore six parallel, two sensors each system [FreeStyle Navigator™ (Navigator), MiniMed Guardian® REAL-Time Enlite sensor (Guardian), DexCom™ Seven® Plus 3rd...
Introduction: The accuracy of continuous glucose monitoring (CGM) systems is often assessed with respect to blood (BG) readings. CGM readings are affected by a physiological and technical time delay when compared BG In this analysis, the dependence performance parameters on rate change was investigated for 2 systems. Methods: Data from previously published study were retrospectively analyzed. An established system (Dexcom G4, Dexcom, San Diego, CA; A) prototype (Roche Diagnostics GmbH,...
Notice Of Update The DDG clinical practice guidelines are updated regularly during the second half of calendar year. Please ensure that you read and cite respective current version.
Currently, two systems for continuous tissue glucose monitoring (CGM) (Dexcom® G5 [DG5] and FreeStyle Libre [FL]) are intended to replace blood (BGM) and, according manufacturer labeling, distributed as such in some jurisdictions, including the United States European Union.The measurement performance of these comparison with a BGM system was analyzed 14-day study 20 participants comprising site visits, which included phases induced rapid changes, home use phases. Performance analysis mainly...
Objective Accuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data. Research design and methods The ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic...
For decades, self-monitoring of blood glucose (SMBG) has been considered a cornerstone adequate diabetes management. Structured SMBG can follow different monitoring patterns, and it results in improved glycemic control, reduced hypoglycemia, better quality life people with diabetes. The technology, usability, accuracy systems have advanced markedly since their introduction few decades ago. Current are small easy to use, require (capillary) sample volumes, provide measurement within seconds....
Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM not standardized; they use various algorithms and calibration methods, leading to readings across This discordance can be addressed by standardizing performance assessments: If manufacturers aim their at the same target, then will align standardization should include comparator device, sample origin, study procedures. With better aligned readings, CGM-derived...
Background: The performance of a continuous glucose monitoring (CGM) system in the early stage development was assessed an inpatient setting that simulates daily life conditions people with diabetes. Performance evaluated at low glycemic, euglycemic, and high glycemic ranges as well during phases rapid excursions. Methods: Each 30 participants type 1 diabetes (15 female, age 47 ± 12 years, hemoglobin A1c 7.7% 1.3%) wore two sensors prototype parallel for 7 days. Capillary blood samples were...
Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important ensure comparable and sufficient accuracy of systems self-monitoring blood glucose (SMBG). Accuracy evaluation was performed different SMBG available in Europe with three reagent lots each.Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were a oxidase (YSI 2300 STAT Plus™ analyzer; YSI Inc., Yellow Springs, OH) hexokinase (cobas...
Background: In continuous glucose monitoring (CGM) system performance studies, it is common to implement specific procedures for manipulating the participants’ blood (BG) levels during collection of comparator BG measurements. Recently, such a procedure was proposed by group experts, and this study assessed its ability produce combinations rates change (RoCs) with certain characteristics. Methods: During three separate in-clinic sessions conducted over 15 days, capillary measurements were...
<p dir="ltr">Objective</p><p dir="ltr">This study analyzed the differences in continuous glucose monitoring (CGM)-derived metrics between three current-generation systems and evaluated their impact on therapeutic decision-making. </p><p dir="ltr">Research Design Methods</p><p dir="ltr">23 participants wore FreeStyle Libre 3, Dexcom G7 Medtronic Simplera CGM for 14 days parallel. were calculated each participant system separately.</p><p...