Manuela Link

Manuela Link
Ulm University | UULM

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54
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Introduction

Publications

Publications (54)
Article
Background The increased use of continuous glucose monitoring (CGM) and automated insulin delivery systems raises the question about therapeutic targets for glucose profiles in people with diabetes. This study aimed to assess averaged pre- and postprandial glucose profiles in people without diabetes to provide guidance for normal glucose patterns i...
Article
Background There is an increasing use of continuous glucose monitoring (CGM) by people with diabetes. Measurement performance is often characterized by the mean absolute relative difference (MARD). However, MARD is influenced by a number of factors and little is known about whether MARD is stable throughout the day. Material and Methods A total of...
Article
Background Continuous glucose monitoring-derived parameters are becoming increasingly important in the treatment of people with diabetes. The aim of this study was to assess whether these parameters, as calculated from different continuous glucose monitoring systems worn in parallel, are comparable. In addition, clinical relevance of differences wa...
Article
Background Measurement accuracy has been assessed for many different blood glucose monitoring systems (BGMS) over the years by different study groups. However, the choice of the comparison measurement procedure may impact the apparent level of accuracy found in such studies. Materials and Methods Measurement accuracy of 18 different BGMS was asses...
Article
Background Noninvasive glucose monitoring (NIGM) in diabetes is a long-sought-for technology. Among the many attempts Raman spectroscopy was considered as the most promising because of its glucose specificity. In this study, a recently developed prototype (GlucoBeam, RSP Systems A/S, Denmark) was tested in patients with type 1 diabetes to establish...
Article
Background International consensus recommends a set of continuous glucose monitoring (CGM) metrics to assess quality of diabetes therapy. The impact of individual CGM sensors on these metrics has not been thoroughly studied yet. This post hoc analysis aimed at comparing time in specific glucose ranges, coefficient of variation (CV) of glucose conce...
Article
Background Skin reactions due to medical devices for diabetes management have become a common problem in diabetes technology. There is a varying degree in how detailed skin reactions are described in scientific literature and diabetes practice, and no uniform structured documentation is given. Whereas most articles only describe findings, some othe...
Article
Full-text available
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 BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, Cont...
Article
Background Currently, two different types of continuous glucose monitoring (CGM) systems are available: real time (rt) CGM systems that continuously provide glucose values and intermittent-scanning (is) CGM systems. This study compared accuracy of an rtCGM and an isCGM system when worn in parallel. Methods Dexcom G5 Mobile (DG5) and FreeStyle Libr...
Article
Zusammenfassung Einleitung Blutglukosemesssysteme (BGMS) zur Eigenanwendung ermöglichen eine selbstständige Stoffwechselüberwachung und eine flexible Therapieanpassung. Auf der Grundlage der gemessenen Blutglukosewerte werden von den Anwendern Entscheidungen über Mahlzeiteneinnahme und Insulindosis getroffen. Die Messgenauigkeit von BGMS sollte dah...
Article
Background: To be able to compare continuous glucose monitoring (CGM) systems, they have to be worn in parallel by the same subjects. This study evaluated the performance and usability of three different CGM systems in direct comparison. Method: In this open, prospective study at two sites, 54 patients with diabetes wore three CGM systems each (...
Article
Full-text available
Background: Continuous interstitial glucose monitoring (CGM) systems often provide glucose trend indicators (e.g., arrows) in addition to current glucose values. These indicators are recommended to be used in therapeutic decisions, because they are ascribed predictive qualities by CGM system manufacturers and expert committees. This study assessed...
Article
Full-text available
Background: Currently, two systems for continuous tissue glucose monitoring (CGM) (Dexcom® G5 [DG5] and FreeStyle Libre [FL]) are intended to replace blood glucose monitoring (BGM) and, according to manufacturer labeling, are distributed as such in some jurisdictions, including the United States and the European Union. Methods: The measurement p...
Article
The flash glucose monitoring system FreeStyle Libre (Abbott Diabetes Care Ltd., Witney, UK) measures interstitial glucose concentrations and continuously stores measurement values every 15 minutes. To obtain a current glucose reading, users have to scan the sensor with the reader. In a clinical trial, 5% of the scanned data showed relative differen...
Article
Full-text available
Background: Real-time continuous glucose monitoring is associated with significant benefits for diabetes management. Implantable sensors could overcome some challenges reportedly associated with device visibility, psychosocial functioning and sensor durability. Methods: A psychosocial assessment was conducted to determine acceptability and impac...
Article
Introduction: Regular self-monitoring of blood glucose (SMBG) is recommended as an integral part of therapy for all patients with diabetes treated with insulin. In the current study, the effects on glycemic control of taking 7-point SMBG profiles and using a diabetes management system (DMA) on a smartphone were investigated. Methods: In a 12-wee...
Article
Full-text available
Objective: It is known that continuous glucose monitoring (CGM) systems can lower mean glucose compared with episodic self-monitoring of blood glucose. Implantable CGM systems may provide additional benefits. Research design and methods: We studied the Eversense (Senseonics Inc.) implantable CGM sensor in 71 participants aged 18 years and older...
Chapter
The goal of this paper is to describe the metrics used for the evaluation of accuracy of blood glucose (BG) meters for self-monitoring of blood glucose (SMBG) and continuous-glucose monitoring (CGM) system and their limitations and to discuss the current status of SMBG and CGM accuracy. SMBG measurement is used by patients for therapy control and f...
Article
Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe with three reagent lots each. Test procedures followe...
Article
Systems for self-monitoring of blood glucose (SMBG) are expected to be accurate enough to provide reliable measurement results. Especially in the low glycemic range, adequate therapeutic decisions based on reliable results can alleviate complications associated with hypoglycemia. The accuracy of four SMBG systems (system 1 was the ACCU-CHEK(®) Aviv...
Article
The standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek® Aviva, Contour®XT, GlucoCheck XL, GlucoMen® LX PLUS) with 3 test strip lots each. To investigate a possible im...
Article
Full-text available
Introduction: The accuracy of continuous glucose monitoring (CGM) systems is often assessed with respect to blood glucose (BG) readings. CGM readings are affected by a physiological and a technical time delay when compared to BG readings. In this analysis, the dependence of CGM performance parameters on the BG rate of change was investigated for 2...
Conference Paper
The accuracy of continuous glucose monitoring (CGM) systems is often assessed with respect to blood glucose (BG) readings. CGM readings are affected by a physiological and a technical time delay when compared to BG readings. In this analysis, the dependence of CGM performance parameters on the BG rate of change was investigated for 2 CGM systems. D...
Article
Background: Point-of-care testing (POCT) of blood glucose (BG) is performed by medical personnel in clinical settings as well as by patients themselves for self-monitoring of blood glucose (SMBG) at home. We investigated if a system mainly intended for SMBG by people with diabetes, but also suitable for BG measurements by medical personnel, can ac...
Article
Background: Systems for self-monitoring of blood glucose (SMBG) have to provide accurate and reproducible blood glucose (BG) values in order to ensure adequate therapeutic decisions by people with diabetes. Materials and methods: Twelve SMBG systems were compared in a standardized manner under controlled laboratory conditions: nine systems were...
Article
Geräte zur Blutzuckerselbstmessung sind aus der Diabetestherapie kaum noch wegzudenken. Die kleinen kompakten Geräte bieten oft eine Vielzahl von Zusatzfunktionen. Dies kann leicht darüber hinwegtäuschen, dass die Systemgenauigkeit bisweilen zu wünschen übrig lässt. Zudem können Anwendungsfehler die Ergebnisse verfälschen. Deshalb: Erklären Sie Ihr...
Article
The performance of a continuous glucose monitoring (CGM) system in the early stage of development was assessed in an inpatient setting that simulates daily life conditions of people with diabetes. Performance was evaluated at low glycemic, euglycemic, and high glycemic ranges as well as during phases with rapid glucose excursions. Each of the 30 pa...
Article
This study aimed at evaluating and comparing the performance of a new generation of continuous glucose monitoring (CGM) system versus other CGM systems, under daily lifelike conditions. A total of 10 subjects (7 female) were enrolled in this study. Each subject wore two Dexcom G4™ CGM systems in parallel for the sensor lifetime specified by the man...
Article
This study is aimed at comparing the performance of three continuous glucose monitoring (CGM) systems following the Clinical and Laboratory Standards Institute's POCT05-A guideline, which provides recommendations for performance evaluation of CGM systems. A total of 12 subjects with type 1 diabetes were enrolled in this study. Each subject wore six...
Conference Paper
Fragestellung: Ziel der Studie war der Vergleich dreier auf dem Markt erhaltlicher Systeme zur kontinuierlichen subkutanen Glukosebestimmung (CGM). Dieser Vergleich wurde in Anlehnung an POCT05-A „Performance Metrics for Continuous Interstitial Glucose Monitoring“ unter alltagsahnlichen Bedingungen durchgefuhrt. Methodik: Die drei untersuchten CGM-...
Article
Full-text available
Background: 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 of studies addressing this question have been published. Methods: In this study, four test strip lots for each of five different BG systems [Accu-Che...
Article
Full-text available
Background: The accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions. Methods: This system accuracy evaluation study was performed according to DIN EN ISO 15197:2003 for 43 Conformité Européenne (CE)-labeled blood glucose (BG) monitoring systems. Measu...
Conference Paper
Hintergrund: Verschiedene Patienteninformationen, die sich mit Blutglucose-(BG-)Messungen befassen, raten Patienten, ihren Blutzucker rasch, nachdem sie sich in den Finger gestochen haben, zu messen. Gelegentlich wird argumentiert, dass es bei verzogerter Messung zu einer Erhohung der Glucosekonzentration kommt. Moderne BG-Messsysteme, die nur weni...

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