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Guido Freckmann, Annette Baumstark, Nina Jendrike, Delia Rittmeyer, Stefan Pleus, Cornelia Haug
BACKGROUND: Self-monitoring of blood glucose (BG) is an integral part in the therapy of people with diabetes, which is why blood glucose monitoring systems (BGMS) have to fulfill minimum accuracy requirements. However, accuracy is often assessed by trained operators, although such assessments do not necessarily allow for drawing conclusions on accuracy in the hands of lay users. METHODS: The accuracy of 4 different BGMS (Accu-Chek(®) Active, Accu-Chek(®) Performa, Contour(®)Plus, and OneTouch(®) SelectSimple™) in the hands of lay users and trained study personnel was assessed in this study...
February 22, 2017: Diabetes Technology & Therapeutics
Rea M Lardelli, Ashleigh E Schaffer, Veerle R C Eggens, Maha S Zaki, Stephanie Grainger, Shashank Sathe, Eric L Van Nostrand, Zinayida Schlachetzki, Basak Rosti, Naiara Akizu, Eric Scott, Jennifer L Silhavy, Laura Dean Heckman, Rasim Ozgur Rosti, Esra Dikoglu, Anne Gregor, Alicia Guemez-Gamboa, Damir Musaev, Rohit Mande, Ari Widjaja, Tim L Shaw, Sebastian Markmiller, Isaac Marin-Valencia, Justin H Davies, Linda de Meirleir, Hulya Kayserili, Umut Altunoglu, Mary Louise Freckmann, Linda Warwick, David Chitayat, Susan Blaser, Ahmet Okay Çağlayan, Kaya Bilguvar, Huseyin Per, Christina Fagerberg, Henrik T Christesen, Maria Kibaek, Kimberly A Aldinger, David Manchester, Naomichi Matsumoto, Kazuhiro Muramatsu, Hirotomo Saitsu, Masaaki Shiina, Kazuhiro Ogata, Nicola Foulds, William B Dobyns, Neil C Chi, David Traver, Luigina Spaccini, Stefania Maria Bova, Stacey B Gabriel, Murat Gunel, Enza Maria Valente, Marie-Cecile Nassogne, Eric J Bennett, Gene W Yeo, Frank Baas, Jens Lykke-Andersen, Joseph G Gleeson
Deadenylases are best known for degrading the poly(A) tail during mRNA decay. The deadenylase family has expanded throughout evolution and, in mammals, consists of 12 Mg(2+)-dependent 3'-end RNases with substrate specificity that is mostly unknown. Pontocerebellar hypoplasia type 7 (PCH7) is a unique recessive syndrome characterized by neurodegeneration and ambiguous genitalia. We studied 12 human families with PCH7, uncovering biallelic, loss-of-function mutations in TOE1, which encodes an unconventional deadenylase...
January 16, 2017: Nature Genetics
Lutz Heinemann, Diana Drossel, Guido Freckmann, Bernhard Kulzer
The estimation is that every third to fourth patient with diabetes suffers from some degree of diabetic retinopathy. Medical products for insulin administration (such as insulin pens and pumps) or glucose monitoring not optimized to the needs of these patients' represent a high barrier for optimal diabetes therapy in daily practice. To date, the number of devices suitable for visually impaired and blind patients with diabetes is scarce. This manuscript outlines the specific needs of this patient group with regard to systems for insulin administration, blood glucose measurement, and continuous glucose monitoring...
November 2016: Journal of Diabetes Science and Technology
Guido Freckmann, Stephan Arndt, Albrecht Fießelmann, Gerhard Klausmann, Kristina Pralle, Thomas Künsting, Bettina Petersen
BACKGROUND: Continuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared. METHODS: In an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46...
September 6, 2016: Journal of Diabetes Science and Technology
Florian Reiterer, Philipp Polterauer, Michael Schoemaker, Guenther Schmelzeisen-Redecker, Guido Freckmann, Lutz Heinemann, Luigi Del Re
BACKGROUND: There is a need to assess the accuracy of continuous glucose monitoring (CGM) systems for several uses. Mean absolute relative difference (MARD) is the measure of choice for this. Unfortunately, it is frequently overlooked that MARD values computed with data acquired during clinical studies do not reflect the accuracy of the CGM system only, but are strongly influenced by the design of the study. Thus, published MARD values must be understood not as precise values but as indications with some uncertainty...
August 25, 2016: Journal of Diabetes Science and Technology
Bernhard Gehr, Martin Holder, Bernhard Kulzer, Karin Lange, Andreas Liebl, Claudia Sahm, Simone von Sengbusch, Sandra Schlüter, Thorsten Siegmund, Ulrike Thurm, Ralph Ziegler, Guido Freckmann, Lutz Heinemann
Optimal usage of continuous glucose monitoring (CGM) requires adequate preparation and training. Patients using a CGM system without special training often do not achieve their intended improvement of metabolic control or even stop using the system due to disappointing results. For this reason a structured training program called "SPECTRUM" was developed in Germany to ensure a high-quality standard for the use of CGM systems. This program is suitable for patients of all age groups and is applicable to all CGM systems and all forms of insulin therapy...
August 10, 2016: Journal of Diabetes Science and Technology
Ralph Ziegler, Guido Freckmann, Lutz Heinemann
Giving a bolus is one major part in multiple dose insulin therapy (MDI) along with basal insulin substitution. To adjust the bolus optimally, different factors like carbohydrate content and composition of the meal, correction factors, and timing have to be considered. Advances in technologies like bolus advisors can assist the patients but still there a several open questions and technical challenges regarding boluses. This commentary provides an opportunity to address several of the above-mentioned factors influencing the result of bolusing...
June 5, 2016: Journal of Diabetes Science and Technology
Michael Erbach, Guido Freckmann, Rolf Hinzmann, Bernhard Kulzer, Ralph Ziegler, Lutz Heinemann, Oliver Schnell
In general, patients with diabetes performing self-monitoring of blood glucose (SMBG) can strongly rely on the accuracy of measurement results. However, various factors such as application errors, extreme environmental conditions, extreme hematocrit values, or medication interferences may potentially falsify blood glucose readings. Incorrect blood glucose readings may lead to treatment errors, for example, incorrect insulin dosing. Therefore, the diabetes team as well as the patients should be well informed about limitations in blood glucose testing...
September 2016: Journal of Diabetes Science and Technology
Guido Freckmann, Stefan Pleus, Sandra Schlüter, Lutz Heinemann
No abstract text is available yet for this article.
May 2016: Diabetes Technology & Therapeutics
Stefan Pleus, Annette Baumstark, Delia Rittmeyer, Nina Jendrike, Cornelia Haug, Guido Freckmann
Objective For patients with diabetes, regular self-monitoring of blood glucose (SMBG) is essential to ensure adequate glycemic control. Therefore, accurate and reliable blood glucose measurements with SMBG systems are necessary. The international standard ISO 15197 describes requirements for SMBG systems, such as limits within which 95% of glucose results have to fall to reach acceptable system accuracy. The 2013 version of this standard sets higher demands, especially regarding system accuracy, than the currently still valid edition...
May 2016: Current Medical Research and Opinion
Emily J Todd, Kyle S Yau, Royston Ong, Jennie Slee, George McGillivray, Christopher P Barnett, Goknur Haliloglu, Beril Talim, Zuhal Akcoren, Ariana Kariminejad, Anita Cairns, Nigel F Clarke, Mary-Louise Freckmann, Norma B Romero, Denise Williams, Caroline A Sewry, Alison Colley, Monique M Ryan, Cathy Kiraly-Borri, Padma Sivadorai, Richard J N Allcock, David Beeson, Susan Maxwell, Mark R Davis, Nigel G Laing, Gianina Ravenscroft
BACKGROUND: Fetal akinesia/hypokinesia, arthrogryposis and severe congenital myopathies are heterogeneous conditions usually presenting before or at birth. Although numerous causative genes have been identified for each of these disease groups, in many cases a specific genetic diagnosis remains elusive. Due to the emergence of next generation sequencing, virtually the entire coding region of an individual's DNA can now be analysed through "whole" exome sequencing, enabling almost all known and novel disease genes to be investigated for disorders such as these...
November 17, 2015: Orphanet Journal of Rare Diseases
Peter Stephan, Christina Schmid, Guido Freckmann, Stefan Pleus, Cornelia Haug, Peter Müller
BACKGROUND: The measurement accuracy of systems for self-monitoring of blood glucose (SMBG) is usually analyzed by a method comparison in which the analysis results are displayed using difference plots or similar graphs. However, such plots become difficult to comprehend as the number of data points displayed increases. This article introduces a new approach, the rectangle target plot (RTP), which aims to provide a simplified and comprehensible visualization of accuracy data. METHODS: The RTP is based on ISO 15197 accuracy evaluations of SMBG systems...
October 9, 2015: Journal of Diabetes Science and Technology
Harald Kirchsteiger, Lutz Heinemann, Guido Freckmann, Volker Lodwig, Günther Schmelzeisen-Redeker, Michael Schoemaker, Luigi Del Re
BACKGROUND: The ongoing progress of continuous glucose monitoring (CGM) systems results in an increasing interest in comparing their performance, in particular in terms of accuracy, that is, matching CGM readings with reference values measured at the same time. Most often accuracy is evaluated by the mean absolute relative difference (MARD). It is frequently overseen that MARD does not only reflect accuracy, but also the study protocol and evaluation procedure, making a cross-study comparison problematic...
September 2015: Journal of Diabetes Science and Technology
Lutz Heinemann, Guido Freckmann
It remains to be seen as to what share of the market FGM will achieve if the manufacturer can supply any amount desired.Will a significant portion of the glucose monitoring market then be taken over by FGM? The availability of FGM as anew option for glucose monitoring can basically be evaluated positively and it does indeed clearly show the benefit of“more information” on the glucose trend. The relatively low price for glucose monitoring using FGM and the unusual market introduction (not first via the National Association of Statutory Health Insurance Funds, as was the case with CGM) have given increased attention to the use of more glucose information...
September 2015: Journal of Diabetes Science and Technology
Günther Schmelzeisen-Redeker, Michael Schoemaker, Harald Kirchsteiger, Guido Freckmann, Lutz Heinemann, Luigi Del Re
BACKGROUND: Continuous glucose monitoring (CGM) is a powerful tool to support the optimization of glucose control of patients with diabetes. However, CGM systems measure glucose in interstitial fluid but not in blood. Rapid changes in one compartment are not accompanied by similar changes in the other, but follow with some delay. Such time delays hamper detection of, for example, hypoglycemic events. Our aim is to discuss the causes and extent of time delays and approaches to compensate for these...
August 4, 2015: Journal of Diabetes Science and Technology
Guido Freckmann, Manuela Link, Christina Schmid, Stefan Pleus, Annette Baumstark, Cornelia Haug
BACKGROUND: 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. MATERIALS AND METHODS: Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc...
September 2015: Diabetes Technology & Therapeutics
Guido Freckmann, Stefan Pleus, Manuela Link, Annette Baumstark, Christina Schmid, Josef Högel, Cornelia Haug
INTRODUCTION: 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. MATERIALS AND METHODS: The accuracy of four SMBG systems (system 1 was the ACCU-CHEK(®) Aviva [Roche Diagnostics GmbH, Mannheim, Germany], system 2 was the Contour(®) XT [Bayer Consumer Care AG, Basel, Switzerland], system 3 was the GlucoCheck XL [aktivmed GmbH, Augsberg, Germany], and system 4 was the GlucoMen(®) LX PLUS [A...
September 2015: Diabetes Technology & Therapeutics
Manuela Link, Christina Schmid, Stefan Pleus, Annette Baumstark, Delia Rittmeyer, Cornelia Haug, Guido Freckmann
BACKGROUND: 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, ContourXT, GlucoCheck XL, GlucoMen LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used. METHODS: The evaluation was performed in a standardized manner following test procedures described in ISO 15197:2003 (section 7...
April 14, 2015: Journal of Diabetes Science and Technology
Guido Freckmann, Christina Schmid, Annette Baumstark, Malte Rutschmann, Cornelia Haug, Lutz Heinemann
In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots...
July 2015: Journal of Diabetes Science and Technology
G Freckmann
Today, assistive technologies are highly important in the treatment of diabetes, especially in the therapy of type 1 diabetes. The use of insulin pumps, for example, has become an established form of treatment. Modern insulin pumps offer various functions, such as different basal rate profiles, split delivery of the meal bolus, and integrated bolus calculators. Some pumps are additionally connected to a blood glucose meter or a continuous glucose-monitoring sensor. Several minimally invasive needle-type sensor systems for continuous tissue glucose monitoring are already available...
May 2015: Der Internist
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