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https://www.readbyqxmd.com/read/29664706/evaluation-of-four-blood-glucose-monitoring-systems-for-self-testing-with-built-in-insulin-dose-advisor-based-on-iso-15197-2013-system-accuracy-and-hematocrit-influence
#1
Nina Jendrike, Annette Baumstark, Stefan Pleus, Christina Liebing, Alexandra Beer, Frank Flacke, Cornelia Haug, Guido Freckmann
BACKGROUND: Self-monitoring of blood glucose (SMBG) is important in diabetes therapy; however, not all SMBG systems are sufficiently accurate. In addition, some SMBG systems are influenced by the user's hematocrit value. METHODS: System accuracy and hematocrit influence was evaluated for four SMBG systems with built-in insulin dose advisors (Accu-Chek® Aviva Expert [1], FreeStyle InsuLinx [2], FreeStyle Precision Neo [3], MyStar DoseCoach® [4]) based on International Organization for Standardization (ISO) 15197:2013 section 6...
April 2018: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29595814/whole-exome-sequencing-reanalysis-at-12-months-boosts-diagnosis-and-is-cost-effective-when-applied-early-in-mendelian-disorders
#2
Lisa J Ewans, Deborah Schofield, Rupendra Shrestha, Ying Zhu, Velimir Gayevskiy, Kevin Ying, Corrina Walsh, Eric Lee, Edwin P Kirk, Alison Colley, Carolyn Ellaway, Anne Turner, David Mowat, Lisa Worgan, Mary-Louise Freckmann, Michelle Lipke, Rani Sachdev, David Miller, Michael Field, Marcel E Dinger, Michael F Buckley, Mark J Cowley, Tony Roscioli
PurposeWhole-exome sequencing (WES) has revolutionized Mendelian diagnostics, however, there is no consensus on the timing of data review in undiagnosed individuals and only preliminary data on the cost-effectiveness of this technology. We aimed to assess the utility of WES data reanalysis for diagnosis in Mendelian disorders and to analyze the cost-effectiveness of this technology compared with a traditional diagnostic pathway.MethodsWES was applied to a cohort of 54 patients from 37 families with a variety of Mendelian disorders to identify the genetic etiology...
March 29, 2018: Genetics in Medicine: Official Journal of the American College of Medical Genetics
https://www.readbyqxmd.com/read/29502304/user-performance-evaluation-of-four-blood-glucose-monitoring-systems-applying-iso-15197-2013-accuracy-criteria-and-calculation-of-insulin-dosing-errors
#3
Guido Freckmann, Nina Jendrike, Annette Baumstark, Stefan Pleus, Christina Liebing, Cornelia Haug
INTRODUCTION: The international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system. In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated. Additionally, accuracy was assessed in the hands of study personnel. METHODS: Accu-Chek® Performa Connect (A), Contour® plus ONE (B), FreeStyle Optium Neo (C), and OneTouch Select® Plus (D) were evaluated with one test strip lot...
March 3, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29459019/real-time-continuous-glucose-monitoring-in-adults-with-type-1-diabetes-and-impaired-hypoglycaemia-awareness-or-severe-hypoglycaemia-treated-with-multiple-daily-insulin-injections-hypode-a-multicentre-randomised-controlled-trial
#4
Lutz Heinemann, Guido Freckmann, Dominic Ehrmann, Gabriele Faber-Heinemann, Stefania Guerra, Delia Waldenmaier, Norbert Hermanns
BACKGROUND: The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals. METHODS: The HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial done at 12 diabetes practices in Germany...
February 15, 2018: Lancet
https://www.readbyqxmd.com/read/29322825/blood-glucose-monitoring-data-should-be-reported-in-detail-when-studies-about-efficacy-of-continuous-glucose-monitoring-systems-are-published
#5
Stefan Pleus, Lutz Heinemann, Guido Freckmann
Recently, two clinical trials about a "sensor-based flash glucose monitoring system" and its efficacy in reducing time in hypoglycemia were published. Interestingly, patients spent more time at low glucose concentrations in these studies than in other studies related to the efficacy of real-time continuous glucose monitoring (rtCGM). Although it is possible that the study populations differed from those in other studies, another potential explanation is that the CGM system used in these two studies had a negative glucose measurement bias...
January 1, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/29284290/occlusion-detection-time-in-insulin-pumps-at-two-different-basal-rates
#6
Guido Freckmann, Ulrike Kamecke, Delia Waldenmaier, Cornelia Haug, Ralph Ziegler
BACKGROUND: The detection of insulin infusion set (IIS) occlusions is an important feature of insulin pumps with regard to patient safety. However, there are no requirements for a time limit until an alarm has to be triggered after an occlusion occurred. The standard IEC 60601-2-24 is applicable for insulin pumps and describes test settings and procedures to determine occlusion detection time (ODT). METHODS: In this study, ODT of six different insulin pump models with different IIS (in total 10 different insulin pump systems) was tested for two basal rates (1...
December 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/29215649/a-craniosynostosis-massively-parallel-sequencing-panel-study-in-309-australian-and-new-zealand-patients-findings-and-recommendations
#7
Eric Lee, Trang Le, Ying Zhu, George Elakis, Anne Turner, William Lo, Hanka Venselaar, Carol-Ann Verrenkamp, Nicole Snow, David Mowat, Edwin Philip Kirk, Rani Sachdev, Janine Smith, Natasha Jane Brown, Mathew Wallis, Chris Barnett, Fiona McKenzie, Mary-Louise Freckmann, Felicity Collins, Maya Chopra, Nerine Gregersen, Ian Hayes, Sulekha Rajagopalan, Tiong Yang Tan, Zornitza Stark, Ravi Savarirayan, Alison Yeung, Lesley Adès, Michael Gattas, Kate Gibson, Michael Gabbett, David John Amor, Wanda Lattanzi, Simeon Boyd, Eric Haan, Mark Gianoutsos, Timothy Chilton Cox, Michael Francis Buckley, Tony Roscioli
PurposeThe craniosynostoses are characterized by premature fusion of one or more cranial sutures. The relative contribution of previously reported genes to craniosynostosis in large cohorts is unclear. Here we report on the use of a massively parallel sequencing panel in individuals with craniosynostosis without a prior molecular diagnosis.MethodsA 20-gene panel was designed based on the genes' association with craniosynostosis, and clinically validated through retrospective testing of an Australian and New Zealand cohort of 233 individuals with craniosynostosis in whom previous testing had not identified a causative variant within FGFR1-3 hot-spot regions or the TWIST1 gene...
December 7, 2017: Genetics in Medicine: Official Journal of the American College of Medical Genetics
https://www.readbyqxmd.com/read/28990438/flash-glucose-monitoring-differences-between-intermittently-scanned-and-continuously-stored-data
#8
Stefan Pleus, Ulrike Kamecke, Manuela Link, Cornelia Haug, Guido Freckmann
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 differences of more than ±10% compared with continuously stored data points (median -0.5%). Such differences might impact results of studies using this system. It should be indicated whether scanned or continuously stored data were used for analyses...
October 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28931322/accuracy-evaluation-of-a-new-system-for-self-monitoring-of-blood-glucose-with-three-test-strip-lots-based-on-iso-15197-2013
#9
Annette Baumstark, Nina Jendrike, Stefan Pleus, Christina Liebing, Cornelia Haug, Guido Freckmann
No abstract text is available yet for this article.
September 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28913822/improved-glycemic-control-in-a-patient-group-performing-7-point-profile-self-monitoring-of-blood-glucose-and-intensive-data-documentation-an-open-label-multicenter-observational-study
#10
Jochen Sieber, Frank Flacke, Manuela Link, Cornelia Haug, Guido Freckmann
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-week, open-label, multicenter, observational study, 51 patients [26 with type 1 diabetes mellitus (T1DM) and 25 with type 2 diabetes mellitus (T2DM)] were instructed to perform SMBG at least seven times a day using DMA combined with the iBGStar ® SMBG system...
October 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28905659/comparative-handling-analysis-of-different-insulin-pump-systems
#11
Delia Waldenmaier, Katharina Schöllkopf, Antje Westhoff, Lutz Heinemann, Guido Freckmann
Insulin pumps are used by many patients with diabetes to manage their diabetes therapy. Adequate handling of the systems is important to avoid errors. In this study, one aspect of device handling-the number of steps required to operate the system-was evaluated for different insulin pump systems. Specific tasks that are usually performed by insulin pump users were simulated and all necessary actions were documented. Differences between the required numbers of steps strongly depended on the specific task. So did the level of guidance for these tasks provided by the systems...
September 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28745088/replacement-of-blood-glucose-measurements-by-measurements-with-systems-for-real-time-continuous-glucose-monitoring-rtcgm-or-cgm-with-intermittent-scanning-isccgm-a-german-view
#12
Guido Freckmann, Sandra Schlüter, Lutz Heinemann
No abstract text is available yet for this article.
July 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28704063/evaluation-of-accuracy-of-six-blood-glucose-monitoring-systems-and-modeling-of-possibly-related-insulin-dosing-errors
#13
Annette Baumstark, Nina Jendrike, Stefan Pleus, Cornelia Haug, Guido Freckmann
OBJECTIVE: Self-monitoring of blood glucose (BG) is an essential part of diabetes therapy. Accurate and reliable results from BG monitoring systems (BGMS) are important especially when they are used to calculate insulin doses. This study aimed at assessing system accuracy of BGMS and possibly related insulin dosing errors. RESEARCH DESIGN AND METHODS: System accuracy of six different BGMS (Accu-Chek ® Aviva Nano, Accu-Chek Mobile, Accu-Chek Performa Nano, CONTOUR ® NEXT LINK 2...
October 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28627219/accuracy-assessment-of-an-improved-version-of-an-established-blood-glucose-monitoring-system-for-self-testing-following-iso-15197-2013
#14
Ulrike Kamecke, Annette Baumstark, Nina Jendrike, Cornelia Haug, Guido Freckmann
No abstract text is available yet for this article.
July 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28587476/do-the-new-fda-guidance-documents-help-improving-performance-of-blood-glucose-monitoring-systems-compared-with-iso-15197
#15
Guido Freckmann, Annette Baumstark, Stefan Pleus
Recently, the Food and Drug Administration (FDA) published guidance documents for point-of-care testing (POCT) and over-the-counter (OTC) blood glucose monitoring systems (BGMS). These are expected to improve weaknesses of the already established ISO 15197:2013 standard accuracy evaluation for OTC BGMS; however, the proposed criteria and procedures rather raise new questions. As an example, the OTC guidance stipulates tighter accuracy criteria in the low glycemic range than the POCT guidance for no obvious reason...
November 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28459160/introduction-of-a-novel-smartphone-coupled-blood-glucose-monitoring-system
#16
Nina Jendrike, Annette Baumstark, Chieh-Hsiao Chen, Delia Rittmeyer, Cornelia Haug, Guido Freckmann
The novel system for self-monitoring of blood glucose (SMBG) PixoTest couples SMBG to a smartphone and does not require a separate glucose meter. The integrated system includes all components necessary for a glucose measurement, and owing to a colorimetric measurement principle, a smartphone camera can capture color changes and a software app calculates the corresponding glucose value. In the presented study, the system was evaluated in terms of system accuracy as described in ISO 15197:2013. It was shown to fulfill system accuracy requirements with 97-99% of results from three different reagent system lots within the accuracy limits and 100% of results within zone A of the consensus error grid...
November 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28443344/strengths-and-limitations-of-new-approaches-for-graphical-presentation-of-blood-glucose-monitoring-system-accuracy-data
#17
Stefan Pleus, Frank Flacke, Jochen Sieber, Cornelia Haug, Guido Freckmann
Graphical presentation of blood glucose monitoring systems' (BGMSs) accuracy typically includes difference plots (DPs). Recently, 3 new approaches were presented: radar plots (RPs), rectangle target plots (RTPs), and surveillance error grids (SEGs). BGMS data were modeled based on 3 scenarios that can be encountered in real life to highlight strengths and limitations of these approaches. Detailed assessment of BGMS data may be easier in plots with individual data points (DPs, RPs, SEGs), whereas RTPs may facilitate display of large amounts of data or comparison of BGMS...
November 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28355924/insulin-pump-occlusions-for-patients-who-have-been-around-the-infusion-block
#18
David C Klonoff, Guido Freckmann, Lutz Heinemann
No abstract text is available yet for this article.
May 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28264584/clinicians-perspectives-of-therapeutic-alliance-in-face-to-face-and-telepractice-speech-language-pathology-sessions
#19
Anneka Freckmann, Monique Hines, Michelle Lincoln
PURPOSE: To investigate the face validity of a measure of therapeutic alliance for paediatric speech-language pathology and to determine whether a difference exists in therapeutic alliance reported by speech-language pathologists (SLPs) conducting face-to-face sessions, compared with telepractice SLPs or in their ratings of confidence with technology. METHOD: SLPs conducting telepractice (n = 14) or face-to-face therapy (n = 18) completed an online survey which included the Therapeutic Alliance Scales for Children - Revised (TASC-r) (Therapist Form) to rate clinicians' perceptions of rapport with up to three clients...
March 7, 2017: International Journal of Speech-language Pathology
https://www.readbyqxmd.com/read/28264186/analysis-of-randomized-cross-over-study-comparing-two-infusion-sets-for-csii-in-daily-life
#20
Eric Renard
In an article in Journal of Diabetes Science and Technology, Freckmann et al report an evaluation of 2 infusion sets used for CSII in daily life, both from Roche. Because the 2 catheters differed at the soft cannula level in terms of geometry and introducer needle, focus was made on pain at insertion. While no significant difference was noted on this primary endpoint, unplanned catheter changes occurred in close to 20% of cases also with both catheter models, mainly driven by apparent insulin delivery issues...
March 2017: Journal of Diabetes Science and Technology
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