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1دورية أكاديمية
المؤلفون: Guido Freckmann, Manuel Eichenlaub, Delia Waldenmaier, Stefan Pleus
المصدر: Biosensors, Vol 13, Iss 7, p 709 (2023)
مصطلحات موضوعية: n/a, Biotechnology, TP248.13-248.65
الوصف: In their recent article entitled “Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study” [...]
وصف الملف: electronic resource
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2دورية أكاديمية
المؤلفون: Norbert Hermanns, Stefan Pleus, Cornelia Haug, Guido Freckmann, Lutz Heinemann, Delia Waldenmaier, Dominic Ehrmann
المصدر: BMJ Open Diabetes Research & Care, Vol 9, Iss 1 (2021)
مصطلحات موضوعية: Diseases of the endocrine glands. Clinical endocrinology, RC648-665
الوصف: Introduction Studies have shown beneficial effects of real-time continuous glucose monitoring (rtCGM) usage on clinical outcomes. The objective of this analysis was to identify which therapy adjustments were made by people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study.Research design and methods In the multicenter randomized controlled trial in people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up. They used rtCGM or self-monitoring of blood glucose for therapy adjustments. This mechanistic analysis looked at changes in various aspects of therapy.Results Logbooks were completed by 70 participants in the rtCGM group and 65 participants in the control group. Participants in the rtCGM group kept their total carbohydrate consumption, daily insulin doses and distribution constant during the study. However, they reported an increased intake of rescue carbohydrates (0.8±0.6 (mean±SD) vs 1.0±0.8 intake/day; baseline-adjusted between-group difference 0.3 intake (0.1–0.5), p=0.031). The glucose threshold at which rescue carbohydrate intake was initiated was elevated from 71±13 mg/dL (3.9±0.7 mmol/L) to 79±14 mg/dL (4.4±0.8 mmol/L) (adjusted between-group difference +7.6 mg/dL (2.4–12.8) (+0.4 mmol/L (0.1–0.7)); p=0.005) in the rtCGM group. Regression analysis showed that follow-up low glucose events were associated with group allocation (p
وصف الملف: electronic resource
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3دورية أكاديمية
المؤلفون: Guido Freckmann, Stefan Pleus, Annette Baumstark
المصدر: The Pan African Medical Journal, Vol 33, Iss 271 (2019)
مصطلحات موضوعية: accuracy, glucometer, precision, Medicine
الوصف: In their article, Choukem et al. report of assessments of the analytical quality of blood glucose monitoring systems. Although there are some commendable aspects regarding the methodology, some major shortcomings could preclude the conclusions drawn by Choukem et al. Nevertheless, independent assessments of the performance of blood glucose monitoring systems are an important issue.
وصف الملف: electronic resource
العلاقة: https://www.panafrican-med-journal.com/content/article/33/271/pdf/271.pdfTest; https://doaj.org/toc/1937-8688Test
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4دورية أكاديمية
المؤلفون: Stefan Pleus, Manuel Eichenlaub, Delia Waldenmaier, Guido Freckmann
مصطلحات موضوعية: Medicine, Endocrinology, Nutrition and Dietetics not elsewhere classified, Health and Community Services, alert evaluation, alert threshold, continuous glucose monitoring, predictive alert, rate of change
الوصف: Supplemental material, sj-docx-1-dst-10.1177_19322968241236504 for A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance by Stefan Pleus, Manuel Eichenlaub, Delia Waldenmaier and Guido Freckmann in Journal of Diabetes Science and Technology
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المؤلفون: Peter Stephan, Manuel Eichenlaub, Delia Waldenmaier, Stefan Pleus, Martina Rothenbühler, Cornelia Haug, Guido Freckmann
المصدر: Diabetes Technology & Therapeutics. 25:212-216
مصطلحات موضوعية: Medical Laboratory Technology, Endocrinology, Endocrinology, Diabetes and Metabolism
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::0174561e748a902409c0678b1c890e56Test
https://doi.org/10.1089/dia.2022.0331Test -
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المؤلفون: Stefan Pleus, Andrea Tytko, Lutz Heinemann, Astrid Petersmann, Guido Freckmann, Matthias Nauck, Patricia Kaiser
المصدر: Diabetes aktuell. 20:170-179
مصطلحات موضوعية: Gynecology, 03 medical and health sciences, medicine.medical_specialty, 0302 clinical medicine, Political science, Endocrinology, Diabetes and Metabolism, medicine, Internal Medicine, 030209 endocrinology & metabolism, 030212 general & internal medicine
الوصف: ZusammenfassungDie Glukose-„Messlandschaft“ in Deutschland deckt viele verschiedene Einsatzzwecke und -gebiete ab. Sie reicht von hochstandardisiert messenden Laboranalysesystemen mit einem großen Gesamtportfolio von Messgrößen bis hin zu einfachen Systemen für den Patientengebrauch. Aus klinischer Sicht muss die Qualität von Glukosemessungen ausreichend hoch sein, um die vorgesehenen Zwecke, also Diagnosestellung und Verlaufskontrolle, zu erfüllen.In der Heilkunde – also bei Messungen im Rahmen der Gesundheitsversorgung durch medizinisches Personal – definiert die Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen Vorgaben an die Qualitätssicherung. Es werden sowohl interne als auch externe (herstellerunabhängige) Qualitätskontrollen gefordert und mit spezifischen Vorgaben versehen. Diese Regelungen gelten demnach auch für alle Glukosemessungen in der Heilkunde, d. h. im Zentrallabor ebenso wie in der patientennahen Sofortdiagnostik.Bei dem Haupteinsatzgebiet von Glukosemessungen, der Verlaufskontrolle durch Patienten mit Diabetes im Rahmen der Blutglukoseselbstmessung, fehlen i. d. R. Kontrollen der Messqualität. Für das kontinuierliche Glukosemonitoring im interstitiellen Gewebe sind Qualitätskontrollen nach dem aktuellen technischen Stand sogar überhaupt nicht möglich. Hinzu kommt, dass eine regelmäßige herstellerunabhängige Kontrolle der Messqualität nicht vorgeschrieben ist. Ziel der Arbeit ist es, einen Überblick über die unterschiedlichen Glukosemesssysteme sowie praktische Aspekte und Probleme bei der Glukosemessung zu geben.
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9aa66a3c8f590da80a3418b18e61625aTest
https://doi.org/10.1055/a-1851-3751Test -
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المؤلفون: Stefan Pleus, Sebastian Schauer, Annette Baumstark, Alexandra Beil, Nina Jendrike, Manuela Link, Eva Zschornack, Anne Beltzer, Cornelia Haug, Guido Freckmann
المصدر: LaboratoriumsMedizin.
مصطلحات موضوعية: Medical Laboratory Technology, Biochemistry (medical), Clinical Biochemistry
الوصف: Objectives Differences between capillary and venous glucose concentrations have been reported in the past. In continuous glucose monitoring (CGM) system performance studies, comparator measurements are often performed in venous samples, despite CGM systems typically aiming at providing capillary-like values. In this study, differences between venous, capillary and interstitial glucose concentrations, measured with a laboratory analyzer, a self-monitoring of blood glucose (SMBG) system and an intermittent-scanning CGM system were investigated in subjects without diabetes after glucose load. Methods During the study, an oral glucose tolerance test (oGTT) was performed with 41 participants who had no known history of diabetes (mean age 25.5 ± 9.7 years). Venous blood samples for measurement with a laboratory analyzer were collected before drinking the standardized 75 g glucose solution and after 60 and 120 min. In parallel, capillary blood was obtained for measurement with a laboratory analyzer and an SMBG system, and interstitial glucose values were measured with an intermittent-scanning CGM system. Results Glucose concentrations in the fasting state were slightly different for the three different compartments whereas considerable differences (some median differences exceeding 30 %) in glucose concentration were observed 60 and 120 min after the start of the oGTT. Conclusions Marked differences with a high inter-individual variability between venous, capillary, and interstitial fluid glucose concentrations were found especially after glucose load. These differences can affect perceived CGM accuracy in performance studies depending on the specific comparator method used, and they are potentially relevant in clinical practice, like diabetes diagnosis.
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::65467d171933372931d3a64dc490f5dfTest
https://doi.org/10.1515/labmed-2023-0013Test -
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المؤلفون: Manuel Eichenlaub, Stefan Pleus, Rimma Shaginian, James Richardson, Scott Pardo, Andreas Stuhr, Guido Freckmann
المصدر: J Diabetes Sci Technol
مصطلحات موضوعية: Endocrinology, Diabetes and Metabolism, Biomedical Engineering, Internal Medicine, Bioengineering, Original Articles
الوصف: Background: The accuracy of blood glucose monitoring systems (BGMS) is crucial for the safe and effective management of diabetes mellitus. Despite standardization of accuracy assessment procedures and requirements, various studies have shown that the accuracy of BGMS on the market can vary considerably. This article therefore provides health care professionals and users with an intuitive illustration of the impact of BGMS accuracy on clinical decision making. Material and Methods: Several hypothetical patient scenarios based on blood glucose (BG) levels in the low, normal, and high BG range are devised. Using data from a recent BGMS accuracy study, a method for calculating the expected range of BG readings from four examined BGMS at the selected BG levels is introduced. Based on these ranges, it is illustrated how clinical decisions and subsequent outcomes of the hypothetical patients are affected by the expected inaccuracies of the BGMS. Results: The range of expected BGMS readings for the same true BG level can vary considerably between different BGMS. The discussion of hypothetical patient scenarios revealed that the use of some BGMS could be associated with an increased risk of adverse events such as failure to detect hypoglycemia, driving with an unsafe BG level, delay of treatment intervention in diabetes during pregnancy, or the failure to prevent diabetic ketoacidosis. Conclusions: This article can support both health care professionals and patients to understand the impact of BGMS accuracy in a relatable, clinical context. Furthermore, it is suggested that current accuracy requirements might be insufficient for the prevention of adverse clinical outcomes in certain circumstances.
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9321c39ab1ef7d8d46d9dc3c5b599fb5Test
https://doi.org/10.1177/19322968221080916Test -
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المؤلفون: Stefan Pleus, Annette Baumstark, Sebastian Schauer, Julia Kölle, Nina Jendrike, Jochen Mende, Cornelia Haug, Guido Freckmann
المصدر: Journal of diabetes science and technology.
مصطلحات موضوعية: Endocrinology, Diabetes and Metabolism, Biomedical Engineering, Internal Medicine, Bioengineering
الوصف: Background: Blood glucose monitoring systems (BGMSs) are a cornerstone in diabetes management. They have to provide sufficiently accurate results in the hands of lay users, particularly in insulin-treated patients. The aim of this study was user performance evaluation and system accuracy assessment of four BGMSs with color coding of results. Methods: Study procedures were based on ISO 15197:2013. User performance evaluation included data from 100 participants, each of whom used every system with one reagent lot. Study personnel observed user techniques. For the system accuracy assessment, 100 capillary samples were obtained for measurement in duplicate with each of three reagent system lots per system, resulting in 600 results per system. Results: All assessed BGMSs exhibited a sufficient level of accuracy, with small differences between them. In the user performance evaluation, study personnel observed the smallest total number of user errors with Contour Next (Ascensia), followed by Accu-Chek Instant (Roche), Medisafe Fit Smile (Terumo), and OneTouch Ultra Plus Reflect (LifeScan). Approximately 90% of participants stated that a consistent color scheme, eg, for low blood glucose (BG) values, should be used across all BGMSs. There was no clear preference among the four tested BGMSs regarding the specific way of displaying color coding. Conclusions: The four BGMSs assessed in this study showed only small differences in an overall sufficient level of accuracy. User handling errors, as observed by study personnel, differed between the systems.
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d86d0d1de3c8fa0c4174e2d13a7ad35Test
https://pubmed.ncbi.nlm.nih.gov/36433806Test -
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المؤلفون: Othmar Moser, Christoph Sternad, Max L. Eckstein, Agnieszka Szadkowska, Arkadiusz Michalak, Julia K. Mader, Haris Ziko, Hesham Elsayed, Felix Aberer, Agnes Sola‐Gazagnes, Etienne Larger, Gian Poalo Fadini, Benedetta Maria Bonora, Daniela Bruttomesso, Federico Boscari, Guido Freckmann, Stefan Pleus, Sverre C. Christiansen, Harald Sourij
المصدر: Diabetes, obesity and metabolism
مصطلحات موضوعية: Adult, Blood Glucose, Periodisk scannet kontinuerlig glukosemåling, Adolescent, type 1 diabetes, Endocrinology, Diabetes and Metabolism, Intermittently scanned continuous glucose monitoring, Medical technology: 620 [VDP], Endocrinology, Continuous glucose measurement, Diabetes Mellitus, Internal Medicine, Humans, Medisinsk teknologi: 620 [VDP], Child, Glukosemåling, Kontinuerlig glukosemåling, Blood Glucose Self-Monitoring, continuous glucose monitoring (CGM), Diabetes Mellitus, Type 1, Type 1 diabetes, Glucose, Glucose sensing, continuous glucose monitoring, typ 1 diabetes, Type 1
الوصف: Aims: To conduct a pooled analysis to assess the performance of intermittently scanned continuous glucose monitoring (isCGM) in association with the rate of change in sensor glucose in a cohort of children, adolescents, and adults with type 1 diabetes. Material and methods: In this pooled analysis, isCGM system accuracy was assessed depending on the rate of change in sensor glucose. Clinical studies that have been investigating isCGM accuracy against blood glucose, accompanied with collection time points were included in this analysis. isCGM performance was assessed by means of median absolute relative difference (MedARD), Parkes error grid (PEG) and Bland-Altman plot analyses. Results: Twelve studies comprising 311 participants were included, with a total of 15 837 paired measurements. The overall MedARD (interquartile range) was 12.7% (5.9-23.5) and MedARD differed significantly based on the rate of change in glucose (P < 0.001). An absolute difference of -22 mg/dL (-1.2 mmol/L) (95% limits of agreement [LoA] 60 mg/dL (3.3 mmol/L), -103 mg/dL (-5.7 mmol/L)) was found when glucose was rapidly increasing (isCGM glucose minus reference blood glucose), while a -32 mg/dL (1.8 mmol/L) (95% LoA 116 mg/dL (6.4 mmol/L), -51 mg/dL (-2.8 mmol/L)) absolute difference was observed in periods of rapidly decreasing glucose. Conclusions: The performance of isCGM was good when compared to reference blood glucose measurements. The rate of change in glucose for both increasing and decreasing glucose levels diminished isCGM performance, showing lower accuracy during high rates of glucose change. Keywords: continuous glucose monitoring (CGM); type 1 diabetes.
وصف الملف: application/pdf
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f8dc9b3327e8e0490a2548e3c5eca65fTest
https://doi.org/10.1111/dom.14609Test
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