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Comparator Data Cha...
Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems
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- Eichenlaub, Manuel (author)
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, Germany
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- Pleus, Stefan (author)
- Institut fur Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universitat Ulm, 580024, Lise-Meitner-Strasse 8/2, Ulm, Germany
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- Rothenbühler, Martina (author)
- Diabetes Center Berne, Freiburgstrasse 3, Bern, Switzerland
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- Bailey, Timothy S. (author)
- AMCR Institute, 625 West Citracado Parkway, Suite 112, Escondido, California, United States
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- Bally, Lia (author)
- Inselspital, Bern University Hospital, Division of Endocrinology, Diabetes & Clinical Nutrition, Freiburgstrasse, Bern, Switzerland
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- Brazg, Ron L. (author)
- Rainier Clinical Research, 723 Sw 10th Str, #100, Renton, Washington, United States
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- Bruttomesso, Daniela (author)
- university , DIMED, Via Giustiniani 2, Padova, Italy
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- Diem, Peter (author)
- Univ. of Bern, Endocrinology, Inselspital, Bern, Switzerland
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- Eriksson Boija, Elisabet (author)
- Equalis AB, 422990, Uppsala, Sweden
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- Fokkert, Marion (author)
- Isala Hospitals, 8772, Clinical Chemistry, Zwolle, Netherlands
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- Haug, Cornelia (author)
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, Baden-Württemberg, Germany
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- Hinzmann, Rolf (author)
- Roche Diagnostics GmbH, Diabetes Care, Sandhofer Straße 116, Mannheim, Germany
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- Jendle, Johan, 1963- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper
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- Klonoff, David C. (author)
- Mills-Peninsula Health Services, 100 South San Mateo Drive, Room 5147, San Mateo, California, United States
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- Mader, Julia K. (author)
- Medical University of Graz, Internal Medicine / Endocrinology and Metabolism, Auenbruggerplatz 15, Graz, Austria
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- Makris, Konstantinos (author)
- KAT General Hospital, Clinical Biochemistry, 2 Nikis Street, Kifissia, Athens, Greece
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- Moser, Othmar (author)
- University of Bayreuth, 26523, Division Exercise Physiology and Metabolism Institute of Sport Science, Universitätsstraße 30, Bayreuth, Bayern, Germany
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- Nichols, James (author)
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
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- Norgaard, Kirsten (author)
- Steno Diabetes Center Copenhagne, Niels Steensensvej 2, Gentofte, Denmark
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- Pemberton, John (author)
- Birmingham Children's Hospital NHS Foundation Trust, 1729, Diabetes Home Care , Birmingham, United Kingdom of Great Britain and Northern Ireland
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- Selvin, Elizabeth (author)
- Johns Hopkins University Bloomberg School of Public Health, 25802, Department of Epidemiology, 2024 E Monument St, Suite 2-600, Baltimore, Baltimore, Maryland, United States
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- Spanou, Loukia (author)
- Geniko Nosokomeio Athenon Korgialeneio Mpenakeio EES, 168201, ENDOCRINOLOGY, ATHENS, Greece
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- Thomas, Andreas (author)
- Independent Scientific Consulting, Pirna, Germany
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- Tran, Nam (author)
- University of California, Davis, Pathology and Laboratory Medicine, PATH Bldg, 4400 V Street, Sacramento, California, United States
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- Witthauer, Lilian (author)
- University of Bern, 27210, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Diabetes Center Berne, Freiburgstrasse 3, Bern, Switzerland
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- Slingerland, Robbert J. (author)
- Isala Clinics, Clinical Chemistry, Groot Wezenland 20, Zwolle, Netherlands
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- Freckmann, Guido (author)
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
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(creator_code:org_t)
- Mary Ann Liebert, 2024
- 2024
- English.
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In: Diabetes Technology & Therapeutics. - : Mary Ann Liebert. - 1520-9156 .- 1557-8593. ; 26:4, s. 263-275
- Related links:
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Abstract
Subject headings
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- Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC), that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing. Specifically, it is proposed that at least 7.5% of comparator BG concentrations are <70 mg/dL (3.9 mmol/L) and >300 mg/dL (16.7 mmol/L), respectively and that at least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypo- or hyperglycemia, respectively. These proposed characteristics of the comparator data can facilitate the harmonization of testing conditions across different studies and CGM systems and ensure that the most relevant scenarios representing real-life situations are established during performance testing. In addition, a study protocol and testing procedure for the manipulation of glucose levels is suggested that enables the collection of comparator data with these characteristics. This work is an important step towards establishing a future standard for the performance evaluation of CGM systems.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Keyword
- Continuous glucose monitoring
- Clinical performance evaluation
- Standardization
- Comparator data characteristics
- Testing procedures
- Glucose rate of change
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Eichenlaub, Manu ...
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Pleus, Stefan
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Rothenbühler, Ma ...
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Bailey, Timothy ...
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Bally, Lia
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Brazg, Ron L.
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show more...
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Bruttomesso, Dan ...
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Diem, Peter
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Eriksson Boija, ...
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Fokkert, Marion
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Haug, Cornelia
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Hinzmann, Rolf
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Jendle, Johan, 1 ...
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Klonoff, David C ...
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Mader, Julia K.
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Makris, Konstant ...
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Moser, Othmar
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Nichols, James
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Norgaard, Kirste ...
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Pemberton, John
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Selvin, Elizabet ...
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Spanou, Loukia
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Thomas, Andreas
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Tran, Nam
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Witthauer, Lilia ...
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Slingerland, Rob ...
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Freckmann, Guido
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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Diabetes Technol ...
- By the university
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Örebro University