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Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems

Eichenlaub, Manuel (author)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, Germany
Pleus, Stefan (author)
Institut fur Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universitat Ulm, 580024, Lise-Meitner-Strasse 8/2, Ulm, Germany
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
Bally, Lia (author)
Inselspital, Bern University Hospital, Division of Endocrinology, Diabetes & Clinical Nutrition, Freiburgstrasse, Bern, Switzerland
Brazg, Ron L. (author)
Rainier Clinical Research, 723 Sw 10th Str, #100, Renton, Washington, United States
Bruttomesso, Daniela (author)
university , DIMED, Via Giustiniani 2, Padova, Italy
Diem, Peter (author)
Univ. of Bern, Endocrinology, Inselspital, Bern, Switzerland
Eriksson Boija, Elisabet (author)
Equalis AB, 422990, Uppsala, Sweden
Fokkert, Marion (author)
Isala Hospitals, 8772, Clinical Chemistry, Zwolle, Netherlands
Haug, Cornelia (author)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, Baden-Württemberg, Germany
Hinzmann, Rolf (author)
Roche Diagnostics GmbH, Diabetes Care, Sandhofer Straße 116, Mannheim, Germany
Jendle, Johan, 1963- (author)
Örebro universitet,Institutionen för medicinska vetenskaper
Klonoff, David C. (author)
Mills-Peninsula Health Services, 100 South San Mateo Drive, Room 5147, San Mateo, California, United States
Mader, Julia K. (author)
Medical University of Graz, Internal Medicine / Endocrinology and Metabolism, Auenbruggerplatz 15, Graz, Austria
Makris, Konstantinos (author)
KAT General Hospital, Clinical Biochemistry, 2 Nikis Street, Kifissia, Athens, Greece
Moser, Othmar (author)
University of Bayreuth, 26523, Division Exercise Physiology and Metabolism Institute of Sport Science, Universitätsstraße 30, Bayreuth, Bayern, Germany
Nichols, James (author)
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Norgaard, Kirsten (author)
Steno Diabetes Center Copenhagne, Niels Steensensvej 2, Gentofte, Denmark
Pemberton, John (author)
Birmingham Children's Hospital NHS Foundation Trust, 1729, Diabetes Home Care , Birmingham, United Kingdom of Great Britain and Northern Ireland
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
Spanou, Loukia (author)
Geniko Nosokomeio Athenon Korgialeneio Mpenakeio EES, 168201, ENDOCRINOLOGY, ATHENS, Greece
Thomas, Andreas (author)
Independent Scientific Consulting, Pirna, Germany
Tran, Nam (author)
University of California, Davis, Pathology and Laboratory Medicine, PATH Bldg, 4400 V Street, Sacramento, California, United States
Witthauer, Lilian (author)
University of Bern, 27210, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Diabetes Center Berne, Freiburgstrasse 3, Bern, Switzerland
Slingerland, Robbert J. (author)
Isala Clinics, Clinical Chemistry, Groot Wezenland 20, Zwolle, Netherlands
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.
In: Diabetes Technology & Therapeutics. - : Mary Ann Liebert. - 1520-9156 .- 1557-8593. ; 26:4, s. 263-275
Related links:
https://doi.org/10.1...
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  • Journal article (peer-reviewed)
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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