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  • Eichenlaub, ManuelInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, Germany (author)

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

  • Article/chapterEnglish2024

Publisher, publication year, extent ...

  • Mary Ann Liebert,2024
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:oru-110639
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-110639URI
  • https://doi.org/10.1089/dia.2023.0465DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • The authors thank the Diabetes Center Berne and the International Federation of Clinical Chemistry and Laboratory Medicine for supporting this work. 
  • 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 and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Pleus, StefanInstitut fur Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universitat Ulm, 580024, Lise-Meitner-Strasse 8/2, Ulm, Germany (author)
  • Rothenbühler, MartinaDiabetes Center Berne, Freiburgstrasse 3, Bern, Switzerland (author)
  • Bailey, Timothy S.AMCR Institute, 625 West Citracado Parkway, Suite 112, Escondido, California, United States (author)
  • Bally, LiaInselspital, Bern University Hospital, Division of Endocrinology, Diabetes & Clinical Nutrition, Freiburgstrasse, Bern, Switzerland (author)
  • Brazg, Ron L.Rainier Clinical Research, 723 Sw 10th Str, #100, Renton, Washington, United States (author)
  • Bruttomesso, Danielauniversity , DIMED, Via Giustiniani 2, Padova, Italy (author)
  • Diem, PeterUniv. of Bern, Endocrinology, Inselspital, Bern, Switzerland (author)
  • Eriksson Boija, ElisabetEqualis AB, 422990, Uppsala, Sweden (author)
  • Fokkert, MarionIsala Hospitals, 8772, Clinical Chemistry, Zwolle, Netherlands (author)
  • Haug, CorneliaInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, Baden-Württemberg, Germany (author)
  • Hinzmann, RolfRoche Diagnostics GmbH, Diabetes Care, Sandhofer Straße 116, Mannheim, Germany (author)
  • Jendle, Johan,1963-Örebro universitet,Institutionen för medicinska vetenskaper(Swepub:oru)jje (author)
  • Klonoff, David C.Mills-Peninsula Health Services, 100 South San Mateo Drive, Room 5147, San Mateo, California, United States (author)
  • Mader, Julia K.Medical University of Graz, Internal Medicine / Endocrinology and Metabolism, Auenbruggerplatz 15, Graz, Austria (author)
  • Makris, KonstantinosKAT General Hospital, Clinical Biochemistry, 2 Nikis Street, Kifissia, Athens, Greece (author)
  • Moser, OthmarUniversity of Bayreuth, 26523, Division Exercise Physiology and Metabolism Institute of Sport Science, Universitätsstraße 30, Bayreuth, Bayern, Germany (author)
  • Nichols, JamesVanderbilt University Medical Center, Nashville, Tennessee, United States (author)
  • Norgaard, KirstenSteno Diabetes Center Copenhagne, Niels Steensensvej 2, Gentofte, Denmark (author)
  • Pemberton, JohnBirmingham Children's Hospital NHS Foundation Trust, 1729, Diabetes Home Care , Birmingham, United Kingdom of Great Britain and Northern Ireland (author)
  • Selvin, ElizabethJohns Hopkins University Bloomberg School of Public Health, 25802, Department of Epidemiology, 2024 E Monument St, Suite 2-600, Baltimore, Baltimore, Maryland, United States (author)
  • Spanou, LoukiaGeniko Nosokomeio Athenon Korgialeneio Mpenakeio EES, 168201, ENDOCRINOLOGY, ATHENS, Greece (author)
  • Thomas, AndreasIndependent Scientific Consulting, Pirna, Germany (author)
  • Tran, NamUniversity of California, Davis, Pathology and Laboratory Medicine, PATH Bldg, 4400 V Street, Sacramento, California, United States (author)
  • Witthauer, LilianUniversity of Bern, 27210, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Diabetes Center Berne, Freiburgstrasse 3, Bern, Switzerland (author)
  • Slingerland, Robbert J.Isala Clinics, Clinical Chemistry, Groot Wezenland 20, Zwolle, Netherlands (author)
  • Freckmann, GuidoInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany (author)
  • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 580024, Ulm, GermanyInstitut fur Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universitat Ulm, 580024, Lise-Meitner-Strasse 8/2, Ulm, Germany (creator_code:org_t)

Related titles

  • In:Diabetes Technology & Therapeutics: Mary Ann Liebert26:4, s. 263-2751520-91561557-8593

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