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Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose Monitoring.

ABSTRACT: BACKGROUND:Currently, two systems for continuous tissue glucose monitoring (CGM) (Dexcom® G5 [DG5] and FreeStyle Libre [FL]) are intended to replace blood glucose monitoring (BGM) and, according to manufacturer labeling, are distributed as such in some jurisdictions, including the United States and the European Union. METHODS:The measurement performance of these two systems in comparison with a BGM system was analyzed in a 14-day study with 20 participants comprising study site visits, which included phases of induced rapid glucose changes, and home use phases. Performance analysis was mainly based on deviations between CGM readings and BGM results. Sensor-to-sensor precision was also analyzed. RESULTS:Approximately 25% of DG5 and FL results showed differences from BGM results exceeding 15?mg/dL or 15% (at glucose concentration below or above 100?mg/dL, respectively) at times of therapeutic decisions, and ?5% of differences exceeded 30?mg/dL or 30%. Performance was different depending on the setting (study site visits, home use phases, and phases of induced rapid glucose changes). In consensus error grid (CEG) analysis, both systems showed >99.5% of results within the clinically acceptable zones A and B. CONCLUSIONS:In this study, both systems showed deviations from blood glucose (BG) measurements, the current standard approach in diabetes therapy. Although a large percentage of results was found in CEG zones A and B, for approximately one in four therapeutic decisions, CGM and BG readings differed by at least 15?mg/dL or 15%. Such deviations should be taken into account when using CGM systems.

SUBMITTER: Freckmann G

PROVIDER: S-EPMC6080122 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose Monitoring.

Freckmann Guido G Link Manuela M Pleus Stefan S Westhoff Antje A Kamecke Ulrike U Haug Cornelia C

Diabetes technology & therapeutics 20180801 8

<h4>Background</h4>Currently, two systems for continuous tissue glucose monitoring (CGM) (Dexcom<sup>®</sup> G5 [DG5] and FreeStyle Libre [FL]) are intended to replace blood glucose monitoring (BGM) and, according to manufacturer labeling, are distributed as such in some jurisdictions, including the United States and the European Union.<h4>Methods</h4>The measurement performance of these two systems in comparison with a BGM system was analyzed in a 14-day study with 20 participants comprising st ...[more]

PMID: 30067410

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Project description:BACKGROUND:Continuous glucose monitorings (CGMs) have been used to manage diabetes with reasonable glucose control amongst patients with type 2 diabetes (T2D) in recent decades. CGMs measure interstitial fluid glucose levels to provide information about glucose levels, which identify fluctuation that would not have been identified with conventional self-monitoring. Self-monitoring of blood glucose (SMBG) is a classical tool to measure glycaemic changes. However, the effectiveness of glucose control, hypoglycemia, weight change, quality of life and user satisfaction, are needed to evaluate and compare CGMs and SMBG amongst adults with T2D. METHODS:The review will compare the various forms of CGM systems (i.e flash CGM, real-time CGM, retrospective CGM) versus SMBG or usual intervention regarding diabetes management amongst adults with T2D. The following databases will be searched: Cochrane Library, PubMed, EMBASE, CINAHL, PsycINFO, Scopus and grey literature (ClinicalTrials.gov, PsycEXTRA, ProQuest Dissertations, Google Scholar and Theses Global) for the identification of studies. The studies involving adults (aged ? 18?years old) will be included. We will only include and summarise randomised clinical trials (RCTs) with respect to authors, publication type, year, status and type of devices. Studies published in English between February 2010 and March 2020, will be included as the field of CGMs amongst T2D patients has emerged over the last decade. Primary outcomes will be HbA1c (glycosylated haemoglobin level) (mmol/L), body weight (kg), time spent with hypoglycaemia (< 70?mg/dl) or hyperglycaemia (? 180?mg/dl), blood pressure (< 140/90?mmHg is considered as good management) and quality of life (understanding and feeling of living situation based on culture and value system). Secondary outcome measures will be user satisfaction (patient or treatment/intervention satisfaction or satisfaction scale) and barriers (physical and mental difficulties or issues). Study selection, data extraction and risk of bias assessment will be conducted independently by at least two reviewers. A third reviewer will determine and resolve discrepancies. Moreover, the quality of the evidence of the review will be assessed according to the Grading of Recommendations Assessment, Development and Evaluation tool (GRADE). DISCUSSION:The review will synthesise evidence on the comparison between using CGMs and SMBG. The results will support researchers and health professionals to determine the most effective methods/technologies in the overall diabetes management. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42020149212.

Dataset Information

Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose Monitoring.

Publications

Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose Monitoring.

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