In Support of Venous Glucose as a Reference Matrix for Evaluating Continuous Glucose Monitoring Accuracy

Jeong Y Park H Jung MJ Kim MS Byun S Choi Y. Comparisons of laboratory results between two blood samplings: venipuncture versus peripheral venous catheter—a systematic review with meta-analysis. J Clin Nurs. 2019;28(19-20):3416-3429. doi:10.1111/jocn.14918.

Fruhstorfer H. Capillary blood sampling: the pain of single-use lancing devices. Eur J Pain. 2000;4(3):301-305. doi:10.1053/eujp.2000.0179.

Administration USFaD. Self-monitoring blood glucose test systems for over-the-counter use, guidance for industry and food and drug administration staff 2020. Published online September 29, 2020. https://www.fda.gov/media/87721/download. Accessed January 12, 2026.

Mathieu C Irace C Wilmot EG , et al. Minimum expectations for market authorization of continuous glucose monitoring devices in Europe—“eCGM” compliance status. Diabetes Obes Metab. 2025;27(3):1025-1031. doi:10.1111/dom.16153.

21 CFR § 862.1355: integrated continuous glucose monitoring system. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-862/subpart-B/section-862.1355. Accessed January 12, 2026.

Freckmann G Pleus S Eichenlaub M , et al. Recommendations on the collection of comparator measurement data in the performance evaluation of continuous glucose monitoring systems. J Diabetes Sci Technol. 2025;19(4):1072-1081. doi:10.1177/19322968251336221.

Pleus S Eichenlaub M Dabla PK , et al. Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: a proposed guideline by the IFCC working group on CGM. Clin Chim Acta. 2026;580:120728. doi:10.1016/j.cca.2025.120728.

Williams A Kelly B Fletcher-Salt T Pemberton J. Making sense of sensors: evaluating CGM devices for safe and personalised insulin management. J Diabetes Nurs. 2025;29(3):378.

Klonoff DC Yeung AM Huang J Nichols JH. A newly FDA-cleared benchtop glucose analyzer heralds the dawn of the post-YSI 2300 era. J Diabetes Sci Technol. 2023;17(2):269-273. doi:10.1177/19322968221139514.

U.S. Food Drug Administration. 510(k) premarket notification K913806: YSI model 2300 STAT PLUS. Published online October 2, 1991. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K913806. Accessed January 12, 2026.

Nova Biomedical Corporation. 510(k) premarket notification K203549: nova primary glucose analyzer system. Published online 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203549.pdf. Accessed January 12, 2026.

YSI Incorporated. 510(k) premarket notification K210933: YSI 2900C biochemistry analyzer. Published online 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210933.pdf. Accessed January 12, 2026.

Klonoff DC Gabbay M Moon SJ Wilmot EG. Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring. J Diabetes Sci Technol. 2025;19(5):1392-1399. doi:10.1177/19322968241250357.

Pleus S Schoemaker M Morgenstern K , et al. Rate-of-change dependence of the performance of two CGM systems during induced glucose swings. J Diabetes Sci Technol. 2015;9(4):801-807. doi:10.1177/1932296815578716.

Andelin M Kropff J Matuleviciene V , et al. Assessing the accuracy of continuous glucose monitoring (CGM) calibrated with capillary values using capillary or venous glucose levels as a reference. J Diabetes Sci Technol. 2016;10(4):876-884. doi:10.1177/1932296815626724.

Baillargeon KR Mace CR. Microsampling tools for collecting, processing, and storing blood at the point-of-care. Bioeng Transl Med. 2023;8(2):e10476. doi:10.1002/btm2.10476.

Wickremsinhe E Fantana A Berthier E , et al. Standard venipuncture vs a capillary blood collection device for the prospective determination of abnormal liver chemistry. J Appl Lab Med. 2023;8(3):535-550. doi:10.1093/jalm/jfac127.

Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev. 2007;28(3):97-104.

Pleus S Eichenlaub M Gerber T , et al. Improving the bias of comparator methods in analytical performance assessments through recalibration. J Diabetes Sci Technol. 2024;18(3):686-694. doi:10.1177/19322968221133107.

Thorpe GH. Analysis of “capillary and venous blood glucose accuracy in blood glucose meters versus reference standards: the impact of study design on accuracy evaluations.” J Diabetes Sci Technol. 2019;13(3):553-558. doi:10.1177/1932296818799365.

De La Cruz-Góngora V Méndez-Gómez-Humarán I Gaona-Pineda EB Shamah-Levy T Dary O. Drops of capillary blood are not appropriate for hemoglobin measurement with point-of-care devices: a comparative study using drop capillary, pooled capillary, and venous blood samples. Nutrients. 2022;14(24):5346. doi:10.3390/nu14245346.

Ganesh A Hipszer B Loomba N Simon B Torjman MC Joseph J. Evaluation of the VIA® blood chemistry monitor for glucose in healthy and diabetic volunteers. J Diabetes Sci Technol. 2008;2(2):182-193. doi:10.1177/193229680800200203.

Doeleman MJH Koster AF Esseveld A , et al. Comparison of capillary finger stick and venous blood sampling for 34 routine chemistry analytes: potential for in hospital and remote blood sampling. Clin Chem Lab Med CCLM. 2025;63(4):747-752. doi:10.1515/cclm-2024-0812.

Schröder D Hafke A Hummers E , et al. Comparison of laboratory results and pain perception in self-sampled capillary blood versus venous blood sampling: a systematic review and meta-analysis. Clin Biochem. 2025;138:110965. doi:10.1016/j.clinbiochem.2025.110965.

Duong C Bermudez S. Biolinq ShineTM granted de novo classification by U.S. FDA for the first fully autonomous, needle-free glucose sensor. Published online September 25, 2025. https://www.biolinq.com/news/biolinq-shine-tm-granted-de-novo?utm_source=chatgpt.com. Accessed January 20, 2026.

Tarasova VD Zena M Rendell M. Artifactual hypoglycemia: an old term for a new classification. Diabetes Care. 2014;37(5):e85-e86. doi:10.2337/dc13-2891.

de Graaff JC Hemmes GJ Bruin T , et al. Influence of repetitive finger puncturing on skin perfusion and capillary blood analysis in patients with diabetes mellitus. Clin Chem. 1999;45(12):2200-2206.