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. 2025 May 31:19322968251325873.
doi: 10.1177/19322968251325873. Online ahead of print.

Multicenter Evaluation of a New Strip-Based Blood Glucose System for Point-of-Care Testing in Critical and Non-Critical Care Settings

Michael Goodman  1 , Sven Bercker  2 , Nancy Breitenbeck  3 , Cristina Canada-Vilalta  4 , Daisy D Canepa  5 , William A Clarke  6 , Christopher W Farnsworth  7 , Edward O Ganser  8 , Nienke Geerts  9 , Barbara Goldsmith  10 , Gary Headden  11 , Debra Hoppensteadt  12 , Birgit Klapperich  5 , Ryan Matika  13 , Gabrielle Miles  14 , Sagori Mukhopadhyay  15 , James H Nichols  16 , Rebecca M O'Dell  4 , Zubaid Rafique  17 , Andre Schuetzenmeister  18 , Robbert Slingerland  19 , Ann F Stankiewicz  4 , Jonathan R Swanson  20 , Nam K Tran  21 , Alan H B Wu  22 , Brad S Karon  23
Affiliations

Multicenter Evaluation of a New Strip-Based Blood Glucose System for Point-of-Care Testing in Critical and Non-Critical Care Settings

Michael Goodman et al. J Diabetes Sci Technol. .

Abstract

Background: Evaluation of the performance of Cobas® Pulse (Roche Diagnostics GmbH, Mannheim, Germany), a new blood glucose (BG) monitoring system (BGMS; referred to here as BGMSA) intended for point-of-care testing using samples from patients in diverse clinical settings by intended point-of-care test operators.

Methods: Arterial, capillary, venous, or heel stick whole blood (WB) samples from patients in non-critical and critical care settings were collected and analyzed using BGMSA and the Nova StatStrip® BGMS (Nova Biomedical, Waltham, MA; referred to here as BGMSB), and a hexokinase comparator (Cobas 6000 Analyzer Series; Roche Diagnostics GmbH). The blood glucose measurement accuracy was assessed by the Food and Drug Administration guidance criteria.

Results: Two studies are presented. In the first, 2678 samples (622 arterial, 706 capillary, 1203 venous, 147 heel stick) were collected from 1577 patients in 14 US and three European sites. All accuracy criteria were met for arterial and venous samples considering all data combined. BGMSA showed better accuracy than BGMSB for arterial, venous, and heel stick, and similar results to BGMSB for capillary WB vs venous comparator. No endogenous interference from pO2, hematocrit, and sodium was identified. BGMSA was also accurate when analyzing contrived samples used to show accuracy over a wide range of glucose concentrations, alone and when combined with extreme hematocrit. In the second study, 117 capillary fingerstick samples collected at one US site were measured on both BGMSA and the comparator, and all accuracy criteria were met. No clinically significant medical risks were observed via Diabetes Technology Society Error Grids.

Conclusions: BGMSA was effective for determining blood glucose in venous, arterial, neonatal arterial, neonatal heel stick, and capillary WB samples.

Keywords: accuracy; blood glucose monitoring systems; critical care; point-of-care.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All authors received third-party writing assistance from Roche; funding from Roche for study supplies. M.G. received grants or contracts from the National Institutes of Health and the Department of Defense; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Johnson & Johnson and Grifols; and participation on a Data Safety Monitoring Board or Advisory Board for the TRAIT study. S.B. received payment for expert testimony from Berlin District Court, Public Prosecutor’s Office Dresden, and Arbitration Centre of the Saxon State Medical Association; support for attending meetings and/or travel from bioMérieux (investigator meeting); participation on a Data Safety Monitoring Board or Advisory Board for DSMB for Hemotune, Switzerland; is Vice Chair of local ethics board. N.B. has no other conflicts of interest. C.C.-V. is an employee of Roche. D.D.C. is an employee of and a shareholder in Roche. W.A.C. received grants or contracts from Thermo Fisher Scientific, Radiometer, Becton Dickenson, and Werfen; consultancy fees from Thermo Fisher Scientific, Saladax Biomedical, Roche Diagnostics, Radiometer, Werfen, and Truvian. C.W.F. received grants or contracts from Abbott Laboratories, Cepheid, Roche Diagnostics, Sebia, Beckman Coutler, The Binding Site, BlueJay Diagnostics, and bioMérieux; consultancy fees from Abbott, Roche, Werfen, and Cytovale; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Werfen, BD, Abbott, and Roche. E.O.G. is an employee of Roche Diabetes Care, Inc. N.G. received provision of study materials and payment for labor (inclusion, sampling handling, etc.) to the institution from Roche for investigations. B.G. has no other conflicts of interest. G.H. has no other conflicts of interest. D.H. received grants or contracts from Sysmex America, Inc., Glycan Therapeutics, and SBIR/NIH. B.K. is an employee of Roche. R.M. has no other conflicts of interest. G.M. is an employee of Roche. S.M. received funding from Roche for study enrollment and procedures. J.H.N. received grants or contracts to institution for support of study from Roche Diagnostics; research support from Werfen, Abbott Laboratories, and Siemens; consultancy fees from Werfen and Abbott Laboratories for Scientific Advisory Boards; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Roche, Werfen, Abbott Laboratories, BD, Thermo Fisher Scientific, Physician’s World/Alexion, and Siemens for speaker honoraria; support for attending meetings and/or travel from the Association of Diagnostic Lab Medicine (ADLM), Clinical and Laboratory Standards Institute (CLSI), and College of American Pathologists (CAP); leadership or fiduciary role in other board, society, committee, or advocacy group for CAP, CLSI, Journal of Applied Laboratory Medicine, and ADLM; is President of CLSI; and Deputy Editor of the Journal of Applied Laboratory Medicine. R.M.O. is an employee of Roche. Z.R. is an Advisory Board Member—renal (personal fees) from Vifor Pharma, Inc. and an Advisory Board Member—cardio renal (personal fees) from AstraZeneca, Inc. A.S. is an employee of Roche Diagnostics GmbH. R.S. received lab funding from Roche for investigations and serves on a Roche Advisory Board. A.F.S. is part of the Roche employee program. J.R.S. received speaker honoraria from Prolacta Bioscience, Inc. N.K.T. serves on the Roche Advisory Board; in a Roche consulting role; and their institution, UC Davis, is a Roche Diagnostic Center of Excellence. A.H.B.W. received funding from Roche; Scientific Advisory Boards for Werfen, Babson, Truvian, and RCE. B.S.K. serves on a Roche Advisory Board.

Figures

Figure 1.
Figure 1.
DTS Error Grid for the BGMSA vs plasma-based hexokinase comparator test results for arterial, venous, heel stick, and capillary blood samples, and for capillary to capillary. DTS Error Grid risk class: (A) None; (B) Mild; (C) Moderate; (D) High; (E) Extreme. Abbreviations: BGMSA, blood glucose monitoring system A; DTS, Diabetes Technology Society; HK, hexokinase.
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