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. 2024 Nov;18(6):1346-1361.
doi: 10.1177/19322968241275701. Epub 2024 Oct 6.

The Diabetes Technology Society Error Grid and Trend Accuracy Matrix for Glucose Monitors

David C Klonoff  1 Guido Freckmann  2 Stefan Pleus  2 Boris P Kovatchev  3   4 David Kerr  5 Chui Cindy Tse  6 Chengdong Li  7 Michael S D Agus  8 Kathleen Dungan  9 Barbora Voglová Hagerf  10   11 Jan S Krouwer  12 Wei-An Andy Lee  13 Shivani Misra  14 Sang Youl Rhee  15 Ashutosh Sabharwal  16 Jane Jeffrie Seley  17 Viral N Shah  18 Nam K Tran  19 Kayo Waki  20 Chris Worth  21 Tiffany Tian  22 Rachel E Aaron  22 Keetan Rutledge  23 Cindy N Ho  22 Alessandra T Ayers  22 Amanda Adler  24 David T Ahn  25 Halis Kaan Aktürk  26 Mohammed E Al-Sofiani  27   28 Timothy S Bailey  29 Matt Baker  30 Lia Bally  31 Raveendhara R Bannuru  32 Elizabeth M Bauer  33 Yong Mong Bee  34 Julia E Blanchette  35   36 Eda Cengiz  37 James Geoffrey Chase  38 Kong Y Chen  39 Daniel Cherñavvsky  40 Mark Clements  41 Gerard L Cote  42 Ketan K Dhatariya  43   44 Andjela Drincic  45 Niels Ejskjaer  46   47 Juan Espinoza  48 Chiara Fabris  4 G Alexander Fleming  49 Monica A L Gabbay  50 Rodolfo J Galindo  51 Ana María Gómez-Medina  52 Lutz Heinemann  53 Norbert Hermanns  54 Thanh Hoang  55 Sufyan Hussain  56   57 Peter G Jacobs  58 Johan Jendle  59 Shashank R Joshi  60 Suneil K Koliwad  61 Rayhan A Lal  62 Lawrence A Leiter  63 Marcus Lind  64 Julia K Mader  65 Alberto Maran  66 Umesh Masharani  61 Nestoras Mathioudakis  67 Michael McShane  68 Chhavi Mehta  69 Sun-Joon Moon  70 James H Nichols  71 David N O'Neal  72 Francisco J Pasquel  73 Anne L Peters  74 Andreas Pfützner  75   76 Rodica Pop-Busui  77 Pratistha Ranjitkar  78 Connie M Rhee  79   80 David B Sacks  81 Signe Schmidt  82 Simon M Schwaighofer  83 Bin Sheng  84 Gregg D Simonson  85 Koji Sode  86   87 Elias K Spanakis  88 Nicole L Spartano  89 Guillermo E Umpierrez  73 Maryam Vareth  90   91   92 Hubert W Vesper  6 Jing Wang  7 Eugene Wright  93 Alan H B Wu  94 Sewagegn Yeshiwas  95 Mihail Zilbermint  96   97   98 Michael A Kohn  37
Affiliations

The Diabetes Technology Society Error Grid and Trend Accuracy Matrix for Glucose Monitors

David C Klonoff et al. J Diabetes Sci Technol. 2024 Nov.

Abstract

Introduction: An error grid compares measured versus reference glucose concentrations to assign clinical risk values to observed errors. Widely used error grids for blood glucose monitors (BGMs) have limited value because they do not also reflect clinical accuracy of continuous glucose monitors (CGMs).

Methods: Diabetes Technology Society (DTS) convened 89 international experts in glucose monitoring to (1) smooth the borders of the Surveillance Error Grid (SEG) zones and create a user-friendly tool-the DTS Error Grid; (2) define five risk zones of clinical point accuracy (A-E) to be identical for BGMs and CGMs; (3) determine a relationship between DTS Error Grid percent in Zone A and mean absolute relative difference (MARD) from analyzing 22 BGM and nine CGM accuracy studies; and (4) create trend risk categories (1-5) for CGM trend accuracy.

Results: The DTS Error Grid for point accuracy contains five risk zones (A-E) with straight-line borders that can be applied to both BGM and CGM accuracy data. In a data set combining point accuracy data from 18 BGMs, 2.6% of total data pairs equally moved from Zones A to B and vice versa (SEG compared with DTS Error Grid). For every 1% increase in percent data in Zone A, the MARD decreased by approximately 0.33%. We also created a DTS Trend Accuracy Matrix with five trend risk categories (1-5) for CGM-reported trend indicators compared with reference trends calculated from reference glucose.

Conclusion: The DTS Error Grid combines contemporary clinician input regarding clinical point accuracy for BGMs and CGMs. The DTS Trend Accuracy Matrix assesses accuracy of CGM trend indicators.

Keywords: accuracy; blood glucose; continuous glucose monitoring; error grid; glucose trend; surveillance.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: D.C.K. is a consultant for Afon, Lifecare, Novo, Samsung, embecta, Glucotrack, SynchNeuro, and Thirdwayv. G.F. is CEO of IfDT. G.F./IfDT has/have received research support, speakers’ honoraria or consulting fees in the last three years from Abbott, Ascensia, Berlin Chemie, Boydsense, Dexcom, Glucoset, i-SENS, Lilly, Menarini, Novo Nordisk, Perfood, Pharmasens, Roche, Sinocare, Terumo, Ypsomed. S.P. is an employee of IfDT. B.P.K. declares patent royalties handled by UVA from: DexCom, J&J, Novo Nordisk, and Sanofi; and research support handled by UVA: Dexcom, Novo Nordisk, Tandem Diabetes Care. D.K. has received research support from Abbott Diabetes Care. M.S.D.A. is currently receiving in kind support (CGM devices) from Dexcom Inc for an investigator-initiated clinical study. K.D. receives research funding from Dexcom, Abbott, Sanofi, Viacyte, Insulet, consulting fees from Eli Lilly, Dexcom, Insulet, Oppenheimer, Elsevier, honoraria from Academy for Continued Healthcare Learning, Med Learning Group, Medscape, Impact Education, and royalties from UptoDate. S.M. is in receipt of an investigator-initiated grant from DexCom, has received speaker fees from Sanofi & Lilly, is funded by a Wellcome Trust (223024/Z/21/Z), and is supported by the NIHR Imperial Biomedical Research Centre. A.S. was supported by the NSF Engineering Research Center for Precise Advanced Technologies and Health Systems for Underserved Populations (PATHS-UP) (#1648451). V.N.S. reports receiving personal fees from Sanofi, Embecta, NovoNordisk, Dexcom, Insulet, Tandem Diabetes Care, Ascensia Diabetes Care, Genomelink and LumosFit for consulting, advising or speaking. N.K.T. is a consultant for Roche Diagnostics / Roche Molecular Systems / Radiometer. UC Davis is a Roche Diagnostics Center of Excellence. N.K.T. has received speaking honoraria for Roche Diagnostics, Nova Biomedical, Thermo Fisher, and Radiometer. N.K.T. is also Chair-Elect for the Association for Diagnostic and Laboratory Medicine (ADLM) Critical and Point-of-Care Testing Division, Co-Founder of the Machine Intelligene Learning Optimizer (MILO), Inc, and a member of the International Federation for Clinical Chemistry (IFCC) continuous glucose monitoring workgroup. T.T. is a consultant for Clinical ink. R.E.A. is a consultant for Clinical ink. D.T.A. has received speaker’s honoraria from Abbott, Ascensia Diabetes Care, Insulet, Lilly Diabetes, Mannkind, Novo Nordisk, and Xeris Pharmaceuticals. D.T.A. has received consulting fees from Ascensia Diabetes Care, Lilly Diabetes, and Senseonics. H.K.A. received research grants through University of Colorado from Dexcom, Tandem Diabetes, Medtronic, Mannkind, IM Therapeutics, IAFMS, and received honorarium through University of Colorado for consulting from Dexcom, Tandem Diabetes, and Medtronic. M.E.A.-S. has served on the advisory boards for Abbott, Medtronic, Insulet, VitalAire, Sanofi, Eli Lilly, and Dexcom; has received honoraria for speaking from Abbott, Eli Lilly, Medtronic, Novo Nordisk, Sanofi, VitalAire, and Eli Lilly; and received research support from Medtronic and Sanofi. T.S.B. has received research support from Abbott Rapid Diagnostics, Biolinq, Dexcom, Eli Lilly, Medtronic, Medtrum, Novo Nordisk, Sanofi, Senseonics, and vTv Therapeutics and consulting honoraria from Abbott Diabetes, Abbott Rapid Diagnostics, ACON, CeQur, HagarTech, Intuity Medical, Lifescan, Mannkind, Medtronic, Novo, Perspirion, Sanofi, Sequel Med Tech, and Ypsomed. M.B. currently participates on the Hospital Advisory board with Dexcom and has received research support from Dexcom. L.B. has received research/product support from Dexcom, Ypsomed, and Boehringer Ingelheim; speaker honoraria from Dexcom and Oviva; and participated in advisory boards of Dexcom, Novo Nordisk, Sanofi, Ypsomed, Oviva, and Roche Diabetes Care. Y.M.B. has received honoraria for lectures and scientific advisory from Roche and AstraZeneca in the past 12 months. J.E.B. is on the Speaker’s bureau for Insulet and on the Advisory Board for Cardinal Health and Lifescan. J.E.B. is a consultant for Embecta. J.E.B. receives research support from the Leona M. and Harry B. Helmsley Charitable Trust. E.C. is on the scientific advisory board for Novo Nordisk, Eli-Lilly, Adocia, Arecor, Proventionbio, Portal Insulin, and MannKind. D.C. was a Dexcom employee from August 2018 to May 2024. D.C. is a shareholder of Dexcom, Lilly, Abbott and Tandem. M.C. has received consulting fees from Glooko and research support from Dexcom and Abbott Diabetes Care. G.L.C. is a shareholder of BioTex, Inc., Basepair Biotechnologies Inc., Coordination Centric, Inc., and Shape Memory Medical, Inc. G.L.C. is supported by the NSF Engineering Research Center for Precise Advanced Technologies and Health Systems for Underserved Populations (PATHS-UP) (#1648451). K.K.D. has received honoraria, travel, or fees for advisory boards from AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Abbott Diabetes, Menarini, and Sanofi in the last 12 months. J.E. receives federal funding from FDA, NIMHD, and NCATS and is a consultant for Sanofi. C.F. receives royalties from Dexcom and Novo Nordisk managed through her institution. G.A.F. is an advisor for 180 Life Sciences, 89bio, Adocia, Abbott, AdipoPharma, Aerami, Amolyt, Carthera, Catalyst, Cohen Global, CMC Magnetics, Diasome, Eleos, Entera Bio, Enterin, Glyscend, Hagar, Hogan Lovells, IM Therapeutics, Innoneo, Intarcia, Levicure, Lilly Asia Ventures, Lumos, Mars Symbioscience, Melior, metaLead Therapeutics, Microbiotix, MMD, Modular Medical, New Amsterdam, Northwestern, NuSirt, NuVox, Oramed, Pano, Pasithea, PhylloPharma, Pleiogenix, Recordati, Regor, Remodeless, Renaissance, RenovoRx, Rivus, RxMP, Sera Biopharma, Seraxis, Serpin, SFC Fluidics, Skinject, SROne, Stalicla, Surf Bio, TIXiMED, Veroscience, Verthermia, WaveBreak, Zealand Pharma, and Zucara. M.A.L.G. is a consultant for Abbott, Medtronic, Novonordisk, and Roche. R.J.G. received research support from Novo Nordisk, Dexcom and Eli Lilly and consulting fees/advisory fees from Abbott Diabetes Care, Aztra Zeneca, Bayer, Boehringer, Dexcom, Eli Lilly, Novo Nordisk, and Medtronic, outside of this work. R.J.G. is partially supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Numbers P30DK111024, K23DK123384, R03DK138255, and U2CD137135. A.M.G.-M. reports speaker fees from Novo Nordisk, Sanofi, Elli Lilly, Boehringer Ingelheim, Abbott, and Medtronic. L.H. is a consultant for a number of companies that are developing innovative solutions for the treatment of people with diabetes. N.H. reports Advisory Board member fees from Abbott Diabetes Care and Insulet as well as honoraria for lectures from Berlin-Chemie AG, Becton Dickenson, Sanofi Germany, Roche Diabetes Care, and Dexcom Germany. T.H. serves on the advisory board for Acella and Horizons Therapeutics (no financial compensation). S.H. has served on the advisory board for Tandem, Dexcom, and Medtronic, and received honoraria for nonpromotional educational and/or consultancy work from Abbott, Insulet, Dexcom, Roche, and Sanofi. P.G.J. is a shareholder of Pacific Diabetes Technologies Inc. and serves on the advisory board for Eli Lilly. P.G.J. received grant support from SFC Fluidics and research support from Eli Lilly and Dexcom. J.J. has received fees from lectures and or advisory boards from Abbott, Astra Zeneca, Boeringer Ingelheim, Eli Lilly, Medtronic, Nordic Infucare, Novo Nordisk, and Sanofi. S.R.J is a consultant for USV, Marico, Glenmark, Franco Indian, Twin Health, Biocon, and Zydus Lifesciences. S.R.J. received speaking honoraria from Abbott, Novo Nordisk, MSD, Sanofi, Boehringer Ingelheim, AstraZeneca, Lupin, Bayer Zydus, USV, DRL, Meyer Organics, Servier, Natco. R.A.L. is a consultant for Abbott Diabetes Care, Biolinq, Capillary Biomedical, Deep Valley Labs, Gluroo, PhysioLogic Devices, Portal Insulin, Sanofi, and Tidepool. R.A.L. has served on advisory boards for. ProventionBio and Lilly. R.A.L. receives research support through his institution from Insulet, Medtronic, Tandem, and Sinocare. L.A.L. has received research funding from, has provided CME on behalf of, and/or has acted as an advisor to Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Lexicon, Merck, Novo Nordisk, Pfizer, and Sanofi. M.L. has been a consultant or received honoraria from Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Nordic InfuCare, and Novo Nordisk, and has received research grants from Eli Lilly and Novo Nordisk, all outside of the submitted work. J.K.M. is a member of advisory boards of Abbott Diabetes Care, Becton-Dickinson, Biomea Fusion, Eli Lilly, Embecta, Medtronic, NovoNordisk A/S, Roche Diabetes Care, Sanofi-Aventis, and Viatris and received speaker honoraria from A. Menarini Diagnostics, Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtrust, MSD, NovoNordisk A/S, Roche Diabetes Care, Sanofi, Viatris, and Ypsomed. J.K.M. is a shareholder of decide Clinical Software GmbH and elyte Diagnostics. A.M. reports speaker fees from Novo Nordisk. M.M. has an existing research & development relationship with Scientific Bioprocessing, Inc and has been a consultant for Abbott. S.-J.M. is a consultant for Abbott, Curestream, Daewoong, EOFlow, G2e, Huons, iSense, Medtronic, Novo Nordisk, and Sanofi. D.N.O. has served on advisory boards for Abbott Laboratories, Medtronic, Merck Sharp & Dohme, Novo Nordisk, Roche, and Sanofi; received research support from Medtronic, Novo Nordisk, Roche, Eli Lilly and Company, and Sanofi; and received travel support from Novo Nordisk and Merck Sharp & Dohme. F.J.P. has received research support (to Emory University) from Dexcom, Insulet, Novo Nordisk, Tandem, and Ideal Medical Technologies, and has received consulting fees from Dexcom. A.L.P. is on the advisory board of Medscape, Vertex, and Lilly; receives research support from Insulin and Abbott; and has stock options in Omada Health. R.P.-B. receives grant support from Novo Nordisk, Lexicon Pharmaceuticals, and Medtronic and received consulting fees from Bayer, Lexicon Pharmaceuticals, Novo Nordisk, and Roche. C.M.R. has received honoraria and/or grant support from AstraZeneca, Dexcom, Fresenius, and Vifor. D.B.S. is supported by the Intramural Research Program of the National Institutes of Health. S.S. was a Novo Nordisk employee from 2022-2023. S.S. has served as advisor for Novo Nordisk and has received speaker fees from Novo Nordisk and Nordic Infucare within the past three years. G.D.S’s employer, nonprofit International Diabetes Center, HealthPartners Institute, has received educational grant funds from Abbott Diabetes Care, Medscape, and Sanofi-Aventis Groupe. G.D.S receives no personal income/honorarium from these activities. K.S. received grant supports from Arkray, Terumo, and Dexcom. E.K.S. is partly supported by the VA Merit Award (1I01CX001825) from the US Department of Veterans Affairs Clinical Sciences Research and has received unrestricted research support from Dexcom and Tandem Diabetes (to Baltimore VA Medical Center and to University of Maryland) for the conduction of clinical trials. N.L.S. received funding from Novo Nordisk for an investigator-initiated research grant unrelated to the current project. G.E.U. is partly supported by research grants from National Institutes of Health (NIH/NATS UL 3UL1TR002378-05S2) from the Clinical and Translational Science Award program, and from National Institutes of Health and National Center for Research Resources (NIH/NIDDK 2P30DK111024-06). G.E.U. has received research support (to Emory University) from Abbott, Bayer, and Dexcom; and has participated in advisory boards for Dexcom and GlyCare. E.W. has received consulting fees from Abbott Diabetes Care, Ascensia, Bayer, Boehringer, Ingelheim, Embecta, GlaxoSmithKline, Lilly, Medtronic, Renalytix, and Sanofi. E.W. has received honoraria from Abbott Diabetes Care, Bayer, Boehringer Ingelheim, GlaxoSmithKline, Lilly, Medtronic, Renalytix, and Sanofi. E.W. is on the Speakers’ Bureau from Abbott Diabetes Care, Bayer, Boehringer, Ingelheim, GlaxoSmithKline, Lilly, Renalytix, and Sanofi. M.Z. is a consultant for DexCom, Inc. M.A.K. is Chief Medical Officer of QuesGen, Inc. C.T., C.L., B.V.H., J.S.K., W.A.L., S.Y.R., J.J.S., K.W., C.W., K.R., C.N.H., A.T.A., A.A., R.R.B., E.M.B., J.G.C., K.Y.C., A.D., N.E., S.K.K., U.M., N.M., C.M., J.H.N., A.P., P.R., S.M.S., B.S., M.V., H.W.V., J.W., A.H.B.W., and S.Y. have nothing to disclose.

Figures

Figure 1.
Figure 1.
The Diabetes Technology Society Error Grid for (a) BGM A, (b) BGM B, and (c) the CGM combined accuracy data set of 3952 reference/monitor data pairs. The percentage in Zone A was 89.7% for BGM A versus 99.1% for BGM B. The percentage in Zone A was 88.3% for the CGM. Abbreviations: BGM, blood glucose monitor; CGM, continuous glucose monitor.
Figure 2.
Figure 2.
The mathematical relationship and line of best fit between the percent of data pairs in Zone A of the Diabetes Technology Society Error Grid and the MARD. Abbreviations: BGM, blood glucose monitor; CGM, continuous glucose monitor; MARD, mean absolute relative difference.
Figure 3.
Figure 3.
The DTS Trend Accuracy Matrix for reference values from 1 to 600 mg/dL (0.0556-33.3 mmol/L) for our combined CGM data set. In 3185 (80.6%) trend accuracy records, the CGM’s trend indicator could be compared with a valid reference trend. This sample data set was based on data from nine CGM accuracy studies. It shows no trend readings in extreme trend risk categories 4 or 5. Abbreviations: CGM, continuous glucose monitor; dL, deciliter; FDA, US Food and Drug Administration; L, liter; mg, milligram; min, minutes; mmol, millimole.
Figure 4.
Figure 4.
The DTS Trend Accuracy Matrix for reference values 1 to 100 mg/dL (0.0556-5.56 mmol/L) for our combined CGM data set. The Trend Accuracy Matrix has six cells corresponding to “CGM Extreme Overestimate.” Abbreviation: CGM, continuous glucose monitor; dL, deciliter; L, liter; mg, milligram; min, minutes; mmol, millimole.
Figure 5.
Figure 5.
The DTS Trend Accuracy Matrix for reference values from >180 to 600 mg/dL (10.0-33.3 mmol/L) for our combined CGM data set. No combinations of reference trend and monitor trend were deemed clinically risky enough to be labeled as trend risk category 5 in the Trend Accuracy Matrix. Abbreviation: CGM, continuous glucose monitor; dL, deciliter; L, liter; mg, milligram; min, minutes; mmol, millimole.

References

    1. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622-628. doi: 10.2337/diacare.10.5.622. - DOI - PubMed
    1. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-1148. doi: 10.2337/diacare.23.8.1143. - DOI - PubMed
    1. Klonoff DC, Lias C, Vigersky R, et al. The surveillance error grid. J Diabetes Sci Technol. 2014;8(4):658-672. doi: 10.1177/1932296814539589. - DOI - PMC - PubMed
    1. FDA. FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions. FDA. https://www.fda.gov/news-events/press-announcements/fda-expands-indicati.... Published March 24, 2020. Accessed April 22, 2024.
    1. Castle JR, Jacobs PG. Nonadjunctive use of continuous glucose monitoring for diabetes treatment decisions. J Diabetes Sci Technol. 2016;10(5):1169-1173. doi: 10.1177/1932296816631569. - DOI - PMC - PubMed

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