Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices

STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT

Martin Bland, J., & Altman, D. (1986) · The Lancet · doi:10.1016/s0140-6736(86)90837-8 · Cited by 47,965 · see citing works

Evaluating clinical accuracy of systems for self-monitoring of blood glucose

Clarke, W. L., Cox, D., Gonder-Frederick, L. A., Carter, W., & Pohl, S. L. (1987) · Diabetes Care · doi:10.2337/diacare.10.5.622 · Cited by 1,435 · see citing works

Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial

Bolinder, J., Antuna, R., Geelhoed-Duijvestijn, P., Kröger, J., & Weitgasser, R. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31535-5 · Cited by 893 · see citing works

The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System

Bailey, T., Bode, B. W., Christiansen, M. P., Klaff, L. J., & Alva, S. (2015) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2014.0378 · Cited by 685 · see citing works

Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial

Beck, R. W., Riddlesworth, T. D., Ruedy, K., Ahmann, A., Haller, S., Kruger, D., McGill, J. B., Polonsky, W., Price, D., Aronoff, S., et al. (2017) · Annals of Internal Medicine · doi:10.7326/m16-2855 · Cited by 635 · see citing works

Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial

Haak, T., Hanaire, H., Ajjan, R., Hermanns, N., Riveline, J.-P., & Rayman, G. (2017) · Diabetes Therapy · doi:10.1007/s13300-016-0223-6 · Cited by 623 · see citing works

Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants

Miller, K. M., Beck, R. W., Bergenstal, R. M., Goland, R. S., Haller, M. J., McGill, J. B., Rodriguez, H., Simmons, J. H., Hirsch, I. B., & for the T1D Exchange Clinic Network (2013) · Diabetes Care · doi:10.2337/dc12-1770 · Cited by 505 · see citing works

Introduction: <i>Standards of Medical Care in Diabetes—2018</i>

(2018) · Diabetes Care · doi:10.2337/dc18-sint01 · Cited by 472 · see citing works

REPLACE-BG: a randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in adults with well-controlled type 1 diabetes

Aleppo, G., Ruedy, K. J., Riddlesworth, T. D., Kruger, D. F., Peters, A. L., Hirsch, I., Bergenstal, R. M., Toschi, E., Ahmann, A. J., Shah, V. N., et al. (2017) · Diabetes Care · doi:10.2337/dc16-2482 · Cited by 329 · see citing works

Evaluating the Accuracy of Continuous Glucose-Monitoring Sensors

Kovatchev, B. P., Gonder-Frederick, L. A., Cox, D. J., & Clarke, W. L. (2004) · Diabetes Care · doi:10.2337/diacare.27.8.1922 · Cited by 312 · see citing works

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Kovatchev, B. P., Patek, S. D., Ortiz, E. A., & Breton, M. D. (2015) · Diabetes Technology &amp; Therapeutics · doi:10.1089/dia.2014.0272 · Cited by 234 · see citing works

Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes

Wadwa, R. P., Laffel, L. M., Shah, V. N., & Garg, S. K. (2018) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0150 · Cited by 197 · see citing works

The Surveillance Error Grid

Klonoff, D. C., Lias, C., Vigersky, R. A., Clarke, W. L., Parkes, J. L., Sacks, D. B., Kirkman, M. S., Kovatchev, B. P., Panel, T. E. G., Aurand, L. A., et al. (2014) · Journal of Diabetes Science and Technology · doi:10.1177/1932296814539589 · Cited by 175 · see citing works

Comparison of Glucose Concentration in Interstitial Fluid, and Capillary and Venous Blood During Rapid Changes in Blood Glucose Levels

Thennadil, S. N., Rennert, J. L., Wenzel, B. J., Hazen, K. H., Ruchti, T. L., & Block, M. B. (2001) · Diabetes Technology &amp; Therapeutics · doi:10.1089/15209150152607132 · Cited by 166 · see citing works

Time Lag of Glucose From Intravascular to Interstitial Compartment in Type 1 Diabetes

Basu, A., Dube, S., Veettil, S., Slama, M. Q., Kudva, Y. C., Peyser, T. A., Carter, R. E., Cobelli, C., & Basu, R. (2014) · Journal of Diabetes Science and Technology · doi:10.1177/1932296814554797 · Cited by 165 · see citing works

Time Delay of CGM Sensors

Schmelzeisen‐Redeker, G., Schoemaker, M., Kirchsteiger, H., Freckmann, G., Heinemann, L., & del Re, L. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815590154 · Cited by 162 · see citing works

Significance and Reliability of MARD for the Accuracy of CGM Systems

Reiterer, F., Polterauer, P., Schoemaker, M., Schmelzeisen‐Redeker, G., Freckmann, G., Heinemann, L., & del Re, L. (2016) · Journal of Diabetes Science and Technology · doi:10.1177/1932296816662047 · Cited by 124 · see citing works

Self-Monitoring of Blood Glucose (SMBG) in Insulin- and Non–Insulin-Using Adults with Diabetes: Consensus Recommendations for Improving SMBG Accuracy, Utilization, and Research

Hirsch, I. B., Bode, B. W., Childs, B. P., Close, K. L., Fisher, W. A., Gavin, J. R., Ginsberg, B. H., Raine, C. H., & Verderese, C. A. (2008) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2008.0104 · Cited by 119 · see citing works

Impact of Blood Glucose Self-Monitoring Errors on Glucose Variability, Risk for Hypoglycemia, and Average Glucose Control in Type 1 Diabetes: An <i>In Silico</i> Study

Breton, M. D., & Kovatchev, B. P. (2010) · Journal of Diabetes Science and Technology · doi:10.1177/193229681000400309 · Cited by 103 · see citing works

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies

Laffel, L. M. (2016) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2015.0380 · Cited by 86 · see citing works

Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Pleus, S., Schoemaker, M., Morgenstern, K., Schmelzeisen‐Redeker, G., Haug, C., Link, M., Zschornack, E., & Freckmann, G. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815578716 · Cited by 84 · see citing works

Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study ( GLADIS )

New, J. P., Ajjan, R., Pfeiffer, A. F. H., & Freckmann, G. (2015) · Diabetic Medicine · doi:10.1111/dme.12713 · Cited by 81 · see citing works

Accuracy of the SEVEN® Continuous Glucose Monitoring System: Comparison with Frequently Sampled Venous Glucose Measurements

Zisser, H., Bailey, T. S., Schwartz, S. L., Ratner, R. E., & Wise, J. K. (2009) · Journal of Diabetes Science and Technology · doi:10.1177/193229680900300519 · Cited by 77 · see citing works

Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640

Twomey, P. J. (2004) · Journal of Clinical Pathology · doi:10.1136/jcp.2003.013417 · Cited by 75 · see citing works

Performance Evaluation of Three Continuous Glucose Monitoring Systems: Comparison of Six Sensors Per Subject in Parallel

Freckmann, G., Pleus, S., Link, M., Zschornack, E., Klötzer, H.-M., & Haug, C. (2013) · Journal of Diabetes Science and Technology · doi:10.1177/193229681300700406 · Cited by 73 · see citing works

Analysis of Time Lags and Other Sources of Error of the DexCom SEVEN Continuous Glucose Monitor

Kamath, A., Mahalingam, A., & Brauker, J. H. (2009) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2009.0060 · Cited by 69 · see citing works

Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose MonitoringParts of the data have previously been presented at the 77th Scientific Sessions of the American Diabetes Association in San Diego, CA; June 9–13, 2017 and at the 17th Annual Diabetes Technology Meeting in Bethesda, MD, November 2–4, 2017.Trial number: DRKS00011920; registered at the Deutsches Register Klinischer Studien (German clinical trials register), an approved Primary Register in the WHO International Clinical Trials Registry Platform.

Freckmann, G., Link, M., Pleus, S., Westhoff, A., Kamecke, U., & Haug, C. (2018) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0105 · Cited by 64 · see citing works

Continuous glucose monitoring: quality of hypoglycaemia detection

Zijlstra, E., Heise, T., Nosek, L., Heinemann, L., & Heckermann, S. (2012) · Diabetes Obesity and Metabolism · doi:10.1111/dom.12001 · Cited by 61 · see citing works

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus

(2013) · doi:10.3403/30208526 · Cited by 61 · see citing works

Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors

Bailey, T. S. (2017) · Diabetes Technology &amp; Therapeutics · doi:10.1089/dia.2017.0050 · Cited by 60 · see citing works

The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System

Nakamura, K., & Balo, A. K. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815577812 · Cited by 46 · see citing works

Performance Comparison of CGM Systems

Kirchsteiger, H., Heinemann, L., Freckmann, G., Lodwig, V., Schmelzeisen‐Redeker, G., Schoemaker, M., & del Re, L. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815586013 · Cited by 45 · see citing works

Overview of a Novel Sensor for Continuous Glucose Monitoring

Schmelzeisen‐Redeker, G., Staib, A., Strasser, M., Müller, U., & Schoemaker, M. (2013) · Journal of Diabetes Science and Technology · doi:10.1177/193229681300700402 · Cited by 43 · see citing works

Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197

Freckmann, G., Pleus, S., Link, M., Baumstark, A., Schmid, C., Högel, J., & Haug, C. (2015) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2015.0043 · Cited by 38 · see citing works

Accuracy and precision of flash glucose monitoring sensors inserted into the abdomen and upper thigh compared with the upper arm

Charleer, S., Mathieu, C., Nobels, F. R. E., & Gillard, P. (2018) · Diabetes Obesity and Metabolism · doi:10.1111/dom.13239 · Cited by 35 · see citing works

Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast‐acting insulin aspart compared with insulin aspart

Basu, A., Pieber, T. R., Hansen, A. K., Sach‐Friedl, S., Erichsen, L., Basu, R., & Haahr, H. L. (2018) · Diabetes Obesity and Metabolism · doi:10.1111/dom.13270 · Cited by 33 · see citing works

Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197

Bedini, J. L., Wallace, J. F., Pardo, S. A., & Petruschke, T. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815609368 · Cited by 29 · see citing works

Untitled work

(2016) · doi:10.1177/1932296816634356 · Cited by 23 · see citing works

The Quantitative Relationship Between ISO 15197 Accuracy Criteria and Mean Absolute Relative Difference (MARD) in the Evaluation of Analytical Performance of Self-Monitoring of Blood Glucose (SMBG) Systems

Pardo, S. A., & Simmons, D. A. (2016) · Journal of Diabetes Science and Technology · doi:10.1177/1932296816644468 · Cited by 19 · see citing works

Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations

MacLeod, K., Katz, L. B., & Cameron, H. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818790228 · Cited by 19 · see citing works

Prediction Quality of Glucose Trend Indicators in Two Continuous Tissue Glucose Monitoring SystemsParts of these data were previously presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes, September 11–15, 2017, Lisbon, Portugal.

Freckmann, G., Link, M., Westhoff, A., Kamecke, U., Pleus, S., & Haug, C. (2018) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0112 · Cited by 18 · see citing works

Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip Product

Setford, S. J., Grady, M., Phillips, S., Miller, L., Mackintosh, S., Cameron, H., & Corrigall, K. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817703133 · Cited by 15 · see citing works

Venous, Arterialized-Venous, or Capillary Glucose Reference Measurements for the Accuracy Assessment of a Continuous Glucose Monitoring System

Kropff, J., van Steen, S. C. J., deGraaff, P., Chan, M. W., van Amstel, R. B. E., & DeVries, J. H. (2017) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0189 · Cited by 14 · see citing works

How Much Accuracy of Interstitial Glucose Measurement Is Enough? Is There a Need for New Evidence?

Hermanns, N., Ehrmann, D., & Kulzer, B. (2016) · Journal of Diabetes Science and Technology · doi:10.1177/1932296816677578 · Cited by 4 · see citing works

Continuous glucose monitoring and metrics for clinical trials: an international consensus statement

Battelino, T., Alexander, C. M., Amiel, S. A., Arreaza-Rubin, G., Beck, R. W., Bergenstal, R. M., Buckingham, B. A., Carroll, J., Ceriello, A., Chow, E., et al. (2023) · The Lancet Diabetes &amp; Endocrinology · doi:10.1016/s2213-8587(22)00319-9 · Cited by 831 · see citing works

American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.

Blonde, L., Umpierrez, G. E., Reddy, S. S., McGill, J. B., Berga, S. L., Bush, M., Chandrasekaran, S., DeFronzo, R. A., Einhorn, D., Galindo, R. J., et al. (2022) · Endocrine Practice · doi:10.1016/j.eprac.2022.08.002 · Cited by 507 · see citing works

Continuous glucose monitors and automated insulin dosing systems in the hospital consensus guideline

Galindo, R. J., Umpierrez, G. E., Rushakoff, R. J., Basu, A., Lohnes, S., Nichols, J. H., Spanakis, E. K., Espinoza, J., Palermo, N. E., Awadjie, D. G., et al. (2020) · Journal of Diabetes Science and Technology · doi:10.1177/1932296820954163 · Cited by 170 · see citing works

Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space

Heinemann, L., Schoemaker, M., Schmelzeisen-Redecker, G., Hinzmann, R., Kassab, A., Freckmann, G., Reiterer, F., & Del Re, L. (2020) · Journal of Diabetes Science and Technology · doi:10.1177/1932296819855670 · Cited by 170 · see citing works

Accuracy of Dexcom G6 continuous glucose monitoring in non-critically ill hospitalized patients with diabetes

Davis, G. M., Spanakis, E. K., Migdal, A. L., Singh, L. G., Albury, B., Urrutia, M. A., Zamudio-Coronado, K. W., Scott, W. H., Doerfler, R., Lizama, S., et al. (2021) · Diabetes Care · doi:10.2337/dc20-2856 · Cited by 160 · see citing works

Continuous glucose monitoring in the intensive care unit during the COVID-19 pandemic

Agarwal, S., Mathew, J., Davis, G. M., Shephardson, A., Levine, A., Louard, R., Urrutia, A., Perez-Guzman, C., Umpierrez, G. E., Peng, L., et al. (2021) · Diabetes Care · doi:10.2337/dc20-2219 · Cited by 138 · see citing works

Use and accuracy of inpatient CGM during the COVID-19 pandemic: an observational study of general medicine and ICU patients

Longo, R. R., Elias, H., Khan, M., & Seley, J. J. (2022) · Journal of Diabetes Science and Technology · doi:10.1177/19322968211008446 · Cited by 89 · see citing works

Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting

Freckmann, G., Eichenlaub, M., Waldenmaier, D., Pleus, S., Wehrstedt, S., Haug, C., Witthauer, L., Jendle, J., Hinzmann, R., Thomas, A., et al. (2023) · Journal of Diabetes Science and Technology · doi:10.1177/19322968231190941 · Cited by 86 · see citing works

Use of continuous glucose monitor in critically ill COVID-19 patients requiring insulin infusion: an observational study

Faulds, E. R., Boutsicaris, A., Sumner, L., Jones, L., McNett, M., Smetana, K. S., May, C. C., Buschur, E., Exline, M. C., Ringel, M. D., et al. (2021) · The Journal of Clinical Endocrinology &amp; Metabolism · doi:10.1210/clinem/dgab409 · Cited by 71 · see citing works

Standardization process of continuous glucose monitoring: Traceability and performance

Freckmann, G., Nichols, J. H., Hinzmann, R., Klonoff, D. C., Ju, Y., Diem, P., Makris, K., & Slingerland, R. J. (2021) · Clinica Chimica Acta · doi:10.1016/j.cca.2020.12.025 · Cited by 62 · see citing works

Self-Monitoring of Blood Glucose as an Integral Part in the Management of People with Type 2 Diabetes Mellitus

Pleus, S., Freckmann, G., Schauer, S., Heinemann, L., Ziegler, R., Ji, L., Mohan, V., Calliari, L. E., & Hinzmann, R. (2022) · Diabetes Therapy · doi:10.1007/s13300-022-01254-8 · Cited by 55 · see citing works

<scp>CGM</scp> accuracy: Contrasting <scp>CE</scp> marking with the governmental controls of the <scp>USA</scp> ( <scp>FDA</scp> ) and Australia ( <scp>TGA</scp> ): A narrative review

Pemberton, J. S., Wilmot, E. G., Barnard‐Kelly, K., Leelarathna, L., Oliver, N., Randell, T., Taplin, C. E., Choudhary, P., & Adolfsson, P. (2023) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.14962 · Cited by 44 · see citing works

Time in range in pregnancy: is there a role?

Wyckoff, J. A., & Brown, F. M. (2021) · Diabetes Spectrum · doi:10.2337/ds20-0103 · Cited by 39 · see citing works

Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study

Hochfellner, D. A., Simic, A., Taucher, M. T., Sailer, L. S., Kopanz, J., Pöttler, T., & Mader, J. K. (2022) · Biosensors · doi:10.3390/bios12020106 · Cited by 15 · see citing works

Blood glucose monitoring devices: current considerations

Sly, B., & Taylor, J. (2023) · Australian Prescriber · doi:10.18773/austprescr.2023.013 · Cited by 11 · see citing works

Continuous Glucose Monitoring (CGM) or Blood Glucose Monitoring (BGM): Interactions and Implications

Heinemann, L. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818768834 · Cited by 39 · see citing works

Alarm Characterization for a Continuous Glucose Monitor That Replaces Traditional Blood Glucose Monitoring

(2010) · doi:10.1177/193229681000400107 · Cited by 14 · see citing works

Implementing a clinical protocol for the use of continuous glucose monitoring devices in the hospital

Marowitz, M., & Minnock, M. (2021) · Journal of Pediatric Nursing · doi:10.1016/j.pedn.2021.03.004

Response to “Blood Glucose Monitoring Data Should Be Reported in Detail When Studies About Efficacy of Continuous Glucose Monitoring Systems Are Published”

Grino, M., Alitta, Q., & Oliver, C. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818805749 · Cited by 2 · see citing works