New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011

Abstract

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting. The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in postapproval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs' analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report.

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

“…The degree of BGM accuracy that is desired and required is likely to depend on the clinical needs of individual patients. There is a growing consensus among endocrinologists and other clinicians that the accuracy and precision performance characteristics of each BGM and CGM device should be made available both to the patient and physician, to properly match a BGM device to the appropriate individual or clinical setting (149).…”

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

“…[3][4][5][6] Our ranking procedure showed that devices performing highly accurate measurements at low and normal BG levels usually also produce accurate measurements at high BG levels (ranking group A). The number of "benign reading errors" was very low (0.34%).…”

“…13 Responses to the consultation process on the new ISO criteria included the suggestion that instead of testing accuracy at BG < 100 mg/dl and > 100 mg/dl, it should be tested at a number of different BG level ranges, making it possible to further differentiate between devices with regard to overall performance. [3][4][5][6] The aim of this more detailed approach to accuracy testing is to identify devices that produce highly accurate measurements, making them suitable for use by patients on intensified insulin therapy. Devices that fail to produce laboratory accuracy at levels below 100 mg/dl might be suitable for use by patients whose therapy regimen excludes the risk of hypoglycemia.…”

“…[3][4][5][6] For example, insulin-dependent patients under intensified glycemic control require highly accurate devices for adequate insulin dosing, whereas patients with Type 2 diabetes who are treated with medication with no or little risk of hypoglycemia could use less accurate GMS. It has, therefore, been suggested that the analytical accuracy of GMS should be tested not only in relation to BG level ranges below and above 100 mg/dL but also in relation to different glycemic ranges, as already previously proposed for continuous glucose monitoring systems.…”

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

“…The lack of uniformity by FDA reviewers creates several inefficiencies, increased costs to the medical device industry, and delays the introduction of new medical products into the market. Having inconsistent regulatory requirements by different FDA reviewers, as was shown by a report from Pricewaterhouse Coopers [50], creates particular challenges for small start-up companies to get investors or venture capitalist funding for new, early-stage technologies [ 51]. The lack of uniform regulatory decision-making also affects the introduction of new technologies, that the FDA had previously identified, as being critical to helping patients [52].…”