{'fraction_non_alphanumeric': 0.01564945226917058, 'fraction_numerical': 0.00594679186228482, 'mean_word_length': 4.98501872659176, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Glyphosate Levels in Older Adults-Reply.

by the FDA that relabeled a class III device as accurate for use in dosing insulin, without the previously required need for a confirmatory blood glucose measurement. The decision was made despite more than 25 000 reports to the FDA of potentially harmful device inaccuracies. These reports were not mentioned to an advisory panel or directly addressed in the summary of safety and effectiveness data for the decision. Dr Beck mentions that current CGMs can, in some instances, be more accurate than some currently marketed blood glucose meters. Typically, though, they are not.1 But the comparative average accuracy of different devices is not directly relevant to the issue of whether it is safe to dose insulin solely using a device potentially susceptible to large intermittent inaccuracies. Inaccuracies in blood glucose meters can lead to insulin-dosing errors,2 and large inaccuracies in CGMs raise the same risks. The risks from severe hypoglycemia or hyperglycemia resulting from an erroneous glucose measurement were illustrated in the Supplement to my article, which presented 100 illustrative cases of reported device inaccuracy including 37 cases of loss of consciousness, 8 accompanied by seizures, 4 car crashes, and 4 hospitalizations for diabetic ketoacidosis. Many others were near misses. Almost all of these incidents occurred during the time when device labeling was still advising users to confirm CGM readings; however, there is no reason to believe that there will now be fewer occurrences with the safety check removed. Two of the studies mentioned by Beck deal with a device and FDA decision other than the one discussed in the Viewpoint. The third study3 is said to demonstrate no increased risk, on average, from nonadjunctive use of CGMs in adults, but the study did not examine the importance of blood glucose confirmation in cases of inaccurate CGM values. Beck states that further studies are needed to assess the safety of nonadjunctive CGM use in children and adolescents. However, even before this study was published, the FDA had determined that nonadjunctive use of the Dexcom G5 CGM was safe and effective for patients 2 years or older. Beck concludes that “any added potential risk in dosing insulin based on use of a CGM alone seems acceptable compared with the potential benefit of more widespread CGM use.” However, this conclusion might not be acceptable to the individuals who experienced stays in an intensive care unit, car crashes, seizures, and loss of consciousness, particularly if such serious outcomes could have been avoided with simple precautions. Most persons living with diabetes who take insulin look forward to the availability of devices that can lift some of the burden of vigilance needed to avoid the hazards of hypoglycemia and hyperglycemia. Many such devices are currently being developed.4 The promise of relief from the strain of this constant vigilance would not be met if it were replaced with a need for constant vigilance for rare device malfunctions. The FDA has the opportunity to ensure that the sense of freedom promised by these devices is delivered. Alan R. Shapiro, MD, MSPH