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Self-monitoring of blood glucose is essential for managing diabetes. Over 30 different blood glucose monitors cleared by the U.S. Food and Drug Administration (FDA) are available to consumers. The FDA relies solely on data provided by manufacturers for clearance. Few physicians or diabetic patients are aware that blood glucose monitor test strips that are exposed to humidity and/or excessive temperature give falsely elevated results. Manufacturers know this, and the information they provide to patients obfuscates the problem; furthermore, the FDA does not require the reporting of environmental effects on accuracy. On more than one occasion, I administered excessive insulin based on results from the last few test strips from vials of 50 that had …
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Richard J. Melker (2003) studied this question.
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