Abstract
The pre-diabetes range is defined as an A1C higher than 5.7% and lower than 6.5%, a narrow range of only 0.8% wide. Because this range is very critical for the patient's health, accurately determining if blood glucose levels stay below 125 mg/ in fasting conditions is essential. This is first assessed through home testing, then confirmed by subsequent professional tests of higher accuracy, until a sufficient statistic is reached. Significant dietary changes, already recommended when blood sugar exceeds 100 mg/dL, become even more strict and mandatory when exceeding 125 mg/dL: home testing by the patients becomes daily to determine the necessary insulin dose, as opposed to the less frequent checks originally required for pre-diabetes (typically every 3 days, which are sufficient to create reliable statistics).
The Note primarily aims to summarise the lack of clarity that patients typically find in the use of tools and in the instructions provided for performing the above-mentioned tests. Some confusion exists even in the documents supplied with the test devices in the literature and online on this subject matter. Most of these materials do not align with the procedures regulating tests in measurement science, being that the focus of the Note.
Even key documents prepared by International Bodies, namely the ISO 15197-2015, are suggested in the Note as urgently requiring more specific information and guidelines, especially in the extremely critical pre-diabetes range (only 25 mg/dL wide), a condition shared by a large number of patients being exempt from the full disease and not classified yet as affected by it—a last stage that they might actually never reach in the rest of their lifetime.