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In This Issue of Diabetes Care

A joint position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes in this issue of Diabetes Care details the recommendations of the International Hypoglycaemia Study Group (IHSG) (p. 155) for the inclusion of the frequency of detection of blood glucose concentrations <3.0 mmol/L (<54 mg/dL) in reports of clinical trials of glucose-lowering drugs for diabetes. According to the IHSG, this level of blood glucose is important as it unequivocally represents a level that is “clinically signifi cant biochemical hypoglycemia.” The defi nition of such a threshold should allow comparison of the effectiveness of interventions in reducing hypoglycemia and additionally permit meta-analysis as a tool to compare interventions. Based on this, the IHSG calls for all relevant publications on clinical trials of relevant drugs to include the number. The IHSG suggests that blood glucose concentrations <3.0 mmol/L do not occur in individuals without diabetes and so, therefore, unequivocally represent hypoglycemia. Additionally, the IHSG suggests that such levels cause defective glucose counterregulation as well as impaired awareness of hypoglycemia and that the level is associated with increased mortality in a number of major studies. Ultimately the study group agreed that a level of <3.0 mmol/L is suffi ciently low to indicate serious clinically important hypoglycemia. The ADA previously has not quantitatively defi ned a blood glucose level that represents hypoglycemia because the threshold likely varies between individuals. It has previously only loosely defi ned hypoglycemia as episodes of abnormally low glucose levels that expose an individual to harm and severe hypoglycemia as an episode additionally requiring another person’s help to recover. Commenting more widely on the statement and recommendations, the chair of the IHSG, Simon Heller said: “It is increasingly clear that hypoglycemic episodes that are not classifi ed as severe are associated with clinically important consequences including mortality. If the diabetes community can agree on an additional glucose level that captures this information, we can both calculate the clinical risk to patients and more effectively compare treatments and approaches that aim to reduce rates of hypoglycemia. This would be an important advance.”