Table 1

Proposed glucose levels when reporting hypoglycemia in clinical trials

Level 1
A glucose alert value of 3.9 mmol/L (70 mg/dL) or less. This need not be reported routinely in clinical studies, although this would depend on the purpose of the study
Level 2
A glucose level of <3.0 mmol/L (<54 mg/dL) is sufficiently low to indicate serious, clinically important hypoglycemia
Level 3
Severe hypoglycemia, as defined by the ADA (6,7), denotes severe cognitive impairment requiring external assistance for recovery