Table 2

Analytic definition of a CGM-determined hypoglycemic event

1.  A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value below a threshold (such as <70 mg/dL, which is continued through the example but could be replaced by 60 or 50 mg/dL).
 a.  At least two sensor values <70 mg/dL that are 15 or more minutes apart plus no intervening values ≥70 mg/dL are required to define an event.
  a.i.  This accounts for a CGM device such as the Abbot Libre only having measurements every 15 minutes.
  a.ii.  This accounts for potential missing sensor values for devices that record a glucose concentration every 5 minutes.
2.  The end of the hypoglycemic event is defined as a minimum of 15 consecutive minutes with a sensor glucose concentration ≥70 mg/dL and ≥10 mg/dL above the nadir of the event (note: the latter requirement only comes into play if the nadir is 61–69 mg/dL).
 a.  At least two sensor values ≥70 mg/dL that are 15 or more minutes apart with no intervening values <70 mg/dL are required to define the end of an event.
  a.i.  This accounts for a CGM device such as the Abbot Libre only having measurements every 15 minutes.
  a.ii.  This accounts for potential missing sensor values for devices that record a glucose concentration every 5 minutes.
3.  When a hypoglycemic event ends, the study participant becomes eligible for a new event.