The primary focus of the event was whether the performance standard currently in place is sufficient, and whether tighter controls would make a difference in how well patients are able to control their blood glucose levels. While the meter accuracy accounts for only one of many contributing factors to good glycemic control, the general consensus was that the performance standards should be increased. For home use self monitoring it was generally felt that a tightening of the specification to within 15% was justified. Additionally, it was suggested on multiple occasions that the 5% of readings that were not accounted for in the ISO specification be recorded and graded in some fashion.

However, when these devices are used in a hospital critical care environment, it was generally felt that an even tighter specification was justified. Aggressive glycemic control (which is becoming a more-common practice in hospitals) requires frequent and very accurate blood glucose measurements especially in the lower glucose ranges.  Here the general consensus was that there should actually be two specifications depending on the intended use of the devices (SMBG or clinical). The specification should also include a standard protocol for measuring and reporting interferences.  Standard reporting of interferences would allow customers to better judge the meter appropriate for their patient population.

The move towards tight glycemic control has been shown to have clear patient benefits.  "At issue, is what is a reasonable clinical glucose target, and what is the protocol for reaching that target," says Mark Vreeke, who attended the meeting. Vreeke is a partner at Rational Systems (Houston, TX).

None of the questions on specifications were answered fully, nor did FDA discuss an official timeline for the agency to make these decisions.