Abbott touts 38% hypoglycemia reduction in FreeStyle Libre study

Abbott (NYSE:ABT) today released data from the Impact study of its FreeStyle Libre glucose monitor, touting significantly reduced hypoglycemia in type 1 diabetes patients.

Data from the 328-patient trial was published in the journal Lancet, the company said.

The Impact study looked to assess the differences in levels of hypoglycaemia between patients using the FreeStyle Libre system and those using self-monitored glucose testing. Also reported was a 40% reduction in the rate of nocturnal hypoglycemia, a 50% reduction in serious hypoglycemia and no increase in HbA1c at 6 months.

“Time spent in hypoglycaemia was reduced almost immediately as sensor-based results became visible to participants (ie, before sensor results were reviewed with their clinician at study visits). This finding indicates fast adaptation to the device. Furthermore, it could suggest that real-time and glucose trend data, rather than retrospective analysis of the recordings, were predominantly used for proactive self-adjustments of glycaemic control,” study authors wrote.

Results indicated a 38% reduction in time in hypoglycaemia for patients using the FreeStyel Libre, with no device related hypoglycaemia or safety issues reported.

A total of 13 adverse events were reported by 10 particpants related to the Freestyle Libre, including 4 allergy events, 1 itching event, 1 rash, 4 insertion-site symptoms, 2 erythema and one oedema. Ten serious adverse events, 5 in each group, were reported by participants, though none were related to the device.

“In summary, use of the novel flash glucose sensor system resulted in a significant reduction in time and incidence of hypoglycaemia, without deterioration in HbA1c levels, demonstrating that the system is a safe replacement for self-monitoring of blood glucose and is highly acceptable to individuals with type 1 diabetes. For many individuals, hypoglycaemia is a barrier to optimum glucose control. Novel sensor-based systems to monitor glucose hold great promise as an effective alternative to conventional self-monitoring of blood glucose,” study authors wrote.

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