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Results from a six-month study called IMPACT showed patients using Abbott Laboratories' (ABT -1.1%) continuous glucose monitor, FreeStyle Libre, reduced the time spent in hypoglycemia (low blood sugar) 38% compared to traditional systems that rely on self-monitoring of blood glucose (SMBG) via a finger-stick blood sample. The data were presented at the 76th Scientific Sessions at the American Diabetes Association meeting in New Orleans, LA.
- IMPACT's primary endpoint was the difference in number of hours per day in hypoglycemia (<70 mg/dL) between the FreeStyle Libre cohort and the SMBG cohort from days 194 - 208. 252 adults participated in the study across 23 sites in Europe.
- Key findings included a 38% reduction in time spent in hypoglycemia, a 40% reduction in time spent in nocturnal (11 pm - 6 am) hypoglycemia and a 50% reduction in serious hypoglycemia (<55 mg/dL). In addition, there was no increase in HbA1c at month 6.
- FreeStyle Libre consists of a small round sensor worn on the back of the upper arm for up to 14 days, measuring glucose in interstitial fluid every minute through a small filament (5 mm long, 0.4 mm wide) inserted under the skin and held in place with a small adhesive pad. A smartphone-sized reader is scanned over the sensor to obtain a glucose result almost simultaneously.
- The device was approved in Europe in September 2014. Its marketing application was submitted in the U.S. in August 2015. Approval is expected later this year.