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June 14, 2016

Abbott reports positive Impact trial results for FreeStyle Libre to treat hypoglycemia

US-based healthcare firm Abbott has reported positive results from its Impact clinical trial of FreeStyle Libre system to treat hypoglycemia in people with type 1 diabetes.

US-based healthcare firm Abbott has reported positive results from its Impact clinical trial of FreeStyle Libre system to treat hypoglycemia in people with type 1 diabetes.

The trial showed that the FreeStyle Libre system met its primary endpoint of a reduction in time spent in hypoglycemia in these patients.

FreeStyle Libre system is a small, round sensor worn on the back of the upper arm for up to two weeks.

A small filament is inserted under the skin to measure glucose every minute and is held in place with a small adhesive pad.

A reader is scanned over the sensor to provide a quick and a painless glucose reading.

"Hypoglycemia is the main barrier to attaining optimum glucose control in persons with insulin-treated diabetes."

IMPACT is a randomised, controlled clinical trial held over a duration of six months and involved 252 patients over the age of 18.

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The study was designed to assesss the effectiveness of the FreeStyle Libre system in improving glycemic control for the self-management of type 1 diabetes, compared to self-monitoring of blood glucose (SMBG).

It focused on measuring the difference in number of hours per day in hypoglycemia between the group administered with the FreeStyle Libre system and the group using traditional finger sticks.

IMPACT study chief investigator Karolinska Institutet FRCPE Jan Bolinder said: "Hypoglycemia is the main barrier to attaining optimum glucose control in persons with insulin-treated diabetes.

"Moreover, hypoglycemic events can not only lead to adverse clinical outcomes including cardiovascular events and death, but they can also incur significant emergency healthcare costs.

"This clinical trial has proven that patients will test more often when they have an easier and more convenient way to do so utilizing a device like FreeStyle Libre, leading them to ultimately being healthier, which is our goal for our patients."

Data from the study exhibited the ability of the FreeStyle Libre system to reduce all measures of hypoglycemia without increasing HbA1c when compared with SMBG.

HbA1c is an average measurement of glucose levels in the blood over the past 90 days, typically understood to be the ‘gold standard’ of measuring overall glucose control.

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