Abbott, a global healthcare company, announced the results of the IMPACT clinical trial, which demonstrated that the FreeStyle Libre system met its primary endpoint of a reduction in time spent in hypoglycemia (low glucose levels, defined as <70 mg/dL1) for people with type 1 diabetes. People in the trial who used Abbott's FreeStyle Libre sensor and reader system spent 38 percent less time in hypoglycemia, as compared to people who managed their glucose with traditional self-monitoring of blood glucose (SMBG) systems (pricking a finger to draw a drop of blood that is added to a test strip inserted into a glucose meter). Data were presented at the American Diabetes Association's 76th Scientific Sessions.
or the first 14 days of the IMPACT study, the participants wore a FreeStyle Libre sensor but did not have access to their glucose results. During the next period, when participants had access to their data via the FreeStyle Libre reader, time spent in hypoglycemia was reduced by 33 percent within two weeks and was sustained by at least this amount (between 33 percent and 42 percent) throughout the study. Time in range (70-180 mg/dL) was increased by one hour per day versus SMBG.
Data from the trial also showed a significant increase in testing frequency with participants scanning their FreeStyle Libre sensors an average of 15 times per day. The FreeStyle Libre system has shown that it reduces time spent in hypoglycemia by 38 percent while also significantly reducing nocturnal hypoglycemia (<70 mg/dL; between the hours of 11 p.m. and 6 a.m.) by 40 percent. In addition, serious hypoglycemia (<55 mg/dL) was reduced by 50 percent. Throughout the study, results showed FreeStyle Libre users significantly reduced time spent in hypoglycemia without increasing HbA1c, showing that more frequent testing and a complete glycemic profile enables better diabetes management.
The IMPACT clinical trial is a randomized, controlled six-month trial to evaluate the effectiveness of the FreeStyle Libre system in improving glycemic control for the self-management of type 1 diabetes as compared to self-monitoring of blood glucose (SMBG). The primary endpoint was a difference in number of hours per day in hypoglycemia (<70 mg/dl) between the group using the FreeStyle Libre system and the group using traditional finger sticks (SMBG) from days 194-208. Two hundred and fifty-two (252) patients over the age of 18 participated in the trial, which took place across 23 sites in Austria, the Netherlands, Spain, Sweden and Germany.
Abbott's FreeStyle Libre system consists of a small, round sensor--approximately the size of two stacked quarters--worn on the back of the upper arm for up to 14 days, which measures glucose every minute in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad. A reader is scanned over the sensor to get a glucose result painlessly in less than one second. Each scan displays a real-time glucose result, an eight hour historical trend and the direction the glucose is heading.
In 2014, Abbott launched the FreeStyle Libre system in France, Germany, Italy, the Netherlands, Spain, Sweden and UK. It is now available in 11 countries in Europe, and recently launched in Australia and Brazil. A professional-use version called FreeStyle Libre Pro utilizes similar technology and is available in India and South Africa.
