Abbott today announced the results of real-world use data showing that people who scan more frequently using Abbott′s FreeStyle® Libre system spend less time in hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) while having improved average glucose levels. According to the data, more than 50,000 people with diabetes using the FreeStyle Libre system checked their glucose levels an average of 16 times per day—which is three times more than the minimum recommended U.S. and European guidelines for testing with the traditional fingerstick technique. The data show that higher rates of scanning with the FreeStyle Libre system were found to be strongly associated with improved glucose control.
"There is now substantial evidence from both real-world usage and clinical studies that reaffirms the powerful impact of the FreeStyle Libre system," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "The FreeStyle Libre system is changing how diabetes has been managed for decades, with one simple swipe. Most importantly, we’re doing that by empowering patients with the information that they need to take action themselves, helping people living with diabetes live fuller, healthier lives."
Abbott′s FreeStyle Libre system consists of a small, round sensor worn on the back of the upper arm for up to 14 days, which measures glucose every minute in interstitial fluid through a small filament that is inserted just under the skin and held in place with a small adhesive pad.
The FreeStyle Libre reader is scanned over the sensor to get a glucose result in less than one second.
The real-world data findings were presented today at the Advanced Technologies and Treatment for Diabetes (ATTD) congress in Paris. The data shows a strong link between real-world use of FreeStyle Libre system and glucose control. The full data set was generated from 50,831 readers, which were used to scan 279,446 sensors. This constituted 409.4 million glucose measurements, 86.4 million monitoring hours and 63.8 million scans – representing more than 50,000 FreeStyle Libre users across the Europe region.
Key findings of the real-world data of the FreeStyle Libre system:
- More scanning: Users checked their glucose levels an average of 16.3 scans per day
- Across the spectrum of scan rates seen in the population, the following trends were observed as scan rates increased:
- Improved HbA1c: Average glucose level decreased as scan rate increased with estimated HbA1c decreasing from 8.0 to 6.7 percent
- Reduction in hypoglycaemia: Time spent with glucose levels of 3.5, 3.1 and 2.5 mmol/L decreased by 15 percent, 40 percent and 49 percent, respectively.
- Reduction in hyperglycaemia: Time above 10 mmol/L decreased from 10.5 to 5.9 hours per day
- Increased time in range: Time in glucose range (3.9 – 10 mmol/L) increased from 12.0 to 16.8 hours per day
Empowering Patients with Actionable Information
According to a published report in Patient Preference and Adherence people test with traditional self-monitoring methods (pricking a finger with a lancet to get a blood sample) less than three times per day, which falls short of U.S. and European guidelines that recommend four to eight self-tests per day. People with diabetes cite the biggest obstacle to more frequent monitoring is the pain and hassle of routine fingersticks.
But when people with diabetes don’t have a clear picture of their glucose levels from regular monitoring, complications such as hypoglycaemia can become life-threatening and require hospitalization, which can lead to a significant increase in healthcare costs.
Abbott's FreeStyle Libre system, which was introduced in Europe in 2014, removes the need for routine fingersticks. In addition, FreeStyle Libre system is factory calibrated—meaning that it does not require a fingerstick test for calibration (a test requiring a blood sample to reset a system's accuracy) unlike continuous glucose monitoring systems, which require two or more fingersticks per day to remain accurate.
"My experience with the FreeStyle Libre system through daily clinical practice and research studies has been very positive," says Ramzi Ajjan, M.D., University of Leeds, U.K. "Patients report that the system helped them gain a better understanding of their glycaemia by enabling multiple daily glucose checks discreetly and conveniently. The system’s painless nature of glucose testing are praised by patients with one commenting to me, 'you saved my fingers.' The real-world data further confirms that patients are checking glucose more frequently, up to 16 times per day on average, which is cumbersome to maintain with the conventional fingerstick method. With comprehensive glucose data, patients now have access to more meaningful information key for optimizing their glycaemia control."
Real-World Usage Supports Randomised Controlled Data of the FreeStyle Libre system
The new real-world data presented at ATTD further support the conclusions of the randomised controlled clinical studies conducted by Abbott with the FreeStyle Libre system including the IMPACT study published in The Lancet in September 2016.
Key findings of the IMPACT trial included (The FreeStyle Libre system users versus traditional SMBG):
- Glucose monitoring increased to an average of 15 scans per day
- 38 percent reduction in time spent in hypoglycaemia (<3.9 mmol/L)
- 50 percent reduction in serious hypoglycaemia (<3.1 mmol/L)
- 40 percent reduction in time spent in nocturnal hypoglycaemia at night (11 p.m. to 6 a.m.)
- No increase in HbA1c at six months
Currently, FreeStyle Libre system is available in more than 30 countries around the globe and is being used by more than 250,000 people living with diabetes. In the U.S., the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration.