Abbott (ABT) Declared The Results Of Real-World Use Data

Abbott (ABT) recently declared the results of real-world use data showing that people who scan more frequently using Abbott′s FreeStyle®Libre system spend less time in hypoglycemia (low blood sugar) or hyperglycemia (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 FreeStyle Libre,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “FreeStyle Libre 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, assisting 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.

A reader is scanned over the sensor to get a glucose result painlessly[4] in less than one second.

The real-world data findings were presented recently at the Advanced Technologies and Treatment for Diabetes (ATTD) congress in Paris. The data show 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 raised:
    • Improved HbA1c: Average glucose level reduced as scan rate raised with estimated HbA1c decreasing from 8.0 to 6.7 percent
    • Reduction in hypoglycemia: Time spent below glucose levels of 70, 55 and 45 mg/dL reduced by 15 percent, 40 percent and 49 percent
    • Reduction in hyperglycemia: Time above 180 mg/dL reduced from 10.5 to 5.9 hours per day
    • Raised time in range: Time in glucose range (70-180 mg/dL) raised from 12.0 to 16.8 hours per day
  • Improved HbA1c: Average glucose level reduced as scan rate raised with estimated HbA1c decreasing from 8.0 to 6.7 percent
  • Reduction in hypoglycemia: Time spent below glucose levels of 70, 55 and 45 mg/dL reduced by 15 percent, 40 percent and 49 percent
  • Reduction in hyperglycemia: Time above 180 mg/dL reduced from 10.5 to 5.9 hours per day
  • Raised time in range: Time in glucose range (70-180 mg/dL) raised from 12.0 to 16.8 hours per day

Empowering Patients with Actionable Information
According to a published report in Patient Preference and Adherence[5] 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.[2] and European[3] 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[5].

But when people with diabetes don’t have a clear picture of their glucose levels from regular monitoring, complications such as hypoglycemia can become life-threatening and require hospitalization, which can lead to a noteworthyincrease in healthcare costs.

Abbott’s FreeStyle Libre system, which was introduced in Europe in 2014, removes the need for routine fingersticks — and the pain and hassles that come together with them. 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 other continuous glucose monitoring systems, which require two or more fingersticks per day to remain accurate.

“My experience with FreeStyle Libre 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 assisted 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.”

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