- February 28, 2017 San Francisco, 9 a.m. / New York, Noon / London, 5 p.m. / Paris, 6 p.m.
- March 2, 2017 New York, 9 a.m. / London, 2 p.m. / Paris, 3 p.m.
By Omar Ford, Staff WriterDiabetes patients could receive more benefit from more noninvasive approaches to checking for glucose levels than the traditional finger-stick method. Abbott Laboratories Inc. released data from a study showing patients who scan more frequently with the company's Freestyle Libre system spend less time in hypoglycemia or hyperglycemia while having improved average glucose levels. The real-world data findings were presented at the Advanced Technologies and Treatment for Diabetes congress in Paris, last week. The full data set was generated from 50,831 readers, which were used to scan 279,446 sensors. According to the data, people with diabetes using the Abbott Park, Ill.-based company's 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 finger stick technique. "With the real-world data this gives us a chance to confirm a lot of those observations from [past clinical studies] particularly around how often people are checking their glucose with the device and how that's different than with traditional glucose monitoring," Tim Dunn, principal clinical research manager from Abbott's diabetes care business, told Medical Device Daily. Results also show that average glucose levels decreased as scan rates increased with estimated HbA1c decreasing from 8 percent to 6.7 percent. The results also show that time spent below glucose levels of 70, 55 and 45 mg/dL decreased by 15 percent, 40 percent and 49 percent, with the use of the device. Time above 180 mg/dL decreased from 10.5 to 5.9 hours per day, according to the study. 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 firm's device has CE mark, but the product isn't available to the general public in the U.S. yet. "We received U.S. approval for the professional use version of Libre in 3Q16, and we look forward to bringing the consumer version of Libre to the U.S. market in the second half of this year," said Miles White, Abbott's chairman and CEO, during the company's most recent earnings call. The Freestyle Libre system helped drive sales of Abbott's diabetes division, which brought in about $1.1 billion last year. Jeffrey Holford, an analyst with Jefferies said the anticipated approval and launch of the U.S. consumer version of Freestyle Libre and ongoing launch in Europe "are key drivers of double-digit sales growth" within the diabetes care business. Libre is also a device that could give Abbott a much greater lead over its competitors in the market, said company executives. "We have a unique position here with Libre that is a completely different product that eliminates the need for that finger stick and gives a continuous glucose read that's, frankly, impactful for the patient, both type 2 and type 1, in a very different way," White said. "I think that puts us in a unique position to see a transformation of that market and to benefit from it, if not lead it." Abbott's biggest challenge could come from San Diego-based Dexcom Inc., which has developed a sensor that can be placed just underneath the skin to measure glucose levels. Last month, Dexcom reported results from the Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD) study. Data published in the January 24 issue of the Journal of the American Medical Association, showed Dexcom CGM System users on MDI achieved a 1 percent average A1C reduction after 24 weeks of regular use, compared to baseline. Abbott said Libre has an advantage over Dexcom's technology, which is already available on the U.S. market. "What really separates Libre is it doesn't require two needle sticks per day to keep it calibrated the way Dexcom or other CGMs do," Dunn told Medical Device Daily. "The Libre also operates up to 14 days, which is longer than any CGM."
UNDER FIRE FROM SEC The Zeltiq deal comes at the same time as Allergan has been sharply criticized by the Securities Exchange Commission over the way it calculated its adjusted earnings per share. The SEC's letter to Allergan was made public last week, and the agency noted it would consider issuing additional guidance on tailored financial measures. The calculation of adjusted earnings per share is a metric that doesn't conform to U.S. generally accepted accounting principles; such figures are known as non-GAAP. The agency has been moving forward with its efforts to curtail the use of tailored accounting. As a result of the measure, many company executives have changed their presentation of results and cut back the use of adjusted figures.