India approves professional version of FreeStyle Libre – April 2, 2015

Abbott announced earlier today the approval in India of FreeStyle Libre Pro, the professional version of its flash glucose monitoring system. The announcement marks India’s Central Drug Standard Control Organization as the first regulatory body to approve the professional-use device, which will be made available in the “coming weeks” in six Indian cities. The Pro is approved for 14-day wear and is designed to record glucose levels every 15 minutes over the two-week period (~1,340 data points). As background, this stands in contrast to the consumer version that takes readings more frequently – on the order of once/minute – which is why the sensor must be scanned with the touchscreen reader every eight hours. We are unsure what fraction of Indian providers actually prescribe professional CGM (probably very low); we believe the technology could give clinicians an opportunity to become acquainted with the latest generation of technology and access to comprehensive data rarely available in India. Indeed, a recent survey (n~1,500) conducted by the Association of Physicians of India (and sponsored by Abbott) has shown that adherence to BGM testing in India continues to be challenged by cost, culture and understanding of the need – for example, close to 60% of patients reported that the ideal frequency of monitoring, in their view, was just once a month. We are hopeful that CGM-like data, especially the pattern recognition in Abbott’s Ambulatory Glucose Profile, could bring value in optimizing patients’ therapy by helping providers feel more successful and making the invisibility of diabetes more tangible to patients. That too, we wonder whether the approval could expand Libre’s long-term market as this will give patients a taste of what such technology is like. Ultimately, it is positive to see Abbott pushing its pipeline forward, and we hope to see the Pro make its way to the US and UK markets in the near future. As a reminder, Abbott began recruiting participants for a US pilot study of the Libre Pro earlier this year ( Identifier: NCT02336945), and we continue to await results.