Abbott Diabetes Care shared some real-world evidence this morning at the International Conference on Advanced Technologies & Treatments for Diabetes, bolstering clinical trial data about the effectiveness of the company's Freestyle Libre device line.
"We’re certainly committed to sharing as much information as is possible with our users and our health providers in order to be able to make appropriate decisions around their diabetes management, and one of the important things along those lines is to show that the device doesn’t only have tangible benefits in clinical trials, which can be rather artificial settings of rather selected populations, but in fact apply to the broad range of users that are out there using the device on a daily basis," Abbott Diabetes Care Medical Director Dr. Mahmood Kazemi told MobiHealthNews.
The FreeStyle Libre system is notable because it doesn't require fingersticks to calibrate and it has a lower cost than other CGMs on the market. The user wears a tiny insertable sensor and a patch on their arm for up to 14 days. The patch records glucose data every 15 minutes and uses NFC technology to transmit the data.
For the FreeStyle Libre Pro, which just got US clearance in September, the doctor uses a special NFC reader at the end of the monitoring period. And while the doctor recieves 14 days of continuous monitoring data, they don't have access to that data until the end of the monitoring period. But for the European version -- and likely for future US versions -- the consumer can read the data with either a special reader device or with their smartphone.
"We think it certainly offers a much more user-friendly option for continuous monitoring, in the sense that it provides that data for individuals on demand," Kazemi said. "And it also does not provide what can be tiresome and distracting alarms, which many individuals who use traditional CGMs find undesireable and which they often try to silence or turn off."
The real world data, mostly of European users, spans two years and includes data from 50,000 readers and 285,000 sensors . It represents 86.4 million monitoring hours and 63.8 million distinct scans. What Abbott found was that users of the FreeStyle Libre system scan about 16 times per day on average.
"If you think about what we’re trying to encourage people to do with traditional blood glucose monitoring, you try to get them to test at least four times a day and that’s very difficult because it’s painful, inconvenient, it’s just not an easy thing to do," Kazemi said. "With the Libre device people are scanning on their own an average of 16 times per day, which is quite remarkable and a testament of how easy the technology is to use."
But even more interesting for the company are the other health benefits that correlate with increased scanning. Although they aren't able to prove causation, Abbott saw that there was a strong correlation between number of scans per day, time below 55 mg/dL, and estimated A1C. That average of 16 scans per day corresponded to an A1C of 7.1 and just under 35 minutes per day under 55 mg/dL, with those numbers going down as scans per day increased. They saw similar correlations for 45 and 70 mg/dL and for time spent above the recommended high ranges for blood glucose as well, Kazemi said.
In addition to receiving clearance for the Pro version, Abbott has submitted the consumer-use version of Freestyle Libre for FDA clearance and is waiting to complete that process.