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Francine Kaufman Part 4, Guardian Sensor 3

In part 4 of this Exclusive Interview, Dr. Francine Kaufman talks with Diabetes in Control Publisher Steve Freed during the ADA meeting in San Diego, California, about the making of and effectiveness of the 670G sensors.

Dr. Francine Kaufman was named Chief Medical Officer and Vice President of Global Medical, Clinical and Health Affairs in April 2009. In this role, Dr. Kaufman is the key architect of the company’s global diabetes strategy, as well as a leading voice for multidisciplinary medical strategy across Medtronic.

Transcript of this video segment:

Steve: Well, the whole concept is really based upon the sensor. It does what the sensor tells it to do. So, it’s really matter of having a really high-quality sensor. Because I know sensors are not the easiest thing to develop and make and produce in mass scale. How do manage to get a high-quality sensor for every single patient?

Dr. Kaufman: So, we’re very committed to this. We have developed a new sensor. It looks like our sensor that’s on the market now but our new sensor, our Guardian Sensor 3, it’s not the same. It’s two generations from where we are now in the U.S., different chemistry, entirely different build, different assembly lines, and different substrates. So, we have spent a lot of time perfecting the sensor. There’s a new specialized chip in it that’s looking for sensors that are drifting and if it sees a drift or what would become an outlier, it asks for another calibration; we call it a Smart Cal. If it can be brought back, it will continue to run closed-loop. If it cannot, it will stop running closed loop, so there is that safety mechanism of his sensor self-diagnostics continuously looking for a sensor drift. Beyond that, we’ve done a pivotal trial. We’ve looked at the data from the use of 670 both in our pivotal, the pivotal sensor trial and now that use at home in the real world and the Mart is excellent with two to three calibrations a day. It’s exactly what we want to be, 10% or less. So, we feel very confident in the sensor. The people using it feel very confident as well and then we got that special chip. If it does start to not perform, it informs the individual and stops running closed-loop if it can’t fix itself.

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