According to the 2017 National Diabetes Statistics Report from the Centers for Disease Control and Prevention (CDC), approximately 30.3 million people in the U.S. have diabetes Type I and Type II. Of that total number, the CDC estimates 23.1 million people have been diagnosed which leaves 7.2 million undiagnosed: 23.8% of the total. Overall, 9.2% of Americans and 25.2% of those aged 65 and older have diabetes. About 90% of the cases are Type II diabetes. The large numbers and continued increase in this chronic condition drive new technology development for treatment and maintenance.
The FDA recently cleared the Medtronic Guardian Connect smartphone-connected continuous glucose monitor for use by patients who administer their own insulin injections. It may seem ironic that Medtronic’s iPro2 closed loop system, which combines a continuous glucose monitor and an insulin pump, received FDA clearance in 2016 while the standalone CGM only got the nod in early 2018. The reason for the iPro2’s earlier approval was the tight coordination between the two components to administer correct insulin dosages. New intelligent algorithms in the smartphone software that help self-injecting patients determine the proper insulin dosages led to the more recent Guardian Connect clearance. The “smarter” system design reports high or low blood sugar levels “60 minutes in advance of a hyperglycemic or hypoglycemic event,” according to Medtronic. This high degree of predictive accuracy helps patients reduce the risk of problems and increase the time with their glucose level in the target range.
FDA clearance for the Guardian Connect system doesn’t allow specifying insulin doses. However, an IBM Watson AI-powered system component helps patients determine a recommended insulin dosage based on their own previous readings and self-reported data. Artificial intelligence using sensor-monitored data in coordination with patient reporting has exciting potential to advance health care.