Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.

"Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (CGM)," Dr. Timothy Bailey, director of the AMCR Institute and clinical associate professor at UC San Diego, said in a statement from Medtronic. "Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia."

The Guardian Connect system consists of the Guardian Sensor 3 and attached transmitter, which sends continuously-collected glucose data via Bluetooth to the Guardian Connect app on a user's smartphone. The app can alert patients about high or low blood sugar 60 minutes in advance of a hyper- or hypoglycemic event.

"The FDA approval of the Guardian Connect system fills a key gap that exists in diabetes treatment today - how to predict dangerous glucose highs and lows so they can be potentially avoided," Annette Brüls, president of diabetes service and solutions at Medtronic, said in a statement. "With predictive alerts and the Sugar.IQ assistant, the Guardian(TM) Connect system enables people to proactively manage their diabetes, so they can focus on living their life, not constantly worrying about their glucose levels."

The app includes the IBM Watson-powered Sugar.IQ recommendation system, which the company debuted and demoed at Health 2.0 in 2016. The system gives users personalized recommendations about diet and exercise based on their glucose readings and self-reported data. 

"The one question a person with diabetes is trying to answer is ‘How much insulin do I need right now?’ That’s the one question people have,” Huzefa Neemuchwala, senior director of data and informatics innovation at Medtronic, told MobiHealthNews back in 2016. “And that’s the one question the FDA will not let us directly answer because it depends on so many things. How did you sleep last night? Are you sick? Are you stressed out this morning? You know. What is your blood sugar? What is your historic blood sugar? There are so many factors that affect how much insulin you take right now. But if you bring in more and more of these data streams, you can get at that answer by saying ‘in a similar circumstance in the past, you took this much insulin, and this was your response.' That’s the closest you can get to a real answer.”

Guardian Connect has been available in Europe since it received its CE Mark in July 2016. Medtronic plans to launch the device in the United States between May and July of this year.