Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes.
This week, Dexcom won FDA approval for its latest continuous glucose monitor. The G6 system is the first of the company’s that does not require a finger-prick for calibration and is also cleared as “fully interoperable” with other medical devices, like insulin pumps and decision support software.
“This Gen 6 system brings to fruition all that I envisioned when I first saw a sensor in the 90’s,” Sayer told Drug Delivery Business News.
The G6 CGM is rooted in a philosophy that has shaped Dexcom since the company first launched, the CEO explained. He pointed out that the company has always looked for ways to make its technology interoperable – its CGM was the first to connect to a user’s phone.
“That really triggered a lot of this line of thought,” Sayer said.
With its latest regulatory win, Dexcom managed to carve out a unique approval that’s the first of its kind from the FDA for glucose monitors. Sayer explained that the move to pursue a “fully interoperable” clearance from the agency was a joint effort from regulators and the company.
“We’re treading new ground,” he said. “It’s the most different thing we’ve ever done.”
The G6 system, which has been in the works at Dexcom for several years, features a redesigned applicator that inserts a small sensor just below the user’s skin. The sensor continuously measures glucose levels and sends the data to a display device via a transmitter, which can be worn for up to 10 days.
The new platform’s transmitter was designed with a 28% lower profile than the G5 system, Sayer explained, because patients wanted a more comfortable, less bulky option to wear throughout the day.
The monitor includes customized alerts to warn users if their blood sugar levels are climbing dangerously high or falling below the desired range. The G6 system also provides accurate glucose readings for patients taking up to 1000-mg doses of acetaminophen – the drug usually artificially inflates CGM readings.
Dexcom is taking a collective breath now that the G6 system is approved, Sayer said, but the company is also charging ahead with a commercial launch later this year and more work to demonstrate the economic and health outcomes tied to its devices.
The San Diego, Calif.-based company has established partnerships with Eli Lilly (NYSE:LLY), Tandem Diabetes Care (NSDQ:TNDM) and Insulet (NSDQ:PODD) – all of which are working on automated insulin delivery systems. The ability to integrate diabetes-related tech will be a crucial component of diabetes care in the near future and it’s something that Dexcom users have been asking for, according to Sayer.
The CEO also wants more diabetics to adopt continuous glucose monitoring into their routine, so Dexcom has been working to make its device less complex and more accessible to a broader patient population.
“This is just the beginning,” Sayer said.