Last week, we sat down with Dexcom CEO and president Kevin Sayer on the exhibition floor of the American Diabetes Association 79th Scientific Sessions in San Francisco to discuss the current state – and the future – of continuous glucose monitoring technology. Dexcom’s current model, the G6, was released a little over a year ago, and remains one of the leading products in the $500 million CGM market.
The G7, their new sensor product, is projected to launch late in 2020, and Dexcom promises it will be the “thinnest CGM ever.” If so, it will continue the trend of the company’s willingness to redesign its CGM line to make improvements.
“The G6 was a complete change from G5,” said Sayer. “Everything about it is different from what we’ve done before, other than the membrane manufacturing process on the center itself. We just went through a mass overhaul, which has lead to a great product and a lot of growth for our company.”
One of the G6’s major features is factory calibration, which represents a dramatic change in sensor usage and lifestyle for many CGM users. For those not familiar with the technology, a factory-calibrated CGM doesn’t require fingerstick calibration in order to deliver blood glucose information – it begins recording blood sugars as soon as it’s inserted.
“No calibrations, with easier insertion, the smaller form factor, accuracy and performance of the system – patients really love this product,” said Sayer.
Growing and embracing new technologies
No product launch – from a new smartphone to a brand-new medical device – will ever go 100 percent according to plan. A new sensor system comprises a variety of separate components, all of which need to work both independently and collectively in order for the system to function correctly. Beyond the core sensor technology, there are the Bluetooth transmitter and receiver, the insertion system, software packages, and even simple adhesives.
The development and release of the G6 hasn’t been without its stumbling blocks, which the company hopes will inform the rollout of the G7. One of the main concerns has been a simple supply and demand question – with patients seeking ever-rising quantities of supplies, Dexcom’s new facilities haven’t always kept up with manufacturing and shipping the necessary parts.
“We launched this product just a year ago and the demand for the product has just been enormous. We’ve had trouble keeping up from time to time,” Sayer told us. “We tackle those issues as they come up … that’s been a process for us.”
Building a new generation of CGMs
With products such as the G7, Dexcom is beginning to run up against some of the limits of miniaturization and balancing technology, usability, and cost.
One of the challenges that many people with diabetes need to face is dexterity and usability. As components and devices get smaller and lower-profile, they may become more difficult for some people to use, or more delicate overall.
In addition, there’s the issue of power generation and consumption, and how that relates to device construction. For example, Sayer points out, the battery fueling the G6 transmitter actually generates enough power to run for three months – yet the sensor itself only runs for about two weeks, due to the fundamental limits behind the chemistry and biology of glucose sensing technology.
“As we look at in the future, to G7 and past G7, if you look at the electronics innovations coming – there are flexible batteries or even smaller power sources, “ said Sayer. “We have some interesting decisions to make in the future. How small does it really have to be?”
Still, Dexcom believes patients will embrace many features of the new G7, including a significantly lower cost, disposable transmitters, factory calibration, and the smallest profile on a CGM yet; as thin, they say, as a penny.
They aren’t done working with the G6 yet, though – just last week in an interview with CNBC, Sayer hinted at an upcoming collaboration with Apple will result in a CGM that communicates directly with the Apple Watch, rather than working through a smartphone.
Access and affordability for diabetes technology
Cost and access to care remain fundamental to every conversation about people with type 1 diabetes today. The most fantastic and accurate technology in the world doesn’t help much if you can’t afford to purchase it, or if your insurance – or lack thereof – make resupplying prohibitive.
“I think CGMs [are] still too hard to get. We live in a durable medical equipment world for CGM, with all the steps patients have to go through to get the system, depending on the insurance carrier,” explained Sayer. “I was traveling with one of our sales reps, and the program that’s the biggest program in his area requires the patient to document several instances where their blood sugars went below 50 before they’ll give you a CGM. Parents literally … give their kids too much insulin and stick their fingers till they get a measurement below 50, and they have to document this.”
Issues like these crop up over and over people with type 1 diabetes, making access to insulin, pumps, and other technologies equally difficult. There will need to be a concerted effort across all of the involved parties, from government and insurance agencies, to PBMs and device manufacturers, in order for patients to get access to the treatments and therapies they need.
Innovation and the future for CGMs
Across the medical device and clinical communities, there’s a broad consensus that CGM technology is vital for people with type 1 diabetes. For example, CGMs form the linchpin of any functioning “loop” system or research.
That’s why so many in the community were elated when Tidepool – a nonprofit organization that provides free software and applications to help people optimize their devices and data – announced their partnership with both Dexcom and Medtronic to work together to bring the Tidepool Loop to market. Loop, currently in development as a hybrid closed-loop insulin delivery system, could mark a major step forward for both diabetes technology and interoperability between different platforms and companies.
“We’re certain [the FDA] will give the device and technology approval based on mostly Dexcom patients,” said Sayer. “We had to take a little time to figure out how the relationship will work from a legal and contractual perspective. We get through all that, I think it’s pretty exciting!”