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Dexcom CEO Kevin Sayer, appearing on CNBC

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There's no doubt that dogging glucose monitors accept get over today's Delaware facto criterional of care for people with type 1 diabetes, who need to unendingly make insulin dosing decisions. Advocates are also working set to gain insurance coverage of CGM for people with type 2 diabetes. Smaller, cheaper, streamlined CGM devices coming soon will out-of-doors up the floodgates to thousands of people with prediabetes and, eventually, health-self-conscious consumers.

At the recent JP Morgan Healthcare conference in San Francisco, we talked with Dexcom CEO Kevin Sayer about how the San Diego-based CGM market leader is approaching these advances and planning to address "the next bounteous flourish of CGM."

Sayer says their first dictate of business is to center on building the economic case for widespread CGM use: "What is the time period drop for type 2s for meters and test strips? How does CGM meet in?" he asks rhetorically.

He points to data from a recent pilot study away Intermountain Healthcare in which 50 people with T2 diabetes used longstanding fingerstick meters and another 50 used CGM over the of course of a year. The annual cost nest egg with CGM clocked in at $5,000 a year per patient, based on hospitalizations, lab tests, drug costs, doctor visits, and follow rising calls — a huge cost reduction across the board!

Qualification CGM a true canonical of tending would mean that every person recently diagnosed with any sort of diabetes would be mandated by both their doctor and underwriter to use CGM.

Sayer notes that the latest emphasis on Time-in-Chain (TIR) means that CGM becomes a diagnostic creature, that butt help many specific groups stoppage healthy.

"Will (Dexcom) go afterwards the hospital commercialise?… We don't currently know the outcomes in hospital settings. We would involve a service line first to gauge improvement," Sayer says.

"And the pregnancy grocery store? That totally makes common sense, and information technology's happening — pregnant women with T1D are being put on CGM routinely — but at that place's no official FDA labeling for that in time."

"We're focused right away connected the consumer market," atomic number 2 says.

"Our core client base is qualifier insulin users. We call for to create an port/platform that supports others," Sayer says.

Dexcom is of course working with Verily to codevelop its next-generation G7 sensor, a miniaturized, low-cost CGM that volition be ideal for a broader grocery — from type 2s, to prediabetes and on the far side. Pivotal medical institution trials are set to start on it presently.

The Sanofi-backed Onduo entity will add a coaching political program for users, as will Dexcom's latest partner, Livongo.

In developing the CGM device itself, Sayer says: "Over time, there will Be different experiences for different needs." For example:

  • An better liquidator-based platform as opposed to the phone app — "because some just want the receiver as a medical twist"
  • An pick for hyperglycaemia (high blood sugar) alerts only when — "because hypodermic (low) alerts are not meaningful for some users"
  • Maybe a target roam of 70-150 mg/decilitre entirely, for those whom it would suit better

Importantly, Dexcom is shooting for outstretched wear in their next-generation CGM sensors — ideally 14 days operating theater longer. That will be at least a 4-day melioration over the ongoing G6 sensors that are FDA-approved for 10-day wear.

We had to ask about how the cutis adhesive might stick up to longer wear, considering that many users struggle with that already. Many use "overpatch" products sold by third parties just to get a full workweek of wear (a huge array is now available for purchase online.)

"We're spending lot of money doing tape research right now. G7 will have stickier tape made of different materials. And we're considering adding overpatches correctly in the product packaging," Sayer says.

This is serious because with a small platform, the tape does affect around more, he notes. "If the sensor were big and wide, the tape would detain put. That's a challenge we're dealing with."

Meanwhile, in an increasingly interconnected world in which CGM Acts as the backbone to new automated insulin delivery (AID) systems, assuring interoperability is key.

In 2018, Dexcom's G6 sensor was the first to receive Food and Drug Administration's new "iCGM" tag, which indicates that the product is interoperability-ready. The company will need to reapply for the iCGM naming with any early product generations.

Achieving this requires overlooking reliability standards and lots of data happening persevering see, which can slow down the blessing process, and can also require about difficult trade-offs.

Sayer notes that before iCGM, accuracy sounded against traditional fingerstick meters could personify off by adequate to 30 percentage. But the new, tighter performance standards mustiness be 99.1 percent on point — allowing for error in just 10 out of every 1,000 data points.

"That's why the G6 sensor shuts cancelled oft — it does so intentionally ­when that standard is not met, meaning the readings are not accurate enough per FDA requirements," Sayer says.

Clearly, regular closed-offs are not something they want to carry over into their new G7 product.

If thousands of new CGM users do come on board atomic number 3 hoped, how will Dexcom handgrip the incredible cargo connected client service, we wondered? Not to mention the increased workload connected their data servers, which famously crashed twice in the last class.

"In 2019, Dexcom created a full Customer Service Department — alternatively of just our original 'Customer Precaution' building block — that's led by VP of Global Marketing Chad Patterson," Sayer says.

"We today have a war room where we hash knocked out every single gradation a patient has to take to get on a Dexcom and use it… We think more or less: How can we make this simpler? What steps prat we eliminate?"

"We've explored every single thing imaginable to try to make this easy for people."

In response to the outages, Dexcom plans to introduce a Server Position website/app where users give notice check the status, and find push on warnings of any data sharing issues. Ideally, they'd as wel corresponding to create a "Sensor Condition Sensing element" that could equal built right into the sensor ironware, that could alert users instantly to any troubles with their device. Although drop-off would not be detected, Sayer notes.

They were looking at doing away with the code that users have to put down when inserting a new sensor. Merely they found that with that omission, the system would lose one half-point of accuracy, which is non OK for iCGM requirements.

Another way they'atomic number 75 looking a simplifying the user experience is aside reducing the warmup time. While the Dexcom G6 currently has a 2-hour warmup, they're aiming for reasonable 1 hour with the G7. "Or could we even get it down to 30 proceedings? We're looking potential impact of that," Sayer says.

They're also aware that PWDs (mass with diabetes) considering using connected Assistance systems may be concerned about client serve departure forward. If the scheme consists of a CGM, an insulin ticker, and a controlling algorithm, which manufacturer bequeath bring on responsibility for troubleshooting? Might customers get caught bouncing between call centers?

Sayer says they've worked that out well in their early integrations with the OmiPod and Tandem insulin pumps by clearly defining roles. "OmniPod owns the system running on their hardware, and then they only call us if they ass't resolve an publication… And we've trained the Tandem citizenry to manage just about issues in calls," he says.

Unitary of Dexcom's boastfully goals to simplify the CGM market going forward would be a different payment fashion mode. In an ideal world, that would be a subscription model in which customers pay flavorless fees to experience a certain sum of money of supplies transmitted to them per month, contingent on their needs.

"We've observed that 80 percent of hoi polloi don't call for more than 6 extra (replacement) sensors per year, so a convinced come of extras could be included up nominal head," he says.

While the idea is imploring to industry and patients, there are some Major roadblocks. For one thing, U.S. pharmacies and drugstores are currently not localize up to wield a pay-arsenic-you-hug dru model. Customers have to invite out each dealings (medication or supply) separately. Thither's also the concern that some users would finished-consecrate their CGM supplies and then turn roughly and sell them on eBay or elsewhere. That would exist difficult to police.

In citing the advantages of a subscription model, Sayer laments the "gaga apparatus" of our American healthcare system. Information technology's the only industry that has to somehow:

  • Market to doctors
  • Ship to customers
  • Commission insurance companies

Their incentives are not allied, which makes for a destiny of contention and inefficiency.

Finally, we asked Sayer for his thoughts on the galore competing CGM products happening the horizon, including several 12 companies developing not-invading glucose monitoring.

Dexcom is presently not exploring non-intrusive technology, he tells us. Overall, Dexcom's philosophy is "the more the merrier" to build out this commercialise.

His final, radical-practical note is that to succeed, some new CGM will have to:

  • Follow more convenient
  • Price less
  • Perform well, in carnal knowledg to active systems