I’ve been wearing the new Eversense implantable continuous glucose monitor since early December, and published a thorough initial product review here.

Three months in, with my 90 days’ wear coming to a close, I had the option to continue by getting a new sensor implanted, or not. I chose yes, based on the accuracy, reliability, and -- not insignificantly -- the wonderful respite this system gives me from

Today I’d like to share some of my additional personal experiences and also some official updates on this novel CGM system – including how to get help paying for it, and where to volunteer for clinical trials.

 

That Eversense “Ambient Light” Alert

When I was first inserted with Eversense, I do remember some cursory mention of an issue with bright light. But it wasn’t emphasized, and didn’t really come to life for me until I shed my winter sweaters for hiking gear in Palm Springs some weeks ago.

The timing was unfortunate, as I’d overestimated breakfast carbs and hit a low just as we were heading out for our first hike of the weekend. There we were on the sun-baked barren hills above Palm Desert, with me gobbling down skittles and checking the Eversense app every few minutes, when I suddenly got a new error message not seen before: “High Ambient Light.” Huh?

Apparently “No glucose reading can be displayed until ambient light is reduced.” Not a happy moment on the hiking trail -- Ack!

All I could think was: “This thing doesn’t work in direct sunlight, what the heck?!

I researched it later online and was reminded that the whole dang system is built on light.

“The Eversense Sensor is a patented miniaturized fluorometer that uses fluorescent intensity to measure glucose in interstitial fluid… A light emitting diode embedded in the sensor excites the polymer, and the polymer then rapidly signals changes in glucose concentration via a change in light output.”

I also spoke with Senseonics Senior Principal Scientist Carrie Lorenz, who explained the “High Ambient Light” alert this way:

“Think about it like sitting around a campfire and someone shines a flashlight in your eyes. It’s just too strong and for a minute you can’t see anything else… It’s a safety mechanism built into our algorithm that essentially says, this light is too bright and it’s blocking out the capability to see the light that matters, that’s related to glucose.”

She also explained that this alert goes “reading by reading, every 5 minutes,” meaning glucose readings should begin to appear again within a few minutes of being removed the ueber-bright area.

Senseonics’ Quick Start Guide suggests:

“If you experience an Ambient Light alert (more common in early wear), try moving away from direct light, covering the smart transmitter with darker clothing, or placing the smart transmitter slightly higher on the arm over the sensor.”

Note that the issue is with the implanted sensor and not the black Transmitter worn on the outside, so one tip I was given is that if you know you’ll be out in bright light, you can simply double-up white adhesive patches to give the sensor more shade. 

When I tweeted about the light interference being a potential major drawback, one savvy fellow Eversense user shot back:

“It's not, in my experience that alert is only a warning, doesn't really effect accuracy. Plus you can always use colored adhesive/tape to cover the sensor site and you're fine. It's not a big deal :)”

Gotcha, but still something to keep in mind if you live in a sunny place.

 

My Second Insertion

In early March, I went back to my doctor’s office to have the Eversense sensor removed from my left shoulder, and a new one inserted in the right.

I was told the doctor would start with the insertion first, specifically to keep everything ultra-sterilized: “clean work before the ‘dirty’ work of removing a substance from your body.”  Got it.

I was covered again with surgical drape, numbed up, and the procedure went quickly and smoothly with no pain.

Next I flipped over, and the drape and numbing injection were applied to my left shoulder. I was expecting and equally quick and easily procedure, but unfortunately it didn’t go that way. This was apparently my doctor’s first removal on a real patient – she had been practicing profusely on those prosthetic arms – and she just couldn’t seem to grasp the tiny sensor with the clamp provided. Numbed as I was, it just felt like a bunch of annoying poking and prodding, but after some long minutes, the position got pretty uncomfortable. My neck was stiff, and I was starting to get worried about scarring on my shoulder (which the team assured me shouldn’t be the case, as the incision remains tiny). Anyhow, they eventually gave up and patched me up with the sensor still in there.

Yes, you read that right: they could not get the sensor out. It can of course be removed at a later date, after my arm heals up and is ready for another go.

And yes, the thought of it stuck in there kind of freaked me out at first. The Eversense experts assured me that even if the sensor stayed in a body for life, it would do no harm, as it’s made of super-safe biocompatible plastic.

“When we started developing Eversense, we had to decide what to encase the electronics in… We found this plastic called polymethyl methacrylate (pmma) that had become embedded in the bodies of numerous World War II air force veterans after their planes had exploded. They had pieces in them for years with no reaction whatsoever,” Eversense scientist Lorenz tells me.

She notes that this plastic is now “universally common” and even documented as safe for cosmetic use.

OK, but I still cringed a bit when I came and told my daughter, “they couldn’t get it out” and her response was simply, “Ewwww.”

I’m not sharing this to scare anyone off – it’s simply my experience, which I am told by the Eversense team is quite rare.

I’m also told they are currently conducting sensor removal training in Las Vegas and elsewhere, teaching doctors to find the sensor using ultrasound, mark it, and then remove it quickly and efficiently. Good to hear.

 

Glooko-Eversense Integration

Have you heard that the Eversense folks have announced integration with the Glooko D-data platform? This means if you download the Glooko app on your phone, you can now simply choose the “Eversense” icon to link to your live sensor, where you can view 1-week, 2-week, 1-month and 3-month data sets.

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This is especially cool for Omnipod (tubeless insulin pump) users like me, as that device is also set up for easy integration with Glooko.

Now I can see my CGM averages alongside insulin average per day, time in target range and percent of highs and lows. By clicking on “See More,” you can also get granular and even break this information down by day. I’m excited to review this info with my doctor soon, as I’ve never had access to CGM and insulin dosing data side-by-side before.

 

Dr. Fran Kaufman Joins Eversense

Kudos to the company behind Eversense, Maryland-based Sensionics, for nabbing probably the most sought-after Chief Medical Officer in the diabetes world: Dr. Fran Kaufman, who “retired” as CMO of Medtronic just three months ago in December 2018.

At the time she said she wanted to focus on her writing hobby and spend more time with her family. One can’t help wondering if she was already in touch with Senseonics about opportunities there.

After all, implantable D-devices have always been a passion of hers, dating back to the implantable insulin pump Medtronic was working on but scrapped in 2011. (See the impromptu poll we ran at the time, asking patients how receptive they would be to an implantable device.)

That device was available for a short time in France, but according to Kaufman, it was “difficult to adopt” and the concentrated insulin formulation necessary to make it work was “still being developed and refined.”

“It is a complex device that requires meticulous attention and care. Refilling and readjusting it is a challenge. We're working to make the pump smaller and easier to adopt,” she wrote at the time.

Now, having championed the first hybrid closed loop system at Medtronic, Kaufman has the opportunity to return to the implantable dream with Eversense.

Her statement in the press release unsurprisingly read:

“I am very excited to join the Senseonics team, especially at this point where I feel I have an opportunity to help lay the foundation for the first long-term implantable continuous glucose monitoring system.”

As noted, kudos to upstart Sensionics for nabbing such a respected veteran MD and med tech expert!

 

“Bridge Program” to Offset Insurance Denials

In their Earnings Call last Tuesday, Senseonics revealed a new “Patient Access Bridge Program” to help overcome delays in insurance coverage for this new system.

Note this is only for people with insurance, and not available to government patients or anyone living in the state of Massachusetts due to specific restrictions there.

Here’s how it works: 

VP and United States GM Mike Gill explains that while hundreds of insured patients are already working with their doctors to get on Eversense, they’re up against coverage denial by five of the country’s major insurers, who have erroneously designed the system as “E/I” aka, experimental / investigational:

  • United
  • Cigna
  • Humana
  • Anthem
  • HCSC (Blue Cross Texas, Illinois, New Mexico, Oklahoma, Montana)

“Even though we had a full panel FDA approval, they slapped the ‘E/I’ label on (Eversense) so are currently not covering it,” Gill says.

To combat this, the new Bridge Program basically offers patients a flat rate of $99 for all the upfront supplies – sensor, transmitter, adhesives, start guide – which normally out-of-pocket would cost about $1400.

Patients will still have to pay for the insertion procedure at their doctor’s rate (usually around $200).

So someone covered by United who is denied, for example, would end up paying just $299 for the whole shebang. Other insurers like Aetna may still require a 20% copay on supplies on top of the $99, but this Bridge Program puts the total price tag on par with other CGM systems, Gill says.

He also notes that the company cannot subsidize the insertion procedure itself, because that would be viewed as illegal “inducement” of doctors to prescribe a certain system. “What we can do is help patients with the supply costs,” he says.

 

Eversense Clinical Trials & Expanding Use

Eversense has several studies underway in Europe currently, and in the U.S. is recruiting patients for its PROMISE pivotal study that will gather evidence for 180-day use approval (as opposed the current 90 days). Trial sites are in California, Georgia, Texas and Washington state.

Note that you can volunteer for that study throughout the next few months, but you have to be an adult already working with your doctor on Eversense; they’re not just providing free sensors to anyone who steps forward. 

On the closed loop front, they’ve completed a study with the iLet Bionic Pancreas system being developed by Beta Bionics – a multicenter feasibility study using Eversense for the first the time in an AP system. Eighteen people were in that study, and they plan to reveal results at the big annual ADA SciSessions in June 2019.

Head of Sales Gill tells us the company has submitted their FDA review for “non-injunctive” designation – that provision stating that a CGM is accurate enough for dosing use without fingerstick tests as a backup. They’re hoping for this “dosing claim” in the first quarter of 2020.

They are also evaluating ways to get that black Transmitter off people’s shoulders (!)

One completed “House Study” so far in Romania looked at wear on the abdomen vs. the upper arm (wouldn’t that be nice?!). The company expects to present a research poster on patient preference on that also at the big ADA meeting this June.

But aren’t some people aren’t testing out alternate sites “off-label”? we asked.

Gill essentially says the manufacturer is not policing that. In fact, in their post-approval study for the 90-day sensor, “if a physician decides to go off-label, we just ask that they record that information.”

And while they’re not recruiting specifically for this purpose, in the post-approval study they’ll also be recording experiences of patients with different skin types – African American, Latin American, and white PWDs. (Think Ambient Light issue, mentioned above).

Senseonics says it currently has 60 million "covered lives," meaning insured patients who have access to Eversense in the U.S., and has a goal of reaching 100 million by the end of 2019. Over 250 physicians have written prescriptions for Eversense CGM, and they hope to expand use by certifying Nurse Practitioners and Physician Assistants in both the U.S. and Europe to insert and support the system.

I’m pleased to be among the early majority.

 

{DISCLAIMER: For the next few weeks, I will be doing some limited consulting work for Senseonics, being compensated to provide detailed user feedback.}