I've been effortful the inexperient 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 non. I chose yes, based on the accuracy, reliability, and — non insignificantly — the wonderful respite this scheme gives Pine Tree State from alarm fatigue.

Now I'd like to contribution some of my additional personal experiences and also more or less official updates along this novel CGM system – including how to get help paying for it, and where to volunteer for clinical trials.

That Eversense "Ambient Light" Cognisant

When I was forward inserted with Eversense, I do call back some cursory mention of an progeny with bright friable. But it wasn't emphasised, and didn't really come to life for Pine Tree State until I throw off my winter sweaters for hiking gear in Palm Springs some weeks agone.

The timing was infelicitous, as I'd overestimated breakfast carbs and hit a low just arsenic we were drift out for our early hike of the weekend. There we were along the Dominicus-dry barren hills in a higher place Palm Desert, with me gobbling down skittles and checking the Eversense app every few minutes, when I on the spur of the moment got a new misplay subject matter non seen before: "High Ambient Light." Huh?

Apparently "Atomic number 102 glucose reading material can be displayed until ambient light is reduced." Non a happy instant on the hiking dog — 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 organization is built along light.

"The Eversense Sensing element is a patented miniaturized fluorometer that uses fluorescent saturation to measure glucose in opening 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 besides spoke with Senseonics Senior Of import Scientist Carrie Lorenz, who explained the "Senior high school Ambient Light" alert this way:

"Imagine 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 other… It's a safety mechanism made-up into our algorithm that essentially says, this light is too bright and it's block KO'd the capability to see the lightness that matters, that's side by side glucose."

She also explained that this awake goes "interpretation by reading material, every 5 minutes," meaning glucose readings should begin to appear over again within a few proceedings of being removed the ueber-bright area.

Senseonics' Nimble Get down Pathfinder suggests:

"If you experience an Close Visible radiation alert (Thomas More mutual in rude break apart), try moving away from direct light, covering the smart transmitter with darker clothing, or placing the cagy vector slightly higher on the arm over the sensor."

Take note that the issue is with the implanted sensing element and non the calamitous Sender waterworn on the outside, so one top I was tending is that if you know you'll be down in bright light, you commode just double-up white adhesive patches to grant the detector more shade.

When I tweeted about the light-footed interference being a expected prima drawback, one savvy fellow Eversense user nip back:

"IT's not, in my experience that lidless is only a warning, doesn't really effect accuracy. Plus you fundament always use colored adhesive/tape recording to cover the sensor site and you're o.k.. It's not a big deal :)"

Gotcha, but still something to hold in mind if you unfilmed in a sunny come out.

My Second Introduction

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

I was told the medico would start with the insertion first, specifically to keep everything immoderate-sterilized: "strip play before the 'dirty' exploit of removing a substance from your body."  Got information technology.

I was clothed again with postoperative drape, numbed up, and the function went quickly and smoothly with no bother.

Side by side I flipped over, and the drape and numbing injection were applied to my unexhausted berm. I was expecting and equally quick and easily procedure, but regrettably it didn't go that way. This was apparently my doctor's first removal along a real patient – she had been practicing copiously connected those prosthetic weaponry – and she just couldn't appear 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 beautiful uneasy. My cervix was stiff, and I was protrusive to get worried astir scarring happening my shoulder (which the team assured me shouldn't be the case, as the incision clay flyspeck). Anyhow, they eventually gave awake and patched me up with the detector static in there.

Yes, you read that right: they could not mystify the sensing element out. It seat of course be removed at a by and by escort, after my gir heals up and is ready for another go.

And yes, the thought of it stuck in in that respect kind of freaked me out at first. The Eversense experts secure Maine that eve if the sensor stayed in a body for life, information technology would do no harm, as it's made of super-safe biocompatible elastic.

"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 atmosphere force veterans after their planes had exploded. They had pieces in them for years with no reaction whatsoever," Eversense man of science Lorenz tells me.

She notes that this plastic is now "universally common" and even documented as secure for cosmetic use.

OK, but I tranquilize cringed a bit when I came and told my daughter, "they couldn't get information technology knocked out" and her response was simply, "Ewwww."

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

I'm too told they are currently conducting sensor removal training in Las Vegas and elsewhere, teaching doctors to find the detector using ultrasound, check off it, and past remove it quickly and efficiently. Smashing to hear.

Glooko-Eversense Integration

Have you detected that the Eversense folks have announced consolidation with the Glooko D-data platform? This means if you download the Glooko app on your headphone, you can now simply choose the "Eversense" icon to link to your bouncy sensor, where you can see 1-week, 2-hebdomad, 1-month and 3-month information sets.

Percentage on Pinterest

This is especially cool for Omnipod (tubeless insulin ticker) users like me, as that device is also set high for relaxed integration with Glooko.

Now I dismiss see my CGM averages alongside insulin moderate per day, time in target range and percent of highs and lows. Past clicking on "See Many," you can also get granular and even break up this information down by day. I'm excited to review this info with my doctor presently, atomic number 3 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 wanted Top dog Medical Officer in the diabetes humankind: Dr. Fran Kaufman, who "retired" as CMO of Medtronic just tercet months ago in December 2018.

At the meter she said she wanted to revolve around her writing hobby and drop more time with her family. One can't service wondering if she was already in tactual sensation 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 simply scrapped in 2011. (See the impromptu crown we ran at the time, asking patients how receptive they would be to an implantable device.)

That twist was usable for a short sentence in France, but according to Kaufman, it was "unenviable to adopt" and the concentrated insulin formulation needful to make it work was "still existence developed and delicate."

"It is a complex gimmick that requires meticulous tending and care. Replenishment and readjusting it is a challenge. We're practical to lay down the pump smaller and easier to adopt," she wrote at the time.

Now, having championed the first hybrid closed-loop system 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 put off the foundation for the first semipermanent implantable uninterrupted glucose monitoring system."

As noted, kudos to upstart Sensionics for nabbing such a respected old-timer MD and med tech adept!

"Bridge Course of study" to Get-go Insurance Denials

In their Earnings Outcry last Tuesday, Senseonics revealed a new "Patient Access Bridge Computer program" to help overcome delays in insurance policy coverage for this other system.

Note this is lonesome for people with insurance, and not available to government patients OR anyone living in the state of Old Colony due to specific restrictions there.

Here's how information technology whole works:

VP and America GM Mike Lamella explains that patc 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 take in erroneously designed the organisation equally "E/I" aka, experimental / investigational:

  • United
  • Cigna
  • Humana
  • Anthem
  • HCSC (Blue Cross Texas, Illinois, NM, OK, Treasure State)

"Even though we had a full panel FDA approval, they slapped the 'E/I' label on (Eversense) so are currently non coating it," Gill says.

To combat this, the recent Bridge Program basically offers patients a flat plac of $99 for all the upfront supplies – detector, transmitter, adhesives, start guide – which ordinarily come out of the closet-of-pocket would cost about $1400.

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

So someone white aside Conjugate who is denied, for example, would end up paid just $299 for the full treatment. Different insurers comparable Aetna may still require a 20% copay on supplies along top of the $99, but this Bridge Broadcast puts the total price tag happening par with unusual CGM systems, Gill says.

He as wel notes that the ship's company cannot subsidize the insertion procedure itself, because that would be viewed as illegal "incentive" of doctors to prescribe a certain system. "What we can do is supporte patients with the supply costs," he says.

Eversense Clinical Trials &adenosine monophosphate; Expanding Use

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

Greenbac that you can volunteer for that study throughout the next some months, but you have to Be an grownup already operative with your doctor on Eversense; they're not just providing unfixed sensors to anyone who steps forward.

Connected the closed loop front, they've completed a subject area with the iLet Bionic Pancreas organization being developed by Beta Bionics – a multicenter feasibility study using Eversense for the first gear the time in an AP system. 18 people were in that discipline, and they architectural plan to unwrap results at the big annual ADA SciSessions in June 2019.

Head of Sales Gill tells us the company has submitted their Food and Drug Administration review for "non-injunctive" identification – that provision stating that a CGM is accurate enough for dosing use without fingerstick tests arsenic a backup man. They're hoping for this "dosing claim" in the first quarter of 2020.

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

One completed "Put up Study" so far in Romania looked at wear on the venter vs. the upper arm (wouldn't that be nice?!). The company expects to nowadays a search notice on unhurried preference on that also at the big ADA meeting this June.

But aren't some people aren't testing dead alternate sites "polish off-label"? we asked.

Gill essentially says the manufacturer is non policing that. In fact, in their post-approval study for the 90-day sensor, "if a physician decides to go off-label, we but ask that they record that information."

And while they're non recruiting specifically for this purpose, in the post-approval branch of knowledg they'll also be transcription experiences of patients with different skin types – African American, Latino, and white PWDs. (Think Ambient Light issue, mentioned above).

Senseonics says it presently 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 MD Assistants in some the U.S. and EEC to insert and backing the organisation.

I'm gratified to beryllium among the ahead of time majority.

{DISCLAIMER: For the succeeding few weeks, I will be doing some narrow consulting make for Senseonics, being compensated to provide careful user feedback.}