Rethinking Glucagon Beyond Just Emergencies

Most of us living with diabetes know glucagon solely as a "break the glass" emergency solution, brought out only for the scariest low blood sugar moments that leave us incapacitated -- assuming we're lucky enough to even have a complicated glucagon kit, and that someone nearby knows how to use it.

But there will be a day soon when glucagon becomes infinitely easier to use, and with these new products we'll be on the verge of a paradigm shift that requires our D-Community to rethink how we use this fast-acting glucose booster beyond just emergency situations.

Two new products expected to shake up the glucagon market soon are the nasal "puff up your nose" glucagon mist by Eli Lilly that went to regulators in Summer 2018, and a ready-to-use rescue injection pen by Chicago-based Xeris Pharmaceuticals set for an FDA hearing in June 2019. Incredibly, these will be the first new forms of glucagon available in SIX DECADES (!).

While that's transformative in itself, they set the stage for a whole new generation of glucagon products; we could soon see a quick-grab glucagon hypo-treatment available in gyms or schools just like defibrillators are today, and future "micro-dosing" glucagon that could be used regularly as needed for quick BG boosts. Wow!

A Glucagon Brainstorm

In November, a group of roughly three dozen diabetes advocates gathered at a forum hosted by Xeris at their Chicago headquarters. Those attending included some older-school bloggers and D-advocates (myself included), as well as numerous D-Instagram'ers, YouTubers and other relatively new members of the DOC (Diabetes Online Community).

This was a first-of-its-kind gathering for Xeris, though many of these so-called "influencer events" have taken place over the past decade -- hosted by Roche, Medtronic, AstraZeneca, Lilly, Novo, Sanofi, and others. I found it impressive that a smaller company like Xeris would invest in convening a decent number of DOCers, and that we had diversity in opinion, D-experience, and life experience in the room.

Naturally, the focus for this event was glucagon, given that Xeris is about to launch its first-ever product soon. They have an FDA date expected in mid-2019, and the hope is that leads to an approval for its GVoke HypoPen as well as a prefilled syringe option for fast-acting glucagon.

In the big group setting as well as small work groups, we got to talk and bounce thoughts off each other, while having the chance to get our hands on the prototype rescue pen (which look pretty much like the SEC-submitted images and clinical trial prototype pics available publicly online). Most of the information shared in this meeting is already public, including in our coverage here at the 'Mine and data on display at big conferences like the ADA Scientific Sessions.

Some of the questions I pondered at this meeting were:

• Is "rescue pen" an appropriate term? Basically the same idea as an EpiPen?
• Should
  the new product be called a pen at all -- given the risk of being
  confused with an insulin pen or other injectable medication in pen-style?
• Can glucagon move beyond emergency use? i.e. will PWDs embrace a next-gen
  product that allows for micro-doses that could be used in everyday situations, for example before
  or during exercise to counter an impending hypo?

Currently, both the first-generation Xeris auto-injector pen and prefilled syringe as well as the nasal glucagon being developed by Lilly that are submitted to the FDA are single-use, disposable products aimed at emergency situations.

But both open the door to future products that would allow for small doses of glucagon being administered on an as-needed basis -- eliminating the need for PWDs to eat or drink fast-acting carbs to thwart a Low.

Mainlining Sugar?

To me, glucagon has always been an emergency BG-booster. Not something I would use myself, but that others would turn to in the event of a severe hypo where I couldn't self-treat.

I recall over the course of my 35 years with T1D, various doctors and endos have referred to glucagon as something to use in the event that I "hit the floor" and am unconscious.

The existing mix-and-inject glucagon kits are difficult to use and intimidating, so even in the event of a severe hypo my wife hasn't resorted to glucagon but rather calling the paramedics.

Traditional glucagon is also a medication that can cause nausea due to the quick-acting glucose rise, and the few times I have had glucagon injected into me, I recall feeling very ill -- a deterrent for ever wanting to use it in the future, unless absolutely, life-or-death (which hypos can certainly be, especially in the middle of the night when Dead in Bed syndrome can occur).

For me, all of this has led to Fear of Hypos (FoH) and a common practice before starting on a CGM was to keep my blood sugars higher at bedtime, just in case of a drop overnight that I might not wake up from.

Having a glucagon kit on hand never offered enough reassurance against these possible severe Lows, but one of these near-term glucagon products just might provide that.

Bottom line: I think I would I be inclined to buy a Xeris rescue pen, or a Lilly nasal glucagon puffer when available.

However, thinking about glucagon as a more regular treatment, akin to another med that I may just use as part of a normal routine, is still too strange a concept for me. As of now, it's not appealing. It would honestly feel like I'm mainlining sugar -- yikes! I'm working on getting my head around the idea of a mini-dose that won't spike me too high. 

Life Preserver vs. Life Jacket

At the Xeris event, most folks were quite excited by both the new rescue pen, and this future mini-dosing concept that is likely 2-3 years down the road at least.

While the existing emergency kits from Lilly and Novo are bulky and costly, Xeris' streamlined ready-to-use device will make it possible for PWDs to easily carry around a glucagon pen (maybe they'll even come in a two-pack), and these pens could also someday be as ubiquitous as defibrillators in gyms, schools, and public places as an emergency tool for the general public. What a fascinating idea!

Someone in the group posed it this way: it's like the difference between a Life Preserver and a Life Jacket when you're out on the water. A Life Preserver is of course only useful once you're in distress, but a Life Jacket protects you from getting there in the first place.

New forms of glucagon could be critical, given the current real-world trends in the D-Community regarding existing glucagon products.

A late 2018 research study on glucagon use shows that not everyone is prescribed an emergency kit by their doctor, or trained properly on how to use it. These next-gen products from Lilly and Xeris could help assure that this potentially life-saving substance is available and easy to administer when needed.

At the Xeris meeting, there was also talk of access and affordability -- especially since existing glucagon kits remain unaffordable to many in the D-Community, priced at roughly $300 or more per kit out-of-pocket.

Several pushed Xeris to keep this top of mind, ensuring they maintain a fair and reasonable price point as they get ready to launch a first-gen product.

Another point was the eventual policy discussions we hope Xeris will take on, such as ensuring glucagon products are more accessible to paramedics, at schools, and even in exercise facilities where PWDs are most likely to be in need of emergency tools.

Of course, with Xeris still working toward FDA at this point, you can't put the cart before the horse -- that aspect of policy change will come in due time.

Xeris did a good job with this debut event, IMHO, and it's good to bring these issues to before the patient community as we move toward future glucagon products hitting the market. We hope you'll all be ready to join the conversation soon.

{Disclosure: Xeris paid for the advocates' travel costs, meals and a taxable stipend for participation -- which I personally chose to donate to diabetes charities. There was no express obligation to write or share about the experience, though that's how we roll at the 'Mine and all opinions shared here are our own.}

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This article was originally published on DiabetesMine.