Baqsimi Nasal Glucagon Makes Hypoglycemia Rescue Simple

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Who’s got your back? Who have you trained on your emergency Glucagon kit? When you – or the person with Type 1 diabetes in your life – has a severe hypo, who do you trust to act?

After I was taught the Glucagon kit process –  first to inject the liquid into the vial of powder, then to remove the syringe, swirl the vial, draw the liquid back into the syringe, and finally inject– I had to consider who to share this lesson with. The learning curve is not insignificant. Was my child old enough to brandish a needle? Was this family member too old, that one too scatterbrained? Who could be trusted to follow these precise steps in a moment of crisis?

Robert Oringer has weighed these sorts of questions extensively. Oringer, the Chairman of Locemia Solutions, had the burning desire for years to innovate glucagon. In 2010, he recruited co-founder and CEO, Claude Piche, to build and lead their small but mighty team to develop Baqsimi, Eli Lilly’s new nasal glucagon treatment that was recently approved by the FDA. Oringer has been fighting hypoglycemia for decades now: he first came to public notice as the creator of Dex4 glucose tabs. He thinks a lot about the emotional impact of hypoglycemia risk, and not just from the perspective of a businessman. He has two sons with Type 1 diabetes.

“The stars aligned for me to understand the screaming need for a better rescue solution … at some point I just said, somebody’s gotta do something here!”

Baqsimi was the solution. This new glucagon rescue is administered nasally: a single puff in the nose is enough to deliver a full dose, even to a completely unresponsive patient. Compared to the old Glucagon kits, Baqsimi nasal glucagon is equally effective and dramatically easier to use. Remove the cap, one puff, done. The kit you have stashed in your closet or in an emergency bag today is about to become obsolete.

 

The Second Diagnosis

While here at ASweetLife we spend much of our time worrying about the debilitating complications of chronic hyperglycemia – and decrying the high-carb diets that lead to them – every person that uses insulin needs to be aware that the most dangerous and immediate complication is that of hypoglycemia. A 2012 analysis in Diabetes Care concluded at least 4% and perhaps as many as 10% of people with Type 1 diabetes will eventually die of acute hypoglycemia. Hospitalizations that do not end in death, of course, are considerably more common.

Robert Oringer refers to this as a second diagnosis:

“When you’re diagnosed with Type 1 diabetes, or when that physician says to anyone with diabetes ‘I’m putting you on insulin,’ you have that first diagnosis. What nobody speaks about is what I call the second diagnosis: hypoglycemia. You’ve been diagnosed with this second thing that’s going to hang over you all of the time. You have this cloud, I refer to it sometimes as the plague of hypoglycemia, because every day, all the time, you’re thinking about hypoglycemia and how to avoid it.”

A justified fear of hypoglycemia can have a pernicious effect on one’s lifestyle. Do you need to think twice before engaging in physical activity? Has it put a damper on your spontaneity? Does the accumulated mental strain of being constantly mindful of your blood sugar and constantly planning for contingencies add up to an enormous stress?

What Oringer hopes is that a better hypo rescue solution can remove some of this stress:

“The fear of hypoglycemia affects many aspects of daily living, and we hope that we’re going to bring confidence back to the insulin user and the people that surround and care for the insulin user.”

 

Confidence

My seven year-old daughter knows where I keep my emergency candy. She knows that there’s an off-limits bottle of Gatorade in pantry. She knows that if she were to find me incoherent, that she should try to get something sweet into my belly, and that if she were to find me unconscious, to call 911 and explain that I had Type 1 diabetes.

But she doesn’t know how to use my Glucagon kit. She’s a sharp kid, but I never seriously considered training her on the steps to administer the medicine, the last of which would be to plunge a syringe into her father’s unresponsive body. I didn’t want to burden her with that image and that responsibility.

As a father of two children with diabetes, Oringer thinks a lot about the emotional toll that the fear of hypoglycemia can have on the people surrounding the person taking insulin: family members, friends, colleagues, caregivers.

“There are parents I know who have kids [with T1d] who knew when we were developing the product, they literally cried with me, about the fear of their child being at a friend’s house or in a public setting helpless and being in seizure or coma with those around them feeling utter fear and helplessness.”

Oringer encouraged me to consider the psychological impact of Baqsimi. Would its ease of use allow me to widen the circle of people that I would trust to take care of me in a hypoglycemia emergency?

“The final label for Baqsimi reads, “For Treatment of Severe Low Blood Sugar, ”but when I originally envisioned the Baqsimi package label, it could’ve said, in big letters, Insulin Insurance. In my head, the version I also imagined and that I’m maybe most proud of would say, Hypoglycemia Discussion Enabler, because the simplicity of nasal delivery makes it so easy to discuss hyperglycemia rescue. All the people that you didn’t talk to because you would’ve – and I’ll use a strong word – traumatized them by displaying the kit, they are now enabled. They can puff it in your nose. That gives people confidence and reduces fear.”

I can only speak for myself. My Glucagon kit sits in a corner of my bathroom closet, and only my wife is aware of it and trained on its use. (My primary insurance against severe hypos is my low-carbohydrate diet, which enables me to use a bare minimum of the powerful bolus insulin that is so often the cause of dangerously low blood sugars.) I don’t often carry it with me, and I don’t bother friends and colleagues with it. They just know if I’m unresponsive to call 911.

But with a Baqsimi prescription, this will change. I would train my daughter in the use of an emergency nasal glucagon without fear of placing an undue psychological burden on her, and with full confidence that she could administer it accurately. I would stash the spray in my bag, bring it around with me, and casually inform friends and colleagues of its location and use. It could greatly increase the number of people that have my back.

And that’s where the name is from. Oringer explains:

“The name is rooted in the word ‘back.’ It was Baqsimi because, my wife and I were always thinking of who could have our boys’ backs? The way I share it, someone that is put on insulin, they know, in their heads, who will have their back. Now, with a puff in the nose, I think we enable a level of confidence, not just for the person who uses insulin to feel that others have their back, but for the people that love or care for them to feel they can have someone’s back.”

“It’s not the drug that has your back, it’s the people that have to deliver it that have your back.”

Sometimes I go hiking, up mountains and into the wilderness, all alone. My backpack has a patch on it: Emergency, Type 1 Diabetes. In truth I’m not sure exactly what that patch would accomplish – if an average hiker were to stumble over my unresponsive body, he or she wouldn’t know what to do, except possibly alert some far away medical professional as to the precise nature of my plight. But with Baqsimi in my backpack, perhaps I could trust that even an untrained stranger could have my back. Perhaps I would sew a new patch onto my pack: “If you find me unconscious, there is a nasal spray in the outside pocket…”

 

The Data

In 2015, Locemia announced the results of a study intended to test the Baqsimi’s ease-of-use in a simulated real-world situation. Adults both trained and untrained in emergency glucagon delivery were asked to quickly administer full doses of either Baqsimi or Glucagon to a mannequin. And the numbers were so striking that they’re worth sharing again.

The results for the old-school glucagon injection kit were horrifyingly, hair-raisingly bad: a mere 13% of trained caregivers were able to inject the proper dose, and exactly 0% of the untrained adults were able to do so, both groups taking about 2 minutes to complete the exercise. By contrast, over 90% of both trained and untrained participants administered the proper dose of Baqsimi, and they did it quickly, in under 30 seconds.

Big pharma was paying attention, and in short order, Lilly – the owner of the dominant but soon-to-be-obsolete glucagon kit we all have now – had acquired Baqsimi. Oringer sounds ecstatic to have partnered with Lilly, which committed to taking the product to FDA approval and will now use its considerable heft to market and manufacture Baqsimi on a grand scale, getting it into the hands of insulin users around the world quickly.

 

The Future

Oringer imagines a future where public service awareness campaigns bring nasal glucagon rescue to the forefront of public knowledge. Could the average person one day be as aware of Baqsimi as they are today of the Epi Pen, or even of the Heimlich Maneuver?

But of course, the irony with such a product is that one hopes that it is entirely unnecessary. Oringer says that “the great win here is when the product never gets used.”

Oringer thinks we should celebrate when our rescue kits expire unused. Toss that tube in the trash, but pause to be thankful for a year without a severe hypoglycemic episode. Take that moment to reengage family members and caregivers, remind them of their responsibilities and reinforce their confidence in the use of medicine in an emergency.

He mentioned that he will continue to invest in diabetes technology, and that he hopes to pivot towards hypoglycemia prevention from hypoglycemia rescue. Before I let Oringer go, I asked him what he’s excited about most for the future:

“I’m very excited about multianalyte sensors that can measure glucose, beta hydroxybutyrate, lactic acid, other analytes that actually might be able to inform algorithms for guiding or automating insulin delivery even better.

“We need better infusion sets. If you’re wearing a pump and you’re gonna be on a closed loop, we need infusions sets that don’t kink, or that can last longer to match up against sensor life.

“We need better insulins. One company is working on an additive that would make insulin more effective because it would get the insulin to go where it really needs to go to work, the liver.

“These little components that you don’t think of – combined, they will give us even better control and prevention in 3 to 5 years.

“That’s the future.”

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Sheila ReidDennis Pillion, PhDDave Penny Recent comment authors
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Sheila Reid
Sheila Reid

I take it the Nasal spray doesn’t need to be kept in the fridge which would be fantastic. Is it likely that it would be used just for low BG? rather than extreme low BG’s. Cost wise would it be possible to use it in this way instead of piling in the carbs? Well done guys and gals for inventing this method. I hope you will be able to answer my questions.

Dennis Pillion, PhD
Dennis Pillion, PhD

Congratulations to Robert Oringer, Dr. Claude Piche and the team at Locemia for making this a reality. Next summer, at diabetes camps around the USA and the world, where more than 22,000 children with T1D go to have fun, the treatment for severe hypoglycemia will be different.

Dave Penny
Dave Penny

This is amazing and the data on ease of application is phenomenal. Is there any indication of when it will be available? Specifically interested re availability in Europe.

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