Coming Soon: A Faster, Simpler Way to Treat Severe Hypoglycemia

Nasal glucagon treatment is under review by the FDA; if approved, doctors say it will be a simpler way to treat a dangerous condition.

nose spray to treat low blood sugarIf approved by the FDA, nasal glucagon won't require mixing or an injection. Doctors say this type of delivery method is a much needed addition for the treatment of hypoglycemia. Photo: 123rf

When blood sugar drops so low it is viewed as an emergency, possibly leading to coma or seizures, glucagon is given as a treatment.

Currently, that typically requires using a glucagon injection kit, manually mixing glucagon powder with a liquid, drawing the fluid up into a syringe and finally injecting it. And the person doing it may not be a trained healthcare professional.

Soon, there may be an easier and simpler option.  In July, the drug maker Lilly submitted a new drug application for nasal glucagon to the FDA (and to European agencies as well).  The new product requires no mixing—it's given, as the name implies, up the nose like a nasal spray with no need to mix or to inject.1

What Doctors Say

The new delivery method is great, says Elena Christofides, MD, FACE. COO of Endocrinology Associates in Columbus, Ohio. A delivery method that doesn't require an injection is needed, she tells OnTrack Diabetes. "Injecting is intimidating," she says.

The injection is often done by a non-medical person, she says, such as a caretaker or family member. And the patient is unconscious, making the procedure more difficult. "Most people don't get the shot they need because of external factors. So having a non-invasive delivery method for an unconscious person is very helpful."

Another physician, J. Michael Gonzalez-Campoy, MD, PhD, FACE,  agrees, calling the new delivery method ''a welcome addition." He is on the editorial board of OnTrack Diabetes and is medical director and CEO of the Minnesota Center for Obesity, Metabolism, and Endocrinology.
"Up until now, glucagon emergency kits came with vials of dessicated glucagon in powder form, to which a solvent had to be added to reconstitute it," he says. The reconstitution and the injection took time, delaying effective treatment, he says.

More from Lilly

If approved, the nasal glucagon ''may also expand the community of people who could quickly render aid in a rescue situation," according to Thomas Hardy, a Lilly Diabetes spokesperson.
He confirmed that ''our regulatory applications for investigational nasal glucagon for the treatment of severe hypoglycemia in adults and pediatric patients with diabetes are under active review by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). "
While he would not provide any more specific information about timing, some press reports predict both the US and European agencies will make approval decisions next year.

More on Hypoglycemia and Treating It

Dr. Gonzalez-Campoy gave this valuable background information about hormones and blood glucose.

"There is one hormone that moves glucose from the circulation into cells, and by doing so lowers the blood glucose. This is insulin. In a normal person, insulin is made in response to a high glucose.

"Conversely, there are four hormones that raise the blood glucose: adrenalin, glucagon, cortisol and growth hormone. Like insulin, glucagon is a protein. Traditionally, proteins had to be infused or injected because oral ingestion leads to them being degraded and ineffective.  Further, proteins, once placed into solution need to be used relatively soon—the shelf life is short.  Therefore, they are marketed in powder form (which is relatively stable in a vial), to be reconstituted prior to injection.

"More recently, protein delivery into the circulation has been explored via the upper and lower airways, in addition to the traditional subcutaneous [under the skin] and intramuscular injections, and intravenous infusions.  Inhaled insulin is an example of this novel approach.''

While the goal of treatment for patients who require insulin or medications that stimulate insulin release, like sulfonylureas, is to lower the blood glucose while minimizing the risk of hypoglycemia, the very low blood sugar episodes can and do happen, he says.

"Although prevention of hypoglycemia is paramount, its treatment, should it happen, needs to be immediate and swift," Dr. Gonzalez-Campoy says. "In addition to glucose ingestion and glucose absorption from the oral cavity through the mucous membranes, we now [with the new pending system] have a glucagon preparation that is an improvement over past options."

Research Found It Faster, Easier

In a study presented in 2017 at the American Diabetes Association meeting, researchers, including some from Lilly, evaluated nasal glucagon in 60 patients with type 1 diabetes who had a total of 157 hypoglycemic episodes.2

They found that in 96.2% of patients, the nasal glucagon returned them to normal status within 30 minutes. No emergency service calls were made. Those who gave the glucagon did so in last than 30 seconds for more than 70% of the episodes and less than two minutes in nearly 98% of them.

Nasal irritation was reported by more than 82% of patients, and headache by more than half.

Preventing Hypoglycemia

How to minimize the risk? Practice ''good diabetes management," 3 advises the American Diabetes Association. That means monitoring, and the ADA suggests:

  • • Check blood sugar before and after meals
  • • Check before and after exercise
  • • If you exercise for a long time, or intensely, check during the workout
  • • Check before bed
  • • Step up your monitoring if your life changes (new insulin routine, work schedule change, more exercise, time zone travel).

Dr. Gonzalez-Campoy has no disclosures. Dr. Christofides has been a consultant and on the speaker's bureau for Lilly.

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