The glucagon kit could be as medically necessary during a bout of severe hypoglycemia as the defibrillator for cardiac arrest, yet many smart people with diabetes don’t own one. That’s because for years the kit has been perceived as a cumbersome device for a crisis, and one that goes out of date quickly.
“I personally never get a glucagon rescue kit because I got tired of paying to replace it every year without using it,” explains Dr. Sheri Colberg-Ochs, Professor of Exercise Science at Old Dominion University and Adjunct Professor of Internal Medicine at Eastern Virginia Medical School.
Type 1 since the age of 4, Dr. Colberg-Ochs has always treated “lows” with food and finds the kits on the market impractical. “The problem with ‘rescue’ glucagon kits that have been available for years is that the glucagon is not that stable,” she says.
Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen into glucose, which is then released into the bloodstream. Kits now on the market contain glucagon as a dry powder in a sealed vial, which must be reconstituted in a multi-step process with a water-filled syringe prior to injection. It’s a complex procedure, and one that’s usually undertaken by someone with little to no medical training during a crisis.
But will there soon be a better way? Like many within the Type 1 diabetes community, Dr. Colberg-Ochs says she’s anxiously following the development of an easier-to-use glucagon pen by Xeris Pharmaceuticals Inc., an Austin, TX-based pharmaceutical company.
The Xeris G-Pen, which is currently in Phase II trials and not expected to hit the market until late 2015, may rewrite the rules of glucagon kits. It offers a room temperature-stable “ready to inject” glucagon for severe hypoglycemia. The simplicity of the design is attractive, says Dr. Colberg-Ochs.
“What Xeris is trying to make is a glucagon solution that is more like insulin in a pen. It would be ready to use without having to be reconstituted, and you could dial up the amount you want to inject,” she says.
The simplicity makes for a game-changing alternative to what currently exists, according to Xeris CEO Dr. Steve Prestrelski. The new pen takes some of the fear out of the process, as well as the potential for error.
“All a parent has to do when they know their child is having a severe hypoglycemic event is pick up the G-Pen, walk to their child’s room, take off the end closure and press the injection end against the skin. The glucagon is already on board and going to work in less than a minute,” says Dr. Prestrelski.
Most diabetes experts agree that a device that’s more like a pen than a multi-step kit should be the way forward. The potential savings in health care costs could be enormous, since many people now reject the complex kits in a pinch in favor of a 911 call and an ambulance ride. Such a choice, though understandable, could delay treatment and raise costs for treating hypoglycemia.
“Many people report being reluctant or nervous to prepare and inject currently-existing glucagon injection devices, resulting in underuse when required,” explains Kellie Rodriguez, Director of Education Services at the Diabetes Research Institute in Hollywood, FL. “An injectable device requiring less preparation steps would be very beneficial during an adrenaline-raising medical emergency.”
Xeris is not the only company working on simplifying the glucagon kit. Enject, Inc. has its own glucagon pen in the works. If such a solution makes intuitive sense, it can be fair to wonder why a glucagon pen hasn’t hit the market already. But Dick Rylander, CEO of Enject, Inc., says what may seem like a simple solution on the surface still has its challenges. There are a number of design issues that must still be worked out in these next-gen glucagon kits, including loss of potency as the temperature rises and whether the reconstituting liquid will contain ingredients that may cause concerns with the FDA.
“The diabetes community has been calling for a glucagon pen for decades,” he says. “The right solution could have a significant positive impact on quality of life of insulin-using diabetics,” Rylander says. “The challenge is finding a way to deliver glucagon that works, is safe, stable, and easy to use in an emergency setting.”
The Phase II clinical trial for the G-Pen has just begun at the Texas Diabetes Institute in San Antonio, with results expected to be released in early 2014. The study, which tracks 24 healthy volunteers, is headed by principal investigator Dr. Ralph DeFronzo, Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center. The trial is designed to evaluate the safety and tolerability of the pen’s glucagon formulation, as well as how the formulation will interact with the body.
Dr. Colberg-Ochs will be following the pen’s progress, as will many others in the diabetes community. She wouldn’t mind having an easy-to-use back-up plan if she has a dangerous low that can’t be solved by food.
“I can’t wait until I can get one myself,” she says.
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