The race for the artificial pancreas

Treatment options currently available to diabetics are limited to imperfect solutions, as both patients and caretakers will attest. Painful, bulky, time-consuming insulin delivery methods abound, and the industry knows it. Therefore, the company that finds an all-in-one solution that makes life easier for patients with diabetes also knows there's a payday in store.

Cue the artificial pancreas. The drug delivery device--combining an insulin pump with a glucose monitor for complete, automated control over insulin dosage--has occupied the sights of several big names in the diabetes arena, giving rise to several iterations currently moving forward in clinical trials. But who is ready to land the coveted approval first? And is the technology effective enough to facilitate an immediate payoff?

Johnson & Johnson

The device: Hypoglycemia-Hyperglycemia Minimizer System (HHM)

Johnson & Johnson's ($JNJ) Animas division took an early lead in 2011, as its Hypoglycemia-Hyperglycemia Minimizer System (HHM) became the first to reach feasibility studies. And at this year's June meeting of the American Diabetes Association in Chicago, the company revealed positive results from a second feasibility study of adults with Type 1 diabetes showing that patients maintained a healthy blood glucose range overnight with the device. In the small, 20-patient study, Animas showed that its HHM could keep patients within a healthy blood glucose range for over 90% of the night, and fewer than half of the patients dropped below that level at all.

But soon after J&J kicked off its success in the field, other companies like Medtronic ($MDT), Becton Dickinson ($BDX) and Tandem Diabetes Care entered the fray, bringing their respective technologies into the development and trial processes, as well, to close the gap.

Medtronic

The device: MiniMed

At the same ADA meeting in June, Medtronic touted two versions of its MiniMed device, one that is an early version of the artificial pancreas and one that is a true closed-loop system. The company revealed positive results from a 247-patient study of its integrated system that pairs continuous glucose monitoring with insulin infusion--not quite an artificial pancreas, but using the same concept to automatically regulate insulin levels. Its other MiniMed pump uses a complete closed-loop system, and the company began enrolling up to 85 patients in a study of overnight use.

Becton Dickinson

The device: Unnamed, in collaboration with JDRF

The Juvenile Diabetes Research Foundation has shown a great amount of interest in the field, backing several horses in this race, including Medtronic, as well as BD and Tandem. BD, in June, welcomed the foundation's support to develop its own insulin-delivery system for people with Type 1 diabetes, agreeing to a three-year partnership. This puts the company a few years behind its counterparts, but the backing of the organization could give it a leg up in the development process.

Tandem Diabetes Care

The device: t:slim with continuous glucose monitor from DexCom

And then there's Tandem. The San Diego company is actively pursuing the first-ever dual chamber infusion pump to manage diabetes, which would also be a version of the fully automated artificial pancreas, delivering both insulin and hormonal therapies from an external device. The JDRF is taking a hand in the development here, too, along with DexCom, which partnered with Tandem to combine Tandem's FDA-cleared t:slim touch-screen pump with its own next-gen glucose monitoring devices. It's also important to note that Tandem has collected a good amount of cash in pursuit of the device, which is already on the market. There's no doubt the fully automated version of the pump would be a hot seller.

So where does it go from here? While these companies duke it out to be the first with an artificial pancreas on the market, several more independent studies have shown that the devices can be extremely effective. One such study, published in the New England Journal of Medicine, showed that the combination of an insulin pump with a continuous glucose monitor offered better control of nocturnal glucose levels and less instances of hypoglycemia than insulin pumps alone at children's diabetic camps in Israel, Slovenia and Germany. It's one of several academic approaches that continue to lend credulity to the industry race.

Although sleek new insulin pumps are fast approaching from every corner, such as Insulet's ($PODD) OmniPod and CeQur's PaQ among others, and new nanotechnology insulin delivery methods make headlines in the early research arena, the artificial pancreas still represents an untapped innovation that could change the way the industry looks at the diabetes market.

And as the race comes to a close, who's ready to take it across the finish line first? Stay tuned. -- Michael Gibney (email | Twitter)

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