The company's focus is on a specific technology that would help enable a true artificial pancreas for type 1 diabetes patients.
|BD last year announced a partnership with Medtronic that created a MiniMed Pro-set using BD's existing FlowSmart technology, which uses a side opening to enable insulin to flow even if the cannula tip is blocked. (Image courtesy of Medtronic)|
The ultimate end game for medical device makers and diabetes patients alike is the development and commercialization of a true artificial pancreas: a closed-loop, fully automated system that both monitors blood glucose and computes and doses insulin--and possibly additional hormones. It would essentially require no manual data entry or calibration.
With that vision in mind, medtech household name BD has announced a new two-year collaboration with JDRF, the organization funding type 1 diabetes research worldwide, to focus specifically on developing an extended-wear insulin infusion set. A key component of the insulin-delivery mechanism, aninfusion set comprises thin plastic tubing that delivers insulin from the pump to the wearer's body. At the end of the tubing is either a soft, flexible cannula or a stainless-steel needle.
Currently, commercially marketed insulin infusion sets are cleared by FDA for up to three days of use. Through its collaboration with JDRF, BD is planning to address the mechanical, material, and biological issues that limit set lifetime. The goal is to design new devices that allow infusion sets to be effective beyond three days for a majority of patients, according to BD's press announcement.
"Insulin infusion therapy has substantial clinical benefits for type 1 diabetes management, yet its potential is limited by an abbreviated three-day infusion set usage life," said Ken Miller, president of Diabetes Care for BD. "Thanks to our latest partnership with JDRF, we can continue to build on the successful innovations BD currently offers in the insulin infusion category."
BD has already had a major focus on infusion set innovation. BD last year announced a partnership with Medtronic that created a MiniMed Pro-set using BD's existing FlowSmart technology, which uses a side opening to enable insulin to flow even if the cannula tip is blocked.
BD's new announcement of the JDRF partnership comes on the heels of other type 1 diabetes-related developments announced within the past several weeks:
- Medtronic's most-recent take on the artificial pancreas, the MiniMed 670G, achieved FDA approval in September.
- Abbott's Freestyle Libre Pro continuous glucose monitoring (CGM) system, featuring a waterproof, disposable sensor that continuously collects blood-glucose data for 14 days, also earned FDA approval in September.
- A month later, a Canadian research team at McGill University announced it had won a JDRF Canada grant to investigate the use of pramlintide along with insulin on Medtronic's artificial-pancreas platform.
Despite these advances, no fully automated, completely closed-loop artificial pancreas device is available to type 1 diabetes patients just yet. While Medtronic's 670Gmeasures glucose levels every 5 minutes and automatically administers or withholds insulin, the user still must manually request insulin doses to counter meal consumption. Similarly, J&J's Animas Vibe CGM and insulin-pump system requires finger-stick blood-glucose data.
One additional promising innovation, this time coming out of academia, is a bionic pancreas dubbed iLet developed by Boston University professor Ed Damiano. His team at start-up company Beta Bionics has received funding to the tune of $5 million from Eli Lilly and is scheduled per FDA to begin its final round of human clinical trials in early 2017.
Maureen Kingsley is a contributor to Qmed.
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