Startup Gets $1.14 Million to Develop Artificial Pancreas Component

The device, an advanced infusion set, combines continuous glucose monitoring and insulin infusion in a single form factor.

Nancy Crotti

A leading juvenile diabetes research organization has awarded an Oregon startup $1.14 million to help develop a novel treatment for Type 1 diabetes.

The JDRF money will go to Pacific Diabetes Technologies, a Portland, OR-based medical device startup that is working on an advanced infusion set that combines continuous glucose monitoring (CGM) and insulin infusion into a single device. The device represents an advancement of the technology that would go toward developing an artificial pancreas and other insulin pumps. An infusion set is one component of artificial pancreas technology. Several companies are working to refine its capabilities, according to a JDRF spokesperson.

The latest collaboration will support Pacific Diabetes's efforts through a series of milestone payments as it refines the device in preparation for market.

This "single-port" CGM solution, as it is called, enables users to track glucose concentration from the same device they use to infuse insulin, eliminating the need to wear a second device. Pacific Diabetes has been refining prototypes in animal studies as it prepares to seek FDA approval to test the device in people.

"JDRF is excited to partner with Pacific Diabetes Technologies to help advance infusion set technology that could improve the lives of people living with type 1 diabetes," Vincent Crabtree, director of research business development, said in a statement from JDRF. "The T1D community is looking forward to advances in their CGM devices that can improve their ability to maintain glucose control safely and conveniently, and JDRF is committed to enabling that type of next-generation technology."

"Finding financial support for medical device startups can be challenging, due to the long timelines and an expensive regulatory process," Pacific Diabetes CEO Robert Cargill said in the statement. "Partnerships like this and support from the NIH help to propel innovative life sciences ideas out of the research lab and into the hands of consumers," he added.

CGM has been shown to improve glycemic control in both patients with type 1 and type 2 diabetes. The technology employs a small subcutaneous sensor that measures the user's glucose concentration in real-time. The system can then alert the user to conditions of hyper- or hypoglycemia, enabling them to take the fastest possible corrective action.

"CGM offers many benefits to both patient and payer, reducing complications, lowering the cost of diabetes care, and improving overall patient health," said W. Kenneth Ward, MD, the company's chief science officer. "Unfortunately, the uptake of CGM systems has been hampered by the added cost and inconvenience to the patient. By combining CGM functionality with insulin infusion in one convenient solution, we hope to significantly increase the adoption of this essential therapy."

An Oregon Health and Sciences University associate professor, Ward, M.D., is a biosensor specialist scientist who has been deeply involved in development of percutaneous glucose sensors for iSense and Bayer, according to his bio on the university website.

Pacific Diabetes Technologies has secured more than $5 million in funding through a combination of grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Health, and The Leona M. and Harry B. Helmsley Charitable Trust.

It is one of several companies competing in the race to develop an artificial pancreas. Medtronic is touting its MiniMed 670G insulin pump as the world's first hybrid, closed-loop artificial pancreas. It has been boasting of a 124-patient study that found the 670G increased the amount of time patients were in the desired blood-glucose range, without any severe complications, according to a report in the Star Tribune of Minneapolis.

Another West-Coast startup, Bigfoot Biomedical recently confirmed it has applied for FDA approval for its version of the device. The Milpitas, CA, company, founded in 2014, has received FDA approvalof an investigational device exemption (IDE) for the first clinical trial of its "smartloop" automated insulin delivery system.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of PACIFIC DIABETES TECHNOLOGIES]