FDA clears BD insulin infusion set developed with diabetes patient advocacy groups

Becton Dickinson ($BDX) worked with diabetes patient advocate groups to develop its latest insulin infusion set, which is designed for improved insulin flow with reduced interruptions. Now the FDA has cleared the new infusion set based on BD FlowSmart.

The infusion set is the result of a collaboration between BD, the Juvenile Diabetes Research Foundation (JDRF), and the Helmsley Charitable Trust, which has a project specifically focused on Type 1 diabetes.

The new product is the company's first diabetes infusion set. It incorporates a side-port catheter designed to improve insulin flow and reduce the number of flow interruptions. A continuous rise in pressure that lasts at least 30 minutes is known as a silent occlusion and can result in unexplained hyperglycemia in some patients. This set is designed to avoid that kind of incident.

The infusion set also has the smallest insertion needle available in order to reduce patient pain and trauma, according to the company.

"JDRF is excited to see the potential of BD's new infusion set for people with type 1 diabetes," said JDRF President and CEO Derek Rapp in a prepared statement. "Experiencing hyperglycemia for even a short period of time can lead to disastrous consequences such as ketoacidosis, and over long periods of time, concerns of serious complications are a major part of living with type 1 diabetes for many people. Having the assurance of this new technology in the arsenal of tools to help relieve the daily burden of type 1 diabetes is very encouraging."

In a previously presented study, head-to-head data showed that BD FlowSmart technology had significantly fewer flow interruptions and less time spent with interrupted flow. The results of three additional clinical studies on the new infusion set with BD FlowSmart technology will be presented at the American Diabetes Association conference in Boston, MA, on June 5 to June 9.

The new infusion set is already past Canadian regulators, with a potential CE mark pending. The product is slated to be available in BD's fiscal 2016, which starts on Oct. 1.

"We believe that our new infusion set with BD FlowSmart technology is a ground-breaking innovation in diabetes technology that redefines the role of infusion sets in pump therapy by reducing the incidence of silent occlusions," said Kenneth Miller, worldwide president of BD Medical-Diabetes Care, in a statement. 

- here is the release

Editor's note: This article was corrected to include an accurate description of the product. It is an infusion set and not an infusion pump, as was previously stated.