Up Close with BD’s New Infusion Set: A Much Needed Improvement to Insulin Pumps

Twitter Summary: .@US_FDA clears BD #insulin pump infusion set, major improvement in reliability, coming in late 2015 or 2016

BD announced FDA clearance of its new insulin pump infusion set, which improves the accuracy and reliability of insulin delivery. The infusion set is expected to launch in the US in late 2015 or sometime in 2016. BD currently has plans to make the set compatible with Medtronic Paradigm reservoirs, as well as Luer-Lock reservoirs offered by Animas, Tandem, and most Roche pumps. The set was approved in Canada this past January, and a European approval could come soon.

BD’s new set revolves around a new catheter, using their "FlowSmart technology," which allows insulin to flow out of two places: the bottom (like current infusion sets) and the side (a new innovation). The result, as was shown in a human study at this year’s ATTD conference in Paris, is significantly more reliable insulin delivery. Compared to Medtronic’s Quick-set, BD’s set led to an ~80% reduction in flow interruptions and a ~78% reduction in occlusion events. The set should especially help patients avoid “silent occlusions,” which are often not detected by the pump and could lead to unexplained high blood sugars in some patients.

We got more acquainted with the new set at an in-person visit to BD’s headquarters on Friday. Here are some of the other notable design features:

• A less painful, 30 gauge insertion needle, making this the smallest infusion set insertion needle on the market (roughly similar to a pen needle in size).

• A multi-position connector that allows patients to connect the tubing to the on-body set in eight different positions (e.g., no need to line it up).

• A sliding shield that covers the insertion needle and contains it after insertion, helping to prevent accidental needlesticks.

• Options for both manual insertion and insertion with the Quick-Set inserter.

• Both 24 and 42 inch tubing lengths.

BD talked to over 1,000 patients in the set’s development process, as well as many healthcare providers – the great feedback is certainly all over the product’s design, and we expect many patients will appreciate these improvements.

The set resulted from a collaboration between BD, JDRF, and the Helmsley Charitable Trust, a notable example of a non-profit/for-profit partnership bringing patients a meaningful advancement. As we noted in our previous coverage, this product is the first major infusion set upgrade in the US in recent years. Current infusion sets have been called the “weak link in insulin delivery,” and one study reported as many as 64% of type 1 pumpers experience infusion set blockages or kinking. This set should help reduce those occurrences.

Better infusion sets will also help the development of artificial pancreas systems that heavily rely on accurate and reliable insulin delivery. For more information on BD’s infusion set, please see the product’s website here. –AB/AJW

[BD paid for our travel, accommodations, and meals in exchange for participation in the event. The opinions expressed in this article are solely our own.]