Fixing the “Weakest Link” of Insulin Delivery – BD’s New Infusion Set Shows Results in Early Pilot Clinical Study
By Adam Brown
Twitter summary: BD shows impressive trial data on new infusion set for #insulin pumps, a current huge unmet need in #diabetes today
At the ATTD Conference in Paris, BD’s Dr. Larry Hirsch presented encouraging data from a pilot study comparing the company’s new insulin pump infusion set to Medtronic’s Quick-set in 25 volunteers without diabetes. In the trial, each participant wore two of each set, and a special machine tracked fluid flow and rises in pressure. The new BD set demonstrated dramatic improvements in more reliable delivery – flow interruptions declined by ~80% and occlusion events dropped by ~78% compared to the Quick-set. Since the study was in people without diabetes, it did not assess the impact of these improvements on glucose control, though these early results suggest there could be a benefit. Future studies should bring more data on this front.
Dr. Hirsch did not share any specific details about the product’s design, though it is expected be compatible with Medtronic, Animas, Roche, and Tandem pumps. The infusion set 501(k) has already been submitted to the FDA, and BD hopes clearance will come this summer.
Infusion sets have seen very little innovation over the years, and we increasingly hear speakers call for safer, more reliable products. Last year, Dr. John Pickup cited a self-report questionnaire on pump complications in type 1 patients, where 64% reported experiencing an infusion set blockage or kinking. Both Drs. Irl Hirsch and Bruce Buckingham have called infusion sets the “weak link in insulin delivery,” an especially big concern now that artificial pancreas systems are coming – the best algorithm or CGM cannot overcome a bad infusion set that is not getting insulin into the body. The ADA/EASD position statement on insulin pumps has also urged for more attention to “the pump apparatus as a whole – i.e., including the infusion set,” bringing additional focus to this unmet need. We hope the new BD set makes some improvements, and we’ll be back with more information as soon as we get to try it out! –AJW/AB
