Insulin pumps have seen innovation in recent years with Tandem Diabetes coming out with the first touchscreen insulin pump - the tslim.
However, on the infusion set side - the accessories that actually deliver the insulin to the body from the pump - there hasn't been that much new in the last 15 odd years or so, says Brian Roper, global market segment leader for infusion sets at Becton Dickinson.
"The features that have changed are really around convenience," Roper says in a recent interview pointing to different colors that are now available as well as the fact that they now come with a disposable inserter which eliminates the need to manually push the catheters in.
But insofar as improving insulin delivery or making diabetes management easier and more reliable, no major change has occurred. Becton Dickinson is hoping to alter that landscape with the official launch of its FlowSmart infusion set technology.
The product was cleared by the FDA in mid May.
Roper explains that insulin flow is sometimes interrupted because of current design of infusion sets and patients ends up with unexplained hyperglycemia.
"What our research had shown is that there will be periods where the pressure is rising in the pump," but because it doesn't reach thresholds set by the pump, no alert is triggered.
In other words a "silent occlusion" is occurring and patients checking their blood glucose levels will see their blood glucose rise but they won't know why.
"They go through the mental checklist- 'I didn’t eat anything unusual. I think I counted my carbs right. I think I did my exercise right. I don’t feel sick today,' " but despite all that the levels are high.
These problems are caused by design of the infusion sets, Roper says.
"It could be the position that they are sitting or laying at night - Is the catheter being pushed in a direction or is it pushing up against muscle or tissue?" Roper explains. "There’s a lot that occurs in the catheter that is unknown to the patient."
Becton Dickinson in collaboration with the Juvenile Diabetes Research Foundation and the Helmsley Charitable Trust developed the FlowSmart technology that has a novel side-ported catheter design. It also has a smaller insertion needle aimed to minimizing pain and trauma during insertion.
"What we have done is we’ve side ported that catheter so we now have a different way for the insulin to come out so it doesn’t rely on one port out of the distal tip," Roper explains.
Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb
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