http://type2diabetestreatment.net/diabetes-mellitus/insulin-pump-infusion-sets-get-better-with-bd-flowsmart/
When you start on an insulin pump, everyone talks about precision calculation of your insulin doses -- as if that alone would magically make your blood glucose levels just right. NOT. There are so many uncontrollable factors and annoying side effects that weigh in! Not least of which are infusion site issues -- problems at the spot where the insulin is supposed to be flowing in, but for a myriad of reasons, is not doing so as it should.
Finally, this issue is getting the attention it deserves!
JDRF and the Helmsley Charitable Trust collaborated with infusion tech leader BD to support new research and product development that culminated this summer in the launch of a joint BD/Medtronic new infusion set called BD FlowSmart that"s designed specifically to help eliminate disruptions in insulin delivery.
And at the big European Association for the Study of Diabetes (EASD) conference in Stockholm last month, a lineup of premiere experts led by JDRF"s Artificial Pancreas director Aaron Kowalski presented a whole symposium on the topic. Around the same time, EASD and the American Diabetes Association issued a joint statement on the benefits and risks of insulin pump therapy that calls out "insulin infusion set blockage" and "infusion site problems" as areas that need a lot more attention and study.
"The dirty little secret of insulin pumps is that we"re not getting insulin all the time. Amazingly, this is not studied well. Why do infusion sets fail? What do we know about them? And about skin reactions, infections, lipohypertrophy, interruptions in absorption of insulin?" muses Kowalski, who lives with type 1 and wears a pump himself.
"Infusion sets have been traditionally treated by the diabetes industry as a commodity – made and sold at the lowest price possible because that drives business. But now BD has data showing a 15-20% failure rate of infusion sets, not completely but even if they partially fail... Pump companies are not happy about this. BD"s work really woke up leadership that should have been (focusing on higher quality infusion technology) a long time ago," Kowalski adds.
The Achilles Heel of Insulin Therapy
A seminal PubMed article published in 2012 called out infusion set issues as "the Achilles heel of continuous subcutaneous insulin infusion." The authors acknowledge how very little the Medical Establishment knows about how often patients encounter these problems, due to a lack of good studies on the topic. "Reading pump wearer blogs... suggests that these are a frequent source of trouble," the authors write.
Wow, good to know that researchers are reviewing PATIENT BLOGS as a valuable source of information about real life with diabetes!
Nevertheless, almost four years later, Bruce Buckingham"s EASD presentation acknowledged that there is still "almost no data published on pathology at an infusion site – either animal or human."
It"s pretty obvious to us pumpers out in the real world that infusion set performance is affected by stuff like sweating a lot, taking a shower, or the day of wear you happen to be on.
It seems a little crazy that there are so many published studies on the relative benefits of insulin pump therapy, when no one knows for sure about the performance of that critical little pipeline that carries the insulin into your body. How can you judge pump therapy on the whole when you don"t know if the patient is getting anywhere near 100% of the insulin they"re attempting to dose?!
Silent Occlusions
Kowalski explains that what BD has done is try to address this problem, which they call "silent occlusions" -- a fancy term for when your cannula gets clogged but the pump doesn"t alarm, so it"s a silent error that you don"t know about. That is, the buildup of trapped insulin takes place at very low pressure -- too low to set off your alarm.
BD has recently published a bunch of new data, presented in three posters at this summer"s ADA conference, that delves into these oft-undetected insulin flow interruptions, and the improved performance of their novel new infusion set, studied using medical imaging in both pigs and people.
They"ve also created a colorful infographic to illustrate the problem, highlighting the factoid that "two-thirds of current insulin pump users have been shown to experience insulin flow interruptions that often go undetected by the pump occlusion alarm system." That data comes from a 2011 study by a group of researchers including insulin pump expert Dr. Bruce Bode of Atlanta Diabetes Associates.
Interestingly, we found an academic letter written in response to that study arguing that the three different insulins used -- Humalog, Novolog and Apidra -- may have indeed played a part in how often pump users experienced these "silent occlusions." There"s certainly been some talk over the last few years that Apidra does not do well in pumps.
Dr. Buckingham"s presentation also addressed inflammation and infection at infusion sites -- issues we pumpers know all too well. He reported that in various studies, 53% of adults and 21% of children who quit insulin pump use reported that inflammation (and those yucky skin bumps!) were the primary reason for quitting. Overall, 29% of pump users reported experiencing at least one site infection. In fact, they had roughly one infection for every 27 patient-months of using a pump. (I personally can beat those odds -- ugh!).
Enter BD FlowSmart
The new FlowSmart infusion set, manufactured by BD and marketed by Medtronic, is meant to address these issues, with these new features:
- smallest catheter on the market
- made of soft pillamer instead of stainless steel
- 28 gauge thickness versus 25 gauge (the bigger the number, the smaller the device, so a 6mm set would have a 30 gauge needle)
- uses "inline infusion pressure" -- like low pressure in plumbing, reducing the tendency for blockage/buildup
- the tubing connection swivels, so you can attach it in multiple directions and lock in the angle that"s most comfortable for you
- Medtronic will offer both Paradigm and Luer Lock versions of the new set so it can be used with many different commercially available systems
- and last not least, IT HAS A SIDE PORT, or second side hole that serves as an "ancillary path for fluid" -- basically an alternate route for the insulin to flow in the case the first path is blocked
That final point is of course the operative one -- the feature that sets this new device apart from any other to date. Check out this visual snippet from a BD promo video posted here:
But I couldn"t help asking Aaron Kowaslki of JDRF if all the fuss was really about an EXTRA HOLE in the plastic? Really? Why did it take so darn long for someone to figure out that a second "port" in this little gadget would help relieve pressure and provide an alternate path for insulin?!
He just chuckled and reminded me that more goes into these small changes than you might think.
"For new things to be successful, they have to offer not only better glucose control but make life easier – this set is an example of both," he says. "You get better infusion / better control, and BD"s made the set smaller, made it swivel, made it more comfortable to wear."
And as noted, the data released in June showed significant reductions in flow interuptions in patients wearing the new set.
"Interestingly, Buckingham"s science looked at dual infusion sets, which are critical for AP (Artificial Pancreas) systems. He showed the differences between CGM sensors and infusion sets – and that sensors don’t cause irritations. So we know insulin is the culprit," Kowalski adds.
The BD FlowSmart set received FDA clearance a few months ago, and the manufacturing plant is gearing up now for a launch date in early 2016, Kowalski tells us.
"The net-net is that for anybody wearing a pump, this will be an important step forward," Kowalski says.
We"re certainly with him in cheering on these imporant efforts to address the weak link in insulin pump therapy: unreliable infusion sites. Welcome, FlowSmart!
Disclaimer: Content created by the Diabetes Mine team. For more details click here.Disclaimer
This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.
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