You might call it the dawn of a new era in infusion set technology. Starting in September, people with diabetes in the U.S. will have access to insulin pump connection apparatus different from anything we've seen before -- designed to curb the number of occlusions (tubing clogs) and offer a more comfortable wearing experience.
Beyond that, exciting research is making headway on infusion sets that will combine insulin delivery and CGM sensing into a single site, and likely extend the number of days we can wear these sets on our skin.
"There really wasn't a lot of innovation on infusion sets for many years. Really, the work that's now being funded by JDRF, Helmsley Charitable Trust and the NIH, and what BD has done in the past few years, has given this kind of research a shot in the arm!" said Dr. Ken Ward, Chief Science Officer of Pacific Diabetes Technologies that recently entered into a partnership with JDRF to develop a combo insulin-CGM infusion set.
New BD FlowSmart (Sold by Medtronic)
We introduced this BD FlowSmart tech late last year. As a refresher:
- 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 the different types of traditional tubed pumps
- 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
At the recent American Association of Diabetes Educators (AADE) conference in San Diego, BD made a big deal about this new infusion set that's just about ready to launch here in the U.S. starting in September. They even invited a group of patient advocates to visit their medical facilities in San Diego for a #BDThoughtLeaders forum focused on advanced infusion techniques.
'Mine editor Amy Tenderich attended, and reports that they pretty much recapped what has been public knowledge for the past year about this new set, but now that it's so close they're in full pitch mode about the new features and benefits, along with new clinical study data showing efficicacy. We're told by BD's public relations manager Matt Coppola that launch will roll out incrementally by region and wrap up by year's end, followed by a broader global rollout next year.
And to be clear, Medtronic will be doing the launching. Even though it's made by BD, Medtronic has exclusive rghts to selling this infusion set for now.
But that doesn't mean you have to be a Medtronic insulin pumper to use it. The so-called Minimed ProSet will come in two versions: one with a proprietary MedT Paradigm cap set and one with a Luer Lock that works with all other types of traditional pump brand.
That might be confusing for some, but BD's Coppola says: "Pump users who are currently not on a Medtronic product will have unrestricted access to this new technology either by ordering directly from Medtronic or by choosing one of our many distributors globally."
Combined Insulin Infusion and CGM Sensing
Meanwhile, probably the most exciting development on this front is the work being done at a medical device startup in Portland, OR.
On August 10, the JDRF announced a partnership with Pacific Diabetes Technologies to create this a new generation of set that combines insulin infusion and CGM sensing capabilities into a single port set -- something that's actually been in the works for a number of years. The effort has received past funding from NIH and Helmsley Charitable Trust, but will now accelerate with this new $1.14 million grant as it preps for the first human study in early 2017.
"The reason we got into this was 'device burden,' where people have to use several devices and it's cumbersome," said Dr. Ward, a bioscience engineer who's been involved in glucose sensing at companies like Bayer and iSense before joining PDT. "Despite the science showing these devices are vert effective, many people don't wear their pumps and sensor all the time. Our belief is 'device burden' has a lot to do with that, so we want to create a single device where the cannula and glucose sensing is all-in-one."
This would be a different type of CGM, although for appearances and functionality it would look and appear to work the same as existing options like Dexcom and Medtronic CGMs, according to Dr. Ward. But underneath the hood, it will function like the Abbott FreeStyle Libre product available outside the U.S., meaning using a "flash" technology to take more frequent readings.
Dr. Ward says they have to use different technology, because his group found that if you put the insulin infusion set too close to existing CGM sensors, you experience a huge rise in glucose levels up to 800 or 900 mg/dL! They discovered this in pig studies found about 15 months ago when the infusion sites were only few millimeters apart.
The cause: preservatives used in insulin that react with traditional CGM sensor, meaning they'd either have to take out the preservatives (not recommended) or find a different way to do the CGM sensing.
What would this look like?
- Physically, it won't look too dissimilar to the Dexcom CGM sensor that's available today
- A built-in Bluetooth transmitter will communicate with the cloud and smartphone tech
- Two versions are in development -- one that looks like the Medtronic Sure-T infusion set that has a steel cannula, and a flexible set with a plastic cannula.
- A quick release port will allow the insulin tubing to snap into the single port set
If all goes according to plan in the coming months, the research will involve more pig studies before Investigational Device Exemption (IDE) allowing for a human study to start, hopefully in February. From there, Dr. Ward expects more studies before eventually getting to the pivotal trial stage in 2018.
"This is a few years off," Dr. Ward says. "There hasn't really been a motivation for new innovations in infusion set technology, but all the recent research has re-generated the interest and excitement."
Longer-Lasting Infusion Sets
In early August, the JDRF also announced a new research collaboration with Capillary Biomedical in Irvine, CA, to develop a longer-lasting infusion set. This biomed company is a spin-off of the Artificial Pancreas Center at the Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, PA.
They hope to develop an infusion set that can be worn for 7 or more days (nice !), while continuing to deliver insulin subcutaneously in a consistent, reliable and safe way. Currently, the FDA recommends infusion sets be changed every 2-3 days -- though many PWDs (myself included) stretch that time window. If successful, this would potentially more than double the amount of time we are officially sanctioned to wear an infusion set -- saving us money and a lot of hassle!
Dr. Jeffrey I. Joseph is leading this research program. His name may not ring a bell, but he has street cred in that he helped found Animas and tested its infusion set technology back in the day. Now in this research project, he's helping develop a prototype catheter that can be used to further study insulin delivery.
According to the Capillary Biomedical website:
"... a catheter with multiple holes along the barrel, similar to a soaker hose or sprinkler needle. Distributing insulin to a larger volume of subcutaneous tissue provides access to more capillary blood and lymph vessels, resulting in more rapid and consistent absorption and a faster mealtime insulin response with a more predictable effect on blood glucose levels. The non-cutting, atraumatic tip design and insertion method cause less tissue trauma, reducing inflammation and helping to preserve precious infusion sites. Gentle warming increases local circulation and soft vibrations break up tissue obstructions, creating fresh pathways for insulin to reach the surrounding capillary and lymph vessels. Together these features are designed to support reliable 7-day use with a faster and more predictable insulin response."
First, they'll do a 14-day swine study to look at the flow of insulin through current sets and this new prototype, using micro-CT imaging to better understand how insulin absorption changes over time when these sets are inserted under the skin. Following that pig trial, if all's successful, Capillary Biomedical will then plan to perform human clinical studies on the path to commercialization.
Dr. Joseph also has a long-term vision of developing a fully implantable system that (like Dr. Ward's single port set) would both sense glucose and infuse insulin doses. But no details were provided on that yet, or how long it may take.
This research is also part of the ongoing JDRF collaboration with BD, and word is that agreement may soon extended for several more years. With the BD-designed FlowSmart tech finally coming to market this Fall, we would expect that to be included in the next phase of research on infusion set longevity.
We shall see.
No matter how you slice it, it's an exciting time for those hooked up to infusion sets, no doubt. We look forward to hearing more (and wearing less)!