The Newest Infusion Set: Medtronic/BD MiniMed Pro-set with FlowSmart
By Adam Brown and Kelly Close
Much less painful insertion, great needle retraction, and better disconnection
We recently received an order of Medtronic/BD’s new MiniMed Pro-Set with FlowSmart technology, a little over a week after the initial limited launch began in the US (At this time, Medtronic is no longer accepting new participation in the limited launch; a full rollout is expected in early 2017, according to BD's recent company update).
Talk of the new insulin pump infusion set has focused on the novel catheter (cannula), which includes two holes for insulin to flow through. BD’s data suggests the additional side hole helps reduce flow interruptions and silent occlusions (blockages). Hopefully that will translate into fewer unexplained highs!
This test drive shares a less-talked-about and exciting part of the new set: what it’s like to insert and wear it. We’ve experienced meaningfully less pain relative to using current sets (very noticeable and welcome!); an excellent needle retraction after insertion; a terrific eight-position tubing connector and two squeeze tabs that make it far easier to disconnect and reconnect; and very secure adhesive. The MiniMed Pro-set is also the same price as current infusion sets – nice to see no extra charge for new innovation.
Adam ran into some hiccups in his initial trial of the set, stemming from incorrect insertion and not reading the instructions. After a couple manual insertions (without using an inserter device), Adam experienced potential kinking and some high blood sugars. Using the Quick-serter device fixed the problem, as it brought more reliable 90-degree insertion – we would highly encourage using this! In talking with BD, Adam learned that he was inserting the set incorrectly: manually inserting MiniMed Pro-set must be done with a fast motion (pop!), but Adam was going slow like a pen needle, potentially causing the catheter to kink. This won’t be an issue for people who automatically use the inserter device, but it did serve as a reminder for new diabetes products: the smartphone era has made reading instructions a foreign concept (not that it was so popular before that either!), and when dosing insulin, the stuff in the folded-up instruction manual really matters! We salute the BD team for being open to hearing about patient experiences, and we’re glad to see how receptive they are to patient feedback, especially on how to make the instructions more visible. Bottom line: we encourage you to user the Quick-serter device – as instructed!
What We Liked
Inserting the MiniMed Pro-set is noticeably less painful than current infusion sets. The 30-gauge insertion needle is the smallest on the market (similar to a pen needle in size) and has some of BD’s special beveling design that reduces the “pop” and makes insertion smoother through the skin (we also noticed this with Astra Zeneca’s Bydureon). The number of gauge is only part of what determines pain – this “beveling” thing is a big deal! We inserted the set both manually and with the Quick-serter device and thought the pain was noticeably lower relative to other infusion sets like the all-in-one Mio (27-gauge needle; lower gauge is larger and the difference in these two gauge sizes is a lot). Needle pain is complex, and individual perceptions definitely vary. Some people are far more “pain-sensitive” than others, and we’re so glad that BD incorporated that fact into its product design.
The set can be inserted with Medtronic’s older blue Quick-serter device; the just-launched, redesigned green/gray Quick-serter; or by hand (manually). We much preferred using the Quick-serter device. The orange needle cover fits nicely into the inserter, and pressing one button launches the set in.
We loved the sliding shield that auto-retracts the needle and contains it after insertion, helping to prevent accidental needlesticks (also great for those who are needle-phobic, though the needle is visible going in). After insertion, the user holds the adhesive with one hand (two fingers, one on top and bottom) and pulls the orange square of plastic off the body (see below) with the other. The needle is automatically retracted into the orange plastic box and the purple cover cannot be removed, so as to prevent needle sticks. The set’s slim packaging also creates much less garbage waste than all-in-one sets. This was very much appreciated, and we’re grateful to all the companies making progress on this environmental front a priority.
The set’s adhesive is very secure on the body, and the eight-position tubing connector and two squeeze tabs make it far easier to disconnect and reconnect. Current sets need to be lined up pretty exactly when disconnecting and we like this set’s flexibility – it’s a small but meaningful experience win, even for a behavior that only occurs once or twice a day (e.g., showering, changing clothes). We have found both the Quick-set and mio to be somewhat finicky for disconnecting, even for those with good dexterity. The Pro-set has a low-volume profile that barely rises off the body, a plus over other sets.
Our insurance (Aetna) covered the set at 80%, the exact same rate as for other infusion sets. We assume current pumpers will not see an out-of-pocket difference with this set vs. others (the price was the same), although this could vary depending on plan. A 10-count box of MiniMed Pro-sets is $162 cash price for both Medtronic AND Luer Lock pumpers (Animas, Roche, Tandem), the same price as Medtronic’s all-in-one mio set, thought slightly more than the $139 10-count Quick-set box.
The set comes in in both Luer Lock and Medtronic pump configurations. We used the Luer Lock version, which worked as expected with a non-Medtronic pump. MiniMed Pro-set comes in both 24’’ and 42’’ tubing lengths and only 6 mm cannulas. Though some pumpers use 9 mm cannulas, BD’s research has found that a longer cannula risks intramuscular infusion or kinking; the company believes 6 mm is optimal for all pumpers. The set is approved for use up to three days.
Medtronic is no longer accepting new users for the set's initial product introduction. The set is expected to fully launch in early 2017, according to BD's recent company update.
Potential Areas for Improvement
Clearer instructions and training materials would be useful on how to insert the set properly. Currently these are buried in the product packaging (must flip over 4 flaps of the manual to get to them!), and current pumpers may simply take the set out of the box and put it on. The smartphone era has made reading instructions a foreign concept, but when dosing insulin, the little stuff in the folded-up instruction manual really matters! The quick-start guide to put the set on requires unfolding a fairly thick instruction manual several times. Medtronic and BD do have a great series of online videos, describing how to insert the set properly, but these were not obvious to find when we received the set. For future users, we hope a quick-start card will be included with clear visual and word descriptions, or perhaps an easy step-by-step guide on the box. This could hopefully focus on the most common mistakes users make when inserting the set.
For example, Adam saw some potential kinking and high blood sugars following manual (by hand) insertion of the Pro-set without an insertion device. These issues resolved upon using the Quick-serter. In talking to the BD team, manually inserting MiniMed Pro-set requires two things: (i) inserting the needle with a fast motion; and (ii) inserting at 90 degrees. Adam was inserting the set like a pen needle (fairly slow) and likely wasn’t achieving perfect 90-degree insertion (e.g., a buttocks or side abdomen insertion makes this difficult). The set also requires placing two fingers firmly on the top and bottom of the adhesive before retracting the needle (the orange part in the picture above), something Adam wasn’t doing either. These two tips meaningfully improved experience with the set, but were not obvious from the instructions provided.
Like all sets, MiniMed Pro-set only comes in a 10-count box for now, though a no-hassle free-trial program would be very helpful to see (before getting a prescription, buying a 10-set box, and running it through insurance). Getting the MiniMed Pro-set currently requires a prescription and running it through insurance or paying $162 cash for a 10-ct box. As we understand it, Medtronic will offer two-set sample packs through healthcare providers once the set launches more broadly (though a prescription will be required). Infusion sets are a 24/7 commitment for pumpers and we love the idea of trying before buying. This has been missing for way too long in diabetes technology across the entire field!
We hope future sets will enable longer wear. The BD/Medtronic MiniMed Pro-set is approved for up to three days of wear, though we wish five or even seven days of wear was possible. A new JDRF/BD partnership is looking into this, and Medtronic has its own longer-wear sets in the pipeline. Ideally, infusion sets could even be integrated with CGM sensors under one patch. However, with sensor wear now at 7-14-days, and products from Abbott (FreeStyle Libre) and Dexcom (G6/Verily) moving to much smaller wearables, this may be less of an issue in the future. We know that a number of other sets are in the midst of design – that’s good news, since we wish this set had been available directly from Animas, Tandem, and Roche rather than only available through Medtronic. We salute BD for taking on so much new innovation and particularly for making it fairly accessible from what we can tell. To those who have used it, what has your experience been? We’d love to find out and report back.