I’ve been following the news for the last 18 months or so of a new-style infusion set developed by Becton Dickinson (BD) using its dual port cannula called FlowSmart. This set was designed to address “silent occlusions.” This happens when a partial occlusion at the cannula tip compromises insulin absorption but is not prominent enough to trigger the pump occlusion alarm.
This is more common than we realize. We often discover this situation when our blood glucose level climbs unexpectedly. I’ve had this happen to me but often didn’t come to this conclusion quickly since I usually attribute this unexpected elevation in blood sugar to a bad insulin to carb ratio or even suspicion that my basal rates need adjustment.
I know that MiniMed Medtronic is the only source for this product and the last I read was that it will be available by the end of the year (2016). The FDA approved it last year. I called MiniMed this morning and found out that it just became available recently. MiniMed calls this infusion set the MiniMed Pro-set infusion set. You can visit their web page for various versions of this set. MiniMed supplies the proprietary connection for MiniMed pumps but also produces the standard luer-lock connection used in many other pumps including my Animas Ping.
This is the first significant technical improvement in infusion sets in a long time. I’m excited to give it a try and I hope it lives up to its promise.
Update
I have some additional info on the Pro-set availability. I placed a tentative order with a Medicare supply house. Their in-house pharmacist contacted MiniMed and learned some more details. I received the info from a member of the Medicare supply business sales staff.
I was told that the Pro-set infusion sets are not available to the general public yet. Apparently there is an issue with the second cannula perforation and cannula kinking upon insertion or thereafter. The sales person told me that these sets are now only available as part of a “pilot program” and only for people with high A1c’s and currently without insurance. Infusion sets supplied under the pilot program are free to the patient. Patients must work through their doctor to access the program.
If everything goes well with the pilot program, the sets may be available after January 1, 2017. I have a feeling that it could easily take longer than that.
This seems similar to other post-FDA approvals that permit a product release along with a concurrent study. This pilot program will apparently assess whether this kinked cannula weakness involving the side port is something that needs more extensive reworking or if the pilot program will prove that it’s not statistically significant.
I thought it was odd that MiniMed did not make a big splash with this release news. This additional info may be the reason why.
Yes, lots of us from the IPF have been also waiting for these. I did learn that you have to get a whole box, no samples are available unless your rep will hand some over. None available here. Did you get samples, Terry? Dying to hear a review on these!
No, though that’s a good idea. I initiated an order through a Medicare subcontractor supply house. I was surprised to see that the list price of this set is $162 each. Yikes! MiniMed customer service told me that all the infusion sets they supply range from $139-$162 each.
Been waiting for a chance to try that ever since BD announced the future release!! I’ve got a ton of infusion sets, but sure want to get my hands on a box of those to try. I think a partial occlusion is exactly what caused my problems this past Saturday. Would have been nice to have avoided that.
I think site absorption problems are at the root of a significant percentage of hyperglycemia. I remember BD assigned a number to this; I can’t remember it off the top of my head.
If this technology delivers on its promise, it will be one more thing to help improve our control.
I’ve had huge problems with Quick-Sets with the cannula tip kinking. I have since switched completely to Mio, which works much better, and causes less pain during the insertion. The only thing I don’t like with Mio is the connector.
I had the exact same experience with Quick Sets. I don’t know why the cannula tips bend so easily. Like you I have switched to Mio and now most problems are gone. I agree that the connector isn’t ideal.
Was the cannula tip kinking associated with certain sites on your body? Do you think it might be from the cannula penetrating muscle tissue and then kinking due to movement of the underlying muscle? What cannula depth were the Quick-Sets? 6mm or 9mm?
@Boerenkool, I’d be interested in your experience, too.
Good question. I don’t think it was associated with certain sites. On the one hand muscle tissue penetration sounds plausible, because I’m lean, but on the other hand, I’m still using the same cannula length (6 mm).
Couldn’t really point at a certain issue, it is probably linked to the way I insert it and so on, but I have been pumping since 1998 and using quicksets since the Paradigm system came out. This issue came up only during recent years.
I think I noticed this once they moved the production to the new plant, in Puerto Rico, or wherever it’s made nowadays. May be something I just connect to that move, but still.
I have had so much trouble with kinks in the quick sets and mios. About 25-50% of my sites. Also some sample silhouettes. I’ve only been using a pump again for a year and a half. I quit the pump years ago due in a large part to the same problem. Now for the past month and a half, Ive been using the little metal sure T 6mm sets. (I also put on 10 lbs so I would have more sites.) The sure Ts are working great! Occasionally I put one in in a spot that is tender and I have to move it right away. But most sites don’t hurt at all and there is no wondering and worrying and watching my sugars climb for a couple of hours before figuring out the new infusion set is kinked. I also used to have problems with the silent occlusion a couple of days into the site. I was planning to try the BD sets when they came out (before the sure T switch). I thought maybe they would still infuse if they were kinked. Thanks for the update, Terry4. Does anyone know anything about the infusion “patch” mentioned in the news release about the Medtronic pump due to come out in April?
Hey all. I’m new here. I just received my 630g last Thursday (Nov 3) with four boxes of The new Pro Sets. So far so good. The connector comes off very easily I’ve noticed. I have always used 9mm (prior to my debacle on Omnipod), I feel like the 7mm is giving random absorption problems, like Omnipod did. Going to ask for another box of 9mm quick sets and see what a week of data looks like. My trainer was very surprised I had them. Search me. I asked about them on one of my phone calls during the ordering process and they sent them.
So I did get 4 boxes of Pro sets in exchange for 4 boxes of Mios about 3 weeks ago. I’ve used them successfully but I still have to change them every 48 hours and a couple did fail with silent occlusions before 48 hours. I just got a call from the Medtronic store saying my order for 5 boxes of the Pro sets has been stopped and they would ship me 5 boxes of a previously used infusion set. What the heck!!! The representative said the set might be available after they get more feedback from the pilot program.
What about my feedback??? I want to use the Pro set not the Mio! When I asked if I could again exchange the Mio for the Pro sets when they become available, the representative said they would only exchange things for 30 days. From the way I’ve been treated by Medtronic in trying to get a new pump and now this with the latest and greatest infusion set, I have to say Medtronic is THE ABSOLUTE WORST insulin pump company in existence. They are only interested in getting new pump users and do not give a crap about long-term patients.
If I wasn’t stuck with UHC insurance I’d definitely go with a different pump and different CGM.
This suggests that Medtronic is not getting the data they hoped for with this post-market trial. I fear that the FlowSmart Pro-Sets may be headed back to the drawing board. It’s much better to stop this distribution now and fix the problem than to forge ahead and distribute flawed product to many more people. Two steps forward, one step back.
I’ve read a couple of Facebook posts by people having questionable to poor results with these sets, so it doesn’t surprise me to see shipping stopped for a while. People have been excited about these sets for years and it would be a great disappointment if actual results are not close to the hype.
Because I have never done well with 90-degree sets, these sets have not interested me at all. But I also think that we all benefit with every new development and choice available to the D-community.
Hi Terry-
I hope you can get some samples to give them a try. I took part in a clinical trial for these infusion sets about a year ago, maybe a little longer. At the time I was using Medtronic soft sets without any issues. so the trial had us use our infusion sets for I think it was 6 set changes and than using the BD sets for 6 changes. I had major issues with the BD canula bending on insertion. A problem I’ve never had in all my years pumping. I also had a major high experience, the in 400 kind and when I pulled it out it wasn’t just a little bent, it was major.
I have since switched to metal infusion sets afte getting different samples to try the different ones out there. I haven’t had any issues with occlusion alarms. I really think infusion sets are the deal breaker using a pump. If the infusion set doesn’t work well for you, it doesn’t really matter what pump you’re using, unless you are tubeless!
I saw them at the AADE convention in San Diego and thought they were already out. Hopefully they will hit the market soon. Even if it’s something I probably won’t use, it they could be very helpful for many with infusion set problems. Hope they can give you some samples or maybe your pump company can. I did get a few different ones from my pump trainer.
Yes, lots of us from the IPF have been also waiting for these. I did learn that you have to get a whole box, no samples are available unless your rep will hand some over. None available here. Did you get samples, Terry? Dying to hear a review on these!