New infusion set targets 'silent occlusions'

The BD company recently received FDA clearance to market an improved infusion set. The company’s studies showed an 80% reduction in flow interruptions and a 78% reduction in occlusions. This infusion set not only has a cannula opening at the bottom like all current sets, but also an additional opening on the side. It incorporates a 30-gage introducer needle, the smallest yet for a pump cannula insertion. This needle size is comparable to the tiny needles used with insulin pens.

As diabetics that use infusion pumps, many of us have noticed the “third day problem” and other unexplained hyperglycemia. This is the first time I’ve read the term “silent occlusion.” This is defined as a flow interruption that impedes consistent insulin absorption but is not severe enough to set off an occlusion alarm. Who knew this even had a name?!!

I’ve experienced many of these silent occlusions over the years; I never had the fancy name to hang on the phenomena, however. In fact, there was one several-month span back in 2012 where I was experiencing this more often than not. I frantically casted about, troubleshooting my pump, changing out my sites early, trying new infusion real estate on my body, and experimenting with new infusion sets. I even went down a five-month failed experiment dead-end with the Omnipod system.

I had read speculation about the body’s immune system responding to the foreign body cannula and building up antibodies so as to interrupt insulin flow. I never read about any tactic to counteract this possibility except for changing out sets/sites every 48 hours, an unattractive practice for me. I resisted this practice due to diabetes’ chore overload!

BD said it intends to release the product later this year or next.

DiaTribe has a nice piece that covers this new technology. If this technology proves to be as useful as it looks, it will answer one of the insulin pump’s main weaknesses for me.

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Here is my opinion on the subject of cannula-type sets. I don’t like them. I used them for more years than I care to think about and they had 3 issues for me:

  1. defects that caused insulin to leak from the connection port (twist-on connector ) periodically.
  2. uncomfortable
  3. so many “no delivery” alarms I came within a hair’s breadth of giving up on pumping–something I never dreamed of doing, but the problems because too pervasive to ignore.

Now I only use Sure-T’s. The upsides of Sure–T’s are:

  1. slightly cheaper but not a huge factor in the scheme of things, esp with insurance covering 80%
  2. WAY more comfort. I just don’t feel them!
  3. “No delivery” alarms reduced by at least 95%. I may get one or two in a year to 2 year period.
  4. No need for an inserter
  5. Lower profile
  6. Better quality control regarding leakage or any other defect in manufacturing.

Did I mention that they are WAY MORE COMFORTABLE??

The allure for new pumpers, in my opinion, for cannula sets is that they think they will be comfortable than a thinner steel needle, but that’s just not borne out by comparing the two. ie, it’s ASSUMED that a soft cannula MUST be more comfortable, just from a logical standpoint.

But here’s the thing–a Quick Set’s cannula is .020" vs .013 for Sure-T. I would venture a guess that that difference in diameter is why I get irritated by Quick Sets and don’t feel Sure-T’s at all.

People that have tried them, in my experience, really like them for the above reasons.

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I tried the “Contact Detach” steel sets that I believe are equivalent to the Sure-Ts. I really like the idea of totally ruling out cannula problems. The problems I’ve had with cannulas have been less than yours.

I read that best practice with the steel sets are to change them every 48 hours. Do you do that. I tried pushing them into the third day but I found the site becoming sensitive, especially when I pressed against it or rolled over in bed. For that reason, primarily, I stayed with the cannula sets.

Glad you’ve sorted out this issue for yourself. I’ll be curious to see if the new BD sets really solve the flow impairment problem of cannula sets.

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I’m also really looking forward to trying the new set. I’ve always maintained the weak link in pump therapy is the canula & the unpredictability of insulin absorption. I am planning on trying the contact detach .

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I go 3-4 days with no problems. So does my wife. There really is no REAL reason to change them in 2 days–even MM is now aware that customers routinely wear them well past 2 days.

I tried the “Contact Detach” steel sets that I believe are equivalent to
the Sure-Ts. I really like the idea of totally ruling out cannula
problems. The problems I’ve had with cannulas have been less than yours.

You would think they would totally rule out cannula problems, but I somehow had a bad site today that seemingly cut off insulin delivery entirely even while using Contact Detach sets. How it can happen, I have no idea. This afternoon I noticed my BG had started to rise without me eating so I did a correction bolus when I was 7.5 mmol/L. Then half an hour later on the way home from work I noticed my BG really skyrocketing and I started to feel sick to my stomach and slightly lightheaded. I checked ketones when I got home and they were 0.7 mmol/L. An hour later (after a correction injection with new insulin and a site change) ketones have increased to 0.9 mmol/L, although my blood sugar has dropped slightly. Hoping the ketones and associated nausea from having zero insulin in my bloodstream go away soon!

I’m not sure I can go back to cannula sites given the allergy issues I had with them before, but it would be nice if the new sites help prevent problems like this.

So I switched to an Asante pump (RIP) in January, and one of the problems I ran into after several weeks was that I was suddenly getting way more occlusion alarms. I was about to give up on it after getting waked up by the alarms like 5 times a night for over a week. Talked to my Asante trainer and she explained that their system uses (used) optical sensors, rather than pressure sensors, that are more sensitive and therefore are picking up occlusions from scarring and inflammation that wouldn’t turn up with my Minimed.

Switching to angular sets made the problem go away (though those have their own problems for me. Kind of a pain, all around). But the Snap was responding to a problem I was already having with the standard pump; it’s just that the standard pump wasn’t alerting me to it. I had been having a lot of unexplained spikes with the Minimed, so this made sense. “Silent occlusions” in so many words, though I didn’t have that term either.

It will be interesting to see if BD goes after Medtronic business, a few years ago Fifty50 came out with a reservoir that converted Minimed pumps so we could use there lure-lock infusion sets. Medtronic was the first to come out with a plastic cannula and it saved the insulin pump industry from failure because a huge number of users where allergic to the bent needle set. I tried the Sure T’s hoping they would be diffrent but they got sore and I rejected them on the second day. The sharp barb on the end is just like a tinny knife that just keeps cutting if it’s not held stable and many times it would leave me with a bloody bruised spot after removing it. I guess some indaviduls can tolerate the stiff steel needle, not me. The plastic cannula softens up when exposed to body heat making it much more comfortable and less irritating.

From the specs in the article: “Both 24 and 42 inch tubing lengths.” Both? Geez how nice. One thing Medtronic gets right is offering a decent variety of tube lengths. It was one of the negatives for me with the Snap (though mostly I love it) that the sets only come in “too short” and “too long.” Why is this such a hard thing for these companies to figure out?

I liked the DiaTribe piece, thanks for posting @Terry4.

They have the research to back this up, but I have to say I find it a bit counterintuitive. If my body is going to attack one hole at the end of the cannula, why wouldn’t it equally attack multiple holes?

@phoenixbound, glad you find the SureT’s so effective. In the YDMV category, I have used angled sets almost all of my pumping life with only a few occlusions.

It’s interesting how diffrent everyone is. I would like to see the tubing even longer so when I put a infusion set on the back of my arm the pump will still drop to the bottom of my pants pocket, the 42 will just give me enough tubing to get it clipped to my wast band but if I put it in my pocket it’s hanging by the tubing. :disappointed:

Yes, actually I just ordered a box of 42’s for the same reason–back of the arm to bottom of pocket. For me it’s long enough for that. But for belly or upper thighs it ends up winding around itself, getting snagged on things and being a general nuisance, whereas the 24 is too short if I want to stick it in a shirt pocket while sleeping, etc etc. I dunno, maybe I should consider an Omnipod now that Snap is defunct, though it’s hard to gin up much enthusiasm. They all feel like going back to MS-DOS to me now.

Annabella - I can usually depend on good insulin absorption. But when it stops, it leads me to various troubleshooting efforts and I don’t usually conclude “bad site” until I’ve tried other things and my BGs get even worse. Nothing worse than correcting a rising BG with the pump only to finally conclude that the site is bad!

phoenixbound - I’m glad the steel sets work so well for you and your wife; I wish they performed that well for me. I definitely feel site pain if I go past two days.

Jen - Your experience demonstrates that even a rock solid steel cannula is not the answer when the receiving tissue won’t cooperate. Your struggle with site allergies sounds super challenging to me. Glad you caught this episode before it got much worse!

DrBB - Interesting that the Snap was more sensitive with occlusion alarms. In my case, I started experiencing absorption problems with angled sets. I had successfully used this style set for years. I changed to the 90 degree sets (QuickSet), started using new real estate, and the problem went away. Not sure if the set change or the real estate change mattered most!

Whichever direction you decide to go with your next pump, I’d definitely recommend at least a 30-day trial before getting your insurance company involved. You really don’t know what the technology is like until you live with it 24/7. When my five month trial of Omnipod failed, I gratefully returned to my tried and true Animas pump!

JohnG - I’ve always used the long tubing. My requirement is to enable bathroom visits. I don’t mind tucking my tubing in and I’m not too fussy if I’ve tidied up sufficiently. In fact, I see errant tubing as part of my look; I have diabetes and use an insulin pump!

YogaO - I like to follow DiaTribe. They do a good job reporting on the technical frontier of diabetes.

I’m guessing here. Perhaps the reduced flow does not irritate the tissue enough to incite the body’s defenses. If you can believe the company’s numbers, they have found something that helps.

Yes, exactly–my real point is that there should be a lot more length choices, because there is certainly a wide variety in the body shapes and infusions sites of the people using these things. What’s the limiting factor? Whose interest does it serve to only offer two? It seems like such a no-brainer–a simple thing they could all do that would make things a little easier for us. Much easier than CGM integration and all the other stuff they spend their time developing.

I wholeheartedly agree. The economies of scale inherent in mass production, should, with modern manufacturing methods, some creativity, and motivation, be able widen set-length offerings without losing a cost-advantage.

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I’ve been using short cannula angles sets for 15 years, and due to tiny basals and sets getting bumped around, I have had a terrible time lately. I have a box of samples here from Roche (sending their pump back because it didnt work for me). I dont know if I will try them or not. Animas had a great suggestion for me. I put a piece of IV 3000 across the site, so I could still see through the window. So far, a dramatic change in how well the site is lasting. I’m getting ready to try a new one, and we shall see if the site is still much better. This is an easy fix for me and since I have six months of angled sets on hand and a terrible 50 percent DME, this will be far cheaper. That said, I cant wait for some new sets to show up on the market.

Have you ever tried sets similar to Sure-T’s? Unomedical makes them for MM and they make them under different names (essentially the same as Sure-T’s but just a tad different) such as Contact Detach for folks who need Luer lock type sets. I guess I am wondering is why you are waiting for something new when there are so many different options NOW.

Laura - Are you using the IV3000 as a barrier that you stick to the site and then punch thru it with the infusion cannula? Or do you mean that you tape the IV3000 over the external portion of the infusion set? I hope you can make use of your stock of sets. They’re not cheap!

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Really there is nothing new under the infusion set sun. Animas and MM and Accuchek offer the same types of sets, though I was surprised that Animas had the Insets as it’s only real 90 degree set offering. I’ve used Silhouettes and Comfort short sets 15 years, because the 90 degree sets didnt work for me (I’m too thin) The Accu chek trainer was wonderful and left me some samples which can be ordered from them even if I am giving up their pump. There’s some steel sets in there, plus the Ultraflex 90 degree sets, 6mm. As an Animas pumper, was kind of surprised to see they do not offer samples. We no longer have a state rep, so no way to get them. But then again, like I said, everyone has essentially the very same thing so I do have these Roche sets to try. I’m just glad to see BD get into the competition.

I found this old box, which I swore I tossed out. I dont know how sort of thin the IV 3000 is supposed to be (mine is very saran wrap like). Anyway, I stuck it over the site, because my sites had been pulling out and sort of just lying across my skin. My CDE thought it might be the site rejecting the set, but I think it was just working it’s way out. So yes, I put it across and it is working fine. Will try a different location tonight to see if that works. I have had months of these darn things occluding or working out of the site, enough to have really thrown my A1c off. Saw something online that said this can start happening to people too. The 3000 is $77 per box at Animas, and I am going to try to make that work. Yes, I hope the Comfort Shorts will last, as I dont want to toss 6 months of sets to the side.
The very helpful Animas CDE thought my sites were coming unstuck, so her suggestion was made for a different reason. But I am very grateful she suggested it, because it may solve a goodly few problems.