I imagine they want to get the product to market as fast as possible. And pump testing would take much longer (just me guessing, not knowledge.)
On that note, I think for their point of view though, it is safer to release this way. And they honestly know that many Dr.s will prescribe this off label for people with a pump anyways. So they WILL get testing done upon release. Not empirically testing in controlled settings, but real world testing that shows other issues they never thought about. You know, LIFE.
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Yeah, I agree with you. It is much safer to reduce the risks and assure approval, but I don’t agree that they get any benefit from off-label other than finding out if there are really bad things that happen in the pump. I think it is just two many new variables being added to the equation that would slow things down and potentially stop their approval from happening. The pump testing must be pretty painful, i.e. leaching tests from each pump manufacturer’s cartridges, heat stability tests that are harder to pass (i.e. 4 days at body pocket temp vs room temp) etc. so they don’t take the risk.
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Ok, so having used it for a little while now, and that is still NO where near long enough to make any real conclusions.
But, I like this stuff!
I will say that I get more stinging than I did with Fiasp.
I will say that my injection site IS a little more tender.
I have not have a single occlusion, even having left in once for more than 4 days.
And I know this is too early, but I think I might back off on my basals a little with it as compared to Fiasp.
Now, I figure this is just the honeymoon period, but this stuff works GREAT with Control-IQ on the Tandem X2 pump! I seriously like it!
I am always in sleep mode.
I set my basals and all settings aggressively to assist Control-IQ.
I have found that with Fiasp, while it will adjust my basals for when my BG is trending higher, it rarely fully corrects them. I usually add a small bolus on top of increased basal.
Now with LoomJev, I am not making nearly as many corrections myself. They are coming back on their own, and not going as high (I am not talking about big spikes, just life as a T1D.)
I figure I need to use this for two months to see how it fully stabilizes out. But I am into my second vial, and I like it.
I think that the site issues with be a show stopper for some people.
I will definitely keep a watch on this, but my quality of life is more important than a little irratation.
And I could see where some people, especially those that have sensitivities, could have much bigger issues with LoomJev.
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I like the re-branding! 
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Yeah, well, at least if I spell it that way, it is pronounceable.
I mean really, who thought that name was something to go with?
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Well, over a month in and I still like it.
I do get site irratations, I get some bumps, and even got what looked like a small bruise around one site. But nothing really different than what I was going through with Fiasp, except I have only had ONE occlusion, but I don’t think it was a real one. I resumed insulin and everything went back to normal.
I haven’t changed my pump profile from what I had set for using Fiasp.
I want to get more data under my belt before I create a new profile for LoomJev.
Also, I want to take into account the honeymoon phase of starting on a new insulin, and give it time to wear off, before I try and fine tune it.
But, having a similar profile as my Fiasp sure makes my life a lot easier! I can quickly calculate what I need to give (I like to input carbs into the pump and see how close my calculations are. I honestly go with the pump’s bolus most of the time, unless I think it is TOO aggressive.)
I will update more after I get more time in with this insulin, but I thought I would chime in to say that things are going well with this insulin.
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Old thread, but I thought this would be the best place to update.
Because of a few different issues, I have been back and forth between Fiasp and LoomJev.
I can honestly say that I truly prefer the LoomJev over Fiasp.
I think most of my issues with Fiasp were concerning the design of the Tandem X2 pump and it’s cartridge design. But I did have a number of site issues as well.
Long term update on LoomJev.
I can keep a site in for 5 days sometimes without issue. Sometimes I will have a little swelling around the infusion site. But nothing serious.
I used to have some pain on boluses. Lot more then the stinging from Fiasp. But I rarely get those now.
Effectiveness. Well, I would have to say that it has remained consistent for me!
This is not the case with Fiasp. Even with my on/off use of Fiasp, it changes effectiveness over time.
I plan on staying with LoomJev for the foreseeable future.
I am finally in a health plan this year, and my prescription plan has really nice coverage for LoomJev as well, so this is a BIG bonus!
I highly recommend LoomJev, but I must give advance notice that it does have certain potential issues.
I have had some bruising around infusion sites, these were when I started using it. I also had some notably painful boluses. Again, mainly at the onset of usage. I get a noticable bolus once in a while now, but not nearly as bad as when I started.
Having said this, I still feel that the advantages of Loomjev far outweigh the downsides for me.
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Hammer,
Thanks for the update on Lyumjev. I would like to try it in my pump (currently on Humolog). Your experience with infusion sites is good to know. On line reviewers have said that over time they see a loss in activity. Have you seen this?
Any other tips?
Thanks
Mike
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If there was a loss, it was minimal.
But I am basing this off of using Fiasp as my comparison insulin. And I definitely had a loss of affect over time with Fiasp (I was on and off Fiasp a number of times of the years since I started using it.)
If you have used Fiasp before? I would start off with that same profile and make adjustments fro there.
If not, then adjust the time on board slowly. I use 5 hrs for novolog, and 3.5 hours for Fiasp. I imagine you will most likely have a brief honeymoon period where it acts more aggressively until your body becomes used to it.
I can’t adjust for LoomJev for time on board with the Control IQ on the X2 pump.
But I imagine that it would probably have a similar time compared to Fiasp.
Also, on LoomJev, I found that different locations have different responses for where I put my infusion sets.
Right now, I am using the side of my pectoral muscles. I have ‘just’ enough fat there to use the 9mm infusion sets. This spot has been my absolute best spot so far! Before that, I was going just below my rib cage, but I often was too close to muscle and felt the pain on boluses.
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Hammer,
No, I have not tried Fiasp before. Interesting information about the infusion site; I have plenty of fat below the rib cage 
I can do pecs, but have a pacemaker on one side. Is the absorption different, or just the pain?
When you cycled back and forth with Fiasp would the effectiveness come back, and the same with the insulin you switched off from? I am curious because of some observations I have made recently with Novolog and Humalog.
I now have the Lyumjev, and my next reload will give it a try.
Mike
Unraveling The Mysteries Of T!D One Step At A Time!
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Switching back to Fiasp after a while on another insulin does show a faster action with Fiasp for a while.
I don’t think it was like the very first honeymoon period with Fiasp, but it is faster at first, then drops off some. I usually don’t have the huge drop offs like other do though.
I think the absorption was better in some spots under the rib cage, but probably due to muscle proximity.
Honestly, I started using the side of my pecs because I was thinking about the possibility of doing a patch pump, and wanted to see if that spot would even work. Also, being virgin territory, I really liked the idea of gaining some real estate for where I can pump.
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I have heard this about Fiasp. Not sure what is up with that. Perhaps the additive they are using to speed it up.
In general, I think that is one of the worst things to have to deal with - inconsistency.
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I don’t think Fiasp was really that inconsistent. The initial period was different. But I can see how the change happens. But overall, it still works much faster, and has a much shorter tail than Novolog, etc.
I honestly think that for most people, it is almost like the novelty wears off from having a faster insulin. They are not paying as much attention to it, etc.
Not that it doesn’t drop it’s affects.
But, I am pretty confident that if I switched back to Fiaps right now, and I have been off it for many months, it would act pretty much the same as before. The first few days I would probably see some faster results and my body adjusts to it. But it stabilizes after that.
My issue with Fiasp, I think, it all based around how the Tandem X2 cartridge is built, etc.
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I have now completed 12 days on Lyumjev, and now am going back to Novolog. The bottom line is that the swelling and pain (continuous) at the insertion sites was more than I could bear for the gain. A lima been sized lump formed at the insertion site, that was very tender, and a burning pain (that increased on succesiuve days) when bolusing. I had 3 blockages 36 hrs or so after changing sites, and one serious bleed. It would take over 24 hrs.
The inflammation and irritation at the site concerned me, and I worried about long term effects on my tissues from continued usage (disregarding the burning pain).
I had switched from Humalog, which seemed to have lost effectiveness over a year. The Lyumjev was not immediate, but took 15-20 min to act, versus Humalog’s 40-60 min. Also, my PP were much lower.
When I switched off of Lyumjev, I went back to Novolog for a comparison. The Novolog exhibited activity more like Lyumjev, but no pain, swelling, redness,or site blockage. I am disappointed the experience with Lyumjev was disappointing.
Mike
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Sorry to hear you had such a bad experience. Thanks for letting us know.
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Hi, this is my first post. T1d 57 years and going strong:)
On a lyumjev sample for a few days now with a Tandem X2 and Control-IQ. So far works really great compared to Humalog. Blood sugars nice and steady in range. Roger in Los Angeles
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Does it sting or HURT when you bolus?
Are you getting any ‘tunneling’ affects?
If you have any issues, I think there might be some work arounds before just giving up.
Btw, I finally found my previous Endo (she moved to a new practice, but a long period of time between.) And I was talking with her about this. She has another patient that had to give it up because of the pain while bolusing, and some other issues.
And while I had them, I made some changes, and definitely feel the benefits are worth the hassle.
Oh, and WELCOME to a great community!
And congrats and living with and surviving this beast for so long.
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Thanks. I had one infusion set that hurt which I replaced, but no pain bolusing or otherwise. I’ve used it for a few weeks so far. Hope to be able to switch to it permenently if my Medicare will cover it. I’m fortunate to have a really great endo for the past 30+ years, and a golden CDE NP out of USC who covers everything and just glides through tweaking my pump settings to be almost on auto pilot.
Medicare did cover the Lyumjev for pumps.
I see my diabetologist next week and I’ll ask what his patients experience. I would like to be able to use it, but I am a sadist.
Sitcur - I also have been T1D for 57 years!!!
Mike
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