FIASP for Insulin Pumps


#182

In the UK the pump supplies are covered by the NHS right? Maybe people change them more frequently because they can afford to, and therefore less issues are reported.


#183

That sounds exactly what I see with FIASP, but I haven’t personally seen it with Humalog. I just finished a cartridge with Humalog and the problem disappeared.

Since my last post I spoke with the local Tandem rep to request sample metal infusion sets. I should have them later this week. I’ll try them using the 2-day change cycle they specify. Hopefully that will do the trick.

The rep wasn’t aware of the problems with FIASP but told me again the pump was never qualified with FIASP. Only Novolog and Humalog. She didn’t think their development group was working on qualification because of their focus on expanding the closed-loop technology beyond Basal-IQ. Too bad. You would think a faster insulin would be critical to any closed-loop techniques.

I’m going to call the NovoNordisk rep later today or tomorrow to get his take on things. Hopefully he’ll have an explanation or at least know about any differences in physical characteristics (not just the formulation - density, viscosity, lifetime in a pump, etc) that might offer a clue.


#184

@Paytone
Medical Reps are extremely restricted in what they can discuss with customers in terms of non-FDA approved devices and drugs. If it is perceived the rep is selling or marketing in a way which was not FDA approved there can be serious repercussions.

Doctors are the best to go to when discussing something not currently approved by the FDA as the Doctor is under no such restriction. Hence the ability for the Doc to prescribe something off-label if they feel it is medically appropriate.

NovoNordisk has completed two trials involving Fiasp. One was in regards to Pediatrics and the other was in regards to pumps. They (Novo) are preparing a submission to the FDA now however I was unclear if they are submitting the results of both clinical studies or if it is only the one or the other. If you can get the Novo Rep to say what is being submitted to the FDA that would be great information.


#185

No this isn’t the case, nothing is free in this world the NHS has to be paid for and we the users are accountable for what we are privileged to use.
If there are problems with faulty sets then we complain and expect to have the sets replaced. We also have no compunction about reporting problems either :slight_smile: I had a conversation with my diabetes nurse regarding the extra usage of sets whilst using Fiasp and she was happy to sanction that.


#186

I think I may have misread the original comment I was replying to, now that I read it again lol. You said “a few reports” and I read it as “few reports”.

So are pump supplies not covered? If not how do you pay for them?

As far as using more infusion sets, I know here my doctor has no problem prescribing more, but insurance will only pay for the amount they think is needed, so I have to pay full price out of pocket for anything more than what they cover.


#187

We pay for our NHS through taxes hence my comment nothing is free :slight_smile:
We have to fight hard to even get a pump in the UK so obviously due to the expense of the pump and consumables it is worked out how much we would need every 3 months and order accordingly if we need more supplies we have to say why we need them.

I tend to go straight to the pump company and tell them there’s a problem and replacements are needed.

My attitude is the goods are faulty so replace them please as the NHS is not a bottomless pit.


#188

@Tim35

My doctor arranged the calls with the reps who otherwise wouldn’t talk with me directly. He must have thought they would share. I agree that the reps are limited on what they can say (and what they even know!), but I would expect them to say “I can’t discuss this” or “I don’t know” if I strayed into those sensitive areas. I have experience with the FDA in drug discovery and development. The Novo rep hasn’t called me back, maybe because they apparently have work underway to get pumps as an ‘on label’ use in the US. If he eventually calls back I’ll ask about what they are submitting to the FDA.

The Tandem rep dropped off the metal infusion sets today and said again they had nothing underway qualifying FIASP. She shared info on Tandem’s product pipeline and development focus, but it’s public knowledge.

https://diatribe.org/whats-next-tandem-predictive-low-glucose-suspend-under-fda-review

Novo has three clinical trials completed on FIASP and pumps that I could find. Results for two of those trials have been published in scientific journals, but that doesn’t mean the FDA approved. I read the papers and all the work was all done with Minimed pumps and infusion sets. Not much help with what some of us are seeing with t:slim x2.

I sure hope the Tandem metal infusion sets work!


#189

@Paytone
Assuming that Novo is submitting (at least) Fiasp for pumps to the FDA, I was wondering if the FDA approves a label change for Fiasp to be used in pumps if Tandem would have to do anything or if Fiasp would automatically be approved for the Tandem.

I assume the answer would not be known until reading the actual FDA approval order.

Hopefully automatically approved in the Tandem. We are using it in our X2 anyway off-label by our Ped Endo who is interested in how it performs for us. However, I am thinking the Fiasp might be really great in conjunction with the Control-IQ/HCL due out next summer.


#190

I think I found something that will work for me…

Here’s what I’ve tried so far that didn’t work. When boluses became infective I -

  • confirmed pump is working by disconnecting infusion site and initiating a bolus
  • changed infusion site
  • Used a different vial of FIASP
  • Swithched to Humalog to comfirm it worked
  • switched to a new cartridge (worked until cartridge had 30u or so left)
  • tried Tandem SS infusion sets (2 times)
  • switched to a cartridge from a different lot number

What did work for me was switching to a newer lot of FIASP that I recently received. I received the previous lot number about 5 months ago. The experiantion dates are pretty close (10/19 vs 5/20). I just finished my second cartridge and both worked properly all the way down to 9u, when I normally change cartridges.

When I first started using FIASP with the older lot everything was fine for the first 3 months. Then the problem started. I hope I don’t see that happen with the new batch.

Novo-Nordisk hopes to have FIASP approved for pumps sometime in 2019. I hope they do somethng to address this, but because all their work was with MiniMed pumps, they may even know it’s happening. They didn’t say anything about it in their clinal trial results.

Jim


#191

One thought is that with an insulin that is working faster, you are able to eat more of the foods you like without as dire of consequences. For instance, with Fiasp you are better able to eat a cookie and see minimal negative effects, BUT on regular Novolog, it would take more fore-thought to eat that cookie (by having to do a pre-bolus about 15-20 min beforehand) and not have a negative effect. I’ve seen that is the case with myself, and could definitely be a reason for someone to gain weight more easily on Fiasp (I am a T1D, a Dietitian, and a Diabetes Educator).

Another thought, if you were exercising to help lower blood sugar, especially postprandial spikes, maybe Fiasp is keeping you from getting such highs, so you are exercising less? I used to exercise when I started to creep up after a meal, but now that I am on Fiasp, I haven’t seen a need to walk after meals.


#192

I think maybe your post was directed at @DrBB?


#193

@Terry4, did you get around to trying Fiasp for corrections? I couldn’t pump with it, because of the site inflammations among other reasons, but recently refilled my prescription so I could use it for periodic corrections of highs. Seeing nice results on my CGM, I began injecting it for regular meal boluses, while pumping Humalog for basal. I am not experiencing any reaction at all at my injection sites, and for whatever reason I’m seeing Fiasp working as predicted when injected, unlike when I pumped with it.


#194

Thank-you for this report. I intended to ask my doctor for a sample at my last appointment but overlooked it. Your experience motivates me to ask for it at my next appointment in a few weeks. I’ll post here when I do.


#195

Using the new batch of Fisap worked for only three cartridges. Then the problem reappeared. I give up! I still want to use FIasp so I’ll change cartridges when there are 30u left. My doctor will increase my perscription to compensate.

I’m not counting on a quick remedy from Novo or Tandem. Neither one is interested at the moment.

Jim


#196

Until the FDA approves Fiasp for pumps then neither company can talk about this with you.

Doctors are not restricted but probably have no information about this anyway.


#197

Companies aren’t restricted in discussing what they’re doing with new products that required FDA approval. Smaller publicly traded companies whose success or failure depend on one or just a few new products regularly report publicly what clinical trials are in place, at what phases, status in those phases, and anticipated outcome. That’s the only way they attract investment. The goverment also discloses detailed data about clinical trials at www.clinicaltrials.gov

Whether a company chooses to disclose information is completely up to each company, but it’s not a formal restriction.


#198

Tandem is not doing a clinical study on Fiasp nor do they have a submission for such with the FDA. Either of these may give them some latitude although they would still have to be careful.

If Tandem is in any way perceived as promoting, marketing, suggesting, condoning or any other similar types of communications with patients (or the general public) involving FDA non-approved products (or the usage thereof) there can be very serious consequences from the FDA.

Tandem can absolutely not be involved in any sort of troubleshooting with any type of insulin in their pumps other then Humalog and Novolog.


#199

I think we’re on the same page. When I talk to tandem TCS (and their rep) the first words out of their mouth is using FIASP is off-label and they don’t support it. The rep also said getting approval isn’t on their their radar screen in the near team. That’s why I said their not interested at this moment.

But if they were seeking approval government regulations would not stop them from discussing it if they chose to do so.


#200

Another disappointing experience last night. My BG climbed slowly from 100 to 340 between 11pm and 3am when the CGM alarm finally woke me up (it was still climbing). There was still 80u in the cartridge. A big correction bolus with no impact. At 5am I changed out the infusion set and cartridge and brought things back in range with Afrezza. All is well now through lunch. I can’t unequivocally pin the blame on Fiasp because I changed the infusion site and cartridge at the same time, but given recent experiences I’m assuming it’s the culprit.

I called Tandem TCS to see if I might be overlooking something. They suggested the usual suspects (infusion site, loose tlock connection, how long the cartridge was in use). They pointed out again that Fiasp was an off label use for the pump but told me other users are reporting similar things and that some are having success by changing cartridges at 50u. I’m willing to do that, but this experience was at 80u. If it happens again I’m going begrudgingly back to Humalog.


#201

Have you tried extended bolus?
We seem to have gotten past nighttime highs (for now - things can always change) but when we had them, if I thought that 8 units was appropriate, I found it far more effective to bolus 8 units extended, 25% up front over 1 hour.
ie - 2 units now and then 1 unit every 10 minutes spread out over the next hour.

If I did all 8 units at once at nighttime it would have very little impact.

However during the day things are quite different.

EDIT: FYI - We are using Fiasp in the Tandem t:slim X2. Off-label obviously.