iLet Insulin Pump Cleared By FDA

@missynikcjGabe, I see your concern. I’m a little hesitant to have them contact my insurance company for a couple of reasons, one being that I have to go via Edgepark to get supplies and DME. I can’t get it directly through iLet. And secondly, I’m not sure I want to bombard my insurance with another claim, since I just got an estimate for another system. Plus, I want an estimate of costs for Medtronic 780G. I don’t want to confuse my insurance and supply company too much. I think I need a case worker to help me with this. Lol.
I am interested in the product though. Especially, the price. I’m very curious about that. Did they share anything about that?

Melissa @missynikcjGabe and Dee @HighHopes, you can get sufficient information from Beta Bionics representative and be added to their list for all updates of information without supplying a doctor name, insurance coverage or anything else. I provided only my name and phone number and received a call within the hour - actually two calls. I then provided an email address as my preferred contact method. I was very clear in my discussions that I was adding iLet info to my study of replacement systems for my current out-of-warranty Tandem; I’m considering 4 “cleared” iAIDs - two which are not yet being distributed.

Melissa, from what I’ve seen, with the iLet, you will be able to make manual adjustments for corrections of wayward BGL.

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@Dennis , Yaaay, that’s awesome. Thanks.

I called and received an email from the company rep. I’m still reviewing the material, but had a couple of initial impressions.

So, I’m relieved the infusion load into the pump is different from Tandem, however, I don’t understand the logic behind requiring a separate syringe to remove the insulin from your vial and then insert into the reservoir. Wouldn’t it make sense to have a retractable needle on top of the reservoir, like those used in Medtronic, that pops off, after the reservoir is full. It seems unnecessarily complicated and requiring an extra piece that could be included with the reservoir is odd. Apparently, you can only buy the reservoirs from them. I’m not sure about the infusion sets.

  1. The infusion set appears to be like those Tandem uses. It says 3 day change out. I was hoping to get a longer time on that. Medtronic now has Extended wear infusion sets and reservoirs that you can wear SEVEN days, not 3. That’s a biggie for me.

  2. The charging is done on a charging station or pad. It appears that you must lay the pump on the station, not plug it in. So, is that safe to have your insulin laying on top of a charging pad? And, do you stay connected during this time?

  3. I believe the cost, if you pay without insurance , is a little less than Tandem. I like that part.

  4. This pump is only available to use with Dexcom 6 and pairing it with G7, is not available and not in their forecast at this time.

I still have a lot more to read about it. It’s still on the table.

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Hello, I was told because I’m paying out of pocket it is speeding up the process. They have already sent the proper paperwork to my Endo. I should have it in 2wks. We received a demo in an email. Good luck. My son is already on tandem pump.

Hello I have been in contact with People at ilet bionic pancreas. Because I’m paying out of pocket it cuts through all the red tape. I will get it in a couple of weeks. They are finishing up giving the pumps back to the people who were in the clinical trials. My Son has the tandem pump. We still have time left on the contract so i have to pay at of pocket. The papers have been sent to my endo already. Supposed to get a confirmation at the middle of next week. Once my Endo sends prescription the rep said it will go fast.

I’m excited about this as well, but I want more information about how the system works. For me, I use very little insulin (20 - 25 units) daily. I would want to know how this system calculates the dosage. If it is by weight and size of the meal, as implied, I would worry about it not giving me the correct dose. I wonder if over time it will adjust the dosing to my personal needs or not. We are not all made the same and our individual needs vary greatly. So, I will wait for more information!

Pam K.
T1D 59 years and counting!

We’re so used to having control over our dosing - I too wonder if I would ever be able to trust a device that does it on its own. That’s quite an adjustment. Of course switching from MDI to a pump was as well for some of us, so I imagine down the road the ilet will be as natural to people who start it now (or in the near future) as switching to a pump was for us - I still can’t imagine it though.

Pam, the literature I’ve read about iLet, including what is on the Beta Bionics webpage, says that iLet stores the induvudyal’s history and bases dosing. Based on that, if I choose the iLet, I will not expect to see “right on” dosing in the first few weeks. I addition to that, I’m wondering if my estimate of “usual, more, less” referencing meal VALUE will shift over time.

Currently my t-Slim is 7 months out-of-warranty and my chart of pro / con has iLet in a close second place.

The iLet pump was talked about at the recent TCOYD conference. TL;DW the iLet is great for people with A1Cs over 7 (or 8?) or people who can’t/won’t/aren’t likely to figure out a fully featured pump.

In the video, on the couch on the right is Aaron J. Kowalski, Ph.D, CEO of JDRF

Hi @Dennis . I was on YouTube looking through videos on the ilet pump and found this one that I thought you might be interested in - apparently Minimed may acquire a tubeless pump at some point in their pipeline (they are not taking over Omnipod - it’s another company). Since you enjoy research I thought you might like to check it out of you have not already.
Apologies to you and the other moderators for staying off topic.

@missynikcjGabe, Wondering if you received and are using the iLet pump. If so, would love to hear your thoughts!

Thanks Dennis, that’s good to know!

I have been curious about the iLet pump but haven’t heard from anyone using it before. Curious to hear people’s thoughts on it! I like the tubeless Omnipod system a lot, but may be willing to try iLet if the control is much better. Curious if anyone can compare it with Omnipod 5.

I am also interested in the iLet pump and have been researching it. Have spoken to my Endo and Nutritionist recently and got my hands on one of their demo units (along with other pumps). They also got me in touch with a local Dexcom rep who was able to connect me with someone who has been on the iLet pump for a bit over a month. He has been T1D for 60 years and works at Stanford Hospital. Below are the questions and answers from this conversation.

Q: How does this pump make you feel?
A: Found himself crying the other week as for the first time in his life he felt what it is like to not have this disease. Said this pump gave him his life back. Freed up his time that provided the ability to give more time and focus on others in his life. (Note that this was not what I was expecting to hear, but very insightful)

Q: How did the pump give you this feeling?
A: Took him a few weeks to gain confidence in having a device auto determine how much insulin he needs after having high levels of control with his previous pumps. Confidence grew as he tested how the iLet would perform in different scenarios. A couple weeks ago he spiked in low 200s and wanted to give himself insulin but told himself that it’s not his job any longer to manage his BGs. It was Marjorie’s job (the name he gave to his pump). Says he still monitors his BGs, but not because he doesn’t trust the pump, but because he’s amazed that he no longer has to worry about managing this complicated disease.

Q: How is battery life and charging?
A: Battery life is good and only takes 15min for a full day use. Charges using the wireless iLet charger, but can also use other phone wireless chargers as well.

Q: How do you manage exercise and not go low?
A: Every pump requires different processes for different people for different amounts of exercise. For minor exercises he doesn’t do anything. For longer bike rides he disconnects the pump to carb up beforehand and reconnects halfway into his exercise.

Q: And for sleep?
A: Just go to sleep and let the pump manage to the targets you set the pump up with.

Q: Is the food announcements as easy as it sounds?
A: When you first get the pump it is important to announce every meal and the selected carb size so the pump can create an accurate profile of your average. Then just announce meals at time you eat them or up to 30min afterward. If you forget to announce a meal two thin 30min then don’t do anything as the pump will do auto corrections every 5 min to get you back into your target.

Q: Tell me about the insulin fill and cartridge size/change?
A: Wish it held more than 180units per cartridge as he refills cartridge between 2-3 days. Currently cartridges are filled manually, however Beta Bionics will have prefilled prescription cartridges coming soon to save time and lessen management complexity. Said this is nit-picking as he’d gladly refill cartridges in exchange for the freedom this pump gave him.

Q: Anything I should have asked and have not?
A: No, this pump is a game changer and has changed not only his life but those around him.

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