# iLet Insulin Pump Cleared By FDA **URL:** \ **Category:** T1D Tech & Daily Management Support\ **Created:** [May 20, 2023, 4:45pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010 "2023-05-20T16:45:52Z")\ **Posts on this page:** 20\ **Page:** 1
**Author:** ![6yGodsGr](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/6ygodsgr/32/4636_2.png) [@6yGodsGr](https://forum.breakthrought1d.org/u/6yGodsGr)\ **Post date:** [May 20, 2023, 4:45pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/1 "2023-05-20T16:45:52Z")
New iLet bionic pancreas has been cleared by the FDA for ages 6+. The pump only needs CGM readings, meal size, and weight. No carb counting required although the website specifies that “use must be carb aware”. > **[Makers of the first and only, fully automated bionic pancreas](https://www.betabionics.com/)** > > Improving lives of people living with diabetes by helping to reduce the data and decision-making overload required with diabetes. > **[FDA Clears Beta Bionics' iLet Bionic Pancreas – No Carb Counting Required](https://diatribe.org/ilet-bionic-pancreas-no-need-to-count-carbs)** > > Beta Bionics has received FDA clearance for its insulin-only iLet Bionic Pancreas, an automated insulin delivery system that eliminates the need for carbohydrate counting. ---
**Author:** ![REESEScups07](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/reesescups07/32/4638_2.png) [@REESEScups07](https://forum.breakthrought1d.org/u/REESEScups07)\ **Post date:** [May 20, 2023, 7:04pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/2 "2023-05-20T19:04:47Z")
That is incredible! I gave a presentation recently on Dr. Edward Damiano (the creator of the iLet) so it’s wonderful to finally see his incredible device come to fruition! ---
**Author:** ![6yGodsGr](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/6ygodsgr/32/4636_2.png) [@6yGodsGr](https://forum.breakthrought1d.org/u/6yGodsGr)\ **Post date:** [May 20, 2023, 9:36pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/3 "2023-05-20T21:36:49Z")
Who’d you give the presentation to? ---
**Author:** ![hanavank](https://avatars.discourse-cdn.com/v4/letter/h/71e660/32.png) [@hanavank](https://forum.breakthrought1d.org/u/hanavank)\ **Post date:** [May 22, 2023, 2:08pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/4 "2023-05-22T14:08:22Z")
How might we get access to this pump? I assume it is not yet on the market? Kathy ---
**Author:** ![6yGodsGr](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/6ygodsgr/32/4636_2.png) [@6yGodsGr](https://forum.breakthrought1d.org/u/6yGodsGr)\ **Post date:** [May 22, 2023, 10:28pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/5 "2023-05-22T22:28:16Z")
It’s not on the market yet. I couldn’t find any info about when it will be- I’m assuming within the next year or two? I bet they’ll be providing information on that soon. They have to bargain with insurance companies, pharmacies, persuade doctors to recommend their pump to their patients, and get training stuff in order. I _think_ this is iLet’s first pump so unlike tandem, omnipod, or Medtronic they may not yet have the capacity to make a bunch of pumps in a short period of time. ---
**Author:** ![HighHopes](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/highhopes/32/5473_2.png) [@HighHopes](https://forum.breakthrought1d.org/u/HighHopes)\ **Post date:** [May 22, 2023, 10:49pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/6 "2023-05-22T22:49:02Z")
I’m really interested in this device. If anyone gets any additional info, please post it! ---
**Author:** ![REESEScups07](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/reesescups07/32/4638_2.png) [@REESEScups07](https://forum.breakthrought1d.org/u/REESEScups07)\ **Post date:** [May 23, 2023, 12:29pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/7 "2023-05-23T12:29:55Z")
I gave my presentation to my school, pretty much as a whole, and some parents. It was a living museum and we got modern era so I decided to use this as an opportunity to not only educate people on Diabetes, but also show them Type One Diabetics can do anything and lead happy lives! I ended up choosing Dr. Ed, and it went really well! ---
**Author:** ![6yGodsGr](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/6ygodsgr/32/4636_2.png) [@6yGodsGr](https://forum.breakthrought1d.org/u/6yGodsGr)\ **Post date:** [May 23, 2023, 10:04pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/8 "2023-05-23T22:04:30Z")
That sounds like a lot of fun! ---
**Author:** ![Dennis](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/dennis/32/5527_2.png) [@Dennis](https://forum.breakthrought1d.org/u/Dennis)\ **Post date:** [May 25, 2023, 6:37pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/9 "2023-05-25T18:37:36Z")
> [@REESEScups07](#): > > Dr. Edward Damiano (the creator of the iLet) so it’s wonderful to finally see his incredible device come to fruition! Landen, keep in mind that this iLet Bionic is not the system that Dr. Damiano envisioned and began developing 20+ years ago to help his son; that really groundbreaking system has overcome many obstacles [including how to build a stable and usable glucagon] and is [hopefully] final testing before applying for release. That said, in my eyes this recently cleared iLet will fully satisfy my needs. I’m currently in the research process for a new pump as my current t-Slim is out-of-warranty and is in the mandated Medicare mandated 1 year extension. I’ve requested additional information from Beta Bionics and am awaiting a call-cack. ---
**Author:** ![HighHopes](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/highhopes/32/5473_2.png) [@HighHopes](https://forum.breakthrought1d.org/u/HighHopes)\ **Post date:** [May 25, 2023, 11:53pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/10 "2023-05-25T23:53:21Z")
I’m reaching out in several ways to get more info on this. ---
**Author:** ![REESEScups07](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/reesescups07/32/4638_2.png) [@REESEScups07](https://forum.breakthrought1d.org/u/REESEScups07)\ **Post date:** [May 26, 2023, 10:27pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/11 "2023-05-26T22:27:09Z")
That is very interesting to note! Thanks for informing me of such! I did extensive research on the doctor for my presentation and heard him in his Ted Talk talking about how he envisioned a cure of some sort, but I did not take much notice. However, it is nonetheless something very important, seeing as I and Dr. Ed are working towards something very similar, with education and age being the only differences; however, I must say that it is, as quoted by Neil Armstrong, “One small step for man, one giant leap for mankind,” at least for diabetics and our pursuit of a cure! ---
**Author:** ![spdif](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/spdif/32/5548_2.png) [@spdif](https://forum.breakthrought1d.org/u/spdif)\ **Post date:** [May 30, 2023, 12:35am UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/12 "2023-05-30T00:35:32Z")
Here is the FDA approval doc which gives a little more detail like iOS only. Interesting that Beta Bionics submitted their application for the iLet as an substantially equivalent device to the Tandem t:slim X2. > **[K223846.pdf](https://www.accessdata.fda.gov/cdrh_docs/reviews/K223846.pdf)** > > 259.60 KB First time I have seen a pump manufacturer submit their software to the FDA separately. Might just be new FDA rules after they improved their software review process. The software approval has additional info such as the lower, usual and higher targets are 110, 120 and 130 mg/dL > **[K220916.pdf](https://www.accessdata.fda.gov/cdrh_docs/reviews/K220916.pdf)** > > 360.69 KB Kudos to the FDA for requiring a follow up study because the study used for approval wasn’t sufficiently powered to determine some safety criteria. ---
**Author:** ![Dennis](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/dennis/32/5527_2.png) [@Dennis](https://forum.breakthrought1d.org/u/Dennis)\ **Post date:** [May 30, 2023, 8:29pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/13 "2023-05-30T20:29:47Z")
Thank you Chris @spdif for posting these documents; these docs have very valuable information for people considering the iLet. NOTE that the iLet was granted FDA “510(k) Clearance” and has NOT received “FDA Approved” rating - significant difference. The iLet as you point out received Clearance based on the “substantially equivalent” path created last year to speed-up time-to-market for devices and the Approved device it chose to follow is the t-Slim x2 with the CIQ algorithm - this necessitated the software submission and, probably, also the follow-up. I’m still trying to learn the difference between iAIDs [integrated Automated Insulin Delivery system] and iACE [integrated Alternate Controller Enabled]. I became very interested in getting the iLet and contacted Beta Bionics and had an informative telephone conversation. One “obstacle” for me is the device does not yet provide, according to company posted data, sufficiently accurate basal insulin at lower volume; my 30-day average basal delivery with t-Slim 5.88 units per day - the iLet delivery at higher uph is very good. - Recall that a major difference between “FDA Approved” and “FDA Approved” is that to obtain Approved the [in this case] the pump and its software has been submitted for independent testing and analysis as well as passing FDA testing; “FDA 510(k) Clearance” is based on government review of the manufacturer’s data. As an example, there are many, many BG Meters “cleared” but none have ever been “approved” for insulin dosing. ---
**Author:** ![wadawabbit](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/wadawabbit/32/3890_2.png) [@wadawabbit](https://forum.breakthrought1d.org/u/wadawabbit)\ **Post date:** [May 31, 2023, 9:29am UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/14 "2023-05-31T09:29:56Z")
Europe tends to be ahead of the US when it comes to clearing new technology y. Do you know if it has been approved there yet? ---
**Author:** ![6yGodsGr](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/6ygodsgr/32/4636_2.png) [@6yGodsGr](https://forum.breakthrought1d.org/u/6yGodsGr)\ **Post date:** [May 31, 2023, 7:08pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/15 "2023-05-31T19:08:20Z")
No approval in Europe yet. I think it’s because betabionics is a based in America and it’s new technology. Omnipod/ tandem/etc have based in those countries so they have an international presence to launch new tech from. Bbionics doesn’t yet have that. ---
**Author:** ![Dennis](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/dennis/32/5527_2.png) [@Dennis](https://forum.breakthrought1d.org/u/Dennis)\ **Post date:** [May 31, 2023, 7:44pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/16 "2023-05-31T19:44:15Z")
Actually Insulet (OmniPod) is based and operated in Massachusetts and Tandem is based and operated out of California. It has appeared that the European Medical Agency (EMA) has been more open to innovation in treatment than the USA FDA and that the FDA will accept results of trial experience devices gained while in use in Europe. My observation. ---
**Author:** ![Dennis](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/dennis/32/5527_2.png) [@Dennis](https://forum.breakthrought1d.org/u/Dennis)\ **Post date:** [May 31, 2023, 7:53pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/17 "2023-05-31T19:53:21Z")
> [@hanavank](#): > > How might we get access to this pump? I assume it is not yet on the market? Kathy Kathy @hanavank, I used the _Beta Bionics_ “contact us” feature on its webpage. I received a phone call within half an hour, had my technical questions answered and was promised that I’d be kept informed - I still need additional information for comparing this device with the two other systems I’m considering. ---
**Author:** ![missynikcjGabe](https://avatars.discourse-cdn.com/v4/letter/m/ecae2f/32.png) [@missynikcjGabe](https://forum.breakthrought1d.org/u/missynikcjGabe)\ **Post date:** [June 7, 2023, 1:56pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/18 "2023-06-07T13:56:37Z")
Hello i spoke to a rep regarding ilet bionic pancreas. It will be out to the public July August. Some will even have it this june. The rep said it does not have glucagon in it yet but the chamber is still their. Im exciting. I put my name down. You can just put in ilet bionic pancreas, click know more. Their is a prompt to put your info and an 866 number. Good luck ---
**Author:** ![HighHopes](https://sea1.discourse-cdn.com/flex025/user_avatar/forum.breakthrought1d.org/highhopes/32/5473_2.png) [@HighHopes](https://forum.breakthrought1d.org/u/HighHopes)\ **Post date:** [June 9, 2023, 1:18pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/19 "2023-06-09T13:18:16Z")
@missynikcjGabe, I’m getting ready to call. What do you mean by putting your name down? To get one or to get samples? ---
**Author:** ![missynikcjGabe](https://avatars.discourse-cdn.com/v4/letter/m/ecae2f/32.png) [@missynikcjGabe](https://forum.breakthrought1d.org/u/missynikcjGabe)\ **Post date:** [June 9, 2023, 2:15pm UTC](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010/20 "2023-06-09T14:15:04Z")
Hello sorry let me clarify. When you give then your name and info. They send you an email with a demo. They want your insurance info and your endo that way you’ll be on the list for one of the pumps. At least thats what i was told. I’m a little nervous though. I have my Son at a 5.7 A1C tbe representative said the targets are basically the same as my Sons tandem pump. I’m interacting with it more than I would like, Just to keep my sons numbers good. So I won’t be able to touch the pump for correction or anything. Thats going to be hard to watch. [Next page](https://forum.breakthrought1d.org/t/ilet-insulin-pump-cleared-by-fda/73010.md?page=2)