iLet Insulin Pump Cleared By FDA

Thanks so much @gmershon . My rep has started the process and I hope to be starting maybe by end of this month.
On the forum people often say that pumps are not “plug and play” or “plug-and-go” devices. I told the rep that that is what the ilet sounds like (no disrespect intended) and he said it actually is - the idea being to minimize the human failure factor. So I’m looking forward to seeing how it works, particularly once Glucagon is on board as well. Trials of that will be coming and I said I would lie to volunteer.
Do you knew when you will be making the switch? Since I’m on Omnipod (no commitment) I can do it any time.

@wadawabbit - That’s Awesome! Hope your transition goes smoothly. I’m waiting to hear if I get into the G7 trials as I can move onto the pump soon. If not have to work a transition to G6 first as I recently refilled my G7 prescription. So thinking mid November will likely be when I can install the pump.

The Glucagon cartridge will be a game changer. Let me know if you get on the early trials for it. Also, they recently released support for prefilled insulin cartridges so no more manually refilling them! Just have your Dr send in a prescription for them.

Note that there is no G7 trials with iLet as the FDA does not allow it. Beta Bionics received G7 samples and integration tools a couple weeks ago. Expect to have support for G7 early next year.

In the meantime I’m moving to the G6 as I will be on the iLet pump next week. Crazy how different the G6 is compared to the G7. It’s like I’m moving to a frankenstein sensor that was put together by piece meal. Oh well, it’s only a short time on the G6 then back to the far superior G7.

Something I learned about the iLet cartridges is that the reservoir is made of glass instead of plastic. This should allow insulin to stay in them for a longer period of time allowing for a use case to be able to pre-fill a bunch of them and store at room temperature as long as you use the insulin before it expires.

iLet does offer prefilled cartridges with FIASP insulin, however it costs more and it must go through multiple reviews with insurance to be “medically necessary”. Am thinking that the glass reservoirs should allow the use case of getting the cartridges at fridge temperature, pre-filling them with fridge temp vial insulin, then storing the filled cartridges in the fridge until needed. Basically creating your own 90-day supply of pre-filled cartridges. By doing it this way there should not be any insulin caused air bubbles forming in the cartridges (and greatly lessen the number of needles needed). Will try to provide any updates on this once I start to use the pump and figure it out.

@gmershon, it might have been better on Beta Bionics part to design the pump so that it used already available prefilled cartridges. The prefilled cartridges, first the 1.6 ml and later the 3 ml size, certainly made pens more convenient for use in the latter 1970s; cartridges first by Lilly and later by Novo Nordisk. I know Novolog is still in use, I don’t know about Humalog which I used.

Based on further analysis, I’ve decided that the iLet is not the best fit for me.

@Dennis, Yes, they have pre-filled cartridges with FIASP insulin. It requires a “medically necessary” Dr request, review and (likely many) appeals to get it. Oh, and it’s near double the cost vs buying humalog in vials. However, given the glass cartridges I can prefill them myself and store them in the fridge. The only thing that makes that possible is the glass reservoir cartridges. Will also make traveling easier.

Hope you find the best pump for you!

Bad news - my plan is not covering it, at least not yet. My rep will continue to check, and sent me the details (codes) they use so I can contact my insurance on my own as well.

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There is always the “medically necessary” process that I believe all insurances do where your Dr. sends them a medically necessary letter. If they reject it there are multiple appeal options.

Hi @wadawabbit, I’ve been on the iLet since Tuesday. So far I’m eating my “usual” meals which is part of training the pump as to my eating habits. The “less” meal will be 50% lower carbs than my usual and the “more” will be 50% more. Once the pump is trained on the usual then I can begin to eat less or more meals. So far I’ve been super impressed with the pump as it is conservative on the amount of insulin to give me during this training period so I’ve been going into the high 100s to <210 and it has always brought my BG reading back down to the low 100’s after each meal. I keep watching it because I’m impressed how it brings me back down in a very steady approach and does a soft landing in the low 100s. It’s like watching a plane land on a runway. And all I do is tell it when I eat a meal.

The glass cartridges are going to give me even more flexibility as I’ll be able to fill up a hand full of them and put them in a drawer to use when I’m ready. I’ll start to try that out tomorrow when I need to swap out my inset and cartridge. Expect I’ll be able to put a bunch of cartridges in the fridge (to get them cold), pre-fill them with a refrigerated insulin vile and put them back into the fridge for future use.

Am scheduling a game of pickleball this weekend so will be interesting to disconnect the pump, carb up, play, and then reconnect. Am thinking I could reconnect when I get midway into the playing time.

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Exciting news - thank you for sharing! Looking forward to hearing more!!

Thanks for the clear info on you’re getting started on iLet! Holding good thoughts for continued, if not improved, results! Please let us all know…

Been 5 days on iLet. Prior to the pump I was on MDI and maintained a 98% in range and 123 average BG by eating around 15g carbs per meal. In training the iLet I switched back to my pre-diabetes usual carb meal size which is >3 times more than when on MDI. While on MDI I used a total of 33units of basil and bolus per day. While on iLet I’m consuming between 19-22units per day (surprised me as my carb intake has increased significantly). The iLet cartridges hold 160units and consumes 12units to fill tubing and cannula. I had 94units in cartridge after the 3-day inset needed to be replaced. Instead of wasting insulin I replaced only the cannula and kept the 3day old tubing and cartridge. Need to replace the inset again in 27 hours and am forecasting to have about 15units of insulin left. Am getting a bit over 6 days of use from a single cartridge. Have been 95% in range at 134 average BG since getting on the pump.

While the pump is still in learning mode and targets are set to “usual” I’ve had an increase in highs (vs MDI) and only one low (which came a few hours after playing 1.5 hours of pickleball). Prior to the pump I experienced fewer highs (180-200) and way more lows. So the pump has been pretty conservative on insulin delivery while learning my usual eating habits.

Before doing a moderate but lengthy workout, I removed the pump and ate a small amount of carbs to get me to a 160 BG. After 1.5 hours of exercise I was at 110 and reconnected the pump. Appeared that exercise dropped my BG 3 hrs later as I hit a low after eating a usual lunch. However they started to rise again as (I’m assuming) digestion continued. I tracked the every 5min algorithm steps/doses and saw no insulin deliveries during that time.

I have two days left of training the pump on usual carb meal sizes and can’t wait as I feel full all the time now and would like to eat a lesser carb meal :wink: However am very much enjoying eating sourdough bread again!

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Exciting news - thank you for sharing! My meals average 60g of carbs - do you keep yours so small because you want to, or because it will help your control? Just curious.

My diabetes educator told me when I switched from mdi to pump that some peoples bodies are a little more sensitive to the short acting insulin that pumps use for basal, and often need less short acting basal on the pump than they needed long acting basal on MDI.
Also like you mentioned, the iLet is likely being conservative so in the next few weeks you might end up using slightly more insulin.

I use my tandem cartridges for far longer than they’re supposed to be used. Nice not having to refill them every few days!

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This doesn’t surprise me at all. Years ago when I decided to try a pump, the endocrinologist told me to create the pump Patterns telling me that I knew more than he. (He was “only” the Professor of Endocrinology at the University College of Medicine.) The one word of advice he gave was for me to calculate my total daily dose [background plus bolus] program my Paradigm pump to deliver no more than 70% of my customary total dose. My pre-pump total was in the 40s and is now about 20 units per day for my customary 230 grams of carbohydrates. Lise @6yGodsGr provided one of the reasons. A general guide for insulin usage is the daily total insulin should not exceed one half unit [0.5 units] per kilogram of weight; with my normal food intake I average about 0.3 units per day - your usage is much less than mine, I surmise.

Do you really have “ideal body health” by starving yourself? A diet with such restricted carbohydrate was the way Dr. Joslin managed diabetes in the 1800s when he opened the first ever clinic devoted to diabetes research and management; even when I was diagnosed in the 1950s long before these wonderful new insulin formulations, the strict diet assigned to me was 200+ grams of carb - and during subsequent decades grew and added to my life span. Current teaching indicates that for total body health a person, including those living with T1D, should eat a “moderate carbohydrate diet”; moderate defined as 230 - 250 grams of carb per day. For reference only - not as “Medical Advice” I’ve attached a diatribe synopsis of a symposium at the 3023 EASD conference: Type 1 Diabetes: New Studies on Vegan and Moderate-Carbohydrate Diets for Type 1 Diabetes (diatribe.org)

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At 15g per meal I did not feel like I was starving myself. The foods I ate were lots of proteins and vegetables and the breads were low-carb that I counted as 6g per slice (note that I counted fiber as half a carb as was recommended to me by endo and diabetes nutritionist). The Kroger brand carb master breads were the best tasting, but nothing like the SF sourdough I ate before being diagnosed as T1D.

To make MDI easy to manage I kept my carbs low mainly by eliminating chips and switching to low carb bread that is high in fiber. would replace pizza dough with a mozzarella/almond flour dough or put shredded rotisserie chicken in bottom of a oven dish and load it with sauce, toppings and cheese. Other than that I really didn’t change much else with my diet as I’ve always enjoyed eating lots of meat, veggies, cheese and nuts. My only weak spot for chips is tortilla chips with salsa which I’d have about once every week or so.

For training the iLet I went back to my usual 40-45 carb meals, however I never calculated it until after I was initially diagnosed. The only outliers were the protein and veggie dinners that would have a smaller amount of carbs or eating pizza that was loaded with carbs.

I do buy a live 1400-1450lbs angus steer every year and split the frozen meat with 4-5 other families. Do the same with hogs, but as they don’t need aging a friend and I cut/wrap and freeze it ourselves. My wife is also not much of a pasta fan so that part of my diet has been limited for the 20+ years of our marriage. Given the above, we don’t eat out much as we love cooking our own meals.

This pump removal should not be necessary for a properly operating pump - unless the activity is something like swimming. In my opinion, the pump should “live” with me 24/7.
The pump algorithm should automatically reduce or suspend insulin flow as SG readings identify a trending toward your preset low setting.

@Dennis, I’m guessing that has to go with intensity exercise levels and possibly even different thoughts on those levels. Pre pump I would have to carb up to 180-190 as after, what I call an intense workout, I would be at 70-85 1.5 hours later. For pumps that do correction doses It would likely send me far lower.

Beta Bionics is working an exercise feature that will enable what you said in being able to keep the pump connected. For me this will work for some exercises, however when I play racquetball I’d be afraid of possibly breaking a pump by hitting a wall, diving on the floor or having it hit with a racquet. They are too expensive and important to put them through that abuse. But other than that or swimming I totally agree with you.

The iLet is expected to have a glucagon reservoir as well, with trials set to begin early next year. As I understand it, initially that means we will have to wear two infusion sets, but in time it may be set to feed through a tube that connects to the one infusing insulin so glucagon can be “joined in” as needed. That is not the best technical description but hopefully you get the idea.
I’m looking forward to having that feature!

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Hi!
I am planning to try the iLet at the end of this month and am curious now that you have been on it for 3 months what your thoughts are. I used Tandem with CIQ since it came out and was not totally happy with it. I am now trying Omnipod 5 which is great actually and I would be happy to stick with it, but the more hands off approach sounds wonderful. If I don’t like it, I can return within 90days.
Thanks!
Kathy