iLet Bionic Pancreas cleared by FDA

BU press release:
FDA announcement: FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery | FDA

It’s good to have options and competition could reduce costs, but is this any different from/better than the Omnipod 5 or Tandem?


The university press releases don’t give any reason to think it’s different from other loop-like, machine-learning guided devices. Digging in a bit, two points of interest:

  1. It seems to need much less information to start with; all that’s mentioned is weight and a rough carb estimate for each meal (i.e., S/M/L, no more fine grained carb counting). The company web page says it doesn’t need correction factors, basal rates, etc. but it isn’t clear whether that means you also can’t configure those things. Not being able to fiddle those parameters requires a lot of trust in the software.

  2. An interesting wrinkle in this article is that it can be configured to be bihormonal, dispensing both insulin and glucagon, either alone or in combination. This tech has been discussed on FUD before–would this be the first market-ready device to have it?


I saw the bihormonal feature mentioned in earlier articles but didn’t see anything about it here, which made me wonder if that feature made it out of the lab and into the approved device. You’d think if that were a part of the approved device and nothing else has it they would have made a big deal about it.
Requiring more trust in the software would be a big non-starter for me. If I used a pump I would want something more, not less, under my control.


My reading of the articles on their release is that the approved iLet device is a single fluid administration, i.e. insulin, but iLet is working on the bi-fluid version as well, i.e. insulin and glucagon. That is, iLet will eventually have two different devices.

While I recall reading good things about the iLet trials, my concern is the black-box nature of the device, i.e. enter your weight and size of meals (normal, less than normal, more than normal) and it automatically provides both basal and bolus doses and adjusts based on results provided via the CGM. IF that works, and I imagine it does or FDA wouldn’t have approved it, it may be good for some people and not for others, similar to the O5. I might be willing to try it (depending on costs and availability), but I’m drawn more to something I can configure more to my needs. We’ll see more as it becomes available. The dual use insulin/glucagon device, when available, could be a game changer for some people like those involved in sports, hiking, etc.


They have the user manual listed online.
Lots of good info to read here.


Not sure but I think I read somewhere that you can’t put this pump into manual mode ever? If someone knows please tell me if I’m wrong about this. Doesn’t seem safe to me knowing how wrong a Dexcom can read in the first 12 hours.


If anyone wants a followup on this, there’s an interview w/ Ed Damiano of Beta Bionics on the latest Juicebox:

He’s very clear that the device is a best fit for people who want to just let go of a lot of their daily management, but not a good fit for “knob-turners” and tinkerers. In their pivotal trial the average A1C in adults was 7.1 and in children was 7.5. There’s a 90-day return policy for people that don’t find it suitable.

Last (I hope) edit: Since I’m sure folks are curious, the way to handle exercise with the iLet is just to disconnect it prior to starting. There’s no way to suspend delivery completely otherwise.