Editor's note: On May 19, the US Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people 6 years of age and older with type 1 diabetes.
This transcript has been edited for clarity.
Today, I'm going to discuss the results of a new automated insulin delivery system that I think can really help many people with type 1 diabetes.
Dr Steven Russell presented the results at the Advanced Technologies & Treatments for Diabetes (ATTD) meeting. The study focused on the iLet system, which is made by Beta Bionics and has been under development for a while. This was the single-hormone study, so it just looked at their algorithm using insulin alone. Eventually they're going to study this, looking at the use of insulin plus glucagon together to see if that further improves outcomes.
One of the main reasons I think this study was so cool is because it included over 25% minority individuals who aren't routinely studied in these insulin device trials. The study also included people who had a wide range of A1c levels; there was no high cut-point here. Over 30% of participants had an A1c greater than 8%. They also studied both children and adults and combined the results together.
Before I talk about the results, let me tell you about the pump. This is a tubed pump that has a sensor that it communicates with — it's the Dexcom sensor — and it has an algorithm so it does automated insulin delivery. Instead of having to enter all sorts of information into the system, this thing requires that you only put in the patient's weight. That's it. From there, the system begins to figure out what the patient needs in terms of automated insulin delivery.
There are several different target settings that can be entered, and they can differ by time of day. There's basically the time of day that one is eating a meal, so breakfast, lunch or dinner, and there is the meal size, basically small, medium, and large. The individual enters this in real time so the system knows they're eating, but other than that, the system just works.
It does this in a way that doesn't allow for the individual using the pump to fidget with it. They can't override the system and they can't put in other insulin doses. The system is just there to take care of their diabetes.
They compared this system with people on any other system, including other automated insulin delivery systems, and put them into this trial. People were randomized to this system vs whatever they'd been on (that was the control group) and they followed them for 13 weeks, which is not all that long.
There was a 0.5% reduction in A1c between the two groups. There was also an increase in the time in range, and this improvement in time in range happened almost immediately — within the first day or two of people being on the system. In terms of actual numbers, the adult patients started out with a time in range of 56% and this increased to 69% by the end of the study. The biggest improvement was time in range overnight, as is seen with other automated insulin delivery systems.
There was no reduction in time below a glucose level of 54 and there was an increase in the number of episodes of severe hypoglycemia in the group treated with the iLet system, but this was not statistically significant between the two groups.
I think these results are hard to compare with other pivotal trials investigating automated insulin delivery systems. The Tandem pivotal trial was a randomized controlled trial similar to this one, but the Medtronic and Omnipod studies were single-arm trials where patients were compared before and after they use the device.
More than anything, I think what's important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.
I couldn't be happier. I love what they're doing at Beta Bionics, and I look forward to more results, and in particular, to see if these results improve further when they do a study of insulin and glucagon in their dual hormone pump system.
Thank you very much. This has been Dr Anne Peters for Medscape.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Anne L. Peters. iLet System Simplifies Insulin Delivery for Type 1 Diabetes - Medscape - Jun 07, 2022.
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