Received FDA Breakthrough designation; pivotal trial to take place “in 2023” with “regulatory submissions to follow”; dual monitor will maintain form factor of FreeStyle Libre 3

Today, Abbott announced that it is developing a dual continuous glucose and ketone monitor building off of the company’s FreeStyle Libre franchise and that the device has received Breakthrough designation from the FDA.

According to Abbott, the company is developing a novel sensor using the form factor of FreeStyle Libre 3, which just earlier this week received FDA clearance as an iCGM, that will be able to measure glucose and ketone levels simultaneously. Excitingly, Abbott has already begun clinical trials for this device and plans to conduct a pivotal trial in 2023 with “regulatory submissions to follow”.

While this news is not necessarily surprising following Abbott’s announcement of its Lingo biowearables at CES 2022 including a non-medical ketone monitor, we are incredibly excited to get confirmation that Abbott will be bringing its ketone monitor to market as a medical device.

We saw data at DTM 2021 from a modified FreeStyle Libre CGM demonstrating that, with altered sensor chemistry, the system can accurately measure ketones. That’s a complete win.

With many researchers, we are curious what steps and innovations need to be taken to support simultaneous glucose and ketone monitoring within the same device – we are also just very curious how fast this can move. For clinical research, is there a faster way even as a separate device to get something approved for research?

DKA remains a massive challenge for people living with diabetes, and while ketone monitors exist and are utilized, we feel that continuous ketone monitoring has the potential to ensure safer and better diabetes management.

While CGM itself is such a pathway to better care, and while we don’t see CKM in a similar respect, we do feel that there are no ways in which to make SGLT-2 for T1D nearly as safe a research pursuit as it could be with CKM that can be very trusted.

Specifically, for people experiencing recurrent DKA, continuous ketone monitoring certainly seems as it if would help people identify DKA events or potential DKA events early and that it could certainly prevent hospitalization and further complications or even ambulance visits or even productivity alone. 

There are a range of questions, of course! How “continuous” does it need to be – is checking every hour or couple of hours good enough? 

Historically, as data on the use of SGLT-2s in type 1s continued to grow, concerns around euglycemic DKA arose. Although it seems “big picture” that the concern is no longer growing (it’s now well-known), having a “safety rail” like CKM seems very promising.

In these contexts, making continuous ketone monitoring to patients would likely have the potential to alert patients to these events and thus could be an important tool to help expand the use of SGLT-2s among type 1s. 

From https://www.closeconcerns.com/knowledgebase

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