FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-wearable-device-continuously-monitors-both-ketone-levels-and-blood-sugar?utm_medium=email&utm_source=govdelivery

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It will be interesting to see if it (dual measurement) becomes a standard. We have never felt much of a need for a ketone sensor on our side, but for sure it is a help to know about it when you are high.

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I wonder if this is intended for those who are on a keto diet. It seems like that might be a more practical use for continuous monitoring.

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This is a product we need, primarily for T1D, particularly with pumps and AID. The secondary user is the T2D using insulin on an SGLT, and the older adult T1Ds who cannot get into independent living or care facilities where may mean a medical professional does not have to be on staff 24/7 to support T1D management.

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My son is T1D for over a decade now, pump user, and only once did he have ketones in all that time. We wouldn’t have much use for it personally. Perhaps it may be more useful to those T1’s who stay in Hyperglycemic state.

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That was my thought as well. I think it would also be useful for newly diagnosed. Personally, I was freaked out about DKA for the first couple of years.

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So were we after K was diagnosed. Of course, this is much more worrisome for very young kids.

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@Mariethm Thanks for posting this! I’m sure Abbot has had it in development for some time. I’ve taken several survey’s for T1/2s and have been puzzled at the interest in ketone’s and adding the ability to track them to CGMs as it seems to impact a very small % of the population, an already very small % of T1s. Are T2’s more susceptible? What other population needs the ability? Perhaps it’s the thought that they can charge more (a lot more), like orphan drugs. In the survey’s I’ve taken with known results, the # of T1’s (those that answer such things) has been less than 10% (perhaps 5%) measure ketones regularly; this is backed up with my own docs (more than one) in effect saying “you don’t need to worry about ketones, we’ll cross that bridge if it becomes an issue.” I don’t mean to discount those that do need to measure or monitor them. But it seems one more thing I/we “can” worry about/track vice “need” to worry about/track. What I’ve read and determined so far, I/we need to be concerned when highs stick around more than a few hours or when ill. I’ll look it up further, but can someone here on FUD educate me about the “when” and “why” of the need?

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While I’ve lived with T1D (LADA) for 42 years, I have never experienced a life threatening case of DKA, even when initially diagnosed. Perhaps my slow onset of T1D at the age of 30 protected me more. I have experienced three or four episodes during that time that required thoughtful intervention and blood testing for ketones. I always keep a ketone meter and test strips on hand and I do take them with me when traveling.

In my case, continuous ketone monitoring just does not make sense. In my last episode bordering DKA, my infusion site failed overnight and I woke up with BG > 200 (11.1) for several hours. My measured ketones were about 3 but headed up. I rarely experience a BG > 180 (10).

If I took SGLT2 inhibitor drugs that may cause euglycemic DKA, I might be more open to the idea. I think a case can be made for use in the elderly cognitively-impaired group.

I’ve been using a keto diet since 2012 and don’t see that as a reason to consider a continuous ketone meter. My ketone levels are usually in the 0.5-2.0 range and that is nowhere near DKA.

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Hi @Terry, I am glad you replied.

In my comment, I was not thinking of DKA. Just that if someone is doing keto, this would might them monitor it without needing to test.

If it was accurate and sensitive enough to pick up the 0.5-3.0 range, or whatever target they had, would this be something that would be useful?

Since you mentioned that you are in the 0.5-2.0 range, I assume that means you have to test to see that. Would a monitor like this make it easier?




We don’t really know what the motivation of the people behind the Libre Duo is!

  • Let’s help people with diabetes prevent DKA!
  • Let’s help people on a keto diet monitor their ketones!
  • Let’s just come up with something Dexcom does not have and try to increase our market share!
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You might want to take your own advice and learn a little more about ketones and the Keto diet before being rude to people. The sensor measures beta-hydroxybutyrate (BHB). BHB is BHB—the body doesn’t produce a special “DKA ketone” that’s different from a “keto-diet ketone.”

BHB can rise from nutritional ketosis (keto diet), fasting, or insufficient insulin. What differs is WHY the ketones are being produced, how high they get, and the person’s overall metabolic state—not the identity of the ketone itself.

So yes, this sensor can detect BHB associated with nutritional ketosis. It doesn’t somehow know, “these ketones came from a keto diet, so don’t measure them.” The glucose level, ketone level/trend, symptoms, and clinical context are what help distinguish nutritional ketosis from something potentially dangerous like DKA.

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Thank you, your comment is valid and correct. But the rise and amount are quite different with the key being the amount of insulin necessary to maintain the lower level of the ketones, the algorithm in the sensor will enable the continued rise and potential risk for DKA to be identified from what I have been told by Abbott.

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My ketone monitoring, outside of rare extended blood sugar episodes > 180 (10), is episodic and infrequent. I’ll spot check my ketone levels maybe three or four times per year just to see what they are. Occasional ketone checking satisfies a curiosity and doesn’t meet an acute metabolic need. I don’t mind if my metabolism moves in and out of ketosis while I pay much closer attention to glycemia.

As a result, my use case would not currently justify a continuous ketone monitor.

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I have had T1D for 40 years. I also have Chronic Kidney Disease. I have been on Farxiga (off label, prescribed by my nephrologist in conjunction with my endo), and honestly, I think that is the main reason my kidney function stabilized at 35%. At one point, my GFR (filtration rate) was down to 25%, so I’m grateful that my doctors recommended Farxiga for me. For someone like me, with T1D on Farxiga, DKA is the main concern. I will definitely be in the market to try this new CGM next year, as long as Medicare pays for it.

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Wow, this is huge! Having continuous ketone and glucose monitoring in one wearable could be a game changer for so many people with diabetes. Excited to see how it works in real life!

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So would the keystone monitor show anything when I fast as a T1 and burn fat? I suspect no, but not sure. I also eat a low carb high protein diet as a T1, but shouldn’t expect to see those protein keystones showing up on the sensor correct?

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Yes. The sensor measures beta-hydroxybutyrate (BHB), so if fasting or a low-carb diet (keto, which my wife also does) raises your BHB from increased fat burning, it should detect that rise. There aren’t separate “protein ketones” that the sensor would identify; ketones are produced primarily through fat metabolism.

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I usually keep blood ketone strips on hand in my diabetes kit. At least once or twice a year I find monitoring ketones to be helpful. Either an illness, a pump issue, extreme or prolonged high, or similar situation.

If a ketone sensor had a separate “high ketones” alert that could be set to be loud like the empty cartridge alert, I think it could help detect interruptions in insulin delivery for those of us on pumps. This is what I woke up to in the early hours of this morning because my high alerts are on vibrate. It was purely human error: first time in nearly 20 years of using a pump that I went to bed with my pump sitting on the nightstand!

In this case, I knew immediately that I had a pump problem, and also that I definitely had high ketones after five hours without insulin, even though I was out of blood ketone strips and couldn’t check.

I’m not sure if a ketone sensor would be useful to me personally over blood ketone strips, but there are some who might benefit. Young kids, people who have a history of DKA, definitely people with Type 1 taking SGLT2 medications, probably more. Blood ketone strips are very convenient compared to the old urine strips, but a sensor would be even more convenient, especially at work or when travelling.

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Honestly, I wouldn’t know what to do with ketone levels. I probably haven’t measured ketone levels in over ten years.

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