Hot off the press: Continuous ketone monitoring guidelines are here 

Ketones and DKA: What you need to know

When there is not enough insulin in the body, glucose cannot be used for energy, and the body uses fat for fuel instead. Excessive breakdown of fat ultimately causes ketones to build up in the blood. Very high levels of ketones in the blood can lead to diabetic ketoacidosis (DKA)—a life-threatening condition that requires immediate medical treatment.

Too often, people are diagnosed with T1D only after they have experienced DKA. Yet, even for people who are aware that they have T1D, DKA can and does happen. There are many reasons that it can occur, including the onset of illnesses, like the flu. Currently, people with diabetes use blood and urine strips to test for ketones—but even so, surveys show that very few people measure their ketones regularly, and DKA rates remain unacceptably high.

Given the current options, it remains very difficult to predict when ketone levels may be rising, and people lose opportunities to intervene early to prevent DKA altogether. So, how can we fill this gap?

The answer: continuous ketone monitoring.

CKMs are coming—but they’re not here yet

CKMs are in the works, and we can expect them to become a reality sooner rather than later. Similar to continuous glucose monitors (CGMs), CKMs will continuously measure ketone levels in the body and can alert users if their ketone levels are rising. This ability to track ketone levels in real-time could have substantial benefits in preventing DKA—and more.

As of today, there are academic groups and early-stage companies working on CKM. Abbott also has a glucose-ketone sensor (CGM-CKM) in development. Other companies, including Tandem, Beta Bionics, Sequel Med Tech, and Ypsomed, are planning to integrate Abbott’s ketone-glucose sensing device into their AID systems once it is available. We’re also keeping an eye a company called SIBIONICS, which currently offers a wellness-focused CKM that has demonstrated strong ketone-tracking data, although it is not available as a medical device yet.

Breakthrough T1D strongly supports the development of CKM to help protect people with T1D from the dangers of DKA. We previously funded five projects—two of which are co-funded by the Helmsley Charitable Trust—to support the development of CGM-CKM. Now, we’re getting ahead of the curve for CKM so we can learn how to use this technology to answer clinical questions about T1D.

We are currently looking for and investing in research projects to understand how ketone monitoring may improve outcomes for people living with T1D from multiple angles, including DKA prevention, understanding disease progression and pathophysiology, learning from clinically meaningful ketone patterns, and more. The goal is to accelerate the generation of evidence surrounding the use of CKM while these devices are on the horizon. This way, we can get a better idea of the kinds of benefits this technology can bring to the T1D community.

Snapshot of CKM recommendations for people with T1D

We feel optimistic that CKMs will become a reality soon. The next question is: how should they be integrated into T1D care? To answer this question, Dr. Danne and an international Breakthrough T1D consensus group published a report about how these novel technologies can be effectively used to help the T1D community.

The experts agreed on the following recommendations:

• CKMs should include trend arrows, akin to those on a CGM, and reflect rates of change of around 0.4 mmol/L per hour.
• Due to the existence of alarm fatigue, alarms should sound if ketone concentrations rise above the threshold of ≥3.0 mmol/L.
• The terminology for ketone levels should be: Normal, Elevated, High, Urgent High.
• All CKM users should be provided with a blood ketone meter to use if they are experiencing the symptoms of High or Urgent High ketones that do not match the CKM reading.
• All individuals who wear a CKM should receive education on what elevated ketones mean and what actions to take.

These are just a few of the highlights. Check out the full publication for a more in-depth look at what the experts recommend.

Why CKM guidelines are important

CKMs have the potential to transform T1D care by stopping dangerous, life-threatening DKA before it ever occurs. It is critically important that healthcare professionals (HCPs) and people living with T1D know how to most effectively use this technology to maximize its benefits.

This publication does just that. It’s a set of established guidelines, put together by experts from around the globe, to help standardize the integration of CKM into clinics once they become available. Both HCPs and the T1D community can refer to these recommendations as this technology is rolled out—and potentially becomes the standard of care—to start realizing the benefits of CKM as soon as possible.

Even more, this document can be used as a resource in future conversations surrounding regulatory decisions and payer coverage. Ultimately, we are preparing all stakeholders for a future that we know will be here soon—one where CKM is a valuable addition to daily T1D management.

“Experts from 12 countries agree: continuous ketone monitoring can be a game-changer. By detecting risk earlier and guiding faster action, CKM has the potential to reduce DKA, strengthen confidence for people with T1D, and transform how we deliver safe, proactive diabetes care.” – Thomas Danne, M.D., Ph.D., Chief Medical Officer, International

How this fits into our Medical Affairs goals

CKMs are coming—how can we ensure they make their way into clinics around the globe? By preparing the T1D community in advance of their arrival, we are setting the stage for CKMs to come. That way, once they are available, HCPs and people with T1D will already know what to do.

In essence, this is clinical adoption: the cornerstone of our Medical Affairs unit. We are preparing the right people at the right time by providing resources, education, and guidelines for a new technology. We are getting our ducks in a row before the new technology is here—so that we are 100% ready when it is.