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Glucose monitoring has come a long way in helping to reduce dangerous low blood sugars, but we haven’t seen the same capabilities for detecting and preventing high blood sugars that can lead to deadly Diabetic Ketoacidosis (DKA).

A new type of technology in development could solve that problem, if it moves forward successfully in early research and clinical development and eventually makes it to the product stage in coming years.

Digital health startup PercuSense in Southern California — which has former Medtronic Diabetes engineering talent at its helm — is working on this next-generation tech for diabetes, a combined continuous glucose monitor (CGM) that also keeps tabs on ketones. It would be dubbed a CGKM, for short.

If successful, it would serve a critical function in helping to tackle DKA in hospitals, as well as for PWDs (people with diabetes) using a newer class of glucose-lowering drug known as SGLT2 inhibitors, which can sometimes lead to spikes in ketone levels.

PercuSense announced in early November 2020 that it received a $2.5 million grant from the prestigious Leona M. and Harry B. Helmsley Charitable Trust, supporting research to develop this CGKM. A separate grant also builds on pre-clinical work by Dr. David O’Neal at the University of Melbourne in Australia, going toward animal and human clinical trials.

DiabetesMine talked with PercuSense CEO Brian Kannard about the company’s future product, as well as Sean Sullivan at the Helmsley Charitable Trust for more details. This is what you can expect.

PercuSense is making an all-in-one system to monitor both glucose and ketones. The biosensor looks similar to an Omnipod, attached to the body with an adhesive. A cannula underneath penetrates the skin to monitor interstitial fluid for both glucose and ketones — yes, a single combined probe to monitor both in your body, so there’s no need for a second cannula.

The PercuSense sensor works like most other CGMs for glucose sensing; it uses an enzymatic, electrochemical process like many of the current products on the market. For the ketone measuring function, it will do the same job as current ketone meters but continuously, via the sensor inserted into the body. The company envisions it as similar to the current hospital-focused platform for effective monitoring of sepsis.

The system will provide glucose results like a traditional CGM and also indicate when ketones levels are moving out of range, showing a trend line, plus alerts and alarms like those currently available with today’s CGMs.

While there is a patent filed for a handheld controller or receiver, it’s still to be determined whether that will be offered, or if the final product will send all data to a mobile app.

If successfully developed, this will be a first of its kind.

“While we have heard of interest by industry in measuring ketones continuously, we are not aware of another company that has a transcutaneous device capable of measuring both glucose and ketones,” said Helmsley’s Sean Sullivan.

Think about it: While most PWDs carry a glucose meter or wear a CGM to keep tabs on their blood sugar levels, most have no good way to measure ketones — which are a critical indicator of the dangerous effects of too-high blood glucose.

While doctors recommend that PWDs keep urine ketone strips around for monitoring dangerous highs during sick days, most patients don’t actually get or fill those prescriptions.

PercuSense and Helmsley cite a 2018 Diabetes Care study showing that DKA causes nearly 200,000 hospitalizations every year in the United States alone, racking up $5.1 billion in healthcare costs.

Reliable glucose monitoring for PWDs in the hospital is hugely important in normal times, but especially now during the COVID-19 crisis.

That is one important aspect this new technology would address, but it’s also aimed at more everyday aspects of managing this condition. It could be especially useful for:

  • those using the newer class of glucose-lowering medications known as SGLT2 inhibitors, or sodium-glucose cotransporter-2 inhibitors (see more below).
  • those utilizing insulin pumps or closed loop technology (i.e. Artificial Pancreas systems) who can experience failed insulin infusion sites.
  • managing common diabetes hurdles, from sick days when glucose levels are higher to high-intensity exercise that sometimes also leads to hyperglycemia.
  • those who follow lower-carb eating, which can lead to ketosis.

“DKA unfortunately still occurs too regularly in general, and continuous ketone monitoring and the early warning that it provides can help reduce incidences of DKA across the spectrum,” Sullivan said. “So we absolutely believe that continuous ketone monitoring can provide a broad benefit with respect to general DKA and hyperglycemia, and this is a focus of ours.”

Indeed, new research published in 2019 illustrates a strong case for integrating continuous ketone monitoring into closed loop systems, that automate insulin delivery for patients.

The increasing use of SGLT2 inhibitors (Jardiance, Invokana, etc.) in recent years adds to this necessity, according to Kannard and Sullivan. These medications help lower glucose levels and lower the risk of heart and kidney failure. While only FDA-approved for people with type 2 diabetes, many with type 1 diabetes often use them off-label to help lower glucose (especially at mealtimes).

While most DKA instances happen in the context of hyperglycemia, it can also occur during what’s known as euglycemia — where ketones are elevated but glucose levels are not. In this case, the person generally does not experience common warning signs like thirst and increased urination that often come with higher blood sugars.

SGLT2 inhibitors can lead to that euglycemia case, where PWDs may not realize they’re becoming ketotic. Having a CGKM to keep tabs on both glucose and ketones would not only help prevent DKA, but could also be used to gather more data sfor regulatory approval of SGLT2 with type 1 diabetes, Sullivan said.

Kannard said the Helmsley grant’s current project means starting clinical trials in the next 12 to 18 months, at best, and what happens after that would depend on the research going forward.

While this isn’t near-term, Kannard and Sullivan are excited about how it may help to address the issues of affordability and access in the long-term.

“We believe patient cost of CGM needs to be reduced across the board. At the same time, continuous ketone measurement has the ability to reduce costs to both the patient and the healthcare system with the reduction of hospitalizations due to DKA,” Sullivan said. “This is extremely important to us.”

Founded in 2016, the startup’s leadership brings diabetes tech experience from both the insulin pump and CGM universe.

Brian Kannard

Prior to becoming CEO of PercuSense, Kannard is a longtime industry veteran who hails from Medtronic Diabetes, where he worked as a senior engineer in CGM sensor development.

PercusSense founder Rajiv Shah actually built the company based on Kannard’s previous role leading CGM sensor development for Alfred E. Mann’s Minimed, that was later acquired by Medtronic in 2001. His vision was to take continuous monitoring beyond glucose.

“The founding principle was that we can reduce the daily burden of diabetes management and improve clinical outcomes if we can go beyond CGM to include other important and relevant analytes,” Kannard told DiabetesMine.

He added that Shah and many others on the PercuSense team have worked in diabetes throughout their careers, and many have friends and colleagues living with type 1 diabetes.

“We have been able to see first-hand the benefits of both standalone CGM and CGM-enabled automated insulin delivery to people with diabetes,” he said. “This personal connection helps drive our passion for providing the right information about what’s happening in your body in the unique moment to help inform the best decisions; this is what we believe is the power of continuous monitoring.”