Abbott recently obtained regulatory authorization in Europe for a dual-biomarker sensor, a development that has sparked widespread discussion in the industry about the advantages and challenges of multi-biomarker sensor technology. The sensor can simultaneously and continuously monitor glucose and ketones, aiming to help users detect elevated ketone levels early—which may be a sign of diabetic ketoacidosis (DKA). DKA is a serious health condition caused by insulin deficiency, and its symptoms, such as nausea, abdominal pain, and thirst, are often mistaken for food poisoning or the flu.

Abbott's new device, named Libre Duo, is planned to launch in some European countries later this year, and a submission has been made to the U.S. Food and Drug Administration (FDA). Alisa Schiffman, Abbott's senior medical director, stated in an email statement that traditionally people detect elevated ketones through urine test strips or blood ketone meters, but the condition may go unnoticed before developing into a medical emergency. Schiffman hopes Libre Duo can continuously monitor ketones in the background, thereby helping to reduce the occurrence of DKA-related events.

Schiffman wrote: "Under the guidance of healthcare providers, users will be able to interpret high ketone levels and take action when needed, potentially reducing the risk of DKA."

Dexcom, another leader in the continuous glucose monitoring (CGM) market, has also discussed plans for multi-biomarker devices, but its path differs from Abbott's. Dexcom CEO Jake Leach believes ketone monitoring is valuable, but the company's first multi-biomarker device will measure glucose and potassium, which could benefit patients with diabetes and chronic kidney disease. Leach told investors last month that Dexcom plans to add this feature after launching its next-generation device in 2027 or 2028.

Small companies also positioning themselves in multi-biomarker sensors

Several smaller competitors in the CGM field are also developing multi-biomarker devices.

PercuSense, a company focused on tracking glucose, lactate, ketones, and tissue oxygen in a single device, has been dedicated to this direction since its inception. Rajiv Shah, who previously worked at Medtronic's diabetes business unit, founded the company in 2016. Shah said: "I knew back then that we would eventually move toward multi-biomarker monitoring."

PercuSense CEO Brian Kannard revealed that the company will launch two studies this summer, focusing on type 1 diabetes, funded by the Helmsley Charitable Trust. One study will test system performance in an intensive care unit (ICU) setting, where some admitted patients may have DKA, and will evaluate the sensor's performance and accuracy. The other study will be conducted in an outpatient setting, testing the device's accuracy against reference measurements in insulin-using diabetic patients.

Kannard said PercuSense focuses on these four biomarkers because they provide a more comprehensive picture of metabolic health. Markers such as lactate and oxygen also help determine the optimal timing for insulin administration. Shah stated that after the studies conclude, PercuSense plans to discuss with clinicians how to present this data to users, and the company intends to use software to help alert users while avoiding information overload.

Kannard added: "People with diabetes already have a good understanding of glucose, but CGM data alone is already overwhelming." He envisions these biomarkers primarily providing insights and health outcomes rather than adding burden to users.

Biolinq, a diabetes technology company, received FDA de novo authorization for its CGM last year. The company also plans to add additional analytes in the future. Biolinq's sensor, called Biolinq Shine, is intended for people with type 2 diabetes who do not use insulin. The sensor sits within the skin rather than inserting a filament into the subcutaneous interstitial fluid like traditional CGMs. Currently, the device tracks glucose, activity, and sleep data. Biolinq CEO Rich Yang said the company plans to launch this CGM in the second half of this year.

Biolinq recently shared results from the study used to obtain de novo authorization, as well as a poster on a continuous lactate sensor. Yang believes lactate is valuable because elevated levels may be a precursor to insulin resistance, and the measurement could also aid athlete training. Yang noted: "The FDA has never approved a continuous lactate sensor." He added that lactate is one of the most important markers Biolinq plans to bring to market, and the company is also considering other biomarkers such as ketones and cortisol. Yang said Biolinq's device design is naturally suited for multi-biomarker monitoring: "We are in the best position to measure these biomarkers."