Multi-Analyte Sensing in CGM

Introduction to Multi-Analyte Sensing in Continuous [Glucose Monitoring](/) (CGM)

Multi-analyte sensing means one wearable sensor measures glucose plus at least one other substance. As of October 2026, only one pairing has FDA authorization: glucose plus ketones. FDA granted Abbott's De Novo request for the Libre Duo 10 Day system on August 25, 2026, for monitoring glucose and ketones, measured as beta-hydroxybutyrate [1]. Abbott says users will see both readings from one sensor [2].

Lactate and cortisol are further behind. In 2020, researchers showed that a single microneedle array could detect ketones along with glucose and lactate, though they tested it in a skin-mimicking gel rather than in people [3]. Cortisol, a stress hormone, has been measured by an experimental wearable that reads sweat on the skin surface [4]. That's a different sample from the interstitial fluid (the fluid between cells under the skin) a CGM reads.

This research is why multi-analyte sensors come up for uses outside diabetes. In 2025, a wearable continuous lactate monitor tested in pigs with severe trauma and shock tracked arterial blood lactate, but agreement between the two was only moderate [5]. Sports scientists are interested too. A 2025 review of technology in professional cycling looked at portable sweat and lactate analyzers and cautioned that some of the tools it covered can't yet produce data reliable enough to guide nutrition decisions [6].

Key Innovations in Multi-Analyte Sensing

Here is where each piece stood in October 2026:

• Glucose + Ketone Monitoring: Libre Duo 10 Day is a prescription device for people with diabetes ages 2 and older. Its FDA indication covers real-time monitoring of both analytes, and the system can sound alarms and help detect high or low glucose and hyperketonemia (high blood ketones) [1]. Abbott designed it to alert people when ketones rise, because rising ketones can lead to diabetic ketoacidosis (DKA), a serious complication that develops when the body lacks insulin and breaks down fat for energy [7]. Abbott's US website still listed the system as "coming soon" in October 2026 [2]. The company expects it to connect with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery (AID) systems by the end of 2026, and with Insulet and Tandem devices in 2027. Abbott and MiniMed also announced an exclusive integration of Abbott-made dual glucose-ketone sensors with MiniMed smart dosing systems, expected in 2027 [7]. Those dates are company plans, not FDA decisions. We look at how dosing algorithms might use the extra data in Closed-Loop Algorithms with Multi-Analyte Data.
• Glucose + Lactate Monitoring: Changes in blood lactate carry prognostic value in serious illness and injury [5], and portable lactate analyzers are among the tools used or considered in professional cycling [6]. Every lactate sensor in the sources we read is still a research device. The continuous lactate monitor was in preclinical testing in animals [5], and the 2020 microneedle array that read lactate alongside glucose and ketones was tested in gel [3].
• Underlying Technology: Abbott's 2021 ketone-only prototype shows the basic design. It kept the structure of Abbott's glucose sensor and swapped the chemistry: a three-electrode system with a silver-silver chloride reference electrode, the enzyme beta-hydroxybutyrate dehydrogenase (β-HBDH), and an osmium-based mediator that "wires" the enzyme to the electrode so electrons can flow [8]. A dual sensor has to run a glucose chemistry and a ketone chemistry side by side. The published sources we read don't show how the two are laid out on the Libre Duo sensor, including whether they share one reference electrode on a single filament.

Challenges in Multi-Analyte Sensing

Each added analyte brings its own engineering and regulatory work:

• Enzyme Stability: The ketone enzyme depends on a helper molecule, NAD+, that floats free and is hard to keep inside the sensing layer. For that reason Abbott's researchers called 14-day stability with this chemistry "even more challenging," and in lab tests their prototype lost 2.1% of its signal over 14 days [8]. The 2020 microneedle study named the same problem, keeping the enzyme and NAD+ confined and stable, as a major hurdle [3]. Libre Duo's labeled wear is 10 days. Abbott reports that 84.1% of sensors worn by adults and 68.8% worn by children lasted the full 10 days [2].
• Regulatory Hurdles: FDA created a new device type for Libre Duo, the integrated continuous glucose ketone monitoring system (iCGK). Its special controls require clinical accuracy data for each analyte, checked against laboratory blood glucose and laboratory blood ketone measurements, plus labeling that reports glucose and ketone accuracy separately [1]. In practice, a dual sensor has to clear two sets of accuracy requirements in its clinical study. Abbott says Libre Duo is the first system to meet both the iCGM standard and the new iCGK standard [7]. Now that the category exists, later devices of this type need 510(k) premarket notification before they can be sold [1].
• Manufacturing Complexity: Abbott built the dual sensor to be factory-calibrated, so users don't calibrate it with fingersticks, and a 2025 Abbott paper describes factory calibration of the ketone component as one of the main challenges in that effort [9]. Abbott's researchers wrote earlier that factory calibration works only when manufacturing keeps sensor-to-sensor variation small; the ketone prototype showed about 5% variability between sensors [8]. The papers we read don't put numbers on how a second chemistry affects manufacturing yield or cost.

Strategic Impact of Multi-Analyte Sensing

The split between prescription and consumer CGMs already exists, and glucose-only sensors created it. FDA cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter sale on March 5, 2024 [10], and the Abbott Lingo Glucose System on May 29, 2024 [11]. Multi-analyte sensing hasn't reached that consumer tier. Libre Duo 10 Day is prescription-only [1], and as of October 2026 it is the only device FDA lists under the new glucose-ketone product code, SJD [12]. We compare the consumer glucose sensors in Over-the-Counter (OTC) CGM Market.

Conclusion

Multi-analyte CGM went from lab papers to an FDA-authorized product in August 2026, but for one pairing and by prescription only [1]. Real-world evidence is the next gap. Abbott registered a three-month observational study of DKA episodes in adults and children with type 1 diabetes who use the dual sensor; its July 2026 listing showed it not yet recruiting, with an estimated start in September 2026 [13]. An international expert panel published recommendations on using continuous ketone monitoring in January 2026 [14], and how to act on a ketone alert is a decision to make with your care team. Lactate and cortisol sensing, for now, remain in the research literature.