FDA Clears Libre Duo: The World’s First Dual Glucose & Ketone Monitor
In India, around 77 million people aged 18 and above are suffering from type 2 diabetes. Another alarming fact is that around 25 million are prediabetic, as of a recent report, and are at higher risk of developing diabetes in the near future. More than 50% are unaware of their diabetes status (1).
Diabetic ketoacidosis (DKA) remains an important acute complication of diabetes in India, occurring predominantly in people with type 1 diabetes but also affecting those with type 2 and pancreatic diabetes. In a tertiary-care study of 138 patients with DKA, 56.52% had type 1 diabetes, 23.19% had type 2 diabetes, and 20.29% had pancreatic diabetes. Common precipitating factors included infection, treatment non-compliance, and pancreatitis, highlighting the importance of assessing factors beyond blood glucose levels when evaluating DKA risk (2).
Diabetic ketoacidosis (DKA) is the most common hyperglycemic emergency in the diabetes population, with hospital admissions for DKA increasing by 55% over the past decade (3). DKA is an acute metabolic crisis that can develop rapidly when severe insulin deficiency causes the body to metabolize fat for energy. This metabolic shift results in the accumulation of acidic ketones in the bloodstream, which can reach hazardous levels (3,4). DKA may progress within hours and, if left untreated, can lead to coma or death (3).
Unmet Needs in Clinical Ketone Monitoring
Delays in detecting ketosis have limited traditional management of DKA. Standard continuous glucose monitors (CGMs) measure glucose but do not provide continuous ketone monitoring (3). DKA can develop even when glucose levels appear stable, meaning glucose monitoring alone may not always provide an early warning of rising ketone levels (3,4).
Clinical guidelines recommend ketone testing during illness or periods of elevated glucose; however, the majority of people do not have access to a blood ketone meter at home (3). Conventional urine and blood ketone tests provide point-in-time measurements and cannot show whether ketone concentrations are rising or falling (3,4). As early signs of ketosis may resemble those of common infections, recognition of worsening ketosis and subsequent medical evaluation may be delayed (3).
US FDA approves Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
On August 25, 2026, the U.S. Food and Drug Administration (FDA) authorized Abbott’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System through the De Novo premarket review pathway (3,4). The wearable is the first device authorized in the United States to continuously monitor ketone levels and the first in the world to continuously monitor both ketones and blood glucose using a single device (4).
The Libre Duo 10 Day received Breakthrough Device designation before receiving De Novo authorization. Abbott stated that the system is the first to meet the FDA’s integrated continuous glucose monitoring (iCGM) standard and the new integrated continuous glucose and ketone monitoring (iCGK) standard (3).
Clinical evidence
The authorization was supported by a clinical program comprising six studies that enrolled more than 600 participants aged 2 years and older. The clinical studies demonstrated that the device accurately tracked clinically meaningful differences in ketone levels across the 10-day wear period, including identifying elevated ketone levels before the onset of diabetic ketoacidosis. The authorization also aligns with the FDA’s Home as a Health Care Hub initiative, which aims to integrate patient-centered monitoring technologies into home-based care (4).
Clinical Indications and Potential Benefits
The Libre Duo 10 Day is intended for people with diabetes aged 2 years and older and is designed for individuals who may be at higher risk of elevated ketones, including people with type 1 or type 2 diabetes using insulin or other glucose-lowering medications such as sodium-glucose cotransporter 2 (SGLT2) inhibitors (3,4).
The device continuously measures glucose and ketone levels in interstitial fluid every minute. Data are transmitted wirelessly to a compatible smartphone application, which displays current glucose and ketone concentrations, trend information, and alerts when ketone levels reach predefined thresholds (4).
Abbott is working with insulin pump manufacturers to enable automated insulin delivery (AID) system connectivity. Abbott expects Libre Duo 10 Day to work with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by the end of 2026, with planned integrations with Insulet and Tandem in 2027. Abbott and MiniMed are also collaborating on an integration with MiniMed smart dosing systems, with integration expected in 2027 (3).
Safety Information and Clinical Monitoring Considerations
Clinicians should counsel patients on several key considerations related to sensor use and interpretation:
Sensor longevity: In a sensor-wear study, 84.1% of adult sensors and 68.8% of pediatric sensors lasted the full 10-day wear period. Accordingly, approximately 16% of adult sensors and 31% of pediatric sensors may not last for the full 10 days (3).
Confirmatory testing: If sensor readings or alerts do not align with a patient’s symptoms or clinical expectations, patients should use a fingerstick blood glucose measurement for treatment decisions (3).
Alert thresholds: The Urgent Low Glucose and Urgent High Ketones alarms may not detect all instances of glucose levels below 55 mg/dL or ketone levels above 3.0 mmol/L. Ketone readings should therefore be interpreted together with glucose readings and the patient’s symptoms (3,4).
Clinical Perspective
The authorization of the Libre Duo 10 Day system introduces continuous ketone monitoring alongside glucose monitoring, addressing limitations associated with conventional point-in-time ketone testing. By providing continuous ketone measurements and trend information, the system may provide earlier awareness of rising ketone levels and support timely evaluation when clinically indicated (3,4).
About the Author
Dr. Manisha Dadlani is a Dental Surgeon and Medical Writer with 5+ years of clinical experience and formal training in medical writing. She combines clinical expertise with analytical thinking to develop evidence-based, insight-driven content that supports effective scientific communication across the healthcare and life sciences landscape.
References:
Diabetes in India. Available at: https://www.who.int/india/diabetes Accessed on 20th September, 2026.
Paul S, et al. Epidemiologic pattern and factors associated with adverse outcomes of diabetic ketoacidosis in medical intensive care units of a tertiary care centre in India. Endocrine and Metabolic Science 16 (2024) 100204.
Abbott receives FDA authorization for world’s first dual glucose-ketone sensing technology for people with diabetes. Available at: https://abbott.mediaroom.com/2026-08-25-Abbott-receives-FDA-authorization-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetes Accessed on 20 September, 2026.
FDA authorizes first wearable device that continuously monitors both ketone levels and blood sugar. Available at: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-wearable-device-continuously-monitors-both-ketone-levels-and-blood-sugar Accessed on 20 September, 2026.
Disclaimer
The content published on this platform has been developed by independent medical writers from diverse healthcare backgrounds, including members of the MedWriters Alumni Network. While every effort has been made to ensure accuracy, the authors, Rxnews team, partners, agents, and sponsors accept no responsibility for errors, omissions, or inaccuracies in this article, whether due to negligence or otherwise, nor for any consequences arising from its use. Inclusion or exclusion of any product does not imply endorsement or rejection by the publisher. For complaints or feedback, please write to contact@rxnews.in
Comments