Medtech giant Abbott has secured a CE mark for two of its glucose-ketone sensing systems for diabetic patients, making the devices the first of their kind to reach this milestone.
The biowearables, which are branded as Libre Duo and Libre Duo 10 Day, are built to monitor glucose and ketone levels at one-minute intervals. These provide patients with either type 1 diabetes (T1D) or type 2 diabetes (T2D) early warning of potential diabetic ketoacidosis (DKA) with real-time insights that were previously only attainable through blood or urine tests.
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The information collated by the devices is integrated into Abbott’s Libre digital health ecosystem, which spans the company’s range of continuous glucose monitoring (CGM) solutions, phone apps and cloud-based reporting platforms. It allows users to share their glucose and ketone data with healthcare providers and caregivers, facilitating proactive and timely care.
Libre Duo is suitable for up to 15 days of wear on adults while Libre Duo 10 Day is suitable for ten days of wear on individuals aged two years of age or older. Abbott plans to launch the Libre Duo systems later this year across select European countries.
The devices could also soon debut on the US market as they are both under review by the US Food and Drug Administration (FDA). In Abbott’s Q1 earnings presentation, CEO Robert Ford noted that he expects approval for the Libre Duo systems in the second half of 2026.
Managing DKA in the diabetic population
DKA is a condition in which the body does not generate enough insulin, so it begins to break down fat for energy instead. This prompts the release of ketones into the blood, which can cause it to become dangerously acidic – potentially leading to the disruption of vital organs and, if left untreated, death.
Currently, the US Centers for Disease Control and Prevention (CDC) names DKA as one of the leading causes of death among patients with T1D who are aged under 58, while also accounting for around four times more US hospitalisations in this patient population than low blood glucose levels.
According to Chris Scoggins, executive vice-president of Abbott’s diabetes care business, diabetics have routinely informed the company that the risk of serious complications is “a constant part of everyday life”.
To curb this trend, Scoggins notes that the Libre Duo system can offer diabetic patients, as well as healthcare providers and families, “clearer, earlier information about what’s happening inside their body, allowing them to act sooner when safety matters most”.
The CGM market’s evolution
Obtaining the European stamp of approval for its Libre Duo range will be welcome news for Abbott, which is currently one of the top players in the CGM space due to its commanding market share.
Despite a rocky Q4 2025 for Abbott, clouded by a sales miss, the company’s diabetes care portfolio shone overall in fiscal year (FY) 2025, being the company’s top-selling segment within its medtech division – drawing in revenues of almost $8bn and topping FY24 values by 17.5%.
However, other key players such as Dexcom are also making a mark on the segment, with the San Diego-based medtech company being the leading CGM provider in the US. The company has recently been looking to expand its presence in this market by tapping into the burgeoning wellness niche, forging partnerships with Finnish smart ring developer Oura and getting its G7 sensor natively integrated with the Apple Watch.
According to GlobalData’s Medical Device Intelligence Center, the global CGM market is expected to post healthy, near double-digit growth over the next decade.
