Admin_Adham
Jump to Key Points The FDA has authorized the first-ever combination continuous glucose and ketone monitoring device.
Abbott’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System was approved for people aged 2 years or older with diabetes. It simultaneously measures both ketones and glucose in interstitial fluid every minute, displaying both values and trend lines. The device sends readings wirelessly to a compatible smartphone and can issue alerts about rising levels.
It is designed for people who may be at an increased risk for elevated ketones or diabetic ketoacidosis (DKA), including those with either type 1 or 2 diabetes who use insulin or other medications, including SGLT2 inhibitors, that have been associated with ketones even at normal glucose levels.
The authorization was based on data from six clinical studies enrolling a total of over 600 participants aged 2 years or older, assessing the accuracy of both the glucose and ketone measurements. “The results demonstrated that the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketone levels before the onset of diabetic ketoacidosis,” the FDA said in a statement.
- FDA authorized first combined continuous glucose + ketone monitor.
- Libre Duo monitors interstitial glucose + ketones every minute for 10 days.
- Approved for diabetes age ≥2 years; smartphone-linked alerts for rising levels.
- Intended for patients at ↑ DKA/ketosis risk, incl insulin users + SGLT2 inhibitors.
- Approval based on >600 participants; accuracy shown across 10-day wear.
The need for continuous ketone monitoring has been debated in diabetes circles. Some experts point to the benefit of avoiding progression to DKA for those at risk and enabling the safer use of SGLT2 inhibitors. However, others argue that the devices are unnecessary, particularly for adults with type 1 diabetes who successfully manage the condition and can use fingerstick test strips if they suspect ketones may be present.
Abbott plans to launch Libre Duo 10 Day in the US later this year.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and diaTribe. She is on X: @MiriamETucker and Bluesky: @miriametucker.bsky.social.
