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FDA De Novo · Abbott · Endocrinology

Libre Duo

First wearable sensor that tracks ketones and glucose together.

CompareFDA press release
Granted · De NovoBreakthrough device

Libre Duo

Abbott · Endocrinology · First continuous ketone and glucose wearable

Type
Wearable or sensor
FDA route
De Novo classification
Setting
Home
Used by
Patients and caregivers
Bottom line for your practice
65s read

Patients with diabetes can now see ketone and glucose levels and trends together in real time from one device, with alerts that may help them and their caregivers recognize rising ketones before diabetic ketoacidosis becomes an emergency. The FDA notes that ketone information should always be interpreted in the context of glucose readings and symptoms.

What it is
A wearable sensor that continuously measures both ketone and glucose levels in the fluid just beneath the skin, every minute, for a 10-day wear period. Readings go wirelessly to a compatible smartphone, which shows current levels and trends and can send automatic alerts if ketones reach a concerning threshold.
Indicated for
People aged 2 years and older living with diabetes.
What changes
Until now, people who needed to monitor ketones did so separately, with tests that gave a single measurement at one point in time and could not show whether ketones were rising or falling. The release describes accuracy studies and does not describe a comparison group.
Evidence
Performance testingStudy not named in the releaseSix clinical studies that together enrolled more than 600 participants aged 2 years and older evaluated accuracy; the FDA says 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. No numeric accuracy figures are given.Accuracy, bench or analytical testing. The source reports no clinical outcome trial, which is common for cleared devices.
Watch for
Ketone information should always be interpreted in the context of glucose readings and symptoms. The release gives no numeric accuracy data and lists no contraindications or adverse events; the FDA is establishing special controls covering labeling and performance testing.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
De Novo classification. A new type of low-to-moderate-risk device (Class I or II) with no predicate. The FDA reviewed its safety and effectiveness and created a new device type, which later devices can cite as a predicate.Breakthrough Device designation: for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

Clinical summary

A 10-day sensor for people with diabetes aged 2 and older that measures ketones and glucose in interstitial fluid every minute and sends readings, trends and rising-level alerts to a smartphone. Across six clinical studies in more than 600 participants it tracked clinically meaningful ketone differences, including elevated ketones before the onset of diabetic ketoacidosis. Ketone readings should be interpreted with glucose values and symptoms, and do not replace confirmatory testing before treatment decisions.

From the source 8

FDA press release

The FDA press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.

    Backs · Authorized for people aged 2 years and older with diabetes; 10-day device

  2. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.

    Backs · First claim

  3. The Libre Duo 10 Day addresses that gap by continuously measuring both ketone and glucose levels in the fluid just beneath the skin, every minute, day and night.

    Backs · Measures every minute

View all 8 lines

  1. The clinical program included data from six clinical studies that together enrolled more than 600 participants aged 2 years and older to evaluate the accuracy of the device’s ketone and glucose monitoring functionality across a range of ketone and glucose levels.

    Backs · Six clinical studies, more than 600 participants, aged 2 years and older (n recorded as 600)

  2. 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.

    Backs · Result across 10-day wear period

  3. Prior to authorization, the FDA granted Breakthrough Device designation for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System.

    Backs · Breakthrough Device designation

  4. The FDA granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

    Backs · Pathway: De Novo

  5. Along with this De Novo authorization, the FDA is establishing special controls that define requirements including those related to labeling and performance testing.

    Backs · Special controls

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