On August 25, 2026, the US Food and Drug Administration authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes, granting Abbott Diabetes Care marketing authorization through the De Novo pathway. The device is the first wearable in the United States that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) in a single wearable. Alongside the authorization, the FDA established special controls covering labeling and performance testing that future dual-monitoring devices of this type must meet. The agency announced the action in a press release dated August 25, 2026.
For regulatory affairs teams at continuous glucose monitoring (CGM) and diabetes-device manufacturers, the novelty is not only Abbott's product clearance: the De Novo order creates a new device classification and binds follower submissions to defined special controls. Competitors with dual glucose-ketone pipelines now have a concrete US regulatory template to measure against.
What did the FDA authorize, and through which pathway?
The Libre Duo 10 Day received a De Novo classification order, the FDA route for novel low- to moderate-risk devices that lack a predicate and therefore cannot use the 510(k) substantial-equivalence path. A De Novo grant authorizes the specific device for marketing and simultaneously creates a new regulatory classification into which future devices of the same type will fall.
The clinical package behind the order included six studies enrolling more than 600 participants aged 2 years and older. The FDA states the data showed the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identification of elevated ketones before diabetic ketoacidosis (DKA) onset. Prior to authorization, the agency had granted Breakthrough Device designation for the system, which is intended to expedite development and review of devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
Who is impacted by the new classification and special controls?
The special controls bind any manufacturer seeking to market a continuous dual glucose-ketone monitoring device in the United States under the new classification. The FDA named labeling and performance testing as the control areas that, together with the general controls of the FD&C Act, provide reasonable assurance of safety and effectiveness. Dexcom, Medtronic, Roche Diabetes Care, Ascensia, Senseonics, and other CGM developers with dual-analyte or ketone-sensing roadmaps must now map their labeling claims and clinical performance programs to that template before a US submission.
Providers and diabetes-care networks are also in scope as adopters: the authorization covers continuous measurement of ketone and glucose levels in interstitial fluid every minute, with wireless transmission to a compatible smartphone, trend direction, and automatic alerts when ketone levels reach a concerning threshold. Ketone readings must still be interpreted with glucose values and symptoms. Until this authorization, ketone monitoring relied on point-in-time tests that could not show whether levels were rising or falling.
What should RA and product teams do now?
First, confirm whether any product in development fits the new dual continuous glucose-ketone classification. If it does, treat the Libre Duo special controls as the baseline for labeling and performance-testing evidence, not as optional guidance. Second, re-read claim language: continuous dual monitoring, pediatric indication from age 2, 10-day wear, and DKA-related early-warning framing all sit inside the authorization narrative and will shape what competitors can claim without their own supporting data. Third, align quality-system work with existing 21 CFR Part 820 / QMSR obligations that already apply to device manufacturers, then layer the new special-control evidence packages on top.
| Parameter | What the De Novo authorization establishes |
|---|---|
| Authorized device | Abbott Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System |
| Pathway | De Novo classification (low- to moderate-risk, novel type with no predicate) |
| Use scope | People aged 2 years and older living with diabetes |
| Wear and sampling | 10-day wear; interstitial ketone and glucose readings every minute |
| Special controls | Labeling and performance testing requirements |
| Clinical package cited | Six studies, more than 600 participants aged 2 and older |
| Prior designation | Breakthrough Device designation before authorization |
Continuous, per-jurisdiction monitoring of the kind Obsidian runs surfaces an FDA De Novo authorization like this the moment it publishes, before special controls reshape competitor submission plans.
Take advantage of this real-time watch
Three steps for regulatory and product leads now. First, decide whether your pipeline falls under the new dual glucose-ketone classification and, if so, gap your labeling and performance-testing files against the special controls. Second, brief clinical and commercial teams on the authorized indication (age 2 and older), the continuous ketone-plus-glucose claim set, and the expectation that ketone data be read with glucose and symptoms. Third, watch for the classification regulation and any follow-on 510(k) predicates that will use this De Novo as the reference. Obsidian will track this classification and any later special-control amendments as the FDA publishes them.
