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FDA clears first wearable that monitors both glucose and ketones

FDA clears first wearable that monitors both glucose and ketones

New Capabilities

Abbott's Libre Duo 10 Day tracks both in one sensor and can alert users to rising ketones linked to diabetic ketoacidosis.

October 2026: Breakthrough T1D funds eight ketone-monitoring studies

Overview

Updated 7 days ago

The FDA on August 25 authorized Abbott's Libre Duo 10 Day, the first wearable that continuously tracks both blood sugar and ketone levels in one sensor. It reads fluid under the skin every minute for up to 10 days, for people as young as 2.

Diabetic ketoacidosis can develop quickly and become life-threatening if untreated, and Abbott has not announced a US launch date or price. In its wear-duration study, 84.1% of adult sensors and 68.8% of pediatric sensors lasted the full 10 days. In October, Breakthrough T1D said it funded eight studies of continuous ketone monitoring in type 1 diabetes.

Why it matters

For 2.1 million Americans with type 1 diabetes, this is the first early-warning system for rising ketones, which can turn fatal within hours.

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Key Indicators

40.1M
Americans living with diabetes
CDC estimate for the US population with diabetes.
2.1M
Americans with type 1 diabetes
Type 1 patients face the highest DKA risk because they produce no insulin.
84.1%
Adult sensors lasted the full 10 days
Abbott wear-duration study; 68.8% of pediatric sensors lasted the full 10 days.
600+
Participants in six clinical studies
The FDA reviewed accuracy data from people aged 2 and older.
10
Days of continuous wear per sensor
Readings transmit wirelessly every minute, day and night.

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People Involved

Michelle Tarver
Michelle Tarver
Director, FDA Center for Devices and Radiological Health
Currently leading CDRH

Organizations Involved

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Regulatory authority that authorized the device

The FDA division that reviews medical devices and authorized Libre Duo 10 Day through the De Novo pathway.
Abbott Laboratories
Abbott Laboratories
Medical device and diagnostics manufacturer
Device authorized; US launch planned for later in 2026

Global healthcare company that makes FreeStyle Libre continuous glucose monitors and developed the Libre Duo 10 Day.
Breakthrough T1D
Breakthrough T1D
Nonprofit research funder
Funding eight continuous ketone monitoring studies

Nonprofit that funds type 1 diabetes research, including studies of continuous ketone monitoring.

Timeline

May 2026 October 2026

3 events Latest: October 2026

  1. Breakthrough T1D funds eight ketone-monitoring studies

    Latest Research

    The nonprofit said eight projects will use dual glucose-ketone sensors donated by Abbott, including a study in children and teenagers using automated insulin delivery.

  2. FDA authorizes Libre Duo 10 Day via De Novo pathway

    Regulatory

    First US device to continuously monitor both glucose and ketones, cleared for ages 2 and older after Breakthrough Device designation.

  3. Abbott wins European CE Mark for Libre Duo

    Regulatory

    European clearance covered the 15-day Libre Duo for adults and the 10-day version for ages 2 and older, but not the US versions.

Scenarios

1

Libre Duo 10 Day ships in the US this year

Likely Resolves by End of 2026

Discussed by: Abbott company statements, MedTech Dive

Abbott said it plans to launch in the US later in 2026, but as of Nov. 4 it had not announced a date or price. The company already makes FreeStyle Libre sensors at scale.

2

Insurance coverage becomes the adoption gate

Possible Resolves by Q3 2027

Discussed by: MedTech Dive interviews with industry experts

As of Nov. 4, Abbott had not published pricing, and coverage was unresolved. Medicare and commercial insurers could treat the ketone function as experimental or limit it to high-risk groups, restricting access to out-of-pocket buyers.

3

Closed-loop integrations arrive on schedule

Likely Resolves by End of 2026

Discussed by: Abbott company projections

Abbott expects Libre Duo 10 Day to integrate with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery systems by end of 2026, with Insulet and Tandem in 2027 and a MiniMed-exclusive version in 2027. If these clear, the sensor becomes part of closed-loop insulin management rather than a standalone monitor.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1970s

Home blood glucose meters replace urine testing (late 1970s)

Before portable meters, patients tested urine at home, which lagged blood glucose by hours and missed rapid swings. Devices like the Ames Glucometer (1978) gave immediate blood readings for the first time.

Then

Point-of-care glucose testing transformed daily diabetes management within a decade.

Now

The test-strip and meter infrastructure CGMs later replaced was built in this era.

Why this matters now

Libre Duo does for ketones what home meters did for glucose: replaces lagging, one-off tests with immediate continuous data.

2005-2007

First continuous glucose monitors approved (2005-2007)

Medtronic's Guardian RT (2005) and DexCom's STS (2006) were the first wearable glucose sensors to stream readings continuously instead of at discrete moments. Early CGMs were expensive, imprecise, and rarely covered.

Then

Adoption was slow for more than a decade as accuracy and coverage improved.

Now

CGM trend data eventually enabled automated insulin delivery systems, approved starting in the late 2010s.

Why this matters now

Libre Duo extends the same continuous-data logic to ketones, and it rides the coverage and AID infrastructure CGMs built—so adoption could be faster this time.

Early 2000s

Fingerstick blood ketone meters (early 2000s)

Before Libre Duo, home ketone testing meant urine strips (available since the 1960s) or fingerstick blood meters like Abbott's Precision Xtra. Blood meters were more accurate, but both gave a single snapshot with no trend.

Then

DKA is often detected only after symptoms appear, because patients have no reason to test until they feel unwell.

Now

Point-in-time tests cannot distinguish rising from falling ketones, limiting their warning value.

Why this matters now

Libre Duo's trend data and alerts target the core limitation of existing ketone tests, which is why the FDA created a new device category for it.

Sources

(13)
+7
US Food and Drug Administration Abbott Media Room PR Newswire MedTech Dive Pharmacy Times Medscape UPI Nova Pharma News US FDA (GovDelivery) Reuters (syndicated) TechRepublic Breakthrough T1D JAMA