FDA godkänner kontinuerlig glukos plus ketonmätare

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.

Artikelns nyckelpunkter

FDA godkände den första kombinerade kontinuerliga glukos- + ketonmätaren.

Libre Duo övervakar interstitiellt glukos + ketoner varje minut i 10 dagar.

Godkänt för diabetes vid ålder ≥2 år;

Smartphone-länkade varningar för stigande nivåer.

Avsedd för patienter med ↑ DKA/ketosrisk, inklusive insulinanvändare + SGLT2-hämmare.

Godkännande baserat på >600 deltagare; noggrannhet visas under 10 dagars användning.

Vilka diabetespatienter har störst nytta av kontinuerlig ketonövervakning?
Hur jämför sig ketonövervakningens noggrannhet med blodketontest?
Vilka bevis stöder kontinuerlig ketonövervakning för DKA-förebyggande?

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.

From FDA

Nyhetsinfo

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