FDA/CDC

FDA clears app for FreeStyle Libre 2 glucose monitor


 

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

Recommended Reading

FDA OKs spinal cord stimulation for diabetic neuropathy pain
MDedge Internal Medicine
‘Wild West’ and weak evidence for weight-loss supplements
MDedge Internal Medicine
Call to Action: Multidisciplinary panel urges coordinated care for ‘NASH epidemic’
MDedge Internal Medicine
Diabetes duration linked to increasing heart failure risk
MDedge Internal Medicine
More on GRADE: Cognitive deficits linked to CV risk factors in T2D
MDedge Internal Medicine
FDA approves first interchangeable biosimilar insulin
MDedge Internal Medicine
ESC heart failure guideline to integrate bounty of new meds
MDedge Internal Medicine
‘Shocking’ early complications from teen-onset type 2 diabetes
MDedge Internal Medicine
Diabetes drug’s new weight-loss indication fuels cost-benefit debate
MDedge Internal Medicine
Certain gut bacteria tied to lower risk of diabetes
MDedge Internal Medicine