FreeStyle Libre 3 System: Formulary Kit

Introduction

This document provides information on the Abbott FreeStyle Libre 3 system, a next-generation real-time continuous glucose monitoring (CGM) device designed for people with diabetes aged 4 and older. It offers real-time glucose readings and alarms streamed directly to a smartphone.

Key Features:

• Real-time glucose readings streamed every minute to smartphones.
• 14-day sensor wear with 7.9% overall MARD accuracy (Adults and Pediatrics).
• Easy, one-piece sensor application requiring no in-person training.
• The world's smallest, thinnest, and most discreet sensor.

The FreeStyle Libre 3 system is indicated for use in people with diabetes age 4 and older. Notifications are received when alarms are enabled and the sensor is within 33 feet of the reading device. The FreeStyle Libre 3 app requires registration with LibreView and is compatible with certain mobile devices and operating systems.

System Components

The FreeStyle Libre 3 system helps build a complete glycemic picture for informed disease management. It consists of:

FreeStyle Libre 3 Sensor:

The smallest CGM sensor on the market, designed for discretion and flexibility. It streams glucose readings to a smartphone, offers 14-day wear and data storage, and features simplified sensor application. It stores retrospective glucose data over the full 14-day wear period.

FreeStyle Libre 3 App:

Designed for people with diabetes, enabling routine glucose monitoring via a compatible smartphone and sensor. The app offers 3 optional alarms (low glucose, high glucose, signal loss) and 1 mandatory urgent low alarm (set at 55 mg/dL).

Alarms

The system provides real-time glucose alarms with readings streamed every minute. Users can configure three optional alarms (low glucose, high glucose, signal loss) and benefit from one mandatory urgent low glucose alarm (set at 55 mg/dL).

• Optional, low glucose alarm: Notifies when glucose is BELOW a set level (60-100 mg/dL).
• Optional, high glucose alarm: Notifies when glucose is ABOVE a set level (120-400 mg/dL).
• Optional, signal loss alarm: Notifies when the sensor is not communicating with the smartphone.

The FreeStyle Libre 3 app includes a mandatory Urgent Low Glucose Alarm for values below 55 mg/dL.

Accuracy

The FreeStyle Libre 3 system demonstrates accuracy comparable to established benchmarks:

Product Comparison: FreeStyle Libre 2 vs. FreeStyle Libre 3

Digital Health Tools

The FreeStyle Libre ecosystem includes digital tools to support diabetes management:

FreeStyle Libre 3 App (for the patient):

Provides real-time glucose readings to a smartphone, enabling faster action and timely treatment decisions. Features helpful reports, easy-to-read charts, and the ability to share readings with up to 20 care team members. Not compatible with the FreeStyle Libre 2 system.

LibreLinkUp App (for caregivers):

Allows family, friends, and other caregivers to follow up to 20 connections using the FreeStyle Libre 3 app. Users receive real-time glucose information and can customize alarms.

LibreView Desktop Application (for healthcare professionals and patients):

A secure, cloud-based data management system that is HIPAA compliant. It allows access to data at any time, compiling streamed glucose data into easy-to-read reports, patterns, and trends to assist with diabetes management.

Clinical Guidelines for CGM Use

Several clinical organizations, including the American Diabetes Association (ADA) and the American Association of Clinical Endocrinology (AACE), have published guidelines for CGM use in diabetes management.

American Diabetes Association (ADA) Recommendations:

• CGM should be offered for diabetes management in adults and youth (type 1 or type 2) on multiple daily injections or continuous subcutaneous insulin infusion, who can use devices safely.
• CGM can be used for diabetes management in adults with diabetes on basal insulin who can use devices safely.
• Device selection should be individualized based on a person's needs, desires, skill level, and availability.
• Users of CGM, continuous subcutaneous insulin infusion, and/or automated insulin delivery should have continued access across third-party payers.

American Association of Clinical Endocrinology (AACE) Recommendations:

• CGMs are strongly recommended for all persons with diabetes treated with intensive insulin therapy (3+ injections/day or insulin pump).
• CGMs are recommended for individuals with problematic hypoglycemia (frequent/severe, nocturnal, or unawareness).

CGM Metrics:

Key metrics like %TIR (Time in Range) and %TBR (Time Below Range) are used for assessing glycemic control and adjusting therapy, with an emphasis on reducing %TBR. Time in range is associated with the risk of microvascular complications.

Clinical Outcomes Highlights

Use of the FreeStyle Libre family of personal CGMs is associated with significant clinical benefits:

Reduced HbA1c:

• 0.42%-0.59% HbA1c reduction observed in a meta-analysis of patients with T1D/T2D.
• 0.4% HbA1c reduction among children and teenagers (4-17 years) with T1D.
• 0.4% HbA1c reduction among patients with T1D.
• 0.52%-1.6% HbA1c reduction among people with T2D.

Increased Time in Range (TIR):

• 1 hour/day increased TIR observed among patients with T1D.
• 2.36 hours/day increased TIR observed among patients with T2D.

Reduced Number of Hypoglycemic Events:

• 26% reduction in hypoglycemic events among patients with T1D.
• 28% reduction in hypoglycemic events among patients with T2D on intensive insulin regimens.

Reduced Resource Utilization:

• 85% reduction in diabetes-related hospital admission rates among patients with T1D.
• 61% reduction in acute diabetes events among patients with T2D on intensive insulin regimens.
• 32% reduction in all-cause hospitalization rates among patients with T2D on intensive insulin regimens.
• 37% reduction in acute diabetes event rates among patients with T2D on basal insulin.
• 25% reduction in acute diabetes event rates among patients with T2D on non-insulin therapies.

Pricing Information

The FreeStyle Libre 3 system is available as the FreeStyle Libre 3 Sensor Kit.

Prescribing Information

A typical prescription for the FreeStyle Libre 3 system includes 2 sensors, providing a 28-day supply, filled monthly (NDC# 57599-0818-00). Refills are available PRN or up to 12 fills annually.

How to get the FreeStyle Libre 3 App:

Once a member receives their prescription, they can download the FreeStyle Libre 3 app at no cost to their compatible smartphone from the App Store or Google Play.

Resources

Abbott provides various resources for different user groups:

For Payers:

• Sign up to learn more at Payer.FreeStyle.Abbott
• Support for Payers
• Latest Clinical Evidence
• Connect with an Account Manager

For Providers:

• Visit FreeStyleProvider.com
• Support for Providers
• How to Prescribe
• Practice Resources

For Members:

• Visit FreeStyle.Abbott
• Support for Members
• Patient Stories
• Getting Started and MyFreeStyle Program

Important Safety Information

FreeStyle Libre 14 day system: Failure to use as instructed may result in missing a severe low or high glucose event and/or making an incorrect treatment decision, leading to injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or www.FreeStyle.abbott/us-en/safety-information.html for safety information.

FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use as instructed may result in missing a severe low or high glucose event or making an incorrect treatment decision, leading to injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or www.FreeStyle.abbott/us-en/safety-information.html for safety information.

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners.