FreeStyle Libre 2 Formulary Kit

The FreeStyle Libre 2 system is a continuous glucose monitoring (CGM) device with real-time alarms, indicated for individuals aged 4 and older living with diabetes. It is part of the FreeStyle Libre portfolio, recognized as the #1 CGM in the US and worldwide. The system offers unsurpassed 14-day accuracy for adults and children, real-time alarms every minute, and is an easy-to-apply integrated CGM (iCGM) requiring no in-person patient training.

This Formulary Kit contains product information, clinical guidelines, clinical highlights, digital health tools, pricing information, prescribing information, and resources.

System Components

The FreeStyle Libre 2 system consists of two primary components: a compatible smartphone or handheld reader, and a disposable sensor worn on the body. Users scan the sensor wirelessly with their smartphone or reader to view glucose readings. The reader is exclusively compatible with FreeStyle Libre 2 sensors.

FreeStyle Libre 2 Sensor

The sensor measures and stores glucose readings while worn. It is applied to the back of the upper arm using a sensor applicator. A small, flexible tip is inserted just under the skin. The sensor can be worn for up to 14 days.

FreeStyle Libre 2 App

The FreeStyle Libre 2 app offers functionalities similar to the reader, allowing users to start a sensor, receive glucose alarms, obtain glucose readings by scanning the sensor, and store glucose history and notes. The app is available for iOS from the App Store and for Android from the Google Play Store.

FreeStyle Libre 2 Reader

The reader retrieves glucose readings from sensor scans and can issue glucose alarms. It is a handheld, lightweight device with a backlit color touchscreen. The reader stores approximately 90 days of glucose history and notes about activities like insulin intake, meals, and exercise, which can help users understand how these affect their glucose levels. It also includes a built-in meter for blood glucose testing, requiring separate purchase of FreeStyle Precision Neo blood glucose test strips, control solution, a lancing device, and lancets.

Alarms

The FreeStyle Libre 2 system provides real-time glucose alarms that trigger every minute. These alarms are enabled by default and include:

Optional, low glucose alarm: Notifies when glucose falls below a set level (60-100 mg/dL).
Optional, high glucose alarm: Notifies when glucose rises above a set level (120-400 mg/dL).
Optional, signal loss alarm: Alerts when the sensor is not communicating with the reader, indicating that glucose alarms may not be received.

The FreeStyle Libre 2 app also features a mandatory Urgent Low Glucose Alarm for glucose values below 55 mg/dL.

Accuracy

The FreeStyle Libre 2 system demonstrates unsurpassed 14-day accuracy for adults and children (ages 4 and older). Accuracy is validated by comparing system glucose measurements with Yellow Springs Instrument (YSI) analyzer blood glucose values. The system achieves high accuracy rates, with a Mean Absolute Relative Difference (MARD) of 9.2% for adults and 9.7% for children (ages 6-17) when compared to YSI reference values.

Subject group	Number of CGM reference pairs	Number of subjects	Percent within ±20% / ±20 mg/dL	Percent within ±20% / ±20 mg/dL on day 1	Percent within ±20% / ±20 mg/dL in first 12 hours	MARD (%)
Adults	18735	144	92.4	87.5	81.7	9.2
Children (age 6-17)	6546	129	91.6	84.1	80.3	9.7
Children (age 4-5)	341	8	85.9	87.9	90.9	11.8

Digital Health Tools

FreeStyle Libre 2 App (for patients)

Designed for individuals with diabetes, this app facilitates routine glucose monitoring via smartphone and the FreeStyle Libre 2 sensor. It is compatible with specific mobile devices and operating systems. Users can access glucose data and receive optional real-time high and low glucose alarms. The app is not compatible with FreeStyle Libre 14 day sensors.

LibreLinkUp App (for caregivers)

This app is for family, friends, and caregivers of patients using the FreeStyle Libre 2 app. It allows users to monitor glucose readings from connected individuals (up to 20 connections) when the patient scans their sensor and alarms are enabled.

LibreView Desktop Application (for healthcare professionals and patients)

LibreView is a secure, cloud-based data management system that is HIPAA compliant. It provides access to glucose data anytime, compiling it into easy-to-read reports, patterns, and trends. LibreView assists both patients and healthcare professionals in managing diabetes effectively.

Clinical Guidelines for the Use of CGM

American Diabetes Association (ADA)

The ADA's 2023 Standards of Care in Diabetes recommend CGM for all insulin-using patients, with device selection based on individual circumstances. CGM can aid in medical nutrition therapy, physical activity, hypoglycemia prevention, and medication adjustment. The ADA advocates for uninterrupted third-party payer access to CGM.

American Association of Clinical Endocrinology (AACE)

AACE recommendations (2022, 2023) highlight CGM as a preferred tool for lifestyle intervention and glucose monitoring. CGM is recommended for all insulin-using patients and those at risk for hypoglycemia, and highly recommended for all patients to achieve glycemic goals safely. CGM metrics like Glucose Variability (GV) and Time in Range (TIR) can serve as surrogates for HbA1c.

CGM Metrics: Recommendations from ADA and AACE

The ADA and AACE recommend using %TIR (Time in Range) and %TBR (Time Below Range) to assess glycemic control and adjust therapy, focusing on reducing %TBR. They also advise clinicians to use judgment with HbA1c and incorporate CGM metrics like GV and TIR for a comprehensive assessment of glycemic control.

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

Reduced HbA1c: Observed reductions across multiple patient groups, including T1D/T2D, children, and adolescents.
Increased Time in Range (TIR): Significant increases in TIR observed in T1D and T2D patients.
Reduced number of hypoglycemic events: Notable decreases in hypoglycemic events for T1D and T2D patients.
Reduced resource utilization: Significant reductions in diabetes-related hospital admissions and acute diabetes events for T1D and T2D patients.

Pricing Information

FreeStyle Libre 2 System

	Reader Kit	Sensor Kit
SKU #	71953-01	71992-01
Package Size	1	1
Unit Price	$70.00	$64.22
NRC	57599-0803-00	57599-0800-00
UPC	357599803001	357599800000
Unit pkg. weight	0.865 lb	0.214 lb
Storage temperature	-4°F to 140°F (-20°C to 60°C)	39°F to 77°F (4°C to 25°C)
Storage humidity	10% to 90%	10% to 90%
Contains battery	Yes	Yes

Prescribing Information

1 Reader

Per year (NRC# 57599-0803-00). No refills.

2 Sensors

28-day supply, filled monthly (NRC# 57599-0800-00). Refills: PRN or 12 fills annually.

How to get the FreeStyle Libre 2 App

Members can download the FreeStyle Libre 2 app at no cost to their compatible smartphone once they receive their prescription for the FreeStyle Libre 2 system.

Learn More

Payer Support: Sign up at Payer.FreeStyle.Abbott for payer support, latest clinical evidence, and to connect with an account manager.
Provider Resources: Visit FreeStyleProvider.Abbott for provider support, prescribing information, and practice resources.
Member Support: Access member support, patient stories, and getting started information at FreeStyle.Abbott.

Important Safety Information

FreeStyle Libre 14 day system: Failure to use as instructed may lead to missing severe glucose events or incorrect treatment decisions, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention or contact Abbott at 855-632-8658 or https://www.FreeStyle.abbott/us-en/safety-information.html for safety information.

FreeStyle Libre 2 system: Failure to use as instructed may lead to missing severe glucose events or incorrect treatment decisions, resulting in 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 or contact Abbott at 855-632-8658 or https://www.FreeStyle.abbott/us-en/safety-information.html for safety information.

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

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