CGM = continuous glucose monitoring
CGM = continuous glucose monitoring
Features |
||
|---|---|---|
 Sensor size |
Smaller than two stacked pennies1 |
Same thickness as two stacked quarters |
 Application |
Easy to apply1 using a 1-piece applicator |
Easy to apply (no in-person patient training |
 Cost |
Less than $40 per month for most covered |
Less than $40 per month for most covered |
 Sensor lifespan |
14 days |
14 days |
 Glucose reading |
Every 1 minute5 (by streaming)
|
Every 1 minute4 (by scanning)
|
 Alarms/Alerts |
Most are optional¶ |
Most are optional# |
 App |
FreeStyle Libre 3 app**
|
FreeStyle Libre 2 app**
|
 Sensor memory storage |
14 days5
|
8 hours4
|
 Sensor warm-up time |
1 hour
|
1 hour
|
 Calibration |
Not required5 |
Not required4 |
 Indication |
Indicated for: |
Indicated for: |
FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes ages 4 and older.
Abbott provides this information as a courtesy, it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.
Medicare coverage is available for FreeStyle Libre systems if their respective readers are used to review glucose data on some days every month. Medicare and other third-party payor criteria apply.
* Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
† Based on a comparison of list prices of the FreeStyle Libre personal CGM systems versus competitors’ CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
‡ Data from these studies were collected with the outside US version of FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional, real-time glucose alarms. Therefore, the study data is applicable to both products.
§ Based on prescription claims for commercially insured patients using the FreeStyle Libre personal CGM systems. Does not include Medicare, Medicaid, uninsured, and other federal or state healthcare program patients. The actual amount a patient pays may vary. The FreeStyle Libre 3 system requires a prescription.
ǁ Based on prescription claims for commercially insured patients using the FreeStyle Libre 2 system. Does not include Medicare, Medicaid, uninsured, and other federal or state healthcare program patients. The actual amount a patient pays may vary. The FreeStyle Libre 2 system requires a prescription.
¶ Notifications will only be received when alarms are turned on and the sensor is within 33 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 3 User’s Manual for more information.
# Notifications will only be received when alarms are turned on and the sensor is within 20 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 2 User’s Manual for more information.
** The FreeStyle Libre 2 or 3 apps are only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the apps. Use of the apps may require registration with LibreView.
ADC-74100 v1.0
Important Safety Information
FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, 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 when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.
FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, 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 when appropriate or contact Abbott at 855‑632‑8658 or FreeStyleLibre.us for safety info.
FreeStyle Libre Pro: The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.
IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.
CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. Review all product information before use or contact Abbott Toll Free (855-632-5297) (or visit provider.myfreestyle.com) for detailed indications for use and safety information.
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ADC-45115 v18.0
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