FreeStyle Libre 2 Flash Glucose Monitoring System

K193371 · Abbott Diabetes Care, Inc. · QLG · Jun 12, 2020 · Clinical Chemistry

Device Facts

• Record ID: K193371
• Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: QLG · Clinical Chemistry
• Decision Date: Jun 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

Device Story

System consists of disposable, subcutaneously implanted glucose oxidase sensor and handheld Reader; sensor measures interstitial fluid glucose via amperometric electrochemical reaction; transmits data via Bluetooth Low Energy (BLE) and RFID. User initiates scan to view current glucose, trend arrows, and history on Reader. Reader provides real-time alarms for high/low glucose and signal loss. Used in home setting by patients; healthcare providers use logged data for therapy adjustments. System replaces fingerstick testing for treatment decisions but requires manual confirmation if symptoms mismatch readings or during first 12 hours of sensor wear. Benefits include continuous monitoring, trend detection, and reduced fingersticks. Must not be used with automated insulin dosing (AID) systems.

Clinical Evidence

Two prospective clinical studies (adult n=146; pediatric n=139) evaluated accuracy against YSI laboratory reference (or SMBG for ages 4-5). Primary endpoints included MARD and percentage of readings within 15/15%, 20/20%, and 40/40% of reference. Adult MARD was 9.9% (beginning) to 9.1% (end). Pediatric MARD was 10.7% (beginning) to 10.2% (end). Concurrence analysis and alarm performance (True/False/Detection rates) were reported across glucose ranges. Bench testing included biocompatibility, sterilization, shelf-life, and electromagnetic compatibility.

Technological Characteristics

Electrochemical sensor (glucose oxidase); interstitial fluid sample; factory calibrated. Sensor: 14-day wear, BLE/RFID communication, 8-hour memory. Reader: Handheld, built-in strip port, BLE/RFID. Materials: Biocompatible sensor tail, adhesive pad, casing. Sterilization: E-beam. Connectivity: Wireless to connected devices. Software: Embedded firmware, rule-based processing.

Indications for Use

Indicated for management of diabetes in persons age 4 and older. Contraindicated for use with automated insulin dosing (AID) systems, including closed loop, hybrid closed loop, and insulin suspend systems. Not for use in pregnant individuals, patients on dialysis, or critically ill patients.

Regulatory Classification

Identification

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) Robust clinical data demonstrating the accuracy of the device in the intended use population. (ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order ( *e.g.,* an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device. (iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period. (v) Clinical study results in the adult population must meet the following performance requirements: (A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent. (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent. (C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent. (D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent. (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent. (H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL. (I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL. (J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements. (K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements. (vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate. (vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use. (2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data. (3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section. (4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications. (5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period. (6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy. (7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites ( *e.g.,* abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL. (ii) A description of the accuracy of positive and negative rate of change data. (iii) A description of the frequency and duration of gaps in sensor data. (iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable. (v) A description of the observed duration of iCGM life for the device.

Predicate Devices

• Dexcom G6 Continuous Glucose Monitoring System (DEN170088)

Reference Devices

• FreeStyle Precision Neo Blood Glucose test strips (K171941)

Submission Summary (Full Text)

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June 12, 2020

Abbott Diabetes Care Inc. Naveen Thuramalla DVP, Quality Assurance and Regulatory Affairs 1360 South Loop Road Alameda, CA 94502

Re: K193371

Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QLG, NBW Dated: May 8, 2020 Received: May 11, 2020

Dear Naveen Thuramalla:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193371

Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System

#### Indications for Use (Describe)

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font. The logo is clean and professional, representing Abbott's presence in the diabetes care industry.

# 1. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K193371

#### 1.1 Submitter:

Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502

Contact: Naveen Thuramalla Title: DVP Quality Assurance and Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

#### 1.2 Device Names and Classification:

| Name of Device: | FreeStyle Libre 2 Flash Glucose Monitoring System |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory<br>Calibrated, Not for use with automated insulin delivery systems |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QLG, NBW |
| Review Panel: | Clinical Chemistry |

#### 1.3 Predicate Device

Dexcom G6 Continuous Glucose Monitoring System, DEN170088 Predicate Device:

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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

#### 1.4 Indications for Use:

## Indications for Use:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

#### Contraindications

- Automated Insulin Delivery: The System must not be used with automated insulin ● dosing (AID) systems, including closed loop and insulin suspend systems.
- MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance ● Imaging (MRI). Computed Tomography (CT) scan. or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

#### 1.5 Device Description

The FreeStyle Libre 2 Flash Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 2 System or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The FreeStyle Libre 2 System consists of two primary components: a sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User-initiated RFID scanning provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may use the sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alerts and alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized letter "a" on the left, followed by the text "Abbott" in bold, black font on the top line, and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.

## FreeStyle Libre 2 Sensor

- The Sensor is single use and disposable. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (sterile device), which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion. The Sensor continuously measures glucose concentration in interstitial fluid every minute and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
## FreeStyle Libre 2 Reader

- The Reader is a small handheld device that uses RFID communication to start new ● sensors, to scan sensors to display and record data and uses BLE communication to issue alarms that notify the user when glucose values pass high or low thresholds, when enabled. The Reader also includes a built-in strip port with blood glucose functionality as a convenience for users (which is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
The FreeStyle Libre 2 System is an interoperable connected device that can communicate glucose readings and other information wirelessly and from interoperable electronic interfaces. This system is not compatible with AID systems, including insulin suspend systems.

#### Test Principle 1.5.1

The FreeStyle Libre 2 Flash Glucose Monitoring System uses an electrochemical sensor to monitor glucose levels in the interstitial fluid (ISF). The sensor is held in place with an adhesive pad and incorporates both the subcutaneously implanted sensor and associated electronics. The sensor uses a glucose oxidase enzyme to oxidize glucose and transfer electrons to a metal electrode, producing a current. The strength of the current is proportional to the amount of glucose present in the subcutaneous space. The FreeStyle Libre 2 System converts the electrical current signal to a glucose value (in mg/dL) for display to the user on the handheld Reader.

#### Substantial Equivalence 1.6

## A. Predicate Device Name:

Dexcom G6 Continuous Glucose Monitoring System

## B. Predicate 510(k) Number(s):

DEN170088

## C. Comparison with Predicate:

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The similarities and differences between the FreeStyle Libre 2 Flash Glucose Monitoring System and the predicate device, Dexcom G6 (DEN170088) are highlighted in the tables below:

| Similarities | | |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | FreeStyle Libre 2 Flash<br>Glucose Monitoring System | Dexcom G6 Continuous<br>Glucose Monitoring System<br>(DEN170088) |
| Indications for Use | The FreeStyle Libre 2 Flash<br>Glucose Monitoring System is a<br>continuous glucose monitoring<br>(CGM) device with real time<br>alarms capability indicated for<br>the management of diabetes in<br>persons age 4 and older. It is<br>intended to replace blood<br>glucose testing for diabetes<br>treatment decisions, unless<br>otherwise indicated.<br>The System also detects trends<br>and tracks patterns and aids in<br>the detection of episodes of<br>hyperglycemia and<br>hypoglycemia, facilitating both<br>acute and long-term therapy<br>adjustments. Interpretation of<br>the System readings should be<br>based on the glucose trends and<br>several sequential readings over<br>time.<br>The System is also intended to<br>autonomously communicate with digitally connected<br>devices. The System can be<br>used alone or in conjunction<br>with these digitally connected<br>devices where the user manually<br>controls actions for therapy<br>decisions. | The Dexcom G6 Continuous<br>Glucose Monitoring System<br>(Dexcom G6 System) is a real<br>time, continuous glucose<br>monitoring device indicated for<br>the management of diabetes in<br>persons age 2 years and older.<br>The Dexcom G6 System is<br>intended to replace fingerstick<br>blood glucose testing for<br>diabetes treatment decisions.<br>Interpretation of the Dexcom<br>G6 System results should be<br>based on the glucose trends and<br>several sequential readings over<br>time. The Dexcom G6 System<br>also aids in the detection of<br>episodes of hyperglycemia and<br>hypoglycemia, facilitating both<br>acute and long-term therapy<br>adjustments.<br>The Dexcom G6 System is also<br>intended to autonomously<br>communicate with digitally connected devices, including<br>automated insulin dosing (AID)<br>systems. The Dexcom G6<br>System can be used alone or in<br>conjunction with these digitally<br>connected medical devices for<br>the purpose of managing<br>diabetes. |
| Device Type | Integrated CGM | Same |
| Principle of Operation | Amperometric measurement of<br>current proportional to glucose<br>concentration in interstitial fluid<br>via glucose oxidase chemical<br>reaction | Same |
| Sample Type | Interstitial fluid | Same |
| Similarities | | |
| Item | FreeStyle Libre 2 Flash<br>Glucose Monitoring System | Dexcom G6 Continuous<br>Glucose Monitoring System<br>(DEN170088) |
| Enzyme | Glucose oxidase | Same |
| Clinical Application | Management of diabetes<br>mellitus | Same |
| Clinical Setting/Sites of Use | Home use | Same |
| Data Displayed | Current glucose value, current<br>glucose trend, graph with recent<br>glucose history, user entered<br>events | Same |
| Differences | | |
| Item | FreeStyle Libre 2 Flash<br>Glucose Monitoring System | Dexcom G6 Continuous Glucose<br>Monitoring System<br>(DEN170088) |
| Situations where fingerstick<br>test is required to confirm<br>sensor reading (adjunctive<br>use) | The user's symptoms do<br>not match the glucose<br>values displayed by the<br>device.The device does not show<br> | The user's symptoms do not<br>match the glucose values<br>displayed by the device.The device does not show a<br>glucose value or a trend<br>arrow. |
| Compatibility with connected<br>devices | Compatible with digitally<br>connected devices where the<br>user manually controls<br>actions for therapy decisions | Compatible with digitally<br>connected devices, including<br>automated insulin dosing (AID)<br>systems |
| Sensor Calibration | Factory calibrated | Factory calibrated, with optional<br>user calibration |
| Glucose reading update<br>interval | Every 1 minute | Every 5 minutes |
| Wireless communications<br>protocol | Near Field Communication<br>(NFC): (13.56 MHz RFID)<br>Bluetooth Low Energy (BLE)<br>4.0 | Bluetooth Core Specification v4.0 |
| Communications range | 20 feet unobstructed | 20 feet unobstructed |
| Glucose Trend Arrow | ↑, > +2 mg/dL/min<br>↗, +1 and +2 mg/dL/min<br>→, -1 to +1 mg/dL/min<br>↘, -2 to -1 mg/dL/min<br>↓, < -2 mg/dL/min | ↑↑, > +3mg/dL/min<br>↑, +2 to +3 mg/dL/min<br>↗, +1 to +2mg/dL/min<br>→, -1 to +1 mg/dL/min<br>↘, -2 to -1 mg/dL/min<br>↓, -3 to -2 mg/dL/min<br>↓↓, < -3mg/dL/min |
| Anatomical sensor wear<br>locations | Back of the upper arm | Abdomen (age 2+ years) or upper<br>buttocks (age 2-17 years) |
| Sensor warm up time | 1 hour | 2 hours |
| Sensor life | Up to 14 days (automatic<br>sensor shut off) | Up to 10 days (automatic sensor<br>shut off) |
| Storage Conditions<br>(Sensor) | Temperature: 36°F – 82°F<br>Humidity: 10-90% RH | Temperature: 36°F – 86°F<br>Humidity: 10%-90% RH |
| Intended Use Population | Persons with diabetes age 4<br>and above | Persons with diabetes age 2+<br>years |
| Alerts and Alarms | Low Glucose Alarm, High<br>Glucose Alarm, Signal Loss<br>Alarm, Scan Error, Sensor<br>Error | Urgent low glucose (55<br>mg/dL), predictable low<br>glucose, threshold low<br>glucose, threshold high |
| Differences | | |
| Item | FreeStyle Libre 2 Flash<br>Glucose Monitoring System | Dexcom G6 Continuous Glucose<br>Monitoring System<br>(DEN170088) |
| | For Low and High Glucose<br>alarms, a user-initiated action<br>is required to see glucose<br>reading. | glucose, rising rate of<br>glucose, falling rate of<br>glucose, signal loss, sensor<br>failure, transmitter failure. |
| Primary Display Device | Reader | Hardware receiver or mobile app<br>installed on compatible smart<br>device…