Dexcom G7 Continuous Glucose Monitoring System
Device Facts
| Record ID | K213919 |
|---|---|
| Device Name | Dexcom G7 Continuous Glucose Monitoring System |
| Applicant | Dexcom, Inc. |
| Product Code | QBJ · Clinical Chemistry |
| Decision Date | Dec 7, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1355 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
Device Story
Interoperable CGM system; measures interstitial fluid glucose via enzymatic electrochemical reaction (glucose oxidase). Sensor probe generates electrical current proportional to glucose concentration; transmitter converts signal via algorithm to glucose value (mg/dL). Reports data every 5 minutes to mobile app or receiver. Used by patients (2+ years) for diabetes management; replaces fingerstick testing; supports AID system integration. Provides real-time glucose trends, alerts for hypo/hyperglycemia, and visual displays. Enables therapy adjustments by patients/clinicians. Wearable sensor (up to 10 days + 12-hour grace period) worn on arm (or buttocks for 2-6 years).
Clinical Evidence
Two prospective clinical studies (N=482 total). Study 1 evaluated safety/effectiveness; Study 2 evaluated data transmission reliability. Accuracy compared to YSI 2300 STAT Plus analyzer. Overall MARD 9.9% (beginning) to 7.2% (end). 93.5% of readings within 20% of comparator. Hypoglycemic/hyperglycemic alert performance and sensor survival rates provided. Bench testing included biocompatibility, sterilization, and electromagnetic compatibility.
Technological Characteristics
Amperometric sensor using glucose oxidase; interstitial fluid sample; BLE v4.2 connectivity; 10-day wear life with 12-hour grace period; 30-minute warm-up; Ethylene Oxide (EO) sterilization; single-use transmitter; 40-400 mg/dL measuring range.
Indications for Use
Indicated for management of diabetes in persons 2 years and older. Intended to replace fingerstick blood glucose testing for treatment decisions and aid in detection of hyperglycemia/hypoglycemia episodes.
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 (CGM) System (K201328)
Related Devices
- K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) System · Dexcom, Inc. · May 15, 2023
- K234133 — Dexcom G7 Continuous Glucose Monitoring System · Dexcom, Inc. · Feb 26, 2024
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K213919
B Applicant
Dexcom, Inc.
C Proprietary and Established Names
Dexcom G7 Continuous Glucose Monitoring (CGM) System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBJ | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitoring System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Glucose in Interstitial Fluid
C Type of Test:
Quantitative, amperometric assay (Glucose Oxidase)
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.
The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
- Users of the Dexcom G7 Continuous Glucose Monitoring System can take a standard dose of acetaminophen (up to 1 gram every 6 hours in adults) and still use the Dexcom G7 System readings. Sensor glucose readings will be falsely higher if the user is taking more than a standard acetaminophen dose.
- Sensor glucose readings will also be falsely higher if the user is taking hydroxyurea. Users should not use the Dexcom G7 System for diabetes treatment decisions if they are taking hydroxyurea.
- Don't wear any Dexcom G7 CGM System component during magnetic resonance imaging (MRI) or high-frequency electrical heat (diathermy) treatment. However, it's safe to have a CT scan if you keep the sensor out of the scanned area and cover the sensor with a lead apron during the scan.
- Don't ignore low/high symptoms: Use BG meter to make treatment decisions when the sensor readings don't match the user's low/high symptoms. If needed, seek immediate medical attention.
- Use BG meter to make treatment decisions when the Dexcom G7 CGM System doesn't show both a number and trend arrow as well as during the 30-minute sensor warmup period.
- Don't use if on dialysis or critically ill: The Dexcom G7 CGM System performance hasn't been evaluated in these populations and sensor readings may be inaccurate.
- Don't ignore broken or detached sensor wires. If this happens, contact 24/7 technical support.
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- Insert only in the arm or buttocks: Don't wear it on other sites as it may not work as expected.
- Store sensors at room temperature or in the refrigerator, between 36° F and 86° F, but not in the freezer.
- Check settings: Make sure the smart device volume is turned up, not muted, and the speaker works. When a headphone is connected, alerts will only sound through the headphone, not on the smart device speaker.
- Make sure Bluetooth is on. Otherwise, the user won't get readings or alerts.
- Make sure the smart device settings follow Dexcom's recommended settings. Certain phone settings such as Android's Digital Wellbeing and Apple's Screen Time may prevent notifications if enabled.
- Allow Dexcom G7 CGM System app notifications to show on Lock screen. This will ensure the user can receive Dexcom notifications and allow the user to see notifications without unlocking the phone.
- Android users must allow Location Permission, Do Not Disturb Access, and Notifications to use the app.
- Apple users must allow Critical Alerts to use the app.
- Battery: Keep the battery charged.
- Quiet Mode (Vibrate): When this setting is enabled all System alerts will vibrate. The Urgent Low Glucose and technical alerts will still escalate to sound if not acknowledged.
- Quiet Mode (Silence All): When this setting is enabled, all System alerts will be silent. The user won't receive sound or vibration for any alerts. The user will still receive visual alerts on the display device. (Exceptions: App Stopped alerts will still sound.) Check the display device frequently to avoid missing a low/high event.
- Before upgrading the smart device or its operating system, check dexcom.com/compatibility. Always update manually and verify correct device settings afterward.
- Let the date and time on the smart device automatically update when traveling across time zones or switch between standard and daylight saving times. Don't manually change the smart device time because the user may not get readings or alerts and it may make the time on the trend screen wrong.
Use electrical equipment as directed:
Portable radio frequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches to any part of the Dexcom G7 CGM System including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Use of this equipment adjacent to, or stacked with, other equipment should be avoided because it could result in improper operation.
Not using supplied USB charger and cable may cause the receiver battery to not charge. Don't use if the supplied USB charger or cable is damaged. Store supplied USB charger and cable safely. Misuse of the USB cable can be a strangulation risk.
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D Special Instrument Requirements:
Not applicable.
IV Device/System Characteristics:
A Device Description:
The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this value available to the user. It consists of the following components:
- G7 Glucose Sensing Subsystem (GSS)
- G7 Mobile Applications Subsystem (MAS)
- G7 Receiver Subsystem (RVS)
To achieve the intended functions and performance of the G7 System, one GSS and one receiving device (MAS or RVS) must be used together. The receiving device acts as the primary display device and the user may choose to use only the MAS or only the RVS as the sole display device; they may also choose to use both display devices simultaneously (MAS and RVS). The user must pair the receiving device(s) with each unique GSS to enable communication and start a sensor session. During an active session, the GSS reports new glucose data to a receiving device every 5-minutes. The receiving device then displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.
The Dexcom G7 System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces; including compatible AID systems.
B Principle of Operation:
The Dexcom G7 Continuous Glucose Monitoring System detects glucose levels from the fluid just beneath the skin (interstitial fluid). The sensor probe continuously measures glucose concentration in the interstitial fluid via an enzymatic electrochemical reaction using glucose oxidase. The enzyme, glucose oxidase, catalyzes the oxidation of glucose and produces hydrogen peroxide. The production of hydrogen peroxide generates an electrical current that is proportionate to the interstitial glucose concentration. The transmitter converts the signal using an algorithm to a glucose value read in mg/dL, which is then transmitted to the receiver/mobile application for the user to see and use accordingly.
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C Instrument Description Information:
1. Instrument Name:
Dexcom G7 Continuous Glucose Monitoring (CGM) System
2. Specimen Identification:
Not applicable.
3. Specimen Sampling and Handling:
Not applicable.
4. Calibration:
The G7 Continuous Glucose Monitoring System is factory calibrated and does not require a sensor code. User may enter optional calibration using fingerstick blood glucose values.
5. Quality Control:
Not applicable.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Dexcom G6 Continuous Glucose Monitoring (CGM) System
B Predicate 510(k) Number(s):
K201328
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K213919 | K201328 |
| --- | --- | --- |
| Device Trade Name | Dexcom G7 Continuous Glucose Monitoring System | Dexcom G6 Continuous Glucose Monitoring System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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 | Same |
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| Device & Predicate Device(s): | K213919 | K201328 |
| --- | --- | --- |
| | in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. | |
| Principle of Operation | Amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction. | Same |
| Sensor Calibration | Factory calibrated, optional manual calibration | Same |
| Primary Display Device | Mobile app installed on compatible smart device or Receiver | Same |
| Compatibility with connected devices | Compatible with digitally connected devices, including automated insulin dosing (AID) systems | Same |
| General Device Characteristic Differences | | |
| Sensor Probe Dimensions | 90° insertion angle | 45° insertion angle |
| Anatomical Wear Location | Arm (age 2+ years) or upper buttocks (age 2-6 years) | Abdomen (age 2+ years) or upper buttocks (age 2-17 years) |
| Sensor Warm Up Time | Within 30 minutes | 2 hours |
| Sensor Useful Life | Up to 10 days with 12 hour grace period (automatic sensor shut off) | Up to 10 days (automatic sensor shut off) |
| Transmitter Useful Life | Single Use (10.5 days) | Reusable (90 days) |
VI Standards/Guidance Documents Referenced:
1. ISO 14971:2007, Medical devices - Application of Risk Management to Medical Devices
2. IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
3. IEC 60601-1-11:2015, Medical Electrical Equipment – Part 1-11 – General requirements for basic safety and essential performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment
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4. ISO 14155: 2011, Clinical investigation of medical devices for human subjects – Good clinical practice
5. IEC 62366-1:2015, Medical Devices – Application of Usability Engineering to Medical Devices
6. ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a Risk Management Process
7. ISO 10993-2:2006, Biological Evaluation of medical devices – Part 2: Animal Welfare Requirements
8. ISO 10993-3: 2014 Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
9. ISO 10993 -5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro toxicity.
10. ISO 10993-6 :2016, Biological evaluation of Medical Devices - Part 6: Tests for local effects after implantation
11. ISO 10993-7:2008, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
12. ISO 10993-10:2010, Biological Evaluation of Medical Devices – Part 10: Tests for irritation and delayed-type hyper sensitivity
13. ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
14. ISO 10993-12:2012, Biological Evaluation of Medical Devices – Part 12: Sample preparation and reference materials
15. ISO 10993-17:2002, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
16. ISO 10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
17. ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: Requirements for Material, Sterile Barrier Systems, and Packaging Systems
18. ISO 11607-2:2019, Packaging for terminally sterilized Medical Devices – Part 2: Validation Requirements for forming, sealing and assembly processes
19. ISO 11737 -1:2018, Sterilization of Medical Devices - Microbiological Methods, Part 1 - Determination of a population of microorganisms on products
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20. ISO 11737-2:2018, Sterilization of Medical Devices - Microbiological Methods, Part 2 Tests of sterility performed in the definition, validation and maintenance of a sterilization process
21. ISO 15223-1:2016, Medical devices – Symbol to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
22. ISO 14644-1:2015, Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
23. ISO 14644-2:2015, Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
24. ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
25. ASTM F2503-20, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
26. ISO 23908:2011, Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
27. IEC 62133-2:2017, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems
28. IEC/TR 60601-4-2: 2016, Medical Electrical Equipment - PART 4-2: Guidance and Interpretation - Electromagnetic Immunity: Performance of Medical Electrical Equipment and Medical Electrical Systems
29. AIM 7351731: 2017-02-23, AIM Standard - Medical Electrical Equipment & System Electromagnetic Immunity Test for RFID Readers
30. IEEE/ANSI C63.27-2017, American National Standard for Evaluation of Wireless Coexistence
31. IEC 60417: 2002, Graphical symbols for use on equipment
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
1. Precision/Reproducibility:
iCGM performance was evaluated in clinical studies described below in section C(3). A subset of subjects wore two G7 CGMs at the same time (n=82). Precision was evaluated by
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comparing the glucose readings from the two systems worn on the same subject on the same location.
Precision by Insertion Site and Age
| | 18+ YO | 7-17 YO | 2-6 YO | |
| --- | --- | --- | --- | --- |
| | Arm | Arm | Arm | Upper Buttocks* |
| CGM-CGM Matched Pairs (n) | 50,542 | 22,345 | 2,611 | 4,245 |
| Number of Subjects (N) | 43 | 21 | 9 | 9 |
| Paired Absolute Difference (mg/dL) | 13.8 | 14.4 | 12.8 | 15.4 |
| Paired Absolute Relative Difference (%) | 8.9 | 9.3 | 6.1 | 9.7 |
| Coefficient of Variation (%) | 6.3 | 6.6 | 4.3 | 6.8 |
*Only pediatrics aged between 2-6 YO wore devices on the upper buttocks.
2. Linearity:
The reportable range for the System is 40 to 400 mg/dL. Data supporting this claimed measurement range was generated in the clinical study described in Section C(3) below.
3. Analytical Specificity/Interference:
Users of the Dexcom G7 Continuous Glucose Monitoring System can take a standard or maximum dose of acetaminophen (up to 1 gram every 6 hours in adults) and still use the Dexcom G7 System readings. Sensor glucose readings will be falsely higher if the user is taking more than a standard acetaminophen dose.
Sensor glucose readings will also be falsely higher if the user is taking hydroxyurea. Users should not use the Dexcom G7 System for diabetes treatment decisions if they are taking hydroxyurea.
4. Assay Reportable Range:
See Linearity section above.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The Dexcom GSS (sensor and transmitter) has a storage shelf-life of up to 9 months with the insert molded needle hub design and up to 6 months with the bonded needle hub design. Shelf life was evaluated at 35.6°-86°F and 10-90% relative humidity. Sensors should be stored at 36°-86°F and 10-90% relative humidity.
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6. Detection Limit:
If a glucose measurement is less than 40 mg/dL, the result is displayed by the system as LOW. If a glucose measurement exceeds 400 mg/dL, result is displayed as HIGH.
7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
Not applicable.
9. Carry-Over:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable. Accuracy is determined by comparing device values to an FDA cleared laboratory grade glucose analyzer (Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer) and referred to as the "comparator method" in Section C(3) below.
2. Matrix Comparison:
Not applicable. Interstitial fluid is the only indicated matrix.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Two prospective clinical studies were conducted to evaluate the Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7):
- Study 1 – a pivotal study conducted at 12 clinic sites in the United States to evaluate the safety and effectiveness of the Dexcom G7 CGM System. A total of 482 adult and pediatric subjects (ages 2 and older) were enrolled.
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- Study 2 – a pivotal study conducted at two clinic sites in the United States to evaluate the data transmission reliability of the Dexcom G7 CGM System. A total of 60 adult and pediatric subjects (ages 12 and older) were enrolled.
The G7 wearables (sensor, data-logging transmitter, and adhesive patch) worn in Study 1 logged the glucose data but did not transmit real-time glucose data to a display device. As such, Study 2 was conducted to characterize the reliability of the real-time communication between the G7 wearable and the G7 display devices.
Data from Study 1 are presented in the tables below.
iCGM Reading Accuracy to Comparator
Percent and Point Accuracy Between iCGM and Comparator by iCGM Glucose Range - ≥ 18 YO Arm (N=308)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 | 4,869 | 92.0 (90.0) | 99.5 (99.1) | --- | --- | -6.5 (-5.4) |
| 70-180 | 18,379 | --- | --- | 85.4 (83.8) | 99.5 (99.3) | -3.1 (-2.0) |
| >180 | 15,945 | --- | --- | 92.2 (91.1) | 99.9 (99.9) | 1.6 (2.8) |
Percent and Point Accuracy Between iCGM and Comparator by iCGM Glucose Range - Pediatrics 7-17 YO Arm (N=122)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 | 881 | 85.7 (79.9) | 96.8 (92.0) | --- | --- | -7.8 (-5.6) |
| 70-180 | 3,996 | --- | --- | 86.0 (82.1) | 99.6 (99.3) | -3.6 (-1.5) |
| >180 | 3,191 | --- | --- | 92.2 (89.4) | 100.0 (99.8) | 1.6 (3.9) |
Percent and Point Accuracy Between iCGM and Comparator by Comparator Glucose Range - ≥ 18 YO Arm (N=308)
| Comparator Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 | 5,262 | 93.4 (91.8) | 99.8 (99.2) | --- | --- | 1.2 (2.2) |
| 70-180 | 17,910 | --- | --- | 85.7 (84.2) | 99.5 (99.3) | -0.5 (0.5) |
| >180 | 16,021 | --- | --- | 91.9 (90.6) | 99.8 (99.7) | -3.9 (-2.5) |
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Percent and Point Accuracy Between iCGM and Comparator by Comparator Glucose Range - Pediatrics 7-17 YO Arm (N=122)
| Comparator Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 | 877 | 93.2 (90.2) | 100.0 (100.0) | --- | --- | -0.2 (1.9) |
| 70-180 | 3,936 | --- | --- | 87.2 (83.6) | 98.6 (97.4) | -1.2 (0.7) |
| >180 | 3,255 | --- | --- | 89.8 (86.5) | 99.9 (99.7) | -2.7 (-0.4) |
The G7 percent and point accuracy between iCGM and the comparator is equal to or better than that of the predicate G6 CGM System (K201328).
Percent of values within 20% of comparator method were calculated across the measuring range overall, and for pediatric and adult populations.
Percent of iCGM Within 20% of Comparator Glucose by Study Population and Wear Location (N=453)
| Patient Population/ Wear location | Matched Pairs (n) | Percent within 20% (95% LB) |
| --- | --- | --- |
| Overall (40-400 mg/dL) | | |
| Arm | 47,261 | 93.5 (92.7) |
| 18 years and up | | |
| Arm | 39,193 | 94.1 (93.3) |
| Pediatrics (7-17 years old) | | |
| Arm | 8,068 | 94.4 (92.7) |
| Pediatrics (2 - 6 years old) | | |
| Arm | 148 | 96.4 (90.8) |
| Upper buttocks | 143 | 87.4 (79.1) |
Percent of values within 15%/15 mg/dL, 20%/20 mg/dL, and 40%/40 mg/dL stratified by glucose ranges of <54, 54-69, 70-180, 181-250, and >250 mg/dL for iCGM and comparator were also provided for arm insertion site in adult and pediatric subjects.
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System Accuracy to Comparator Within iCGM Glucose Ranges - ≥ 18 YO Arm (N=308)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 1,140 | 79.7 | 88.9 | 98.9 | --- | --- | --- | -9.3 | 16.0 |
| 54-69 | 3,729 | 92.8 | 96.1 | 99.3 | --- | --- | --- | -2.3 | 9.1 |
| 70-180 | 18,379 | --- | --- | --- | 83.6 | 91.9 | 99.0 | 0.4 | 8.9 |
| 181-250 | 6,055 | --- | --- | --- | 89.3 | 95.2 | 99.8 | -2.7 | 7.5 |
| >250 | 9,890 | --- | --- | --- | 94.5 | 98.2 | 100.0 | -2.3 | 6.0 |
System Accuracy to Comparator Within iCGM Glucose Ranges - Pediatrics 7-17 YO Arm (N=122)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 162 | 52.5 | 71.0 | 92.0 | --- | --- | --- | -17.7 | 24.1 |
| 54-69 | 719 | 89.8 | 94.0 | 97.4 | --- | --- | --- | -4.7 | 9.0 |
| 70-180 | 3,996 | --- | --- | --- | 85.1 | 92.6 | 99.6 | -0.7 | 8.3 |
| 181-250 | 1,316 | --- | --- | --- | 87.9 | 95.9 | 99.9 | -3.2 | 7.5 |
| >250 | 1,875 | --- | --- | --- | 94.1 | 99.3 | 100.0 | -3.2 | 6.3 |
System Accuracy to Comparator Within Comparator Glucose Ranges - ≥ 18 YO Arm (N=308)
| Comparator Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 732 | 91.0 | 93.7 | 98.8 | --- | --- | --- | 4.0 | 14.0 |
| 54-69 | 4,530 | 92.0 | 97.0 | 99.8 | --- | --- | --- | 1.1 | 10.7 |
| 70-180 | 17,910 | --- | --- | --- | 84.6 | 92.6 | 99.3 | 1.1 | 8.6 |
| 181-250 | 5,905 | --- | --- | --- | 89.9 | 95.0 | 99.6 | -1.9 | 7.4 |
| >250 | 10,116 | --- | --- | --- | 92.8 | 97.1 | 99.9 | -6.6 | 6.4 |
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System Accuracy to Comparator Within Comparator Glucose Ranges - Pediatrics 7-17 YO Arm (N=122)
| Comparator Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 66 | 92.4 | 98.5 | 100.0 | --- | --- | --- | 2.0 | 10.4 |
| 54-69 | 811 | 91.0 | 96.9 | 100.0 | --- | --- | --- | 0.7 | 9.8 |
| 70-180 | 3,936 | --- | --- | --- | 85.5 | 92.4 | 98.6 | -0.4 | 8.5 |
| 181-250 | 1,275 | --- | --- | --- | 88.0 | 94.7 | 99.8 | -2.3 | 7.6 |
| >250 | 1,980 | --- | --- | --- | 90.9 | 97.8 | 99.9 | -7.9 | 6.8 |
## Concurrence
Concurrence of iCGM values compared to the comparator method across the entire measuring range was also evaluated. iCGM glucose ranges of <40, 40-60, 61-80, 81-120, 121-160, 161-200, 201-250, 251-300, 301-350, 351-400, and >400 mg/dL were evaluated against comparator glucose ranges and percent of iCGM values within those ranges were reported in the following tables.
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Concurrence of iCGM and Comparator by iCGM Glucose Range - ≥ 18 YO Arm (N=308)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM (mg/dL) (%) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| <40 | 16
7.1% | 105
46.9% | 97
43.3% | 3
1.3% | 3
1.3% | | | | | | | 224 |
| 40-60 | 9
0.4% | 1,418
58.0% | 944
38.6% | 71
2.9% | 2
0.1% | | | | | | | 2,444 |
| 61-80 | 1
0.0% | 657
12.0% | 4,134
75.4% | 678
12.4% | 11
0.2% | 4
0.1% | | | | | | 5,485 |
| 81-120 | | 49
0.7% | 1,175
15.7% | 5,570
74.2% | 671
8.9% | 30
0.4% | 7
0.1% | | | | | 7,502 |
| 121-160 | | 2
0.0% | 2
0.0% | 855
15.5% | 3,950
71.7% | 636
11.5% | 58
1.1% | 5
0.1% | | | | 5,508 |
| 161-200 | | | 6
0.1% | 9
0.2% | 691
15.9% | 2,916
67.0% | 668
15.4% | 55
1.3% | 4
0.1% | | | 4,349 |
| 201-250 | | | | | 9
0.2% | 608
15.1% | 2,687
66.9% | 651
16.2% | 51
1.3% | 6
0.1% | 3
0.1% | 4,015 |
| 251-300 | | | | | | 4
0.1% | 538
12.2% | 2,604
59.0% | 1,187
26.9% | 77
1.7% | | 4,410 |
| 301-350 | | | | | | | 7
0.2% | 547
13.8% | 2,795
70.7% | 598
15.1% | 6
0.2% | 3,953 |
| 351-400 | | | | | | | | 9
0.6% | 530
34.7% | 940
61.6% | 48
3.1% | 1,527 |
| >400 | | | | | | | | | 14
5.0% | 143
51.4% | 121
43.5% | 278 |
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Concurrence of iCGM and Comparator by iCGM Glucose Range - Pediatrics 7-17 YO Arm (N=122)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM (mg/dL) (%) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| <40 | 3
4.1% | 33
44.6% | 33
44.6% | 5
6.8% | | | | | | | | 74 |
| 40-60 | | 186
46.3% | 196
48.8% | 15
3.7% | 5
1.2% | | | | | | | 402 |
| 61-80 | | 61
5.6% | 895
82.2% | 120
11.0% | 11
1.0% | 2
0.2% | | | | | | 1,089 |
| 81-120 | | 2
0.1% | 278
17.9% | 1,103
70.9% | 168
10.8% | 5
0.3% | | | | | | 1,556 |
| 121-160 | | | | 156
12.0% | 908
70.1% | 215
16.6% | 16
1.2% | | | | | 1,295 |
| 161-200 | | | | 1
0.1% | 173
18.5% | 605
64.6% | 148
15.8% | 10
1.1% | | | | 937 |
| 201-250 | | | | | | 122
13.3% | 610
66.7% | 169
18.5% | 13
1.4% | | | 914 |
| 251-300 | | | | | | | 87
12.2% | 344
48.2% | 279
39.1% | 3
0.4% | | 713 |
| 301-350 | | | | | | | | 86
10.9% | 589
74.9% | 110
14.0% | 1
0.1% | 786 |
| 351-400 | | | | | | | | 1
0.3% | 114
30.3% | 240
63.8% | 21
5.6% | 376 |
| >400 | | | | | | | | | 3
3.8% | 43
55.1% | 32
41.0% | 78 |
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Concurrence of iCGM and Comparator by Comparator Glucose Range - ≥ 18 YO Arm (N=308)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM (mg/dL) (%) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 |
| <40 | 16
61.5% | 105
4.7% | 97
1.5% | 3
0.0% | 3
0.1% | | | | | | |
| 40-60 | 9
34.6% | 1,418
63.6% | 944
14.8% | 71
1.0% | 2
0.0% | | | | | | |
| 61-80 | 1
3.8% | 657
29.4% | 4,134
65.0% | 678
9.4% | 11
0.2% | 4
0.1% | | | | | |
| 81-120 | | 49
2.2% | 1,175
18.5% | 5,570
77.5% | 671
12.6% | 30
0.7% | 7
0.2% | | | | |
| 121-160 | | 2
0.1% | 2
0.0% | 855
11.9% | 3,950
74.0% | 636
15.2% | 58
1.5% | 5
0.1% | | | |
| 161-200 | | | 6
0.1% | 9
0.1% | 691
12.9% | 2,916
69.5% | 668
16.8% | 55
1.4% | 4
0.1% | | |
| 201-250 | | | | | 9
0.2% | 608
14.5% | 2,687
67.8% | 651
16.8% | 51
1.1% | 6
0.3% | 3
1.7% |
| 251-300 | | | | | | 4
0.1% | 538
13.6% | 2,604
67.3% | 1,187
25.9% | 77
4.4% | |
| 301-350 | | | | | | | 7
0.2% | 547
14.1% | 2,795
61.0% | 598
33.9% | 6
3.4% |
| 351-400 | | | | | | | | 9
0.2% | 530
11.6% | 940
53.3% | 48
27.0% |
| >400 | | | | | | | | | 14
0.3% | 143
8.1% | 121
68.0% |
| Total | 26 | 2,231 | 6,358 | 7,186 | 5,337 | 4,198 | 3,965 | 3,871 | 4,581 | 1,764 | 178 |
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Concurrence of iCGM and Comparator by Comparator Glucose Range - Pediatrics 7-17 YO Arm (N=122)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM (mg/dL) (%) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 |
| <40 | 3
100.0% | 33
11.7% | 33
2.4% | 5
0.4% | | | | | | | |
| 40-60 | | 186
66.0% | 196
14.0% | 15
1.1% | 5
0.4% | | | | | | |
| 61-80 | | 61
21.6% | 895
63.8% | 120
8.6% | 11
0.9% | 2
0.2% | | | | | |
| 81-120 | | 2
0.7% | 278
19.8% | 1,103
78.8% | 168
13.3% | 5
0.5% | | | | | |
| 121-160 | | | | 156
11.1% | 908
71.8% | 215
22.7% | 16
1.9% | | | | |
| 161-200 | | | | 1
0.1% | 173
13.7% | 605
63.8% | 148
17.2% | 10
1.6% | | | |
| 201-250 | | | | | | 122
12.9% | 610
70.8% | 169
27.7% | 13
1.3% | | |
| 251-300 | | | | | | | 87
10.1% | 344
56.4% | 279
28.0% | 3
0.8% | |
| 301-350 | | | | | | | | 86
14.1% | 589
59.0% | 110
27.8% | 1
1.9% |
| 351-400 | | | | | | | | 1
0.2% | 114
11.4% | 240
60.6% | 21
38.9% |
| >400 | | | | | | | | | 3
0.3% | 43
10.9% | 32
59.3% |
| Total | 3 | 282 | 1,402 | 1,400 | 1,265 | 949 | 861 | 610 | 998 | 396 | 54 |
## Tread Accuracy
Trend accuracy describes the accuracy of the sensor during times of rapidly changing glucose and are characterized by slopes, such as from >2 mg/dL to <-2 mg/dL. Trend accuracy was assessed by the concurrence rate of the glucose rate of change (changes in mg/dL of glucose per minute) determined by the iCGM values and the corresponding comparator values for each iCGM-comparator measured pairs (typically collected once every 15 minutes).
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Trend Accuracy Between iCGM and Comparator - ≥ 18 YO Arm (N=308)
| | Comparator Rate Range (mg/dL/min) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Rate Range (mg/dL/min) N (Row %) | <-2 | [-2,-1) | [-1,-0) | [0,1] | (1,2] | >2 | Number of Paired iCGM-Comparator (Row N) |
| <-2 | 221 (29.2) | 235 (31.0) | 213 (28.1) | 69 (9.1) | 17 (2.2) | 3 (0.4) | 758 |
| [-2,-1) | 209 (7.3) | 989 (34.7) | 1,314 (46.1) | 281 (9.9) | 48 (1.7) | 10 (0.4) | 2,851 |
| [-1,0) | 143 (1.0) | 951 (6.8) | 9,822 (70.3) | 2,792 (20.0) | 221 (1.6) | 51 (0.4) | 13,980 |
| [0,1] | 63 (0.6) | 230 (2.0) | 3,292 (29.1) | 6,370 (56.4) | 1,140 (10.1) | 200 (1.8) | 11,295 |
| (1,2] | 4 (0.1) | 43 (1.3) | 262 (7.9) | 1,114 (33.7) | 1,401 (42.4) | 469 (14.2) | 3,302 |
| >2 | 2 (0.1) | 8 (0.4) | 84 (4.1) | 258 (12.7) | 622 (30.6) | 1,058 (52.0) | 2,035 |
Note: RoC was calculated using comparator data with consecutive measurements greater than 5 minutes
Trend Accuracy Between iCGM and Comparator - Pediatrics 7-17 YO Arm (N=122)
| | Comparator Rate Range (mg/dL/min) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Rate Range (mg/dL/min) N (Row %) | <-2 | [-2,-1) | [-1,-0) | [0,1] | (1,2] | >2 | Number of Paired iCGM-Comparator (Row N) |
| <-2 | 63 (29.6) | 78 (36.6) | 50 (23.5) | 19 (8.9) | 3 (1.4) | 0 (0.0) | 213 |
| [-2,-1) | 54 (6.6) | 386 (47.5) | 308 (37.9) | 56 (6.9) | 7 (0.9) | 2 (0.2) | 813 |
| [-1,0) | 16 (0.6) | 222 (8.3) | 1,860 (69.8) | 522 (19.6) | 37 (1.4) | 9 (0.3) | 2,666 |
| [0,1] | 6 (0.3) | 38 (1.7) | 545 (24.5) | 1,403 (63.2) | 202 (9.1) | 27 (1.2) | 2,221 |
| (1,2] | 3 (0.4) | 7 (1.0) | 66 (9.0) | 263 (35.7) | 324 (44.0) | 73 (9.9) | 736 |
| >2 | 0 (0.0) | 4 (0.9) | 21 (4.6) | 49 (10.8) | 138 (30.4) | 242 (53.3) | 454 |
Note: RoC was calculated using comparator data with consecutive measurements greater than 5 minutes
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Agreement When iCGM Reads "LOW" or "HIGH"
G7 reports glucose readings between 40 and 400 mg/dL. When G7 determines the sensor reading is below 40 mg/dL, it displays "LOW" on the receiver or mobile app. When G7 determines the glucose level is above 400 mg/dL, it displays "HIGH" on the receiver or mobile app. Because the System does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual blood glucose levels (as determined by the comparator method) when the iCGM value is classified as LOW or HIGH is evaluated separately, and the cumulative percentages when laboratory comparator values were less than certain glucose levels (for LOW), and when laboratory comparator values were greater than certain glucose levels (for HIGH) are presented in the table below.
Distribution of Comparator for iCGM Readings LOW or HIGH - Adults and Pediatrics 7-17 YO Arm (N=430)
| | | Comparator (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Readings | iCGM-Comparator Pairs | <55 | <60 | <70 | <80 | ≥80 | Total |
| LOW | n | 99 | 145 | 233 | 286 | 12 | 298 |
| | Cumulative Percent | 33 | 49 | 78 | 96 | 4 | |
| | | | | | | | |
| iCGM Readings | iCGM-Comparator Pairs | >340 | >320 | >280 | >250 | ≤250 | Total |
| HIGH | n | 347 | 356 | 356 | 356 | 0 | 356 |
| | Cumulative Percent | 97 | 100 | 100 | 100 | 0 | |
## Alert Performance
The Hypoglycemic Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the device alarmed (as confirmed by the comparator method). The False Alert Rate is the % of time the device alarmed when the blood glucose level was above the alert setting within 15 minutes before or after the device alarmed. The Correct Detection Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the hypoglycemic event. The Missed Detection Rate is the % of time the device did not alarm when the blood glucose level was at or below the alert setting within 15 minutes before and after the hypoglycemic event.
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Hypoglycemic Threshold Alerts and Detections - ≥ 18 YO Arm (N=308)
| Hypoglycemic Alert Setting (mg/dL) | Alerts | | | Detections | | |
| --- | --- | --- | --- | --- | --- | --- |
| | # of alerts (n) | True Alert (%) | False Alert (%) | # of events (n) | True Detection (%) | Missed Detection (%) |
| 55 | 2,189 | 51.0 | 49.0 | 1,037 | 75.8 | 24.2 |
| 60 | 3,504 | 69.7 | 30.3 | 2,263 | 81.1 | 18.9 |
| 70 | 7,339 | 86.9 | 13.1 | 5,651 | 88.8 | 11.2 |
| 80 | 11,893 | 90.2 | 9.8 | 8,645 | 93.7 | 6.3 |
| 90 | 16,749 | 92.2 | 7.8 | 10,674 | 96.1 | 3.9 |
Hypoglycemic Threshold Alerts and Detections - Pediatrics 7-17 YO Arm (N=122)
| Hypoglycemic Alert Setting (mg/dL) | Alerts | | | Detections | | |
| --- | --- | --- | --- | --- | --- | --- |
| | # of alerts (n) | True Alert (%) | False Alert (%) | # of events (n) | True Detection (%) | Missed Detection (%) |
| 55 | 462 | 36.8 | 63.2 | 106 | 80.2 | 19.8 |
| 60 | 728 | 59.9 | 40.1 | 288 | 89.2 | 10.8 |
| 70 | 1,543 | 81.5 | 18.5 | 976 | 90.4 | 9.6 |
| 80 | 2,477 | 89.9 | 10.1 | 1,692 | 92.5 | 7.5 |
| 90 | 3,415 | 92.4 | 7.6 | 2,059 | 96.8 | 3.2 |
The Hyperglycemic Alert Rate shows how often the alert is right or wrong. The True Notification Rate is the % of time the device alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the device alarmed. The False Notification Rate is the % of time the device alarmed when the blood glucose level was below the alert setting within 15 minutes before or after the device alarmed. The Correct Detection Rate is the % of time the device alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the hyperglycemic event. The Missed Detection Rate is the % of time the device did not alarm when the blood glucose level was at or above the alert setting within 15 minutes before and after the hyperglycemic event.
Hyperglycemic Threshold Alerts and Detections - ≥ 18 YO Arm (N=308)
| Hyperglycemic Alert Setting (mg/dL) | Alerts | | | Detections | | |
| --- | --- | --- | --- | --- | --- | --- |
| | # of alerts (n) | True Alert (%) | False Alert (%) | # of events (n) | True Detection (%) | Missed Detection (%) |
| 120 | 56,899 | 97.0 | 3.0 | 24,147 | 98.5 | 1.5 |
| 140 | 48,771 | 96.8 | 3.2 | 21,222 | 98.2 | 1.8 |
| 180 | 35,465 | 96.4 | 3.6 | 16,454 | 97.8 | 2.2 |
| 200 | 29,941 | 96.3 | 3.7 | 14,521 | 97.1 | 2.9 |
| 220 | 25,145 | 96.2 | 3.8 | 12,799 | 96.5 | 3.5 |
| 240 | 20,970 | 95.6 | 4.4 | 11,244 | 95.9 | 4.1 |
| 300 | 8,884 | 90.1 | 9.9 | 6,630 | 88.7 | 11.3 |
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Hyperglycemic Threshold Alerts and Detections - Pediatrics 7-17 YO Arm (N=122)
| Hyperglycemic Alert Setting (mg/dL) | Alerts | | | Detections | | |
| --- | --- | --- | --- | --- | --- | --- |
| | # of alerts (n) | True Alert (%) | False Alert (%) | # of events (n) | True Detection (%) | Missed Detection (%) |
| 120 | 11,557 | 97.6 | 2.4 | 5,192 | 98.6 | 1.4 |
| 140 | 9,695 | 97.7 | 2.3 | 4,542 | 97.9 | 2.1 |
| 180 | 6,600 | 96.3 | 3.7 | 3,374 | 97.2 | 2.8 |
| 200 | 5,476 | 95.7 | 4.3 | 2,951 | 97.1 | 2.9 |
| 220 | 4,384 | 93.7 | 6.3 | 2,532 | 96.0 | 4.0 |
| 240 | 3,496 | 94.6 | 5.4 | 2,218 | 96.1 | 3.9 |
| 300 | 1,649 | 93.5 | 6.5 | 1,467 | 87.7 | 12.3 |
## Sensor Stability
Sensor stability describes the performance over the sensor intended lifetime (up to 10 days, including the optional 12-hour grace period). Performance was estimated by calculating the percentage of iCGM readings within 15 mg/dL or 15% (15/15%), 20 mg/dL or 20% (20/20%), and 40 mg/dL or 40% (40/40%) of the laboratory comparator values at the beginning (Day 1, 2), middle (Day 4, 7), and end (Day 10, 10.5) of the System lifecycle. The mean of the absolute relative difference was evaluated over the sensor life within the measuring range.
Accuracy of iCGM vs Comparator by Wear Period - ≥ 18 YO and Pediatrics 7-17 YO Arm (N=430)
| Wear Period | Matched Pairs (n) | MARD (%) | %15/1 5 (%) | %20/2 0 (%) | %40/4 0 (%) |
| --- | --- | --- | --- | --- | --- |
| Beginning | 17,658 | 9.9 | 82.2 | 91.0 | 98.9 |
| Middle | 16,551 | 7.1 | 92.2 | 97.1 | 99.9 |
| End | 13,052 | 7.2 | 91.9 | 96.4 | 99.8 |
## Sensor Life
A total of 460 sensors worn on the arm by adult and pediatric subjects were evaluated to determine the percentage of sensors that lasted through the 10-day sensor life. Seventy-nine percent (79%) of the 460 sensors lasted through the end of the entire wear period (e.g., Day 10). Among the 460 sensors evaluated, 66 sensors (14.3%) had "early sensor shut-off" where the sensor algorithm would have detected sensors that did not function as intended and shut them off.
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The survival rates summarized separately for adult and pediatric populations are provided in the tables below:
Summary of System Survival by Day - ≥ 18 YO Arm (N = 315)
| Day of Wear | Number of Sensors (N=315) | Survival Rate (%) |
| --- | --- | --- |
| 1 | 310 | 98.4 |
| 2 | 303 | 96.8 |
| 3 | 300 | 95.9 |
| 4 | 291 | 93.6 |
| 5 | 286 | 92.0 |
| 6 | 282 | 90.7 |
| 7 | 273 | 88.5 |
| 8 | 267 | 86.5 |
| 9 | 259 | 83.9 |
| 10 | 152 | 80.5 |
From the 315 sensors with valid CGM readings, 256 did not fail prior to Day 10 and reached the planned device removal (n=250) or were removed early due to subject withdrawal (n=6). The remaining 59 sensors (18.7%) failed before Day 10. In total, 38 sensors had early sensor shutoff (ESS) failure and 21 had adhesive failure.
Summary of System Survival by Day - Pediatrics 2-17 YO Arm (N = 145)
| Day of Wear | Number of Sensors (N=145) | Survival Rate (%) |
| --- | --- | --- |
| 1 | 141 | 97.2 |
| 2 | 140 | 96.6 |
| 3 | 138 | 95.2 |
| 4 | 137 | 95.2 |
| 5 | 135 | 93.8 |
| 6 | 132 | 91.7 |
| 7 | 128 | 88.9 |
| 8 | 122 | 84.8 |
| 9 | 115 | 79.9 |
| 10 | 102 | 75.0 |
From the 145 sensors with valid CGM readings (Table 20-35), 109 did not fail prior to Day 10 and reached the planned device removal (n=108) or were removed early due to subject withdrawal (n=1). The remaining 36 sensors (24.8%) failed early. In total, 28 sensors had early sensor shutoff (ESS) failure and 8 had adhesive failures.
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Summary of System Survival by Day - Pediatrics 2-6 YO Buttocks (N = 16)
| Day of Wear | Number of Sensors (N=16) | Survival Rate (%) |
| --- | --- | --- |
| 1 | 15 | 93.8 |
| 2 | 13 | 81.3 |
| 3 | 13 | 81.3 |
| 4 | 13 | 81.3 |
| 5 | 13 | 81.3 |
| 6 | 13 | 81.3 |
| 7 | 11 | 68.8 |
| 8 | 10 | 62.5 |
| 9 | 10 | 62.5 |
| 10 | 8 | 50.0 |
Data Capture Rate
The data capture rate characterizes the reliability of the communication between components of the system.
The next table describes the data availability rate as the percentage of readings expected to be calculated throughout the 10-day life span of the sensor life for adults and pediatrics (arm only).
Data Availability Rate by Wear Day - Adults and Pediatrics 2-17 YO Arm (N=460) (Study 1)
| Wear Day | Number of Sensors | Data Availability Rate (%) |
| --- | --- | --- |
| 1 | 460 | 99.5 |
| 2 | 451 | 99.8 |
| 3 | 443 | 99.9 |
| 4 | 438 | 99.7 |
| 5 | 428 | 99.6 |
| 6 | 421 | 99.6 |
| 7 | 414 | 99.5 |
| 8 | 401 | 99.2 |
| 9 | 389 | 98.5 |
| 10 | 374 | 98.1 |
| Overall | 460 | 99.4 |
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D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
F Other Supportive Instrument Performance Characteristics Data:
Not applicable.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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