Dexcom G4 User Manual
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Dexcom G4 User Manual

Dexcom G4 User Manual

Continuous glucose monitoring system
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Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
1.858.200.0200
1.877.339.2664
www.dexcom.com
LBL012514 Rev X01 MT21686
LBL-011119 Rev 09 MT21433
3
Stay Between the Lines
CONTINUOUS GLUCOSE
MONITORING SYSTEM
USER'S GUIDE

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  • Page 1 CONTINUOUS GLUCOSE MONITORING SYSTEM USER’S GUIDE Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.com LBL012514 Rev X01 MT21686 LBL-011119 Rev 09 MT21433 Stay Between the Lines...
  • Page 2 INDICATIONS FOR USE AND SAFETY STATEMENT Dexcom G4 PLATINUM User’s Guide Dexcom G4 PLATINUM Continuous Glucose Monitoring System...
  • Page 3 The Dexcom G4 PLATINUM System is indicated for use as ‡ 7DNLQJ PHGLFDWLRQV ZLWK DFHWDPLQRSKHQ VXFK DV 7\OHQRO an adjunctive device to complement, not replace, information while wearing the sensor may falsely raise your sensor obtained from standard home glucose monitoring devices.
  • Page 4 The sensor should not be stored in a freezer. that your blood glucose meter displays within 5 minutes of a Storing the sensor improperly might cause the sensor Dexcom G4 PLATINUM User’s Guide Dexcom G4 PLATINUM Continuous Glucose Monitoring System...
  • Page 5 U.S. (Federal) law restricts the sale of the Dexcom G4 water bed, etc. Types of obstruction differ and have not PLATINUM System to sale by or on order of a physician.

  • Page 6: Technical Information

    chapter fourteen TECHNICAL INFORMATION...
  • Page 7 NOTE: We recommend that you review the information in this chapter with your healthcare provider to understand how well the Dexcom G4 PLATINUM System performs. The Dexcom G4 PLATINUM System (the System) uses a glucose sensor to continuously measure and monitor your glucose levels. The sensor is “calibrated” using a commercially available blood glucose meter;...
  • Page 8 Subjects in both studies used the System for seven days. In the Original Study, thirty-six subjects each wore 2 sensors; in the Study, all subjects wore 1 sensor only. Throughout the 7-day wear Software 505 period, the sensor was calibrated with an average of 2 fingersticks per day (approximately once every 12 ®...
  • Page 9 Table 1. System Agreement to YSI within CGM Glucose Ranges Percent Percent Percent Percent Number of within within within Greater than Glucose Study paired 15/15% 20/20% 30/30% 40/40% Range CGM-YSI (mg/dL) Original 9152 Overall Software 505 2263 Original 40-60 Software 505 Original 61-80 Software 505...
  • Page 10 The System reports glucose readings between 40 and 400 mg/dL. When the System determines the glucose reading is below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the Dexcom G4 PLATINUM System determines that the glucose level is above 400 mg/dL, it displays “HIGH” in the Receiver Status Box.
  • Page 11 Table 3-A. Concurrence of CGM Readings and YSI Values (Original Study) YSI (mg/dL) Row percentage of matched pairs in each CGM glucose range (mg/dL) Number of < 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400 Paired CGM-YSI <...
  • Page 12 Table 3-B. Concurrence of CGM Readings and YSI Values (Software 505 Study) YSI (mg/dL) Row percentage of matched pairs in each CGM glucose range (mg/dL) Number of < 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400 Paired CGM-YSI <...
  • Page 13 Accuracy Relative to YSI Accuracy between matched pairs was also estimated by calculating the percent difference between the System reading and the YSI value. For example, if the YSI value is 100 mg/dL and the System reading is 90 mg/dL, a 10% difference between the System and the YSI is reported. The System and YSI values were compared by pairing the System reading that fell immediately after the YSI value was collected.
  • Page 14 Table 4. System Difference to YSI within CGM Glucose Ranges Mean Median Number of Median Glucose Mean Percent Absolute Absolute Study Paired CGM- Percent Ranges Difference Percent Percent Difference (mg/dL) Difference Difference Original 9152 2.9% 1.7% 13.3% 9.8% Overall Software 505 2263 2.5% 2.4%...

  • Page 15: The Low Glucose Alert

    Low and High Glucose Alerts The ability of the System to detect high and low glucose levels is assessed by comparing System results to YSI results at low and high blood glucose levels and determining if the alert may have sounded. The System and YSI values were compared by pairing the System reading that occurred immediately after the YSI value was collected.
  • Page 16 Table 5. Hypoglycemic Alert Evaluation Hypoglycemic True False Hypoglycemia Hypoglycemia Alert Level Study Alert Alert Missed Detection Detection Rate (mg/dL) Rate Rate Rate Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505...

  • Page 17: The High Glucose Alert

    The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6. Hyperglycemia Alert Rate The 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 above the alert setting within 15 minutes before or after the device alarmed.
  • Page 18 Table 6. Hyperglycemic Alert Evaluation Hyperglycemic True False Hyperglycemia Hyperglycemia Alert Level Study Alert Alert Missed Detection Detection Rate (mg/dL) Rate Rate Rate Original Software 505 100% Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505...

  • Page 19: Calibration Stability

    Table 7. Percentage of System Readings within YSI Values with Data Stratified in 2-Hour Increments after Calibration Percent Percent Percent Percent Number of greater Time from within within within Study paired than Calibration 15/15% 20/20% 30/30% CGM-YSI 40/40% Original 1929 0-2 hours Software 505 Original...

  • Page 20: Sensor Life

    Table 8. Sensor Stability (Accuracy over Time) Median Percent Percent Percent Percent Number of Mean Absolute Day of Absolute within within within greater Study paired CGM- Percent Wear Percent 15/15% 20/20% 30/30% than Differences Differences 40/40% YSI Original 3023 16.7% 13.2% Day 1 Software...
  • Page 21 Table 9. Number of Readings Provided by Each Sensor Over 7-Days Total Readings % of Total Possible % of Systems Providing that Study Provided (Min- Readings Provided Number of Readings Max) Original 167-491 0-25% Software 505 Original 719-914 26-50% Software 505 856-856 Original 1267-1267...
  • Page 22 For the Software 505 Study (SW10505), 96% of Systems provided between 1,497 and 1,992 valid glucose readings (or more than 75% of the expected number of readings). Adjusted within each system wear-day, Software 505 System provided an average of 98% of all expected glucose readings (288) as seen in Table 10.
  • Page 23 Table 11. CGM System Agreement to SMBG within CGM Glucose Ranges Percent Percent Percent Percent Number of greater Glucose within within within Study paired than Ranges 15/15% 20/20% 30/30% CGM-SMBG 40/40% (mg/dL) SMBG SMBG SMBG SMBG Original 7508 Overall Software 505 2992 Original 40-60...
  • Page 24 Table 12. CGM System Difference to SMBG within CGM Glucose Ranges Median Median Mean Absolute CGM Glucose Ranges Number of Paired Mean Percent Absolute Study Percent Percent (mg/dL) CGM-SMBG Difference Percent Difference Difference Difference Original 7508 -0.4% -1.4% 14.0% 11.0% Overall Software 505 2992...

  • Page 25: Adverse Events

    than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 8.6% or less different than SMBG values. Adverse Events No serious adverse events or device-related serious adverse events occurred during either study. Mild or very slight skin irritation, such as erythema or edema, occurred in low frequency around the adhesive area.

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