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Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor.

Mark P Christiansen1, Satish K Garg2, Ronald Brazg3

  • 11 Diablo Clinical Research , Walnut Creek, California.

Diabetes Technology & Therapeutics
|July 13, 2017
PubMed
Summary

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The Guardian Sensor 3 provides accurate glucose readings for diabetes management, performing well in both abdominal and arm placements. This continuous glucose monitoring system offers reliable performance for its intended 7-day use.

Area of Science:

  • Medical Devices
  • Diabetes Technology
  • Biomedical Engineering

Background:

  • Evaluation of the fourth-generation Guardian Sensor 3 subcutaneous glucose sensor.
  • Assessment of sensor accuracy and performance in abdominal and arm locations.

Purpose of the Study:

  • To determine the accuracy and performance of the Guardian Sensor 3 in different body sites.
  • To compare sensor performance with a Yellow Springs Instrument (YSI) reference.

Main Methods:

  • Eighty-eight participants with type 1 or type 2 diabetes were enrolled.
  • Sensors were worn in the abdomen (paired with MiniMed 640G insulin pump or Guardian Connect system) and arm (connected to a glucose sensor recorder).
  • Frequent blood glucose testing using a YSI reference was conducted during in-clinic visits.
Keywords:
Glucose sensorMARDMobile deviceSensor accuracySensor-integrated pump

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Main Results:

  • Mean Absolute Relative Difference (MARD) ranged from 8.7% to 9.6% across different sensor placements and systems.
  • Over 90% of sensor glucose values were within 20% agreement of the YSI reference.
  • Functional sensor life averaged approximately 146 hours, supporting 7-day use.

Conclusions:

  • The Guardian Sensor 3 demonstrates accurate glucose readings in both abdominal and arm placements.
  • The sensor's functional life is consistent with its intended 7-day usage period.
  • Favorable user feedback was received regarding sensor comfort and ease of use.