Summary Safety Review - Enlite Glucose Sensor- Assessing the Potential Risk of Improper Glucose Management

November 14, 2016

Product

Enlite Glucose Sensor manufactured by Medtronic MiniMed

Potential Safety Issue

Improper glucose (sugar) management

Key Messages

  • The Enlite Glucose Sensor is a single-use, disposable device that is intended to continuously monitor sugar levels in the fluid surrounding the body's tissues (interstitial glucose levels) for up to 6 days in persons with diabetes.
  • Health Canada's safety review was triggered by reports that describe potentially inaccurate readings by the Enlite Glucose Sensor as compared to traditional blood sugar readings measured with the manual fingerstick method.
  • As a result of this safety review, Health Canada concluded that the evidence does not suggest that there is a new safety risk. Health Canada will continue to monitor safety information regarding the Enlite Glucose Sensor and improper sugar management.

Overview

Health Canada carried out a safety review of information related to the use of the Enlite Glucose Sensor after receiving reports that describe potentially inaccurate readings as compared to methods that measure blood sugar levels. If a person manages their diabetes based on inaccurate readings, they could experience potentially dangerous side effects from low blood sugar or high blood sugar (hypoglycemia or hyperglycemia).

Use in Canada

  • The Enlite Glucose Sensor is a single-use, disposable device that is intended to continuously monitor sugar in the fluid surrounding the body's tissues (interstitial glucose levels) for up to 6 days in persons with diabetes.
  • A sensor on the device is inserted under the patient's skin and the device sends information wirelessly to an insulin pump or other display or recording device. These systems notify the patient about trends in the rise and fall of their sugar levels.
  • It is expected that readings from the Enlite Glucose Sensor may differ slightly from the blood sugar levels. Therapy decisions should not be based on readings from the sensor alone. Fingerstick testing (to prick a finger with a small, needle-like lancet) of blood sugar levels is required to confirm if a patient needs treatment for high or low blood sugar.
  • The Enlite Glucose Sensor was first licensed in Canada in February 2013 and is manufactured by Medtronic MiniMed.

Safety Review Findings

  • At the time of the review, Health Canada had received a total of 33 reports describing a potential difference between measured blood sugar and the interstitial sugar reading provided by the Enlite Glucose Sensor. The report that triggered the review described that a user fainted after giving themselves too much insulin, based on readings from an Enlite Glucose Sensor. The report lacked additional information as to whether or not they were using their Enlite Glucose Sensor, fingerstick tests and insulin properly. The majority of the remaining reports described high or low blood sugar values with no resulting health consequences.
  • The number of reports received by Health Canada related to potentially inaccurate readings is considered to be within the manufacturer's expected performance for the Enlite Glucose Sensor. The available scientific literature generally indicates that some inaccuracy of the Enlite Glucose Sensor device (in terms of reflecting blood sugar values) is expected and can vary depending on the individual, time of day, state of the sugar level (high or low) and age of the device.
  • The Canadian Enlite Glucose Sensor "Step by Step Guide" specifies that interstitial sugar is measured by the sensor and highlights that a fingerstick test to confirm the blood sugar level is required prior to taking action to manage blood sugar, if needed.
  • Based on Canadian and American diabetes association publications, a device like the Enlite Glucose Sensor is considered a useful addition to the self-monitoring of blood sugar, but it should not be used by itself for decision-making to manage blood sugar levels.

Conclusions and Actions

  • Health Canada's safety review concluded that the evidence does not suggest that there is a new safety risk associated with the Enlite Glucose Sensor at this time.
  • Health Canada will continue to monitor safety information involving the Enlite Glucose Sensor, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information and what is known about the use of this device both in Canada and internationally.

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