11
3 Risk and Efficacy
3.1 Risk
Inserting sensors and wearing adhesive tapes are less likely to cause infection,
bleeding, pain or skin irritation (redness, swelling, bruising, itching, scarring or
discoloration). If these symptoms occur, the patient may feel uncomfortable at the
location where the sensor is inserted.
In rare cases, the sensor electrode may break and remain in the body. This
phenomenon did not appear in the clinical study. If you feel the sensor is broken
inside your skin, contact your medical diabetes team and technical support.
When the prompt function is turned off or the transmitter and App are not within the
communication range, the prompt cannot be obtained.
When you cannot hear the tone or feel the vibration, you may not notice the prompt.
Sometimes the sensor glucose readings may be slightly different from the values
measured by blood glucose meter. In most cases, the sensor glucose reading moves
with the blood glucose level and will remind you when the glucose level exceeds the
target range.
If you are at high/low blood glucose levels and you miss the reminding and warning
message, you might not test your blood glucose with blood glucose meter and miss
high/low blood glucose values.
3.2 Efficacy
The Continuous Glucose Monitoring Systems provides more effective and
comprehensive information than the blood glucose meter. In 14-day monitoring, the
continuous glucose monitoring system provides a glucose reading every three
minutes to inform you where your glucose is heading. Dynamic information can
help you check the current glucose status, as well as the glucose direction and speed
of glucose changes. Recognizing trends in glucose can help you be proactive and
take the necessary actions to avoid high/low glucose levels.
App alerts when blood glucose levels exceed your target glucose limits or when
blood glucose drops or rises rapidly. The alerts can remind you to take the necessary
actions and be proactive, in order to avoid low/high glucose levels.
