Type1 Diabetes Mellitus Clinical Trial
Official title:
A Comparative Study on the Accuracy, Ease of Use and Skin Reactions Between the Enlite Sensor With Guardian 2 Link Transmitter and the FreeStyle Libre Flash Glucose Sensor
1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with
a standardized breakfast test. Patients receive a standardized breakfast. The usual
insulin bolus will be administered at breakfast. After breakfast, a venous blood sample
is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time,
the glucose value shown by the sensors will be noted. A comparison of the blood glucose
value with the data recorded by the sensor can evaluate the accuracy of the sensor and
also estimate the lag-time between the sensor glucose and the venous glucose.
2. Patient satisfaction will be evaluated using a questionnaire that will be completed
after the Enlite sensor has been worn for 1 month.
3. The development of skin reactions will be checked by a short questionnaire, supplemented
with a picture of possible skin phenomena.
4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within
target,% under target, amount of hypoglycemia) in the month prior to sensor switching
will be compared to the same data recorded by the Enlite sensor during the first month
of use.
n/a
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