Product Info

• The study involved a relatively small number of patients.
• There was no control group for comparison purposes.
• The amount of time the system was used in the Manual mode was much
shorter than the time it was programmed to the Auto Mode.
• Additionally, for each subject, the study period lasted only three months.
Due to these limitations, the results of the clinical trial must be interpreted with
caution and you should understand that your individual results when using the
MiniMed 670G System may be significantly different from those of the subjects
who participated in the trial.
E. Guardian Sensor (3) Performance in users ages 7 to 13
CGM performance
The use of the Guardian Sensor (3) with the Guardian Link (3) transmitter enables
CGM technology. The transmitter transmits SG values calculated by the real-time
algorithm to a primary display device, allowing you to monitor your SG values.
Clinical study description
The performance of the Guardian Sensor (3) was evaluated in a clinical study.
5
This
in-patient (in-clinic) and outpatient (at home) study included subjects 7 to 13 years
in age. The study design was a multi-center, prospective single sample
correlational design without controls.
All subjects were assigned to treatment. Each subject was instructed to wear two
Guardian Sensor (3) sensors in the abdomen or buttock.
• One Guardian Sensor (3) connected to the Guardian Connect Transmitter,
which transmitted to the Guardian Connect app, a standalone CGM display
device.
• One Guardian Sensor (3) connected to the Guardian Link (3) transmitter, which
served as a glucose sensor recorder (GSR, transmitter and recorder for sensor-
integrated pump systems).
5 Medtronic Inc., A Performance Evaluation of the Enlite™ and Enlite™ 3 Glucose Sensor to Support Use
in Children; CEP249 Data From Subjects 7-13 Years of Age 10703807DOC. November 2017.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 353