Freestyle Libre 2 Manual Del Usuario página 144

ART46983-001_rev-A 24-Aug-2022 2:30pm
performance of FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 Sensor
that has 14 day wear duration. One study included adults (Adult study) and the other study included
children (Pediatric study). All subjects in both studies required insulin to manage their diabetes. To
measure the precision of the System, each subject wore two Sensors, one on the back of each upper
arm, for a period of up to 14 days. The data presented here represent the performance of the system in
the first 10 days of the sensor wear, consistent with the wear duration of the FreeStyle Libre 2 MediRx
Sensor. While in the clinic, subjects had their venous blood glucose analyzed using a laboratory
reference method, the Yellow Springs Instrument Life Sciences 2300 STAT Plus™ Glucose & Lactate
Analyzer (YSI). Sensor glucose readings were then compared to the YSI glucose results to evaluate the
System's performance. In the Pediatric study, no YSI measurements were obtained for children under
the age of six.
Adult study: The Adult study was conducted at 5 centers with 146 subjects in total (91.1% Type 1, 8.9%
Type 2), all aged eighteen and older. Subjects had their venous blood glucose analyzed over three
separate visits to the clinical center. Each visit lasted up to ten hours. 144 subjects were analyzed during
the beginning of the Sensor wear period (day 1, 2, or 3), 91 subjects were analyzed during the middle
period (day 7 or 8), 36 subjects were analyzed during the end period (day 9). During each visit, adult
subjects had their glucose levels deliberately manipulated per the study protocol to raise or lower
glucose. This was done to assess performance of the System over the range that the System measures
glucose (40 – 400 mg/dL).
Pediatric study: The Pediatric study was conducted at 4 centers with 139 subjects in total (98.6% Type 1,
1.4% Type 2), all aged four to seventeen. Subjects age six and older had their venous blood glucose
analyzed for up to 16 hours over one or two separate visits to the clinical center. Each visit lasted up to
eight hours. During each visit, subjects age 11 and older had their glucose levels deliberately
manipulated per the study protocol to raise or lower glucose. This was done to assess performance of
the System over the range that the System measures glucose (40 – 400 mg/dL). 48 subjects were
analyzed during the beginning of the Sensor wear period (day 1 or 2), 50 subjects were analyzed during
the middle period (day 7 or 8), 25 subjects were analyzed during the end period (day 9). All subjects
tested their blood glucose using fingerstick capillary samples at least four times during each day of the
study.
Accuracy:
Accuracy of the System was measured by comparing paired System Glucose Measurement (CGM) and
YSI blood glucose values. The percentage of total System readings that were within 20 mg/dL for YSI
blood glucose values < 70 mg/dL or 20% of YSI for blood glucose values ≥ 70 mg/dL is displayed in
Table B-1a. The Mean Absolute Relative Di!erence (MARD) gives an indication of the average percent
disagreement between the CGM and the reference. For example, in the Adult study, 92.2% of the
readings fell within ± 20 mg/dL of YSI blood glucose values < 70 mg/dL and within ± 20% of YSI blood
glucose values ≥ 70 mg/dL for the first 10 days of sensor wear. The total number of data pairs
considered in the 10 day analysis was 13,334. In the Adult study, the Mean Absolute Relative Di!erence
was 9.3% for the comparison with YSI reference. In the Pediatric study, the Mean Absolute Relative
Di!erence was 9.5% for the comparison with YSI reference.
Table B-1a: Overall Accuracy to YSI