Product Info

Table G-5: Number of Subjects that Spent a Certain Time Range in Each Glucose Range During the Study Phase
Time Range Number of Subjects (% of Subjects) in the Glucose Range (mg/dL) Indicated
≤ 50 mg/dL ≤ 60 mg/dL ≤ 70 mg/dL 70 to 180
mg/dL
> 180 mg/dL > 250 mg/dL >300 mg/dL >350 mg/dL
4-8 hr 0(0.0%) 0(0.0%) 0(0.0%) 0(0.0%) 18 (39.1%) 7 (15.2%) 0(0.0%) 0(0.0%)
8-12 hr 0(0.0%) 0(0.0%) 0(0.0%) 3(6.5%) 22 (47.8%) 0(0.0%) 0(0.0%) 0(0.0%)
12-16 hr 0(0.0%) 0(0.0%) 0(0.0%) 25 (54.3%) 3(6.5%) 0(0.0%) 0(0.0%) 0(0.0%)
16-20 hr 0(0.0%) 0(0.0%) 0(0.0%) 17 (37.0%) 0(0.0%) 0(0.0%) 0(0.0%) 0(0.0%)
20-24 hr 0(0.0%) 0(0.0%) 0(0.0%) 1(2.2%) 0(0.0%) 0(0.0%) 0(0.0%) 0(0.0%)
Table G-6: Time Spent in Auto Mode at Different
Glucose Ranges during the Study Phase
Glucose Range
(mg/dL)
Study Phase Time in Glucose
Range (min) Mean±SD
≤ 50 6.2±5.4
≤ 60 18.1±11.4
≤ 70 42.4±19.8
70–180 805.1±139.8
>180 371.9±106.1
>250 107.7±56.5
>300 mg/dL 32.3±23.9
>350 mg/dL 7.7±7.5
All 1219.4±93.0
The pediatric pivotal clinical trial of the 670G suggested that the system was safe;
however, this trial had a number of limitations which included the following:
• 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
670G system may be significantly different from those of the subjects who
participated in the trial.
H. Guardian Sensor (3) Performance in users ages 2 through 6
CGM performance
376 Chapter 17