Product Info

CAUTION: Note that since this study did not include a control group,
no claims regarding effectiveness can be made. However, the study
does support that the device is relatively safe for use.
Device related adverse events reported during the different phases of the pivotal
trial are listed in the following table.
Table A-1: Device Related Adverse Events
Event Run-In Period Study Period
Severe hyperglycemia 5 12
Hyperglycemia 0 6
Skin irritation 3 0
Irritation on sensor site 0 1
Rash 0 1
The following table shows the time spent per day in specific glucose ranges
during the run-in and study phases by all subjects.
Table A-2: Time Spent in Specific Glucose Ranges During the Run-In and Study Phases by All Subjects
Glucose Range (mg/dL) Run-In Phase Time in Glucose Range Mean
±SD
Study Phase Time in Glucose Range Mean
±SD
≤50 12.8 mins ± 14.5 mins 7.7 mins ± 7.6 mins
≤60 35.2 mins ± 31.2 mins 19.9 mins ± 14.8 mins
≤70 1 hr 18.6 mins ± 55.3 mins 42.9 mins ± 25.4 mins
70–180 14 hrs 54.4 mins ± 3 hrs 1.4 min 16 hrs 2.2 mins ± 2 hrs 35.6 mins
>180 6 hrs 2.1 mins ± 2 hrs 52.7 mins 5 hrs 20.7 mins ± 1 hr 46.9 mins
>250 1 hr 30.4 mins ± 1 hr 32.3 mins 1 hr 12.1 mins ± 52.6 mins
>300 29.6 mins ± 51.7 mins 21.1 mins ± 22.2 mins
>350 8.9 mins ± 20.7 mins 6.1 mins ± 8.35 mins
The following table shows the range of changes in HbA1C observed in the study
and indicates the number of subjects that demonstrated each type of change in
HbA1C observed.
Table A-3: Number of Subjects with Change in HbA1C at Different Baselines
HbA1C Change Range Number of Subjects (% of Subjects) with Change in A1C
Baseline A1C (%) Decrease >1% Decrease 0 to 1% No Change Increase 0 to 1% Increase >1%
5% ≤ A1C < 6% 0 (0.0%) 1 (0.8%) 0 (0.0%) 3 (2.4%) 0 (0.0%)
6% ≤ A1C < 7% 1 (0.8%) 20 (16.1%) 5 (4.0%) 11 (8.9%) 0 (0.0%)
7% ≤ A1C < 8% 8 (6.5%) 34 (27.4%) 1 (0.8%) 9 (7.3%) 0 (0.0%)
8% ≤ A1C < 9% 11 (8.9%) 12 (9.7%) 1 (0.8%) 0 (0.0%) 0 (0.0%)
326 Chapter 17