Product Info

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%
9% ≤ A1C < 10% 6 (4.8%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Overall 26 (21.0%) 67 (54.0%) 7 (5.6%) 23 (18.5%) 0 (0.0%)
The following table shows the number of subjects that spent a specific range of
time per day in specific glucose ranges during the study phase.
Table A-4: 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 ≤60 ≤70 70 to 180 >180 >250 >300 >350
0 to 15 mins 105 (84.7%) 58 (46.8%) 12 (9.7%) 0 (0.0%) 0 (0.0%) 8 (6.5%) 66 (53.2%) 112 (90.3%)
15 to 30 mins 16 (12.9%) 43 (34.7%) 33 (26.6%) 0 (0.0%) 0 (0.0%) 16 (12.9%) 31 (25.0%) 6 (4.8%)
30 to 45 mins 3 (2.4%) 12 (9.7%) 29 (23.4%) 0 (0.0%) 0 (0.0%) 24 (19.4%) 12 (9.7%) 6 (4.8%)
45 mins to 1 hr 0 (0.0%) 10 (8.1%) 25 (20.2%) 0 (0.0%) 0 (0.0%) 17 (13.7%) 6 (4.8%) 0 (0.0%)
1 to 4 hr 0 (0.0%) 1 (0.8%) 25 (20.2%) 0 (0.0%) 34 (27.4%) 58 (46.8%) 9 (7.3%) 0 (0.0%)
4 to 8 hr 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 83 (66.9%) 1 (0.8%) 0 (0.0%) 0 (0.0%)
8 to 12 hr 0 (0.0%) 0 (0.0%) 0 (0.0%) 12 (9.7%) 7 (5.6%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
12 to 16 hr 0 (0.0%) 0 (0.0%) 0 (0.0%) 38 (30.6%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
16 to 20 hr 0 (0.0%) 0 (0.0%) 0 (0.0%) 70 (56.5%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
20 to 24 hr 0 (0.0%) 0 (0.0%) 0 (0.0%) 4 (3.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
The following table shows the average amount of time spent in Auto Mode per
day.
Table A-5: Time Spent in Auto Mode at Different Glucose Ranges during the Study Phase
Glucose Range (mg/dL) Study Phase Time in Glucose Range Mean±SD (95% CI)
≤50 4.8 mins ± 4.6 mins (4.0 mins, 5.6 mins)
≤60 13.2 mins ± 10.1 mins (11.4 mins, 15.0 mins)
≤70 29.9 mins ± 18.8 mins (26.6 mins, 33.2 mins)
70 to 180 13 hrs 50.3 mins ± 3 hrs 1.4 mins (13 hrs 18.1 min, 14 hrs 22.5 mins)
>180 4 hrs 5.2 mins ± 1 hr 5.0 mins (3 hrs 53.7 mins, 4 hrs, 16.8 mins)
>250 44.8 mins ± 24.9 mins (40.4 mins, 49.2 mins)
>300 9.3 mins ± 7.6 mins (8.0 mins, 10.7 mins)
>350 1.7 mins ± 2.0 mins (1.3 mins, 2.0 mins)
All 18 hrs 25.4 mins ± 2 hrs 44.4 mins (17 hrs 56.2 mins, 18 hrs 54.7 mins)
The pivotal clinical trial of the MiniMed 670G System 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.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 327