Product Info
Table Of Contents
- M998590A011DOC_A_FINAL_UserGuide_Part2
- Troubleshooting
- Maintenance
- Product specifications and safety information
- Product specifications
- Alarm and alert escalation
- Altitude range
- Audio frequency
- Backlight
- Basal delivery
- BG Target
- BG meter value
- Bolus delivery
- Bolus Wizard feature default settings
- Bolus Wizard feature specifications
- Carb ratios
- Delivery accuracy
- Easy Bolus feature
- Environmental conditions
- Essential performance
- Filling the infusion set and cannula
- Infusion pressure
- Insulin delivery default settings
- Bolus settings
- Basal settings
- Insulin sensitivity factor
- Low Reservoir reminder
- Max Bolus
- Normal bolus
- Occlusion detection
- Percent temp basal
- Program safety checks
- Pump dimensions
- Pump memory
- Pump weight
- Sensor default settings
- Wireless communication
- FCC notice
- IEC60601-1-2:4th Edition notice
- Guidance and manufacturer's declaration
- Icon glossary
- Product specifications
- 670G Performance Data and Technical Information
Table D-4: 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%) 0(0.0%) 0(0.0%) 1(1.0%) 0(0.0%)
6% ≤ A1C < 7% 0(0.0%) 1(1.0%) 0(0.0%) 9(8.6%) 0(0.0%)
7% ≤ A1C < 8% 3(2.9%) 22(21.0%) 6(5.7%) 16(15.2%) 0(0.0%)
8% ≤ A1C < 9% 9(8.6%) 21(20.0%) 3(2.9%) 4(3.8%) 0(0.0%)
9% ≤ A1C < 10% 4(3.8%) 6(5.7%) 0(0.0%) 0(0.0%) 0(0.0%)
Overall 16(15.2%) 50(47.6%) 9(8.6%) 30(28.6%) 0(0.0%)
The following table shows the number of subjects that spent a specific range of
time in specific glucose ranges during the study phase.
Table D-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
0 to 15 mins 93(88.6%) 41(39.0%) 13(12.4%) 0(0.0%) 0(0.0%) 1(1.0%)
15 to 30 mins 10(9.5%) 46(43.8%) 23(21.9%) 0(0.0%) 0(0.0%) 1(1.0%)
30 to 45 mins 2(1.9%) 12(11.4%) 24(22.9%) 0(0.0%) 0(0.0%) 4(3.8%)
45 mins to 1 hr 0(0.0%) 3(2.9%) 23(21.9%) 0(0.0%) 0(0.0%) 2(1.9%)
1-4 hr 0(0.0%) 3(2.9%) 22(21.0%) 0(0.0%) 2(1.9%) 83(79.0%)
4-8 hr 0(0.0%) 0(0.0%) 0(0.0%) 0(0.0%) 54(51.4%) 14(13.3%)
8-12 hr 0(0.0%) 0(0.0%) 0(0.0%) 5(4.8%) 49(46.7%) 0(0.0%)
12-16 hr 0(0.0%) 0(0.0%) 0(0.0%) 54(51.4%) 0(0.0%) 0(0.0%)
16-20 hr 0(0.0%) 0(0.0%) 0(0.0%) 45(42.9%) 0(0.0%) 0(0.0%)
20-24 hr 0(0.0%) 0(0.0%) 0(0.0%) 1(1.0%) 0(0.0%) 0(0.0%)
The following table shows the average amount of time spent in Auto Mode per
day.
Table D-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 5.0±4.0
≤60 14.0±9.0
≤70 31.2±16.8
70–180 797.0±142.2
>180 321.9±59.2
>250 84.2±32.4
All 1150.1±132.9
The pediatric 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:
352 Chapter 17