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
The following table shows the time spent per day in specific glucose ranges
during the run-in and study phases by all subjects.
Table G-3: Time Spent in Specific Glucose Ranges During the Run-In and Study Phases by All Subjects
Glucose Range (mg/dL) Run-In Phase Study Phase
Time in Glucose Range (min) Mean±SD Time in Glucose Range (min) Mean±SD
≤50 7.5±8.8 7.4±6.5
≤60 22.4±20.2 21.4±13.6
≤70 51.9±37.7 49.7±23.7
>70–180 797.6±191.6 915.5±134.8
>180 590.5±211.1 474.8±142.6
>250 210.6±136.0 153.5±85.4
>300 75.0±70.8 53.5±41.2
>350 23.9±30.8 16.6±16.4
The following table shows the ranges of changes in HbA1C observed in the study
and indicates the number of subjects that demonstrated each type of change in
HbA1C observed.
Table G-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% -----
6% ≤ A1C<7% 0(0.0%) 0(0.0%) 0(0.0%) 6(13.0%) 0(0.0%)
7% ≤ A1C<8% 2(4.3%) 7(15.2%) 0(0.0%) 4(8.7%) 0(0.0%)
8% ≤ A1C<9% 4(8.7%) 11(23.9%) 1(2.2%) 2(4.3%) 0(0.0%)
9% ≤ A1C<10% 5(10.9%) 2(4.3%) 0(0.0%) 0(0.0%) 0(0.0%)
Overall 11(23.9%) 20(43.5%) 1(2.2%) 12(26.1%) 0(0.0%)
Note: For the blank cells (-), there are no subjects age 2-6 with a baseline A1C in this category.
The following table shows the number of subjects that spent a specific range of
time in specific glucose ranges during the study phase.
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
0 to 15 mins 41 (89.1%) 17 (37.0%) 0(0.0%) 0(0.0%) 0(0.0%) 1(2.2%) 11 (23.9%) 28 (60.9%)
15 to 30 mins 4 (8.7%) 21 (45.7%) 8 (17.4%) 0(0.0%) 0(0.0%) 2(4.3%) 5 (10.9%) 9 (19.6%)
30 to 45 mins 1(2.2%) 5 (10.9%) 16 (34.8%) 0(0.0%) 0(0.0%) 1(2.2%) 7 (15.2%) 6 (13.0%)
45 mins to 1
hr
0(0.0%) 2(4.3%) 12 (26.1%) 0(0.0%) 0(0.0%) 1(2.2%) 6 (13.0%) 2(4.3%)
1-4 hr 0(0.0%) 1(2.2%) 10 (21.7%) 0(0.0%) 3(6.5%) 34 (73.9%) 17 (37.0%) 1(2.2%)
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 375