Product Info

Table D-1: Run-In Period Severe Hyperglycemia:
Cause Total
Infusion set change 9
Occlusion Alarm 3
Infusion set fell out 2
Bent or Kinked Cannula 1
Total 15
Table D-2: Study Period Severe Hyperglycemia:
Cause Total
Infusion set change 28
Occlusion Alarm 12
Infusion set fell out 7
Bent or Kinked Cannula 5
Infusion set change or safe basal 3
Safe basal 2
Suspend before low suspension 1
Automatic & manual suspensions 1
Unclipped infusion set 1
Internal Battery Connector Resistance 1
Manual suspension and safe basal 1
Total 62
The following table shows the time spent per day in specific glucose ranges
during the run-in and study phases by all subjects.
Table D-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 12.2±16.9 7.8±7.3
≤60 32.3±32.7 20.3±14.2
≤70 68.3±55.4 43.1±23.6
70–180 808.6±163.5 936.2±110.4
>180 563.1±184.3 460.7±110.5
>250 191.0±111.5 148.4±74.1
>300 68.1±54.8 53.7±39.4
>350 23.0±24.9 17.4±17.1
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.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 351