OmniPod 5 - Page 341

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AppendixAppendix
High Basal Rate Delivery Performance (30.00 U/hr)
Basal Duration
(Number of units
requested)
1 hour
(30.00 U)
6 hours
(180.00 U)
Amount Delivered 29.82 U 179.33 U
[min, max] [28.85, 31.39] [177.49, 181.15]
Note: A measurement at the 12-hour period with a 30.0 U/hr basal rate is not
applicable to the Omnipod 5 System as the reservoir will empty at approximately
6 ⅔ hours at this rate.
Bolus Delivery: In order to assess bolus delivery accuracy, 12 Pods were tested by
delivering a minimum, intermediate, and maximum bolus amount (0.05, 5.00,
and 30.0 Units). Water was used as a substitute for insulin. e water was pumped
into a container on a scale and the weight of the liquid delivered was used to assess
pumping accuracy.
e following table summarizes the typical bolus performance observed for the
requested minimum, intermediate, and maximum size bolus for all pumps tested.
For each individual target bolus size, the number of boluses observed is shown
along with the average (mean), minimum, and maximum units delivered as
measured by a scale.
Individual Bolus
Accuracy
Performance
Target
Bolus
Size
(Units)
Mean
Bolus
Size
(Units)
Min
Bolus
Size
(Units)
Max
Bolus
Size
(Units)
Min Bolus Delivery
Performance
(n= 5987 boluses)
0.05 U 0.050 U 0.00 U 0.119 U
Intermediate Bolus
Delivery Performance
(n= 300 boluses)
5.00 U 5.01 U 4.49 U 5.37 U
Max Bolus Delivery
Performance
(n= 72 boluses)
30.00 U 30.05 U 29.56 U 30.62 U