Users Manual Part 7

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Overview of Omnipod 5 System Pivotal Clinical Study 2525 Overview of Omnipod 5 System Pivotal Clinical Study
Glycemic Results
e tables below include information on the primary and secondary glycemic
results from the standard therapy phase compared to the 3-month Omnipod
5 System treatment phase. e primary results of the study included change in
average A1C% and % time in range (70-180mg/dL). Adolescents, adults, and
children experienced improvements in overall A1C and time in range aer 3
months of Omnipod 5 System use. is was achieved with a reduction of time
>180 mg/dL in adolescents, adults, and children as well as a reduction in median
time <70 mg/dL in adolescents and adults.
Some limitations to the study include: 1) single-arm design with no control group
which could lead to an over-estimate of glycemic improvement; 2) standard
therapy phase was shorter than the Omnipod 5 System phase; 3) minimal use of
the 140 and 150 mg/dL Target Glucose settings in adults and adolescents limited
the assessment of glycemic results at those settings and, for that reason, results at
these Target settings were not included in this user guide.