Overview of the Omnipod 5 System Pivotal Clinical Study 25
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25 Overview of the Omnipod 5 System Pivotal Clinical Study
Glycaemic Results
e tables below include information on the primary and secondary glycaemic
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 (3.9–10 mmol/L, 70–180 mg/dL).
Adolescents, adults and children experienced improvements in overall A1C and
time in range aer 3 months of Omnipod 5 System use. is was achieved with a
reduction of time >10 mmol/L (>180 mg/dL) in adolescents, adults and children
as well as a reduction in median time <3.9 mmol/L (<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 glycaemic improvement; 2) the standard-
therapy phase was shorter than the Omnipod 5 System phase; 3) minimal use of
the 7.8 and 8.3 mmol/L (140 and 150 mg/dL) Target Glucose settings in adults and
adolescents limited the assessment of glycaemic results at those settings and, for
that reason, results at these Target settings were not included in this user guide.
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