Users Manual Part 7
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CHAPTER 25
Omnipod 5 Clinical Studies
e goal of the pivotal study of the Omnipod 5 System was to assess the safety and
ecacy of the system. is single-arm, multicenter, prospective study enrolled
112 children (6 to 13.9 years) and 128 adolescents and adults (14 to 70 years).
A 2-week standard therapy phase (usual insulin regimen) was followed by 3
months of the Omnipod 5 System use in Automated Mode. e primary analysis
consisted of A1C and sensor glucose time in range (70-180 mg/dL) results. e
primary safety endpoints included an assessment of severe hypoglycemia and
diabetic ketoacidosis (DKA) events. An analysis of the secondary endpoints and
additional metrics was also performed. An analysis of the primary, secondary,
and safety results are presented in the tables below.
Of the 240 subjects enrolled, 98% completed the trial (111 children and 124
adolescents and adults). e study population consisted of people with type 1
diabetes for at least 6 months. All subjects were required to have a A1C < 10.0% at
screening. Subjects < 18 years had to be living with a parent or legal guardian. No
subjects with the following conditions were enrolled:
• History of severe hypoglycemia or DKA in the past 6 months
• Sickle cell disease, adrenal insuciency , eating disorder, abnormal kidney
function (eGFR < 45), hemophilia or any other bleeding disorders, untreated
thyroid disease
• History of cardiovascular disease including coronary artery disease, heart
attack, and cardiac intervention procedure or coronary bypass surgery in past
year
• Abnormal ECG in subjects > 50 years or diagnosed with diabetes >20 years
• Plans to receive blood transfusion during study
• Taking oral or injectable steroids or diabetes medications other than
metformin and insulin
• Pregnant or lactating women
e safety and eectiveness of the Omnipod 5 System in users with the conditions
above is unknown. Please note that the study exclusion list above is condensed
and does not include every exclusion criterion. e trial was registered at
clinicaltrials.gov, a national database of clinical trials in the United States, with ID
number NCT04196140. Full details of the study criteria can be found there.