The primary endpoints were change in HbA1c, Time in Range (70-180 mg/dl), and incidence of diabetic ketoacidosis and severe hypoglycemia.
The study included a 2-week standard therapy phase followed by a 3-month Omnipod® 5 automated insulin delivery phase.
Enrolled 112 children (6-13.9 years) and 128 adults (14-70 years) with type 1 diabetes.
Single-arm, multicenter, prospective clinical study across 17 sites in the United States.
Study design:
Demonstrated Clinical Outcomes
View Results
View Study Design
HbA1c
Time in Range
hypoglycemia
Children
HbA1c significantly decreased
by 0.71% (p<0.0001).
7.67±0.95%
6.99±0.63%
Adults and Adolescents
HbA1c significantly decreased
by 0.38% (p<0.0001).
7.16±0.86%
6.78±0.68%
HbA1c
Time in Range
Children
TIR was improved by 15.6±11.5% or 3.7 hours/day (p<0.0001).
Adults and Adolescents
TIR was improved by 9.3±11.8% or 2.2 hours/day in adults (p<0.0001).
Time in Range (TIR)
hypoglycemia
Children
Time in hypoglycemia <70mg/dL
remained low, from 1.38% (0.42, 2.67) to 1.48% (0.65, 2.23), P=0.8153.
Adults and Adolescents
Time in hypoglycemia <70mg/dL decreased from 2.00% (0.63, 4.06) to 1.09% (0.46, 1.75), p<0.0001).
Time in hypoglycemia <70mg/dL
Clinical Study Results
Adults and adolescents: median time spent in automated mode was 97%.
Children: median time spent in automated mode was 96%. View Article
Results displayed as mean ± standard deviation
Results displayed as mean ± standard deviation
Results displayed as median (quartile 1, quartile 3)
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