1. Study in 240 people with T1D aged 6 - 70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average day time (6AM-12AM) in Target Glucose range (from CGM) in adults/adolescents and children for standard therapy vs Omnipod 5 = 64.8% vs. 72.5%; 51.5% vs. 64.6%. Average overnight (12AM-6AM) in Target Glucose range (from CGM) in adults/adolescents and children for standard therapy vs Omnipod 5 = 64.3% vs. 78.1%; 55.3% vs. 78.1%. Brown et al. Diabetes Care (2021).
2. Study in 80 people with T1D aged 2 - 5.9 yrs involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average time in Target Glucose range (6AM-12AM) from CGM in standard therapy vs Omnipod 5 = 58.2% vs. 64.3%. Average time in Target Glucose range (12AM-6AM) from CGM in standard therapy vs. Omnipod 5 = 60.6% vs 82.4%. Sherr JL, et al. Diabetes Care (2022).
3. Insulet Data on File. SECURE-T2D Clinical Study Report. 2024. Prospective pivotal trial in 305 participants with T2D aged 18-75 yrs. Study included a 14-day standard therapy (ST) phase followed by a 13-week Omnipod 5 hybrid closed-loop phase. Mean overnight time 70-180 mg/dL (12AM-6AM) as measured by CGM: ST = 49%, 3-mo Omnipod 5 = 70%. Mean daytime 70-180 mg/dL (6AM-12AM) as measured by CGM: ST = 44%, 3-mo Omnipod 5 = 64%. Statistical testing not done to assess significance of change between ST phase and Omnipod 5 System phase.
4. Study in 240 people with T1D aged 6 - 70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average overnight time (12AM-6AM) with high blood glucose in adults/adolescents and children for standard therapy vs. Omnipod 5 = 32.1% vs. 20.7%; 42.2% vs. 20.7%. Average day time (6AM-12AM) with high blood glucose in adults/adolescents and children for standard therapy vs. Omnipod 5 = 32.6% vs. 26.1%; 46.4% vs. 33.4%. Median overnight time (12AM-6AM) with low blood glucose in adults/adolescents and children for standard therapy vs. Omnipod 5 = 2.07% vs. 0.82%; 0.78% vs. 0.78%. Median day time (6AM-12AM) with low blood glucose in adults/adolescents and children for standard therapy vs. Omnipod 5 = 1.91% vs. 1.08%; 1.17% vs. 1.62%. Brown et al. Diabetes Care (2021).
5. Study in 80 people with T1D aged 2 - 5.9 yrs involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average time with high blood glucose overnight from CGM in standard therapy vs. Omnipod 5 = 38.4% vs. 16.9%. Average time with high blood during daytime from CGM in standard therapy vs. Omnipod 5 = 39.7% vs. 33.7%. Average time with low blood glucose overnight from CGM in standard therapy vs. Omnipod 5 = 3.41% vs. 2.13%. Average time with low blood glucose during daytime from CGM in standard therapy vs. Omnipod 5 = 3.44% vs. 2.57%. Sherr JL, et al. Diabetes Care (2022).
6. Pasquel FJ, et al. Presented at: ADA; June 21-24, 2024; Orlando, FL. Prospective pivotal trial in 305 participants with T2D aged 18-75 yrs. Study included a 14-day standard therapy (ST) phase followed by a 13-week Omnipod 5 hybrid closed-loop phase. Mean time <70 mg/dL as measured by CGM: ST = 0.2%, 3-mo Omnipod 5 = 0.2%, P<001. Mean time >180 mg/dL as measured by CGM: ST = 54%, 3-mo Omnipod 5 = 34%, P<0.001. Comparison is relative change.
