Omnipod® 5 with Dexcom Integration

*When used in automated mode with Dexcom G7, the Omnipod 5 System makes adjustments to insulin delivery every 5 minutes based on the user's current CGM value, glucose values predicted 60 minutes in the future, glucose trend, and past insulin delivery to bring glucose to a user defined target.

†For a list of compatible devices, visit www.dexcom.com/compatibility

1. Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop (HCL) phase. Mean time in range (3.9-10.0 mmol/L or 70-180mg/dL) in adults/adolescents as measured by CGM: ST = 64.7%, 3-mo Omnipod 5 = 73.9%, P<0.0001. Mean time in range (3.9-10.0 mmol/L or 70-180mg/dL) in children as measured by CGM: ST = 52.5%, 3-mo Omnipod 5 = 68.0%, P<0.0001. Mean HbA1c: ST vs. Omnipod 5 use in adults/adolescents (14-70 yrs) and children (6-13.9 yrs), respectively (7.16% vs 6.78% or 55 mmol/mol vs. 51 mmol/mol, P<0.0001; 7.67% vs 6.99% or 60mmol/mol vs 53 mmol/mol), P<0.0001. Mean time >10.0 mmol/L or >180mg/dL (12AM-<6AM) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod 5: 32.1% vs. 20.7%; 42.2% vs 20.7%, P<0.0001, respectively. Mean time >10.0 mmol/L or >180mg/dL (6AM-<12AM) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod 5: 32.6% vs. 26.1%; 46.4% vs 33.4%, P<0.0001, respectively. Mean time <3.9 mmol/L or <70 mg/dL (12AM-<6AM) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod 5: 3.64% vs. 1.17%, P<0.0001; 2.51% vs. 1.78, P=0.0456, respectively. Mean time <3.9 mmol/L or <70 mg/dL (6AM-<12AM) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod 5: 2.64% vs. 1.37%, P<0.0001; 2.13% vs. 1.98%, P=0.2545, respectively.

2. Sherr J. et al. Diabetes Care. 2022; 45:1907-1910. Single-arm multicenter clinical trial in 80 pre-school children (aged 2-5.9 yrs) with T1D. Study included a 14-daystandard therapy (ST) phase followed by a 3-month AID phase with Omnipod 5 system. Mean HbA1c as measured in very young children, ST vs. Omnipod 5 use:7.4% vs 6.9% or 57 mmol/ml vs. 53 mmol/mol; (P<0.0001). Mean time in range (3.9-10.0 mmol/L or 70-180mg/dL) as measured by CGM in children ST vs. 3-mo Omnipod 5: 57.2% vs 68.1%, P<0.0001. Mean time >10.0 mmol/L or >180mg/dL (12AM-<6AM) as measured by CGM in children ST vs. 3-mo Omnipod 5: 38.4% vs. 16.9%, P<0.0001, respectively. Mean time >10.0 mmol/L or >180mg/dL (6AM-<12AM) as measured by CGM in children ST vs. 3-mo Omnipod 5: 39.7% vs. 33.7%, P<0.0001, respectively. Mean time <3.9 mmol/L or <70 mg/dL (12AM-<6AM) as measured by CGM in children ST vs. 3-mo Omnipod 5: 3.41% vs. 2.13%, P=0.0185. Mean time <3.9 mmol/L or <70 mg/dL (6AM-<12AM) as measured by CGM in children ST vs. 3-mo Omnipod 5: 3.44% vs. 2.57%, P=0.0799.

3. Renard E et al. Diabetes Care. 2024. doi:10.2337/dc24-1550. A 13-week randomised control trial conducted among 194 adults (age 18-70 years) with type 1 diabetes in France and the U.S., comparing the safety and effectiveness of the Omnipod 5 Automated Insulin Delivery (AID) System versus conventional non-AID pump therapy and CGM (control). Mean change in HbA1c at 13-weeks: Control = -0.68% or -7.4 mmol/mol, Omnipod 5 = -1.24% or -13.6 mmol/mol. Mean adjusted difference Omnipod 5—control = -0.58% or -6.3 mmol/mol, P<0.0001.