Omnipod® 5 Automated Insulin Delivery System

*The Pod has an IP28 rating for up to 7.6 metres (25 feet) for up to 60 minutes. The Controller is not waterproof. Please consult sensor manufacturer user guide for sensor waterproof rating.

​†Compatible with the Dexcom G6 and Dexcom G7 Sensors. Sensor is required for Automated Mode. Boluses for meals and corrections are still necessary. Sensors are sold separately and require a separate prescription. The Dexcom Sensors must be used with the respective Dexcom mobile app. The Dexcom receiver is not compatible. Devices compatible with Dexcom apps can be found at https://www.dexcom.com/compatibility.  

‡Routine fingerpricks required for diabetes treatment decisions if symptoms or expectations do not match readings.

References:
1. Brown SA, et al. Diabetes Care. 2021;44(7):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. Mean time >180 mg/dL or >10 mmol/L overall in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%, p<0.0001, respectively. Mean time <70 mg/dL or <3.9 mmol/L in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 2.9% vs. 1.3%, p<0.0001; 2.2% vs. 1.8%, p=0.8153, respectively. Results measured by CGM. 

2. Sherr JL, et al. Diabetes Care. 2022;45(8):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. Hood KK et al. Diabetes Obes Metab. 2024. Study of 81 children aged 6-11.9 with type 1 diabetes using standard therapy (ST) for 2 weeks followed by 3-months of the Omnipod 5 System. Mean caregiver self-reported Hypoglycemia Confidence Scale score ST vs Omnipod 5: 3.34 vs 3.59, p-value <0.0001, respectively. During the Omnipod 5 pivotal trial, parents of children aged 6-11.9 years (N=82) experienced an improvement in emotional distress levels and mental well-being survey scores after 3 months of Omnipod 5 use compared to standard therapy: mean P-PAID-C score = 40.7 vs. 47.4; mean WHO-5 score = 72.9 vs. 67.5, respectively. During the Omnipod 5 pivotal trial, adults aged 18-70 (N=115) experienced an improved diabetes distress survey score after 3 months of AID use: mean: 1.48 vs. 1.64 (p< 0.001). During the Omnipod 5 pivotal trial, parents of children aged 6-11.9 years (N=82) experienced an improvement in emotional distress levels and mental well-being survey scores after 3 months of Omnipod 5 use compared to standard therapy: mean P-PAID-C score = 40.7 vs. 47.4; mean WHO-5 score = 72.9 vs. 67.5, respectively. During the Omnipod 5 pivotal trial, parents of children 6-11.9 years (N=82) experienced an improvement in sleep quality survey score after 3 months of Omnipod 5 use compared to standard therapy: mean PSQI Overall Sleep Quality Subscore = 0.70 vs 1.12, respectively.

4. Polonsky WH et al. Diabetes Res Clin Pract 2022;190:109998. Study of 115 adults aged 18-70 years with type 1 diabetes using standard therapy (ST) for 2 weeks followed by 3-months of the Omnipod 5 System. Mean self-reported Hypoglycemia Confidence Scale score ST vs Omnipod 5: 3.52 vs 3.65, p-value = 0.0002, respectively. Adults aged 18-70 (N=115) experienced reduction in eating distress score in T1-DDS survey after 3 months of Omnipod 5 use vs baseline: 1.73 vs. 1.97, (p=0.0003), respectively.