| Primary | Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | Number of severe hypoglycemia events reported in "events per person months" units. | | Posted | | Number | | events per person months | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
| | | Title | Denominators | Categories |
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| Phase 2 | | | | Phase 3 | | |
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| Primary | Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | Number of DKA events reported in "events per person months" units. | | Posted | | Number | | events per person months | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Primary | Glycated Hemoglobin (A1C) | Measures device effectiveness | | Posted | | Mean | Standard Deviation | percent A1C | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Primary | Time in Range 70-180 mg/dL | Measures device effectiveness | | Posted | | Mean | Standard Deviation | percent time in range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Glycated Hemoglobin (A1C) | Measures device effectiveness | | Posted | | Mean | Standard Deviation | percent A1C | | Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percent of Time in Range 70-140 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | percent time in range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percent of Time > 180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | percent of time | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percent of Time ≥ 250 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | percent of time | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percent of Time ≥ 300 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | percent of time | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percent of Time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | percent of time | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percent of Time < 54 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | percent of time | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Mean Glucose | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | mg/dL | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Standard Deviation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | | Posted | | Mean | Standard Deviation | mg/dL | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) | | Posted | | Mean | Standard Deviation | percent coefficient of variation | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Measure of system usage in Automated and Manual modes. Percentage of time in Automated and Manual mode do not add up to 100% due to missing data from participants not using the Omnipod 5 system (e.g., not wearing a Pod). | | Posted | | Mean | Standard Deviation | percent of time | | Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Glucose Management Indicator (GMI) | Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more. | | Posted | | Mean | Standard Deviation | percent of gmi | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Total Daily Insulin (TDI) (Units) | Measure of insulin requirements | | Posted | | Mean | Standard Deviation | units | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Total Daily Insulin (TDI) (Units/kg) | Measure of insulin requirements | | Posted | | Mean | Standard Deviation | units/kg | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Total Daily Basal Insulin (Units) | Measure of insulin requirements | | Posted | | Mean | Standard Deviation | units | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Total Daily Basal Insulin (Units/kg) | Measure of insulin requirements | | Posted | | Mean | Standard Deviation | units/kg | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Total Daily Bolus Insulin (Units) | Measure of insulin requirements | | Posted | | Mean | Standard Deviation | units | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Total Daily Bolus Insulin (Units/kg) | Measure of insulin requirements | | Posted | | Mean | Standard Deviation | units/kg | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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| Secondary | Body Mass Index (BMI) (kg/m^2) | Measure of change in weight | | Posted | | Mean | Standard Deviation | kg/m^2 | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. |
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