| Primary | Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | Measure of serious device-related adverse events | | Posted | | Number | | events per person month | | Phase 2 hybrid closed-loop (94 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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| Primary | Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | Measure of serious device-related adverse events | | Posted | | Number | | events per person month | | Phase 2 hybrid closed-loop (94 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 | percentage of HbA1C | | 6 weeks continuous Phase 2 participation 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 | % Time in Range | | Phase 2 hybrid closed-loop (94 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 | Percent of Time >180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | % Time in Range | | Phase 2 hybrid closed-loop (94 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 | Percent of Time <70 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | % Time in Range | | Phase 2 hybrid closed-loop (94 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 | % A1C | | at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 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 | 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 (270 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 in Range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 in Range 70-140 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 |
| |
| Secondary | Percent of Time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (of Glucose) | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | mg/dL | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 Coefficient of Variation (of Glucose) | Glucose metric from study continuous glucose monitoring system (CGM)- measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period. | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent coefficient of variation | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 | | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent time spent | | Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 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 | Percent 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. Percent GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of <7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more). | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | Percent GMI | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) | | | | ID | Title | Description |
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| 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 | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | units of insulin | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | units of insulin/kg | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 | 240 subjects were analyzed in Phase 2. 224 subjects were analyzed in Phase 3. | Posted | | Mean | Standard Deviation | units of insulin | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | units of insulin/kg | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 | 240 subjects were analyzed in Phase 2. 224 subjects were analyzed in Phase 3. | Posted | | Mean | Standard Deviation | units of insulin | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 |
| |
| Secondary | Total Daily Bolus Insulin (Units/kg) | Measure of insulin requirements | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | units of insulin/kg | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 | 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3. | Posted | | Mean | Standard Deviation | kg/m^2 | | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 |
| |
| Other Pre-specified | Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) | | | Posted | | Number | | Percentage with hypoglycemia events | | HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge) | | | | 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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| Other Pre-specified | Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) | Number of hypoglycemic events less than 70mg/dL which was confirmed with a blood glucose reading. | | Posted | | Number | | Number of events | | HypoProtect compared to Automated Mode (3-day exercise challenge) | | | | 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 |
| |
| Other Pre-specified | Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | hours x mg/dL | | HypoProtect compared to Automated Mode (3-day exercise challenge) | | | | 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 |
| | |
| Other Pre-specified | Minimum Continuous Glucose Monitor Value (Nadir Glucose) | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | mg/dL | | HypoProtect compared to Automated Mode (3-day exercise challenge) | | | | 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 |
| | |
| Other Pre-specified | Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | hours x mg/dL | | HypoProtect compared to Automated Mode (3-day exercise challenge) | | | | 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 |
| | |
| Other Pre-specified | Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | mg/dL | | HypoProtect compared to Automated Mode (3-day exercise challenge) | | | | 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 |
| | |
| Other Pre-specified | Carbohydrates Consumed During Exercise (Grams) | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | grams | | HypoProtect compared to Automated Mode (3-day exercise challenge) | | | | 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 |
| | |
| Other Pre-specified | Mean Glucose | Glucose metric from study continuous glucose monitoring system (CGM) | | Posted | | Mean | Standard Deviation | mg/dL | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Percent of Time in Range 70-180 mg/dL | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | Percent of time | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Percent of Time > 180 mg/dL | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | Percent of time | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Percent of Time ≥ 250 mg/dL | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | Percent of time | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Percent of Time ≥ 300 mg/dL | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | percent of time | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Percent of Time < 70 mg/dL | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | Percent of time | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Percent of Time < 54 mg/dL | Measure of device effectiveness | | Posted | | Mean | Standard Deviation | Percent of time | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| | |
| Other Pre-specified | Standard Deviation (of Glucose) | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | | Posted | | Mean | Standard Deviation | mg/dL | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| |
| Other Pre-specified | Coefficient of Variation (of Glucose) | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period. | | Posted | | Mean | Standard Deviation | Percent coefficient of variation | | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | | | | 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 |
| |