| Primary | Change in HbA1c | The change in HbA1c at 13 weeks from baseline | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Mean | Standard Deviation | Percentage of HbA1C | | Comparing the change in HbA1c during the 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| | | Title | Denominators | Categories |
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| Baseline or Standard Therapy (2 weeks) | | | | End of treatment or treatment phase (13 weeks) | | |
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| Secondary | Mean Glucose | Glucose metric from study provided continuous glucose monitor (CGM) | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | mg/dL | | Measuring mean glucose during the 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 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 Range 70-180 mg/dL | | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 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 CGM | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Percent of Time ≥ 300 mg/dL | | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Percent of Time > 250 mg/dL | | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Percent of Time >180 mg/dL | | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 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 [Non-inferiority; Non-inferiority Limit 2.0%] | | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%] | | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Change From Baseline in T2-DDAS Total Score | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | | Posted | | Mean | Standard Deviation | Score | | Baseline compared to end of week 13 visit | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
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| Secondary | Percentage Meeting MCID for T2-DDAS | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | | Posted | | Number | | Percentage | | Baseline compared to end week 13 visit | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Change From Baseline in Pittsburgh Sleep Quality Index Total Score | Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality). | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline compared to end of week 13 visit | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | % Meeting MCID for Pittsburgh Sleep Quality Index | Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Number | | Percentage | | Baseline compared to end of week 13 visit | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Change From Baseline in HCS Total Score | Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline compared to end week 13 visit | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | % Meeting MCID for HCS | Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Number | | Percentage | | Baseline compared to end week 13 visit | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Percentage of Time <70 mg/dL (Superiority) | | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Percentage of Time <54 mg/dL (Superiority) | | The number of participants with available data ranged from 294 to 305 across outcomes. | Posted | | Mean | Standard Deviation | Percent Time in Range | | Measured during 13 weeks study phase | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |
| Secondary | Coefficient of Variation | 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. | Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics. | Posted | | Mean | Standard Deviation | Percent coefficient of variation | | Measured during 13 weeks study phase and compared to standard therapy | | | | ID | Title | Description |
|---|
| OG000 | Treatment | All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
| |