| Primary | Time in Target Range | The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group. | | Posted | | Mean | Standard Deviation | percentage of time | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | <0.001 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | CGM Time Above 180 | CGM-measured % above 180 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Mean Glucose | CGM-measured mean glucose | | Posted | | Mean | Standard Deviation | mg/dL | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | HbA1c at 26 Weeks | Hemoglobin A1c measured at 26 weeks | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Time Below 70 | CGM-measured % below 70 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Time Below 54 | CGM-measured % below 54 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Time in Range 70-140 mg/dL | CGM-measured % in range 70-140 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Coefficient of Variability | CGM measured glucose variability measured with the coefficient of variation (CV) | | Posted | | Mean | Standard Deviation | percentage SD of Mean | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Standard Deviation of CGM | CGM measured glucose variability measured with the standard deviation (SD) | | Posted | | Mean | Standard Deviation | mg/dL | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Time Below 60 | CGM-measured % below 60 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | LBGI | Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998) | | Posted | | Mean | Standard Deviation | units on a scale | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Hypoglycemia Events | CGM-measured events of at least 15 consecutive minutes <70mg/dL per week | | Posted | | Mean | Standard Deviation | events per week | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Time >250 | CGM-measured % >250 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | CGM Time >300 | CGM-measured % >300 mg/dL | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | HBGI | High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347) | | Posted | | Mean | Standard Deviation | index | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Number of Participants With HbA1c <7.0% at 26 Weeks | Number of participants HbA1c <7.0% at 26 weeks | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Number of Participants With HbA1c <7.5% at 26 Weeks | Number of Participants with HbA1c <7.5% at 26 weeks | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5% | HbA1c improvement from baseline to 26 weeks >0.5% | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% | HbA1c improvement from baseline to 26 weeks >1.0% | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | HbA1c Relative Improvement From Baseline to 26 Weeks >10% | HbA1c relative improvement from baseline to 26 weeks >10% | | Posted | | Mean | Standard Deviation | percentage | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks | HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | HFS-II | For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia. The teen survey has a total of 25 items and the range of Total scores is 0 to 100. The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108. | | Posted | | Mean | Standard Deviation | score on a scale | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) in Adults | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) in Adults | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Hyperglycemia Avoidance Scale | Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia. | | Posted | | Mean | Standard Deviation | score on a scale | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Diabetes Distress Scale | Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress. | | Posted | | Mean | Standard Deviation | score on a scale | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Hypoglycemia Confidence Scale | Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4. | First two items on hypoglycemia confidence scale | Posted | | Mean | Full Range | score on a scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) in Adults | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) in Adults | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Clarke Hypoglycemia Awareness Scores | Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness) | | Posted | | Median | Inter-Quartile Range | score on a scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | INSPIRE Survey Scores | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items. | Scores are measured at 26 weeks | Posted | | Mean | Standard Deviation | score on a scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) in Adults | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) in Adults | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | System Usability Scores (SUS) | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability | Administered to CLC group only. Results from 26-week. | Posted | | Mean | Standard Deviation | score on a scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. |
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| Secondary | Technology Acceptance Questionnaire | Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185. | Administered to CLC arm only. Result from 26-weeks. | Posted | | Mean | Standard Deviation | score on a scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. |
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| Secondary | Total Daily Insulin | Total Daily Insulin (units) | | Posted | | Mean | Standard Deviation | units | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Basal:Bolus Insulin Ratio | Basal:Bolus Insulin Ratio | | Posted | | Mean | Standard Deviation | ratio | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | Weight | | | Posted | | Mean | Standard Deviation | kilograms | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Secondary | BMI | Body Mass Index (BMI) kg/m^2 | | Posted | | Mean | Standard Deviation | kg/m^2 | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Number of Participants With Severe Hypoglycemia (Per Protocol) | Severe hypoglycemia (per protocol) | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Number of Participants With Diabetic Ketoacidosis (Per Protocol) | Diabetic ketoacidosis (per protocol) | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | Ketone events defined as day with ketone level >1.0 mmol/L | | Posted | | Number | | days | | 26 weeks | Days | Days | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) | | Posted | | Median | Inter-Quartile Range | events per week | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL) | | Posted | | Median | Inter-Quartile Range | events per week | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | BG-measured Hypoglycemic Events (One BG Record <54 mg/dL) | BG-measured hypoglycemic events (one BG record <54 mg/dL) | | Posted | | Number | | days | | 26 weeks | Days | Days | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | BG-measured Hyperglycemic Events (One BG Record >350 mg/dL) | BG-measured hyperglycemic events (one BG record >350 mg/dL) | | Posted | | Number | | days | | 26 weeks | Days | Days | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Worsening of HbA1c From Baseline to 26 Weeks by >0.5% | Worsening of HbA1c from baseline to 26 weeks by >0.5% | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) | Other serious adverse events (SAE) and serious adverse device events (SADE) | Other Serious Adverse Events that do not include DKA or Severe Hypoglycemia | Posted | | Number | | participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Adverse Device Effects (ADE) | Adverse device effects (ADE) | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) in Adults | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) in Adults | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADE) | | Posted | | Number | | Unanticipated Adverse Device Effects | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Number of Participants With SH Events | For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | SH Event Rate Per 100 Person-years | For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate. | | Posted | | Number | | rate per 100 person-years | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Number of Participants With DKA Events | For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated. | | Posted | | Count of Participants | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | DKA Event Rate Per 100 Person-years | For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate. | | Posted | | Number | | rate per 100 person-years | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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| Other Pre-specified | Any Adverse Event Rate Per 100 Person-years | For this outcome, the adverse event rate per 100 person-years calculated as a rate. | | Posted | | Number | | events per 100 person-yr | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Closed Loop Control (CLC) | Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home. | | OG001 | Sensor-Augmented Pump (SAP) | Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology. |
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