| Primary | Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000105.9± 2.66
- OG00194.8± 2.63
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| Primary | Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. | Posted | | Least Squares Mean | Standard Error | Scores on a Scale | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | The PAID-5 questionnaire consisted of 5 questions with answers ranging from 0 (not a problem) to 4 (serious problem). The total score was calculated as the sum of the individual questions, resulting in a number between 0 and 20 where lower scores represented lower distress. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Week 26 up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Device Satisfaction and Treatment Preference | Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | |
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| Secondary | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39 | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | Percentage | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Therapy Success Indicated by Change in Body Mass Index (BMI) | This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m^2. Change in BMI from Baseline to Week 39. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Error | kg/m^2 | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Therapy Success Indicated by Change in Weight | Change in Weight from Baseline to Week 39 | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | kg | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Change in Glycemic Index | Change in Glycemic Index from Baseline to Week 39 | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Number | | Participants | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Change in Therapy Parameters Based on Type of Insulin Used | | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Number | | U/kg | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Total Daily Insulin Dose at Baseline compared to dose at Week 39 | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | U/kg | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39 | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | U/kg | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day | Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39 | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Please note that for this Outcome Measure, incomplete SMBG data was collected which meant that data for Weeks 13, 26 and 39 could not be calculated. | Posted | | Mean | Standard Deviation | SMBGs per day | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | Percentage of Time Spent | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges. | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Mean | Standard Deviation | Percentage of Time Spent | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Number of Consultations | Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school. | Please note that this Outcome Measure was not analysed because data was not collected. | Posted | | | | | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Number of Pods/Infusion Assemblies Falling Off Prematurely | | Please note that this Outcome Measure was not analysed because data was not collected. | Posted | | | | | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Average Time Spent on Infusion Assembly | | Please note that this Outcome Measure was not analysed because data was not collected. | Posted | | | | | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Number of Participants With Skin Reactions (Including Type and Intensity) | Number of Participants who experienced Skin Reactions at the Insulin Pump Insertion Sites (along with their Type and Intensity) are presented below, from Baseline up to Week 39. Participants were asked to assess five different properties describing potential problems at the pump insertion site, namely "itching", "redness", "swelling", "heat" and "pain". Each of these questions could be answered with one of four alternatives, "None", "Minor", "Moderate" and "Severe". | The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis. | Posted | | Number | | Number of Participants | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
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| Secondary | Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard | | Please note that this Outcome Measure was not analysed because data was not collected. | Posted | | | | | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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| Secondary | Amount of Waste, Inferred by Total Material Consumption | | Please note that this Outcome Measure was not analysed because data was not collected. | Posted | | | | | | Baseline up to Week 39 | | | | ID | Title | Description |
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| OG000 | Group A: Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG001 | Group B: MDI, Then Accu-Chek® Solo | Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. | | OG002 | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy. |
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