Diabetes Mellitus, Type 1
Conditions
Brief summary
This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.
Interventions
DEVICEAccu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
DEVICEmylife™ OmniPod® Insulin Management System
A patch pump system delivering insulin.
OTHERMultiple Daily Injections (MDI) therapy
Injecting insulin as per participant's need.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed type 1 diabetes mellitus * At least 6 months experience with MDI therapy * Age ≥18 years and age ≤ 65 * Able to perform carbohydrate counting * Clinically suitable for CSII including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently * HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months) * Ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures * Ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase * Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device that can be downloaded via Accu-Chek® Smart Pix or willingness to use a compatible meter that will be provided for the duration of the study
Exclusion criteria
* Prior insulin pump use * Relevantly impaired hypoglycemia awareness * History of \>1 hospitalization due to severe hypoglycemia within the previous 3 months * History of \>1 hospitalization due diabetic ketoacidosis within the last 3 months * Significant manifestation of diabetes-related late complications * Pregnant or planning to become pregnant or breastfeeding * Known allergic reactions to plaster adhesive * Chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy * Serious or unstable chronic medical or psychological condition(s) * Addiction to alcohol or other substance(s) of abuse as determined by the investigator * Psychological condition rendering the participant unable to understand the nature and the scope of the study * Plans for relocation or extensive travel * Participation in another clinical study within 4 weeks prior to the screening visit * Dependency on Sponsor or Investigator (e.g. co-worker or family member)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | 26 weeks | 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. |
| Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | 26 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | Baseline up to Week 39 | Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39 |
| Therapy Success Indicated by Change in Body Mass Index (BMI) | Baseline up to Week 39 | 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. |
| Therapy Success Indicated by Change in Weight | Baseline up to Week 39 | Change in Weight from Baseline to Week 39 |
| Change in Glycemic Index | Baseline up to Week 39 | Change in Glycemic Index from Baseline to Week 39 |
| Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Baseline up to Week 39 | 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. |
| Change in Therapy Parameters Based on Type of Insulin Used | Baseline up to Week 39 | — |
| Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Baseline up to Week 39 | Total Daily Insulin Dose at Baseline compared to dose at Week 39 |
| Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Baseline up to Week 39 | Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39 |
| Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 26 up to Week 39 | 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. |
| Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | Baseline up to Week 39 | Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges. |
| Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | Baseline up to Week 39 | Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges. |
| Number of Consultations | Baseline up to Week 39 | Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school. |
| Number of Pods/Infusion Assemblies Falling Off Prematurely | Baseline up to Week 39 | — |
| Average Time Spent on Infusion Assembly | Baseline up to Week 39 | — |
| Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline up to Week 39 | 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. |
| Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard | Baseline up to Week 39 | — |
| Amount of Waste, Inferred by Total Material Consumption | Baseline up to Week 39 | — |
| Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day | Baseline up to Week 39 | Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39 |
| Device Satisfaction and Treatment Preference | Baseline up to Week 39 | 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. |
Countries
Austria, Germany, Poland, United Kingdom
Participant flow
Recruitment details
The study was conducted at 21 centers in 4 countries.
Pre-assignment details
A total of 187 participants were screened into this study, of whom 6 participants were screen failures meaning that a total of 181 participants were randomised into this study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| 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. | 61 |
| 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. | 58 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 |
| Overall Study | Covid-19 | 1 | 4 | 3 |
| Overall Study | Eligibility Criteria | 0 | 0 | 5 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Multiple Reasons | 0 | 1 | 1 |
| Overall Study | Personal Reasons | 1 | 0 | 1 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 7 | 6 |
Baseline characteristics
| Characteristic | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Total |
|---|---|---|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 11.8 | 38.6 years STANDARD_DEVIATION 10.8 | 40.6 years STANDARD_DEVIATION 13.1 | 39.0 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 59 Participants | 60 Participants | 56 Participants | 175 Participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 21 Participants | 79 Participants |
| Sex: Female, Male Male | 33 Participants | 32 Participants | 37 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 61 | 0 / 58 | 0 / 165 |
| other Total, other adverse events | 44 / 62 | 35 / 61 | 35 / 58 | 82 / 165 |
| serious Total, serious adverse events | 6 / 62 | 1 / 61 | 5 / 58 | 4 / 165 |
Outcome results
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.
Time frame: 26 weeks
Population: The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A: Accu-Chek® Solo | Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | 105.9 Scores on a Scale | Standard Error 2.66 |
| Group B: MDI, Then Accu-Chek® Solo | Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | 94.8 Scores on a Scale | Standard Error 2.63 |
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.
Time frame: 26 weeks
Population: The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A: Accu-Chek® Solo | Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | 105.1 Scores on a Scale | Standard Error 3.04 |
| Group B: MDI, Then Accu-Chek® Solo | Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | 108.7 Scores on a Scale | Standard Error 2.85 |
Secondary
Amount of Waste, Inferred by Total Material Consumption
Time frame: Baseline up to Week 39
Population: Please note that this Outcome Measure was not analysed because data was not collected.
Secondary
Average Time Spent on Infusion Assembly
Time frame: Baseline up to Week 39
Population: Please note that this Outcome Measure was not analysed because data was not collected.
Secondary
Change in Glycemic Index
Change in Glycemic Index from Baseline to Week 39
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Change in Glycemic Index | Week 26 to Week 39 | 75.0 mg/dL | Standard Deviation 17 |
| Group A: Accu-Chek® Solo | Change in Glycemic Index | Week 13 to Week 26 | 75.0 mg/dL | Standard Deviation 21.6 |
| Group A: Accu-Chek® Solo | Change in Glycemic Index | Baseline to Week 13 | 77.0 mg/dL | Standard Deviation 15 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Glycemic Index | Week 26 to Week 39 | 73.9 mg/dL | Standard Deviation 15.2 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Glycemic Index | Baseline to Week 13 | 71.7 mg/dL | Standard Deviation 15.6 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Glycemic Index | Week 13 to Week 26 | 70.2 mg/dL | Standard Deviation 13.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Glycemic Index | Week 13 to Week 26 | 68.9 mg/dL | Standard Deviation 10 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Glycemic Index | Week 26 to Week 39 | 77.1 mg/dL | Standard Deviation 15.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Glycemic Index | Baseline to Week 13 | 68.1 mg/dL | Standard Deviation 10.2 |
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
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day | 3.2 SMBGs per day | Standard Deviation 3 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day | 3.4 SMBGs per day | Standard Deviation 3.8 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day | 2.5 SMBGs per day | Standard Deviation 3.1 |
Secondary
Change in Therapy Parameters Based on Type of Insulin Used
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 39) | 3 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: NovoRapid (Week 26) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Protaphane (Screening) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 26) | 19 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 13) | 34 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Screening) | 21 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 26) | 2 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 13) | 2 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Screening) | 37 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 26) | 34 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 13) | 20 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 39) | 2 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 13) | 1 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 13) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Regular human insulin (Screening) | 2 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 13) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 39) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 39) | 36 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulatard (Screening) | 1 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 39) | 1 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 26) | 1 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Screening) | 9 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Screening) | 2 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 26) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Screening) | 10 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 39) | 22 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 26) | 0 U/kg |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Screening) | 42 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 39) | 22 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 39) | 8 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 39) | 3 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Protaphane (Screening) | 1 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Screening) | 30 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Screening) | 9 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Screening) | 22 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Regular human insulin (Screening) | 0 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulatard (Screening) | 1 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Screening) | 9 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Screening) | 12 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Screening) | 38 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 13) | 11 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 13) | 5 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 13) | 9 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 13) | 3 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 13) | 8 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 13) | 14 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 26) | 20 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 26) | 7 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 26) | 16 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: NovoRapid (Week 26) | 1 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 26) | 10 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 26) | 9 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 26) | 25 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 39) | 27 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 39) | 1 U/kg |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 39) | 3 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Screening) | 32 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 39) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: NovoRapid (Week 26) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Screening) | 13 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Week 39) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin degludec (Screening) | 13 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Screening) | 39 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulatard (Screening) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin glargine (Week 39) | 2 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Regular human insulin (Screening) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Insulin detemir (Week 39) | 2 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 13) | 20 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 39) | 32 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 13) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Screening) | 17 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 26) | 32 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin aspart (Week 13) | 32 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 39) | 21 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Week 26) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Long Acting Insulin: Protaphane (Screening) | 0 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin glulisine (Screening) | 2 U/kg |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Based on Type of Insulin Used | Short Acting Insulin: Insulin lispro (Week 26) | 20 U/kg |
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
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Screening | 0.3 U/kg | Standard Deviation 0.1 |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 13 | 0.3 U/kg | Standard Deviation 0.1 |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 26 | 0.3 U/kg | Standard Deviation 0.1 |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 39 | 0.3 U/kg | Standard Deviation 0.1 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 39 | 0.3 U/kg | Standard Deviation 0.1 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Screening | 0.3 U/kg | Standard Deviation 0.1 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 26 | 0.3 U/kg | Standard Deviation 0.1 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 13 | 0.3 U/kg | Standard Deviation 0.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 39 | 0.3 U/kg | Standard Deviation 0.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 13 | 0.2 U/kg | Standard Deviation 0.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Week 26 | 0.3 U/kg | Standard Deviation 0.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Screening | 0.3 U/kg | Standard Deviation 0.1 |
Secondary
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Total Daily Insulin Dose at Baseline compared to dose at Week 39
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 39 | 0.6 U/kg | Standard Deviation 0.2 |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Screening | 0.7 U/kg | Standard Deviation 0.2 |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 13 | 0.6 U/kg | Standard Deviation 0.2 |
| Group A: Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 26 | 0.6 U/kg | Standard Deviation 0.2 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 26 | 0.6 U/kg | Standard Deviation 0.2 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 39 | 0.6 U/kg | Standard Deviation 0.2 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 13 | 0.6 U/kg | Standard Deviation 0.2 |
| Group B: MDI, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Screening | 0.6 U/kg | Standard Deviation 0.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 26 | 0.6 U/kg | Standard Deviation 0.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Screening | 0.7 U/kg | Standard Deviation 0.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 13 | 0.6 U/kg | Standard Deviation 0.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) | Week 39 | 0.6 U/kg | Standard Deviation 0.2 |
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.
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 13 (Insulin Pump) | 32.7 Scores on a Scale | Standard Deviation 7.3 |
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 26 (Insulin Pump) | 33.4 Scores on a Scale | Standard Deviation 6.6 |
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 39 (Insulin Pump) | 33.4 Scores on a Scale | Standard Deviation 6.9 |
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Screening (Blood Glucose Meter) | 35.3 Scores on a Scale | Standard Deviation 5.7 |
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 13 (Blood Glucose Meter) | 34.9 Scores on a Scale | Standard Deviation 6.1 |
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 26 (Blood Glucose Meter) | 34.3 Scores on a Scale | Standard Deviation 6.1 |
| Group A: Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 39 (Blood Glucose Meter) | 34.7 Scores on a Scale | Standard Deviation 7.3 |
| Group B: MDI, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Screening (Blood Glucose Meter) | 33.8 Scores on a Scale | Standard Deviation 5.4 |
| Group B: MDI, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 39 (Blood Glucose Meter) | 34.5 Scores on a Scale | Standard Deviation 5.8 |
| Group B: MDI, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 13 (Blood Glucose Meter) | 34.0 Scores on a Scale | Standard Deviation 5.6 |
| Group B: MDI, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 26 (Blood Glucose Meter) | 33.8 Scores on a Scale | Standard Deviation 5.1 |
| Group B: MDI, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 39 (Insulin Pump) | 33.8 Scores on a Scale | Standard Deviation 6.3 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 39 (Blood Glucose Meter) | 34.8 Scores on a Scale | Standard Deviation 5.8 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 39 (Insulin Pump) | 31.0 Scores on a Scale | Standard Deviation 7 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 26 (Insulin Pump) | 35.3 Scores on a Scale | Standard Deviation 5.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Screening (Blood Glucose Meter) | 35.7 Scores on a Scale | Standard Deviation 5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 26 (Blood Glucose Meter) | 34.9 Scores on a Scale | Standard Deviation 6.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 13 (Insulin Pump) | 35.3 Scores on a Scale | Standard Deviation 4.9 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Device Satisfaction and Treatment Preference | Week 13 (Blood Glucose Meter) | 34.9 Scores on a Scale | Standard Deviation 5.5 |
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.
Time frame: Week 26 up to Week 39
Population: The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 26 | 7.0 Scores on a Scale | Standard Deviation 4.7 |
| Group A: Accu-Chek® Solo | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 39 | 6.3 Scores on a Scale | Standard Deviation 4.2 |
| Group B: MDI, Then Accu-Chek® Solo | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 26 | 7.8 Scores on a Scale | Standard Deviation 4.3 |
| Group B: MDI, Then Accu-Chek® Solo | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 39 | 7.1 Scores on a Scale | Standard Deviation 4.5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 26 | 5.3 Scores on a Scale | Standard Deviation 3.5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | Week 39 | 5.8 Scores on a Scale | Standard Deviation 3.8 |
Secondary
Number of Consultations
Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.
Time frame: Baseline up to Week 39
Population: Please note that this Outcome Measure was not analysed because data was not collected.
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.
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Moderate Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Minor Intensity) | 16 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Minor Intensity) | 3 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Minor Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Moderate Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Minor Intensity) | 2 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Minor Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Minor Intensity) | 4 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Minor Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Moderate Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Moderate Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Minor Intensity) | 5 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Minor Intensity) | 3 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Minor Intensity) | 2 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Moderate Intensity) | 2 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Minor Intensity) | 3 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Minor Intensity) | 5 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Severe Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Moderate Intensity) | 2 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Minor Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Moderate Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Minor Intensity) | 4 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Moderate Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Minor Intensity) | 8 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Minor Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Moderate Intensity) | 2 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Minor Intensity) | 3 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Minor Intensity) | 6 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Minor Intensity) | 15 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Minor Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Moderate Intensity) | 0 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Severe Intensity) | 1 Number of Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Moderate Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Minor Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Minor Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Minor Intensity) | 2 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Minor Intensity) | 8 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Moderate Intensity) | 3 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Minor Intensity) | 3 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Minor Intensity) | 4 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Minor Intensity) | 3 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Minor Intensity) | 11 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Moderate Intensity) | 6 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Severe Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Minor Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Minor Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Minor Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Minor Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Moderate Intensity) | 4 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Minor Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Minor Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Moderate Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Minor Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Minor Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Moderate Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Severe Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Minor Intensity) | 3 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Minor Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Minor Intensity) | 3 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Moderate Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Minor Intensity) | 4 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Moderate Intensity) | 1 Number of Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Severe Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Moderate Intensity) | 4 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Severe Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Redness) (Minor Intensity) | 9 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Moderate Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Minor Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Minor Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Moderate Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Moderate Intensity) | 5 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Moderate Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Redness) (Minor Intensity) | 11 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Minor Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Moderate Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Moderate Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Itching) (Minor Intensity) | 4 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Heat) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Redness) (Minor Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Moderate Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Minor Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Severe Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Pain) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Moderate Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Moderate Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Minor Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Pain) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Moderate Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Moderate Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Itching) (Minor Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Swelling) (Minor Intensity) | 7 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Itching) (Minor Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Minor Intensity) | 6 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Minor Intensity) | 3 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Moderate Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Moderate Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Swelling) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Swelling) (Minor Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Moderate Intensity) | 5 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Minor Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Severe Intensity) | 1 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Pain) (Moderate Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Moderate Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Moderate Intensity) | 6 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 26 (Itching) (Minor Intensity) | 2 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Baseline (Heat) (Severe Intensity) | 0 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Redness) (Minor Intensity) | 10 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 39 (Pain) (Minor Intensity) | 4 Number of Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Skin Reactions (Including Type and Intensity) | Week 13 (Heat) (Minor Intensity) | 3 Number of Participants |
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.
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | HbA1c goals not met | 62 Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Participant wish | 47 Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Frequent hypoglycemia | 9 Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Dawn phenomenon | 3 Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Glycemic variability | 1 Participants |
| Group A: Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Shift working | 1 Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Shift working | 0 Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | HbA1c goals not met | 61 Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Dawn phenomenon | 2 Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Glycemic variability | 3 Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Participant wish | 45 Participants |
| Group B: MDI, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Frequent hypoglycemia | 9 Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Participant wish | 32 Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Frequent hypoglycemia | 13 Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Shift working | 1 Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Dawn phenomenon | 2 Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | HbA1c goals not met | 56 Participants |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Glycemic variability | 2 Participants |
Secondary
Number of Pods/Infusion Assemblies Falling Off Prematurely
Time frame: Baseline up to Week 39
Population: Please note that this Outcome Measure was not analysed because data was not collected.
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.
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Week 13 to Week 26) | 15.6 Percentage of Time Spent | Standard Deviation 12.5 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Week 26 to Week 39) | 20.3 Percentage of Time Spent | Standard Deviation 19.3 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Week 13 to Week 26) | 19.3 Percentage of Time Spent | Standard Deviation 12.6 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Baseline to Week 13) | 17.4 Percentage of Time Spent | Standard Deviation 10.4 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Baseline to Week 13) | 19.3 Percentage of Time Spent | Standard Deviation 11 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Week 26 to Week 39) | 20.3 Percentage of Time Spent | Standard Deviation 8.9 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Baseline to Week 13) | 25.9 Percentage of Time Spent | Standard Deviation 9 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Baseline to Week 13) | 19.5 Percentage of Time Spent | Standard Deviation 9.5 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Week 13 to Week 26) | 18.9 Percentage of Time Spent | Standard Deviation 8.1 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Week 26 to Week 39) | 21.6 Percentage of Time Spent | Standard Deviation 10.1 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Week 13 to Week 26) | 25.5 Percentage of Time Spent | Standard Deviation 7.9 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Week 26 to Week 39) | 26.8 Percentage of Time Spent | Standard Deviation 17.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Week 13 to Week 26) | 21.0 Percentage of Time Spent | Standard Deviation 15.5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Week 26 to Week 39) | 29.2 Percentage of Time Spent | Standard Deviation 16.7 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Baseline to Week 13) | 26.4 Percentage of Time Spent | Standard Deviation 11.4 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Week 13 to Week 26) | 25.4 Percentage of Time Spent | Standard Deviation 12.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >250 mg/dL (Baseline to Week 13) | 16.4 Percentage of Time Spent | Standard Deviation 12.4 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | >180 to <250 mg/dL (Week 26 to Week 39) | 26.6 Percentage of Time Spent | Standard Deviation 10.5 |
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.
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Baseline to Week 13) | 5.8 Percentage of Time Spent | Standard Deviation 6.5 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Week 26 to Week 39) | 7.3 Percentage of Time Spent | Standard Deviation 6.8 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Week 26 to Week 39) | 5.6 Percentage of Time Spent | Standard Deviation 5.5 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Week 13 to Week 26) | 4.9 Percentage of Time Spent | Standard Deviation 6.2 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Baseline to Week 13) | 3.0 Percentage of Time Spent | Standard Deviation 7.5 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Week 13 to Week 26) | 6.7 Percentage of Time Spent | Standard Deviation 8.8 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Week 26 to Week 39) | 1.7 Percentage of Time Spent | Standard Deviation 2.2 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Week 13 to Week 26) | 1.8 Percentage of Time Spent | Standard Deviation 3.5 |
| Group A: Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Baseline to Week 13) | 8.8 Percentage of Time Spent | Standard Deviation 9.4 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Week 13 to Week 26) | 4.2 Percentage of Time Spent | Standard Deviation 4.2 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Baseline to Week 13) | 1.6 Percentage of Time Spent | Standard Deviation 2.1 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Week 13 to Week 26) | 1.6 Percentage of Time Spent | Standard Deviation 1.9 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Week 26 to Week 39) | 0.8 Percentage of Time Spent | Standard Deviation 1.1 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Baseline to Week 13) | 4.5 Percentage of Time Spent | Standard Deviation 3 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Week 26 to Week 39) | 3.0 Percentage of Time Spent | Standard Deviation 3.1 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Baseline to Week 13) | 6.1 Percentage of Time Spent | Standard Deviation 4.7 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Week 13 to Week 26) | 5.8 Percentage of Time Spent | Standard Deviation 5.1 |
| Group B: MDI, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Week 26 to Week 39) | 3.8 Percentage of Time Spent | Standard Deviation 3.7 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Week 26 to Week 39) | 1.1 Percentage of Time Spent | Standard Deviation 2.9 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Baseline to Week 13) | 1.1 Percentage of Time Spent | Standard Deviation 1.9 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Baseline to Week 13) | 4.2 Percentage of Time Spent | Standard Deviation 6.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <54 mg/dL (Week 13 to Week 26) | 0.9 Percentage of Time Spent | Standard Deviation 2.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Week 26 to Week 39) | 2.5 Percentage of Time Spent | Standard Deviation 3.5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Week 13 to Week 26) | 3.2 Percentage of Time Spent | Standard Deviation 4.5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Baseline to Week 13) | 3.1 Percentage of Time Spent | Standard Deviation 5.6 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | <70 mg/dL (Week 13 to Week 26) | 4.1 Percentage of Time Spent | Standard Deviation 4.8 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | >=54 and <70 mg/dL (Week 26 to Week 39) | 1.4 Percentage of Time Spent | Standard Deviation 2 |
Secondary
Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard
Time frame: Baseline up to Week 39
Population: Please note that this Outcome Measure was not analysed because data was not collected.
Secondary
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c at Baseline | 8.0 Percentage | Standard Deviation 0.6 |
| Group A: Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 13 weeks | 7.8 Percentage | Standard Deviation 0.8 |
| Group A: Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 26 weeks | 7.9 Percentage | Standard Deviation 0.9 |
| Group A: Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 39 weeks | 7.8 Percentage | Standard Deviation 0.9 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 39 weeks | 8.2 Percentage | Standard Deviation 1.1 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c at Baseline | 8.0 Percentage | Standard Deviation 0.5 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 26 weeks | 8.2 Percentage | Standard Deviation 0.7 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 13 weeks | 8.0 Percentage | Standard Deviation 0.6 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 39 weeks | 8.1 Percentage | Standard Deviation 0.9 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 13 weeks | 7.9 Percentage | Standard Deviation 0.9 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c after 26 weeks | 7.9 Percentage | Standard Deviation 0.9 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | HbA1c at Baseline | 8.0 Percentage | Standard Deviation 0.6 |
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.
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Baseline | 25.4 kg/m^2 | Standard Error 3.5 |
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 13 | 25.3 kg/m^2 | Standard Error 3.5 |
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 26 | 25.4 kg/m^2 | Standard Error 3.5 |
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 39 | 25.7 kg/m^2 | Standard Error 3.4 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 39 | 27.4 kg/m^2 | Standard Error 5 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Baseline | 27.1 kg/m^2 | Standard Error 4.7 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 26 | 27.3 kg/m^2 | Standard Error 5 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 13 | 27.1 kg/m^2 | Standard Error 4.7 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 39 | 27.3 kg/m^2 | Standard Error 5.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 13 | 27.0 kg/m^2 | Standard Error 5.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Week 26 | 27.3 kg/m^2 | Standard Error 5 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Body Mass Index (BMI) | Baseline | 27.0 kg/m^2 | Standard Error 5.2 |
Secondary
Therapy Success Indicated by Change in Weight
Change in Weight from Baseline to Week 39
Time frame: Baseline up to Week 39
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Baseline | 77.2 kg | Standard Deviation 14.1 |
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 13 | 77.6 kg | Standard Deviation 14.3 |
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 26 | 78.4 kg | Standard Deviation 14.9 |
| Group A: Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 39 | 78.8 kg | Standard Deviation 14.6 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 39 | 82.4 kg | Standard Deviation 18.2 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Baseline | 81.7 kg | Standard Deviation 17.7 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 26 | 82.2 kg | Standard Deviation 18.2 |
| Group B: MDI, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 13 | 82.3 kg | Standard Deviation 18 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 39 | 81.8 kg | Standard Deviation 17.1 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 13 | 83.8 kg | Standard Deviation 17.2 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Week 26 | 84.3 kg | Standard Deviation 17.4 |
| Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Therapy Success Indicated by Change in Weight | Baseline | 83.4 kg | Standard Deviation 18.1 |