Trial Outcomes & Findings for Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System (NCT NCT03478969)
NCT ID: NCT03478969
Last Updated: 2021-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
26 weeks
Results posted on
2021-08-20
Participant Flow
The study was conducted at 21 centers in 4 countries.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
58
|
|
Overall Study
Participants at End of Parallel Phase
|
55
|
58
|
52
|
|
Overall Study
COMPLETED
|
53
|
49
|
40
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
6
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Personal Reasons
|
1
|
0
|
1
|
|
Overall Study
Covid-19
|
1
|
4
|
3
|
|
Overall Study
Multiple Reasons
|
0
|
1
|
1
|
|
Overall Study
Eligibility Criteria
|
0
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Baseline characteristics by cohort
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=58 Participants
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.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.
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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
94.8 Scores on a Scale
Standard Error 2.63
|
—
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.
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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=58 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
108.7 Scores on a Scale
Standard Error 2.85
|
—
|
SECONDARY outcome
Timeframe: Week 26 up to Week 39Population: The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.
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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=58 Participants
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.
|
|---|---|---|---|
|
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
|
7.8 Scores on a Scale
Standard Deviation 4.3
|
5.3 Scores on a Scale
Standard Deviation 3.5
|
|
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
|
7.1 Scores on a Scale
Standard Deviation 4.5
|
5.8 Scores on a Scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=58 Participants
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.
|
|---|---|---|---|
|
Device Satisfaction and Treatment Preference
Screening (Blood Glucose Meter)
|
35.3 Scores on a Scale
Standard Deviation 5.7
|
33.8 Scores on a Scale
Standard Deviation 5.4
|
35.7 Scores on a Scale
Standard Deviation 5.0
|
|
Device Satisfaction and Treatment Preference
Week 13 (Blood Glucose Meter)
|
34.9 Scores on a Scale
Standard Deviation 6.1
|
34.0 Scores on a Scale
Standard Deviation 5.6
|
34.9 Scores on a Scale
Standard Deviation 5.5
|
|
Device Satisfaction and Treatment Preference
Week 26 (Blood Glucose Meter)
|
34.3 Scores on a Scale
Standard Deviation 6.1
|
33.8 Scores on a Scale
Standard Deviation 5.1
|
34.9 Scores on a Scale
Standard Deviation 6.1
|
|
Device Satisfaction and Treatment Preference
Week 39 (Blood Glucose Meter)
|
34.7 Scores on a Scale
Standard Deviation 7.3
|
34.5 Scores on a Scale
Standard Deviation 5.8
|
34.8 Scores on a Scale
Standard Deviation 5.8
|
|
Device Satisfaction and Treatment Preference
Week 13 (Insulin Pump)
|
32.7 Scores on a Scale
Standard Deviation 7.3
|
—
|
35.3 Scores on a Scale
Standard Deviation 4.9
|
|
Device Satisfaction and Treatment Preference
Week 26 (Insulin Pump)
|
33.4 Scores on a Scale
Standard Deviation 6.6
|
—
|
35.3 Scores on a Scale
Standard Deviation 5.1
|
|
Device Satisfaction and Treatment Preference
Week 39 (Insulin Pump)
|
33.4 Scores on a Scale
Standard Deviation 6.9
|
33.8 Scores on a Scale
Standard Deviation 6.3
|
31.0 Scores on a Scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=60 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=60 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=53 Participants
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.
|
|---|---|---|---|
|
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
HbA1c at Baseline
|
8.0 Percentage
Standard Deviation 0.6
|
8.0 Percentage
Standard Deviation 0.5
|
8.0 Percentage
Standard Deviation 0.6
|
|
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
HbA1c after 13 weeks
|
7.8 Percentage
Standard Deviation 0.8
|
8.0 Percentage
Standard Deviation 0.6
|
7.9 Percentage
Standard Deviation 0.9
|
|
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
HbA1c after 26 weeks
|
7.9 Percentage
Standard Deviation 0.9
|
8.2 Percentage
Standard Deviation 0.7
|
7.9 Percentage
Standard Deviation 0.9
|
|
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
HbA1c after 39 weeks
|
7.8 Percentage
Standard Deviation 0.9
|
8.2 Percentage
Standard Deviation 1.1
|
8.1 Percentage
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=60 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=60 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=53 Participants
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.
|
|---|---|---|---|
|
Therapy Success Indicated by Change in Body Mass Index (BMI)
Baseline
|
25.4 kg/m^2
Standard Error 3.5
|
27.1 kg/m^2
Standard Error 4.7
|
27.0 kg/m^2
Standard Error 5.2
|
|
Therapy Success Indicated by Change in Body Mass Index (BMI)
Week 13
|
25.3 kg/m^2
Standard Error 3.5
|
27.1 kg/m^2
Standard Error 4.7
|
27.0 kg/m^2
Standard Error 5.2
|
|
Therapy Success Indicated by Change in Body Mass Index (BMI)
Week 26
|
25.4 kg/m^2
Standard Error 3.5
|
27.3 kg/m^2
Standard Error 5.0
|
27.3 kg/m^2
Standard Error 5.0
|
|
Therapy Success Indicated by Change in Body Mass Index (BMI)
Week 39
|
25.7 kg/m^2
Standard Error 3.4
|
27.4 kg/m^2
Standard Error 5.0
|
27.3 kg/m^2
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Change in Weight from Baseline to Week 39
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=60 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=60 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=53 Participants
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.
|
|---|---|---|---|
|
Therapy Success Indicated by Change in Weight
Week 26
|
78.4 kg
Standard Deviation 14.9
|
82.2 kg
Standard Deviation 18.2
|
84.3 kg
Standard Deviation 17.4
|
|
Therapy Success Indicated by Change in Weight
Baseline
|
77.2 kg
Standard Deviation 14.1
|
81.7 kg
Standard Deviation 17.7
|
83.4 kg
Standard Deviation 18.1
|
|
Therapy Success Indicated by Change in Weight
Week 13
|
77.6 kg
Standard Deviation 14.3
|
82.3 kg
Standard Deviation 18.0
|
83.8 kg
Standard Deviation 17.2
|
|
Therapy Success Indicated by Change in Weight
Week 39
|
78.8 kg
Standard Deviation 14.6
|
82.4 kg
Standard Deviation 18.2
|
81.8 kg
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Change in Glycemic Index from Baseline to Week 39
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=40 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=41 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Glycemic Index
Baseline to Week 13
|
77.0 mg/dL
Standard Deviation 15.0
|
71.7 mg/dL
Standard Deviation 15.6
|
68.1 mg/dL
Standard Deviation 10.2
|
|
Change in Glycemic Index
Week 13 to Week 26
|
75.0 mg/dL
Standard Deviation 21.6
|
70.2 mg/dL
Standard Deviation 13.1
|
68.9 mg/dL
Standard Deviation 10.0
|
|
Change in Glycemic Index
Week 26 to Week 39
|
75.0 mg/dL
Standard Deviation 17.0
|
73.9 mg/dL
Standard Deviation 15.2
|
77.1 mg/dL
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=58 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
HbA1c goals not met
|
62 Participants
|
61 Participants
|
56 Participants
|
|
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
Participant wish
|
47 Participants
|
45 Participants
|
32 Participants
|
|
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
Frequent hypoglycemia
|
9 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
Dawn phenomenon
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
Glycemic variability
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
Shift working
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=58 Participants
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.
|
|---|---|---|---|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin aspart (Week 39)
|
36 U/kg
|
27 U/kg
|
32 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin glulisine (Week 39)
|
2 U/kg
|
8 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulatard (Screening)
|
1 U/kg
|
1 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin lispro (Week 39)
|
22 U/kg
|
22 U/kg
|
21 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin degludec (Week 39)
|
3 U/kg
|
1 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin detemir (Week 39)
|
1 U/kg
|
3 U/kg
|
2 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin glargine (Week 39)
|
0 U/kg
|
3 U/kg
|
2 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin aspart (Screening)
|
37 U/kg
|
30 U/kg
|
39 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin glulisine (Screening)
|
2 U/kg
|
9 U/kg
|
2 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin lispro (Screening)
|
21 U/kg
|
22 U/kg
|
17 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Regular human insulin (Screening)
|
2 U/kg
|
0 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin degludec (Screening)
|
9 U/kg
|
9 U/kg
|
13 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin detemir (Screening)
|
10 U/kg
|
12 U/kg
|
13 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin glargine (Screening)
|
42 U/kg
|
38 U/kg
|
32 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Protaphane (Screening)
|
0 U/kg
|
1 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin aspart (Week 13)
|
34 U/kg
|
11 U/kg
|
32 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin glulisine (Week 13)
|
2 U/kg
|
5 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin lispro (Week 13)
|
20 U/kg
|
9 U/kg
|
20 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin degludec (Week 13)
|
0 U/kg
|
3 U/kg
|
—
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin detemir (Week 13)
|
0 U/kg
|
8 U/kg
|
—
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin glargine (Week 13)
|
1 U/kg
|
14 U/kg
|
—
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin aspart (Week 26)
|
34 U/kg
|
20 U/kg
|
32 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin glulisine (Week 26)
|
2 U/kg
|
7 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: Insulin lispro (Week 26)
|
19 U/kg
|
16 U/kg
|
20 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Short Acting Insulin: NovoRapid (Week 26)
|
0 U/kg
|
1 U/kg
|
0 U/kg
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin degludec (Week 26)
|
0 U/kg
|
10 U/kg
|
—
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin detemir (Week 26)
|
0 U/kg
|
9 U/kg
|
—
|
|
Change in Therapy Parameters Based on Type of Insulin Used
Long Acting Insulin: Insulin glargine (Week 26)
|
1 U/kg
|
25 U/kg
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Total Daily Insulin Dose at Baseline compared to dose at Week 39
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=60 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=60 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=53 Participants
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.
|
|---|---|---|---|
|
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Screening
|
0.7 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
0.7 U/kg
Standard Deviation 0.2
|
|
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Week 13
|
0.6 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
|
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Week 26
|
0.6 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
|
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Week 39
|
0.6 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
0.6 U/kg
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=60 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=60 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=53 Participants
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.
|
|---|---|---|---|
|
Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
Week 26
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
|
Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
Week 39
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
|
Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
Screening
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
|
Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
Week 13
|
0.3 U/kg
Standard Deviation 0.1
|
0.3 U/kg
Standard Deviation 0.1
|
0.2 U/kg
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=62 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=61 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=58 Participants
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.
|
|---|---|---|---|
|
Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day
|
3.2 SMBGs per day
Standard Deviation 3.0
|
3.4 SMBGs per day
Standard Deviation 3.8
|
2.5 SMBGs per day
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=48 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=33 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=38 Participants
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.
|
|---|---|---|---|
|
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
|
1.6 Percentage of Time Spent
Standard Deviation 2.1
|
1.1 Percentage of Time Spent
Standard Deviation 1.9
|
|
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
|
1.6 Percentage of Time Spent
Standard Deviation 1.9
|
0.9 Percentage of Time Spent
Standard Deviation 2.1
|
|
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
|
0.8 Percentage of Time Spent
Standard Deviation 1.1
|
1.1 Percentage of Time Spent
Standard Deviation 2.9
|
|
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
|
4.5 Percentage of Time Spent
Standard Deviation 3.0
|
3.1 Percentage of Time Spent
Standard Deviation 5.6
|
|
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
|
4.2 Percentage of Time Spent
Standard Deviation 4.2
|
3.2 Percentage of Time Spent
Standard Deviation 4.5
|
|
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
|
3.0 Percentage of Time Spent
Standard Deviation 3.1
|
1.4 Percentage of Time Spent
Standard Deviation 2.0
|
|
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
|
6.1 Percentage of Time Spent
Standard Deviation 4.7
|
4.2 Percentage of Time Spent
Standard Deviation 6.2
|
|
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
|
5.8 Percentage of Time Spent
Standard Deviation 5.1
|
4.1 Percentage of Time Spent
Standard Deviation 4.8
|
|
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
|
3.8 Percentage of Time Spent
Standard Deviation 3.7
|
2.5 Percentage of Time Spent
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges.
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=48 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=33 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=38 Participants
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.
|
|---|---|---|---|
|
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
|
18.9 Percentage of Time Spent
Standard Deviation 8.1
|
21.0 Percentage of Time Spent
Standard Deviation 15.5
|
|
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 11.0
|
25.9 Percentage of Time Spent
Standard Deviation 9.0
|
26.4 Percentage of Time Spent
Standard Deviation 11.4
|
|
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
|
25.5 Percentage of Time Spent
Standard Deviation 7.9
|
25.4 Percentage of Time Spent
Standard Deviation 12.1
|
|
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
|
21.6 Percentage of Time Spent
Standard Deviation 10.1
|
26.6 Percentage of Time Spent
Standard Deviation 10.5
|
|
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
|
19.5 Percentage of Time Spent
Standard Deviation 9.5
|
16.4 Percentage of Time Spent
Standard Deviation 12.4
|
|
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
|
26.8 Percentage of Time Spent
Standard Deviation 17.2
|
29.2 Percentage of Time Spent
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: Please note that this Outcome Measure was not analysed because data was not collected.
Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: Please note that this Outcome Measure was not analysed because data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: Please note that this Outcome Measure was not analysed because data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: 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.
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".
Outcome measures
| Measure |
Group A: Accu-Chek® Solo
n=60 Participants
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.
|
Group B: MDI, Then Accu-Chek® Solo
n=60 Participants
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.
|
Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo
n=53 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Heat) (Moderate Intensity)
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Itching) (Severe Intensity)
|
1 Number of Participants
|
0 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Redness) (Minor Intensity)
|
15 Number of Participants
|
3 Number of Participants
|
9 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Swelling) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Pain) (Moderate Intensity)
|
1 Number of Participants
|
1 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Itching) (Minor Intensity)
|
2 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Itching) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Itching) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Itching) (Minor Intensity)
|
4 Number of Participants
|
0 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Itching) (Moderate Intensity)
|
2 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Itching) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Itching) (Minor Intensity)
|
6 Number of Participants
|
2 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Itching) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
5 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Itching) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Itching) (Minor Intensity)
|
5 Number of Participants
|
8 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Itching) (Moderate Intensity)
|
0 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Redness) (Minor Intensity)
|
1 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Redness) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Redness) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Redness) (Minor Intensity)
|
8 Number of Participants
|
4 Number of Participants
|
11 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Redness) (Moderate Intensity)
|
2 Number of Participants
|
0 Number of Participants
|
5 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Redness) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Redness) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Redness) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Redness) (Minor Intensity)
|
16 Number of Participants
|
11 Number of Participants
|
10 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Redness) (Moderate Intensity)
|
1 Number of Participants
|
6 Number of Participants
|
6 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Redness) (Severe Intensity)
|
0 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Swelling) (Minor Intensity)
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Swelling) (Moderate Intensity)
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Swelling) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Swelling) (Minor Intensity)
|
3 Number of Participants
|
1 Number of Participants
|
7 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Swelling) (Moderate Intensity)
|
2 Number of Participants
|
0 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Swelling) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Swelling) (Minor Intensity)
|
5 Number of Participants
|
0 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Swelling) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Swelling) (Minor Intensity)
|
2 Number of Participants
|
1 Number of Participants
|
6 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Swelling) (Moderate Intensity)
|
0 Number of Participants
|
4 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Swelling) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Heat) (Minor Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Heat) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Heat) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Heat) (Minor Intensity)
|
1 Number of Participants
|
0 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Heat) (Moderate Intensity)
|
1 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Heat) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Heat) (Minor Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Heat) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Heat) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Heat) (Minor Intensity)
|
1 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Heat) (Severe Intensity)
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Pain) (Minor Intensity)
|
4 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Pain) (Moderate Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Baseline (Pain) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Pain) (Minor Intensity)
|
3 Number of Participants
|
1 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 13 (Pain) (Severe Intensity)
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Pain) (Minor Intensity)
|
3 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Pain) (Moderate Intensity)
|
1 Number of Participants
|
0 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 26 (Pain) (Severe Intensity)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Pain) (Minor Intensity)
|
3 Number of Participants
|
4 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Pain) (Moderate Intensity)
|
1 Number of Participants
|
1 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Skin Reactions (Including Type and Intensity)
Week 39 (Pain) (Severe Intensity)
|
0 Number of Participants
|
2 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: Please note that this Outcome Measure was not analysed because data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 39Population: Please note that this Outcome Measure was not analysed because data was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Group A: Accu-Chek® Solo (Parallel Phase)
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
Group B: MDI (Parallel Phase)
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Group C: Mylife™ OmniPod® (Parallel Phase)
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Group D: Groups A+B+C (Solo Phase)
Serious events: 4 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Accu-Chek® Solo (Parallel Phase)
n=62 participants at risk
Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks.
|
Group B: MDI (Parallel Phase)
n=61 participants at risk
Multiple daily injections (MDI) for 26 weeks.
|
Group C: Mylife™ OmniPod® (Parallel Phase)
n=58 participants at risk
Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks.
|
Group D: Groups A+B+C (Solo Phase)
n=165 participants at risk
From Week 26 until Week 39, all Groups (A, B and C) used the Accu-Chek® Solo Micropump system for CSII therapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
General disorders
Chest pain
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
General disorders
Nodule
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Hepatobiliary disorders
Liver injury
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Diabetic Ketosis
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.8%
3/62 • Number of events 3 • Baseline up until a maximum of 40 weeks.
|
1.6%
1/61 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 2 • Baseline up until a maximum of 40 weeks.
|
1.2%
2/165 • Number of events 2 • Baseline up until a maximum of 40 weeks.
|
|
Nervous system disorders
Tension headache
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
1.6%
1/62 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.61%
1/165 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
1.7%
1/58 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/62 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.61%
1/165 • Number of events 1 • Baseline up until a maximum of 40 weeks.
|
Other adverse events
| Measure |
Group A: Accu-Chek® Solo (Parallel Phase)
n=62 participants at risk
Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks.
|
Group B: MDI (Parallel Phase)
n=61 participants at risk
Multiple daily injections (MDI) for 26 weeks.
|
Group C: Mylife™ OmniPod® (Parallel Phase)
n=58 participants at risk
Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks.
|
Group D: Groups A+B+C (Solo Phase)
n=165 participants at risk
From Week 26 until Week 39, all Groups (A, B and C) used the Accu-Chek® Solo Micropump system for CSII therapy.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
4.8%
3/62 • Number of events 6 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/58 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/165 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.5%
4/62 • Number of events 6 • Baseline up until a maximum of 40 weeks.
|
0.00%
0/61 • Baseline up until a maximum of 40 weeks.
|
6.9%
4/58 • Number of events 5 • Baseline up until a maximum of 40 weeks.
|
12.7%
21/165 • Number of events 31 • Baseline up until a maximum of 40 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
51.6%
32/62 • Number of events 743 • Baseline up until a maximum of 40 weeks.
|
45.9%
28/61 • Number of events 653 • Baseline up until a maximum of 40 weeks.
|
37.9%
22/58 • Number of events 183 • Baseline up until a maximum of 40 weeks.
|
29.7%
49/165 • Number of events 838 • Baseline up until a maximum of 40 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
5/62 • Number of events 7 • Baseline up until a maximum of 40 weeks.
|
11.5%
7/61 • Number of events 9 • Baseline up until a maximum of 40 weeks.
|
15.5%
9/58 • Number of events 10 • Baseline up until a maximum of 40 weeks.
|
7.3%
12/165 • Number of events 12 • Baseline up until a maximum of 40 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER