PRO Solo: Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03478969
Collaborator
(none)
181
21
3
24
8.6
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes
Actual Study Start Date
:
May 17, 2018
Actual Primary Completion Date
:
May 18, 2020
Actual Study Completion Date
:
May 18, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
|
| Experimental: 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. |
Device: Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
Other: Multiple Daily Injections (MDI) therapy
Injecting insulin as per participant's need.
|
| Experimental: 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. |
Device: Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
Device: mylife™ OmniPod® Insulin Management System
A patch pump system delivering insulin.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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
- 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
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VIVIT Institut am LKH Felkirch | Feldkirch | Austria | 6800 | |
| 2 | LKH Graz, Medizinische Universität Graz | Graz | Austria | 8036 | |
| 3 | Medizinische Universität Innsbruck | Innsbruck | Austria | 6020 | |
| 4 | Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK) | Salzburg | Austria | 5020 | |
| 5 | Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel | Salzburg | Austria | 5026 | |
| 6 | Hietzing Hospital | Vienna | Austria | 1130 | |
| 7 | Diabetes Klinik Bad Mergentheim GmbH | Bad Mergentheim | Germany | 97980 | |
| 8 | InnoDiab Forschung GmbH | Essen | Germany | 45136 | |
| 9 | Gemeinschaftspraxis im Altstadt-Carree | Fulda | Germany | 36037 | |
| 10 | Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms | Lage | Germany | 32791 | |
| 11 | Diabeteszentrum am CKQ | Quakenbrueck | Germany | 49610 | |
| 12 | Diabendo Praxiszentrum | Rostock | Germany | 18057 | |
| 13 | Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
| 14 | Jagiellonian University | Krakow | Poland | 31-501 | |
| 15 | Central Clinical Hospital of the MSWiA in Warsaw | Warsaw | Poland | 02-507 | |
| 16 | Bournemouth Diabetes and Endocrine Centre | Bournemouth | United Kingdom | BH7 7DW | |
| 17 | Wolfson Diabetes & Endocrine Clinic | Cambridge | United Kingdom | CB2 0QQ | |
| 18 | Centre for Clinical Research and Innovation | Darlington | United Kingdom | DL3 6HX | |
| 19 | King's College London, Diabetes Research Group | London | United Kingdom | SE5 9RS | |
| 20 | Imperial College London, Diabetes, Endocrinology and Metabolism Division | London | United Kingdom | W12 0NN | |
| 21 | Manchester Royal Infirmary, University Hospital | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Iris Vesper, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03478969
Other Study ID Numbers:
- RD002718
First Posted:
Mar 27, 2018
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 21 centers in 4 countries. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 62 | 61 | 58 |
| Participants at End of Parallel Phase | 55 | 58 | 52 |
| COMPLETED | 53 | 49 | 40 |
| NOT COMPLETED | 9 | 12 | 18 |
Baseline Characteristics
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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 of all reporting groups |
| Overall Participants | 62 | 61 | 58 | 181 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
38.1
(11.8)
|
38.6
(10.8)
|
40.6
(13.1)
|
39.0
(11.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
29
46.8%
|
29
47.5%
|
21
36.2%
|
79
43.6%
|
| Male |
33
53.2%
|
32
52.5%
|
37
63.8%
|
102
56.4%
|
| Race/Ethnicity, Customized (Number) [Number] | ||||
| White |
59
95.2%
|
60
98.4%
|
56
96.6%
|
175
96.7%
|
| Asian |
1
1.6%
|
1
1.6%
|
1
1.7%
|
3
1.7%
|
| Other |
2
3.2%
|
0
0%
|
1
1.7%
|
3
1.7%
|
Outcome Measures
| Title | Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 62 | 61 |
| Least Squares Mean (Standard Error) [Scores on a Scale] |
105.9
(2.66)
|
94.8
(2.63)
|
| Title | Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 62 | 58 |
| Least Squares Mean (Standard Error) [Scores on a Scale] |
105.1
(3.04)
|
108.7
(2.85)
|
| Title | Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 62 | 61 | 58 |
| Week 26 |
7.0
(4.7)
|
7.8
(4.3)
|
5.3
(3.5)
|
| Week 39 |
6.3
(4.2)
|
7.1
(4.5)
|
5.8
(3.8)
|
| Title | Device Satisfaction and Treatment Preference |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 62 | 61 | 58 |
| Screening (Blood Glucose Meter) |
35.3
(5.7)
|
33.8
(5.4)
|
35.7
(5.0)
|
| Week 13 (Blood Glucose Meter) |
34.9
(6.1)
|
34.0
(5.6)
|
34.9
(5.5)
|
| Week 26 (Blood Glucose Meter) |
34.3
(6.1)
|
33.8
(5.1)
|
34.9
(6.1)
|
| Week 39 (Blood Glucose Meter) |
34.7
(7.3)
|
34.5
(5.8)
|
34.8
(5.8)
|
| Week 13 (Insulin Pump) |
32.7
(7.3)
|
35.3
(4.9)
|
|
| Week 26 (Insulin Pump) |
33.4
(6.6)
|
35.3
(5.1)
|
|
| Week 39 (Insulin Pump) |
33.4
(6.9)
|
33.8
(6.3)
|
31.0
(7.0)
|
| Title | Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels |
|---|---|
| Description | Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39 |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 60 | 60 | 53 |
| HbA1c at Baseline |
8.0
(0.6)
|
8.0
(0.5)
|
8.0
(0.6)
|
| HbA1c after 13 weeks |
7.8
(0.8)
|
8.0
(0.6)
|
7.9
(0.9)
|
| HbA1c after 26 weeks |
7.9
(0.9)
|
8.2
(0.7)
|
7.9
(0.9)
|
| HbA1c after 39 weeks |
7.8
(0.9)
|
8.2
(1.1)
|
8.1
(0.9)
|
| Title | Therapy Success Indicated by Change in Body Mass Index (BMI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 60 | 60 | 53 |
| Baseline |
25.4
(3.5)
|
27.1
(4.7)
|
27.0
(5.2)
|
| Week 13 |
25.3
(3.5)
|
27.1
(4.7)
|
27.0
(5.2)
|
| Week 26 |
25.4
(3.5)
|
27.3
(5.0)
|
27.3
(5.0)
|
| Week 39 |
25.7
(3.4)
|
27.4
(5.0)
|
27.3
(5.2)
|
| Title | Therapy Success Indicated by Change in Weight |
|---|---|
| Description | Change in Weight from Baseline to Week 39 |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 60 | 60 | 53 |
| Baseline |
77.2
(14.1)
|
81.7
(17.7)
|
83.4
(18.1)
|
| Week 13 |
77.6
(14.3)
|
82.3
(18.0)
|
83.8
(17.2)
|
| Week 26 |
78.4
(14.9)
|
82.2
(18.2)
|
84.3
(17.4)
|
| Week 39 |
78.8
(14.6)
|
82.4
(18.2)
|
81.8
(17.1)
|
| Title | Change in Glycemic Index |
|---|---|
| Description | Change in Glycemic Index from Baseline to Week 39 |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 40 | 41 | 33 |
| Baseline to Week 13 |
77.0
(15.0)
|
71.7
(15.6)
|
68.1
(10.2)
|
| Week 13 to Week 26 |
75.0
(21.6)
|
70.2
(13.1)
|
68.9
(10.0)
|
| Week 26 to Week 39 |
75.0
(17.0)
|
73.9
(15.2)
|
77.1
(15.2)
|
| Title | Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 62 | 61 | 58 |
| HbA1c goals not met |
62
100%
|
61
100%
|
56
96.6%
|
| Participant wish |
47
75.8%
|
45
73.8%
|
32
55.2%
|
| Frequent hypoglycemia |
9
14.5%
|
9
14.8%
|
13
22.4%
|
| Dawn phenomenon |
3
4.8%
|
2
3.3%
|
2
3.4%
|
| Glycemic variability |
1
1.6%
|
3
4.9%
|
2
3.4%
|
| Shift working |
1
1.6%
|
0
0%
|
1
1.7%
|
| Title | Change in Therapy Parameters Based on Type of Insulin Used |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 62 | 61 | 58 |
| Short Acting Insulin: Insulin aspart (Screening) |
37
|
30
|
39
|
| Short Acting Insulin: Insulin glulisine (Screening) |
2
|
9
|
2
|
| Short Acting Insulin: Insulin lispro (Screening) |
21
|
22
|
17
|
| Short Acting Insulin: Regular human insulin (Screening) |
2
|
0
|
0
|
| Long Acting Insulin: Insulatard (Screening) |
1
|
1
|
0
|
| Long Acting Insulin: Insulin degludec (Screening) |
9
|
9
|
13
|
| Long Acting Insulin: Insulin detemir (Screening) |
10
|
12
|
13
|
| Long Acting Insulin: Insulin glargine (Screening) |
42
|
38
|
32
|
| Long Acting Insulin: Protaphane (Screening) |
0
|
1
|
0
|
| Short Acting Insulin: Insulin aspart (Week 13) |
34
|
11
|
32
|
| Short Acting Insulin: Insulin glulisine (Week 13) |
2
|
5
|
0
|
| Short Acting Insulin: Insulin lispro (Week 13) |
20
|
9
|
20
|
| Long Acting Insulin: Insulin degludec (Week 13) |
0
|
3
|
|
| Long Acting Insulin: Insulin detemir (Week 13) |
0
|
8
|
|
| Long Acting Insulin: Insulin glargine (Week 13) |
1
|
14
|
|
| Short Acting Insulin: Insulin aspart (Week 26) |
34
|
20
|
32
|
| Short Acting Insulin: Insulin glulisine (Week 26) |
2
|
7
|
0
|
| Short Acting Insulin: Insulin lispro (Week 26) |
19
|
16
|
20
|
| Short Acting Insulin: NovoRapid (Week 26) |
0
|
1
|
0
|
| Long Acting Insulin: Insulin degludec (Week 26) |
0
|
10
|
|
| Long Acting Insulin: Insulin detemir (Week 26) |
0
|
9
|
|
| Long Acting Insulin: Insulin glargine (Week 26) |
1
|
25
|
|
| Short Acting Insulin: Insulin aspart (Week 39) |
36
|
27
|
32
|
| Short Acting Insulin: Insulin glulisine (Week 39) |
2
|
8
|
0
|
| Short Acting Insulin: Insulin lispro (Week 39) |
22
|
22
|
21
|
| Long Acting Insulin: Insulin degludec (Week 39) |
3
|
1
|
0
|
| Long Acting Insulin: Insulin detemir (Week 39) |
1
|
3
|
2
|
| Long Acting Insulin: Insulin glargine (Week 39) |
0
|
3
|
2
|
| Title | Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) |
|---|---|
| Description | Total Daily Insulin Dose at Baseline compared to dose at Week 39 |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 60 | 60 | 53 |
| Screening |
0.7
(0.2)
|
0.6
(0.2)
|
0.7
(0.2)
|
| Week 13 |
0.6
(0.2)
|
0.6
(0.2)
|
0.6
(0.2)
|
| Week 26 |
0.6
(0.2)
|
0.6
(0.2)
|
0.6
(0.2)
|
| Week 39 |
0.6
(0.2)
|
0.6
(0.2)
|
0.6
(0.2)
|
| Title | Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) |
|---|---|
| Description | Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39 |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 60 | 60 | 53 |
| Screening |
0.3
(0.1)
|
0.3
(0.1)
|
0.3
(0.1)
|
| Week 13 |
0.3
(0.1)
|
0.3
(0.1)
|
0.2
(0.1)
|
| Week 26 |
0.3
(0.1)
|
0.3
(0.1)
|
0.3
(0.1)
|
| Week 39 |
0.3
(0.1)
|
0.3
(0.1)
|
0.3
(0.1)
|
| Title | Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day |
|---|---|
| Description | Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39 |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 62 | 61 | 58 |
| Mean (Standard Deviation) [SMBGs per day] |
3.2
(3.0)
|
3.4
(3.8)
|
2.5
(3.1)
|
| Title | Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 48 | 33 | 38 |
| <54 mg/dL (Baseline to Week 13) |
3.0
(7.5)
|
1.6
(2.1)
|
1.1
(1.9)
|
| <54 mg/dL (Week 13 to Week 26) |
1.8
(3.5)
|
1.6
(1.9)
|
0.9
(2.1)
|
| <54 mg/dL (Week 26 to Week 39) |
1.7
(2.2)
|
0.8
(1.1)
|
1.1
(2.9)
|
| >=54 and <70 mg/dL (Baseline to Week 13) |
5.8
(6.5)
|
4.5
(3.0)
|
3.1
(5.6)
|
| >=54 and <70 mg/dL (Week 13 to Week 26) |
4.9
(6.2)
|
4.2
(4.2)
|
3.2
(4.5)
|
| >=54 and <70 mg/dL (Week 26 to Week 39) |
5.6
(5.5)
|
3.0
(3.1)
|
1.4
(2.0)
|
| <70 mg/dL (Baseline to Week 13) |
8.8
(9.4)
|
6.1
(4.7)
|
4.2
(6.2)
|
| <70 mg/dL (Week 13 to Week 26) |
6.7
(8.8)
|
5.8
(5.1)
|
4.1
(4.8)
|
| <70 mg/dL (Week 26 to Week 39) |
7.3
(6.8)
|
3.8
(3.7)
|
2.5
(3.5)
|
| Title | Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 48 | 33 | 38 |
| >180 to <250 mg/dL (Baseline to Week 13) |
19.3
(11.0)
|
25.9
(9.0)
|
26.4
(11.4)
|
| >180 to <250 mg/dL (Week 13 to Week 26) |
19.3
(12.6)
|
25.5
(7.9)
|
25.4
(12.1)
|
| >180 to <250 mg/dL (Week 26 to Week 39) |
20.3
(8.9)
|
21.6
(10.1)
|
26.6
(10.5)
|
| >250 mg/dL (Baseline to Week 13) |
17.4
(10.4)
|
19.5
(9.5)
|
16.4
(12.4)
|
| >250 mg/dL (Week 13 to Week 26) |
15.6
(12.5)
|
18.9
(8.1)
|
21.0
(15.5)
|
| >250 mg/dL (Week 26 to Week 39) |
20.3
(19.3)
|
26.8
(17.2)
|
29.2
(16.7)
|
| Title | Number of Consultations |
|---|---|
| Description | Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school. |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please note that this Outcome Measure was not analysed because data was not collected. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 |
| Title | Number of Pods/Infusion Assemblies Falling Off Prematurely |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please note that this Outcome Measure was not analysed because data was not collected. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 |
| Title | Average Time Spent on Infusion Assembly |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please note that this Outcome Measure was not analysed because data was not collected. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 |
| Title | Number of Participants With Skin Reactions (Including Type and Intensity) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 60 | 60 | 53 |
| Baseline (Itching) (Minor Intensity) |
2
3.2%
|
1
1.6%
|
1
1.7%
|
| Baseline (Itching) (Moderate Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Baseline (Itching) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 13 (Itching) (Minor Intensity) |
4
6.5%
|
0
0%
|
4
6.9%
|
| Week 13 (Itching) (Moderate Intensity) |
2
3.2%
|
0
0%
|
1
1.7%
|
| Week 13 (Itching) (Severe Intensity) |
0
0%
|
0
0%
|
1
1.7%
|
| Week 26 (Itching) (Minor Intensity) |
6
9.7%
|
2
3.3%
|
2
3.4%
|
| Week 26 (Itching) (Moderate Intensity) |
0
0%
|
0
0%
|
5
8.6%
|
| Week 26 (Itching) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 39 (Itching) (Minor Intensity) |
5
8.1%
|
8
13.1%
|
3
5.2%
|
| Week 39 (Itching) (Moderate Intensity) |
0
0%
|
3
4.9%
|
3
5.2%
|
| Week 39 (Itching) (Severe Intensity) |
1
1.6%
|
0
0%
|
2
3.4%
|
| Baseline (Redness) (Minor Intensity) |
1
1.6%
|
3
4.9%
|
3
5.2%
|
| Baseline (Redness) (Moderate Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Baseline (Redness) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 13 (Redness) (Minor Intensity) |
8
12.9%
|
4
6.6%
|
11
19%
|
| Week 13 (Redness) (Moderate Intensity) |
2
3.2%
|
0
0%
|
5
8.6%
|
| Week 13 (Redness) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 26 (Redness) (Minor Intensity) |
15
24.2%
|
3
4.9%
|
9
15.5%
|
| Week 26 (Redness) (Moderate Intensity) |
0
0%
|
0
0%
|
4
6.9%
|
| Week 26 (Redness) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 39 (Redness) (Minor Intensity) |
16
25.8%
|
11
18%
|
10
17.2%
|
| Week 39 (Redness) (Moderate Intensity) |
1
1.6%
|
6
9.8%
|
6
10.3%
|
| Week 39 (Redness) (Severe Intensity) |
0
0%
|
1
1.6%
|
1
1.7%
|
| Baseline (Swelling) (Minor Intensity) |
1
1.6%
|
0
0%
|
0
0%
|
| Baseline (Swelling) (Moderate Intensity) |
1
1.6%
|
0
0%
|
0
0%
|
| Baseline (Swelling) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 13 (Swelling) (Minor Intensity) |
3
4.8%
|
1
1.6%
|
7
12.1%
|
| Week 13 (Swelling) (Moderate Intensity) |
2
3.2%
|
0
0%
|
3
5.2%
|
| Week 13 (Swelling) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 26 (Swelling) (Minor Intensity) |
5
8.1%
|
0
0%
|
3
5.2%
|
| Week 26 (Swelling) (Moderate Intensity) |
0
0%
|
0
0%
|
1
1.7%
|
| Week 26 (Swelling) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 39 (Swelling) (Minor Intensity) |
2
3.2%
|
1
1.6%
|
6
10.3%
|
| Week 39 (Swelling) (Moderate Intensity) |
0
0%
|
4
6.6%
|
2
3.4%
|
| Week 39 (Swelling) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Baseline (Heat) (Minor Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Baseline (Heat) (Moderate Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Baseline (Heat) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 13 (Heat) (Minor Intensity) |
1
1.6%
|
0
0%
|
3
5.2%
|
| Week 13 (Heat) (Moderate Intensity) |
1
1.6%
|
1
1.6%
|
0
0%
|
| Week 13 (Heat) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 26 (Heat) (Minor Intensity) |
0
0%
|
0
0%
|
1
1.7%
|
| Week 26 (Heat) (Moderate Intensity) |
0
0%
|
0
0%
|
1
1.7%
|
| Week 26 (Heat) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 39 (Heat) (Minor Intensity) |
1
1.6%
|
1
1.6%
|
1
1.7%
|
| Week 39 (Heat) (Moderate Intensity) |
0
0%
|
1
1.6%
|
0
0%
|
| Week 39 (Heat) (Severe Intensity) |
0
0%
|
1
1.6%
|
0
0%
|
| Baseline (Pain) (Minor Intensity) |
4
6.5%
|
3
4.9%
|
3
5.2%
|
| Baseline (Pain) (Moderate Intensity) |
0
0%
|
0
0%
|
2
3.4%
|
| Baseline (Pain) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 13 (Pain) (Minor Intensity) |
3
4.8%
|
1
1.6%
|
3
5.2%
|
| Week 13 (Pain) (Moderate Intensity) |
1
1.6%
|
1
1.6%
|
2
3.4%
|
| Week 13 (Pain) (Severe Intensity) |
1
1.6%
|
0
0%
|
0
0%
|
| Week 26 (Pain) (Minor Intensity) |
3
4.8%
|
3
4.9%
|
3
5.2%
|
| Week 26 (Pain) (Moderate Intensity) |
1
1.6%
|
0
0%
|
2
3.4%
|
| Week 26 (Pain) (Severe Intensity) |
0
0%
|
0
0%
|
0
0%
|
| Week 39 (Pain) (Minor Intensity) |
3
4.8%
|
4
6.6%
|
4
6.9%
|
| Week 39 (Pain) (Moderate Intensity) |
1
1.6%
|
1
1.6%
|
3
5.2%
|
| Week 39 (Pain) (Severe Intensity) |
0
0%
|
2
3.3%
|
0
0%
|
| Title | Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please note that this Outcome Measure was not analysed because data was not collected. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 |
| Title | Amount of Waste, Inferred by Total Material Consumption |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 39 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please note that this Outcome Measure was not analysed because data was not collected. |
| Arm/Group Title | Group A: Accu-Chek® Solo | Group B: MDI, Then Accu-Chek® Solo | Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 |
Adverse Events
| Time Frame | Baseline up until a maximum of 40 weeks. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Group A: Accu-Chek® Solo (Parallel Phase) | Group B: MDI (Parallel Phase) | Group C: Mylife™ OmniPod® (Parallel Phase) | Group D: Groups A+B+C (Solo Phase) | ||||
| Arm/Group Description | Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. | Multiple daily injections (MDI) for 26 weeks. | Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. | From Week 26 until Week 39, all Groups (A, B and C) used the Accu-Chek® Solo Micropump system for CSII therapy. | ||||
All Cause Mortality |
||||||||
| Group A: Accu-Chek® Solo (Parallel Phase) | Group B: MDI (Parallel Phase) | Group C: Mylife™ OmniPod® (Parallel Phase) | Group D: Groups A+B+C (Solo Phase) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/61 (0%) | 0/58 (0%) | 0/165 (0%) | ||||
Serious Adverse Events |
||||||||
| Group A: Accu-Chek® Solo (Parallel Phase) | Group B: MDI (Parallel Phase) | Group C: Mylife™ OmniPod® (Parallel Phase) | Group D: Groups A+B+C (Solo Phase) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/62 (9.7%) | 1/61 (1.6%) | 5/58 (8.6%) | 4/165 (2.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Vomiting | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| General disorders | ||||||||
| Chest pain | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Nodule | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Liver injury | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Immune system disorders | ||||||||
| Anaphylactic shock | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| Infections and infestations | ||||||||
| Osteomyelitis | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| Gastroenteritis | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 1/165 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Arthropod bite | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| Lower limb fracture | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| Tendon rupture | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Diabetic Ketoacidosis | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Diabetic Ketosis | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
| Hyperglycaemia | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Hypoglycaemia | 3/62 (4.8%) | 3 | 1/61 (1.6%) | 1 | 1/58 (1.7%) | 2 | 2/165 (1.2%) | 2 |
| Ketoacidosis | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 1/165 (0.6%) | 1 |
| Nervous system disorders | ||||||||
| Tension headache | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Tubulointerstitial nephritis | 1/62 (1.6%) | 1 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertensive crisis | 0/62 (0%) | 0 | 0/61 (0%) | 0 | 1/58 (1.7%) | 1 | 0/165 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Group A: Accu-Chek® Solo (Parallel Phase) | Group B: MDI (Parallel Phase) | Group C: Mylife™ OmniPod® (Parallel Phase) | Group D: Groups A+B+C (Solo Phase) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 44/62 (71%) | 35/61 (57.4%) | 35/58 (60.3%) | 82/165 (49.7%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 5/62 (8.1%) | 7 | 7/61 (11.5%) | 9 | 9/58 (15.5%) | 10 | 12/165 (7.3%) | 12 |
| Metabolism and nutrition disorders | ||||||||
| Diabetic ketosis | 3/62 (4.8%) | 6 | 0/61 (0%) | 0 | 0/58 (0%) | 0 | 0/165 (0%) | 0 |
| Hyperglycaemia | 4/62 (6.5%) | 6 | 0/61 (0%) | 0 | 4/58 (6.9%) | 5 | 21/165 (12.7%) | 31 |
| Hypoglycaemia | 32/62 (51.6%) | 743 | 28/61 (45.9%) | 653 | 22/58 (37.9%) | 183 | 49/165 (29.7%) | 838 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03478969
Other Study ID Numbers:
- RD002718
First Posted:
Mar 27, 2018
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021