Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System

Study Overview
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Brief Summary
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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.

Official Title
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Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Accu-Chek® Solo micropump system
* Device: mylife™ OmniPod® Insulin Management System
* Other: Multiple Daily Injections (MDI) therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Accu-Chek® Solo<br>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<br>* Medical device for subcutaneous delivery of insulin in a personalized way.<br>|
| Experimental: Group B: MDI, then Accu-Chek® Solo<br>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<br>* Medical device for subcutaneous delivery of insulin in a personalized way.<br>Other: Multiple Daily Injections (MDI) therapy<br>* Injecting insulin as per participant's need.<br>|
| Experimental: Group C: mylife™ OmniPod®, then Accu-Chek® Solo<br>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<br>* Medical device for subcutaneous delivery of insulin in a personalized way.<br>Device: mylife™ OmniPod® Insulin Management System<br>* A patch pump system delivering insulin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes. | 26 weeks | 
| Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score | The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 | The PAID-5 questionnaire consisted of 5 questions with answers ranging from 0 (not a problem) to 4 (serious problem). The total score was calculated as the sum of the individual questions, resulting in a number between 0 and 20 where lower scores represented lower distress. | Week 26 up to Week 39 | 
| Device Satisfaction and Treatment Preference | Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device. | Baseline up to Week 39 | 
| Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels | Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39 | Baseline up to Week 39 | 
| Therapy Success Indicated by Change in Body Mass Index (BMI) | This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m^2. Change in BMI from Baseline to Week 39. | Baseline up to Week 39 | 
| Therapy Success Indicated by Change in Weight | Change in Weight from Baseline to Week 39 | Baseline up to Week 39 | 
| Change in Glycemic Index | Change in Glycemic Index from Baseline to Week 39 | Baseline up to Week 39 | 
| Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) | Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy. | Baseline up to Week 39 | 
| 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) | Total Daily Insulin Dose at Baseline compared to dose at Week 39 | Baseline up to Week 39 | 
| Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) | Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39 | Baseline up to Week 39 | 
| Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day | Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39 | Baseline up to Week 39 | 
| Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges | Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges. | Baseline up to Week 39 | 
| Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges | Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges. | Baseline up to Week 39 | 
| Number of Consultations | Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school. | Baseline up to Week 39 | 
| 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) | 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. | Baseline up to Week 39 | 
| 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 |