Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Accu-Chek® Solo micropump systemDevice: mylife™ OmniPod® Insulin Management SystemOther: Multiple Daily Injections (MDI) therapy
- Registration Number
- NCT03478969
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B: MDI, then Accu-Chek® Solo Accu-Chek® Solo micropump system 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 mylife™ OmniPod® Insulin Management System 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. Group A: Accu-Chek® Solo Accu-Chek® Solo micropump system 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) 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. Group C: mylife™ OmniPod®, then Accu-Chek® Solo Accu-Chek® Solo micropump system 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Average Time Spent on Infusion Assembly Baseline up to Week 39 Device Satisfaction and Treatment Preference Baseline up to Week 39 Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device.
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.
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.
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 Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard 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
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.
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
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 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".
Amount of Waste, Inferred by Total Material Consumption Baseline up to Week 39
Trial Locations
- Locations (21)
Hietzing Hospital
🇦🇹Vienna, Austria
Diabetes Klinik Bad Mergentheim GmbH
🇩🇪Bad Mergentheim, Germany
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
🇩🇪Lage, Germany
VIVIT Institut am LKH Felkirch
🇦🇹Feldkirch, Austria
Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
🇦🇹Salzburg, Austria
LKH Graz, Medizinische Universität Graz
🇦🇹Graz, Austria
Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
🇦🇹Salzburg, Austria
Jagiellonian University
🇵🇱Krakow, Poland
Bournemouth Diabetes and Endocrine Centre
🇬🇧Bournemouth, United Kingdom
Diabeteszentrum am CKQ
🇩🇪Quakenbrueck, Germany
Central Clinical Hospital of the MSWiA in Warsaw
🇵🇱Warsaw, Poland
Diabendo Praxiszentrum
🇩🇪Rostock, Germany
Imperial College London, Diabetes, Endocrinology and Metabolism Division
🇬🇧London, United Kingdom
Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
King's College London, Diabetes Research Group
🇬🇧London, United Kingdom
Centre for Clinical Research and Innovation
🇬🇧Darlington, United Kingdom
Wolfson Diabetes & Endocrine Clinic
🇬🇧Cambridge, United Kingdom
Gemeinschaftspraxis im Altstadt-Carree
🇩🇪Fulda, Germany
Manchester Royal Infirmary, University Hospital
🇬🇧Manchester, United Kingdom
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria