Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
PRO Solo
Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes
1 other identifier
interventional
181
4 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
May 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2020
CompletedResults Posted
Study results publicly available
August 16, 2021
CompletedAugust 20, 2021
August 1, 2021
2 years
March 13, 2018
May 13, 2021
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (19)
Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5
Week 26 up to Week 39
Device Satisfaction and Treatment Preference
Baseline up to Week 39
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
Baseline up to Week 39
Therapy Success Indicated by Change in Body Mass Index (BMI)
Baseline up to Week 39
Therapy Success Indicated by Change in Weight
Baseline up to Week 39
- +14 more secondary outcomes
Study Arms (3)
Group A: Accu-Chek® Solo
EXPERIMENTALContinuous 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
EXPERIMENTALMultiple 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
EXPERIMENTALContinuous 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.
Interventions
Medical device for subcutaneous delivery of insulin in a personalized way.
A patch pump system delivering insulin.
Injecting insulin as per participant's need.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
VIVIT Institut am LKH Felkirch
Feldkirch, 6800, Austria
LKH Graz, Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
Salzburg, 5020, Austria
Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
Salzburg, 5026, Austria
Hietzing Hospital
Vienna, 1130, Austria
Diabetes Klinik Bad Mergentheim GmbH
Bad Mergentheim, 97980, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
Gemeinschaftspraxis im Altstadt-Carree
Fulda, 36037, Germany
Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
Lage, 32791, Germany
Diabeteszentrum am CKQ
Quakenbrück, 49610, Germany
Diabendo Praxiszentrum
Rostock, 18057, Germany
Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Jagiellonian University
Krakow, 31-501, Poland
Central Clinical Hospital of the MSWiA in Warsaw
Warsaw, 02-507, Poland
Bournemouth Diabetes and Endocrine Centre
Bournemouth, BH7 7DW, United Kingdom
Wolfson Diabetes & Endocrine Clinic
Cambridge, CB2 0QQ, United Kingdom
Centre for Clinical Research and Innovation
Darlington, DL3 6HX, United Kingdom
King's College London, Diabetes Research Group
London, SE5 9RS, United Kingdom
Imperial College London, Diabetes, Endocrinology and Metabolism Division
London, W12 0NN, United Kingdom
Manchester Royal Infirmary, University Hospital
Manchester, M13 9WL, United Kingdom
Related Publications (1)
Barnard-Kelly K, Thienel F, Mader JK, Oliver N, Franek E, Vesper I, Dagenbach N, Vogt G, Etter T, Kunsting T. A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections. J Diabetes Sci Technol. 2025 Sep;19(5):1310-1316. doi: 10.1177/19322968241234055. Epub 2024 Mar 8.
PMID: 38456441DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Iris Vesper
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2018
First Posted
March 27, 2018
Study Start
May 17, 2018
Primary Completion
May 18, 2020
Study Completion
May 18, 2020
Last Updated
August 20, 2021
Results First Posted
August 16, 2021
Record last verified: 2021-08