Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
NCT ID: NCT03478969
Last Updated: 2021-08-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
181 participants
INTERVENTIONAL
2018-05-17
2020-05-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes
NCT02403375
AHCL System Initiation in T1D Patients naïve to Technology
NCT04616391
Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators
NCT01050868
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
NCT02748018
Use of an Automated Insulin Delivery System Compared to Sensor Augmented Pump at Patients With Type 1 Diabetes (T1D)
NCT02636491
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
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.
Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
Multiple Daily Injections (MDI) therapy
Injecting insulin as per participant's need.
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.
Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
mylife™ OmniPod® Insulin Management System
A patch pump system delivering insulin.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Accu-Chek® Solo micropump system
Medical device for subcutaneous delivery of insulin in a personalized way.
mylife™ OmniPod® Insulin Management System
A patch pump system delivering insulin.
Multiple Daily Injections (MDI) therapy
Injecting insulin as per participant's need.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iris Vesper
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VIVIT Institut am LKH Felkirch
Feldkirch, , Austria
LKH Graz, Medizinische Universität Graz
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
Salzburg, , Austria
Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
Salzburg, , Austria
Hietzing Hospital
Vienna, , Austria
Diabetes Klinik Bad Mergentheim GmbH
Bad Mergentheim, , Germany
InnoDiab Forschung GmbH
Essen, , Germany
Gemeinschaftspraxis im Altstadt-Carree
Fulda, , Germany
Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
Lage, , Germany
Diabeteszentrum am CKQ
Quakenbrück, , Germany
Diabendo Praxiszentrum
Rostock, , Germany
Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Jagiellonian University
Krakow, , Poland
Central Clinical Hospital of the MSWiA in Warsaw
Warsaw, , Poland
Bournemouth Diabetes and Endocrine Centre
Bournemouth, , United Kingdom
Wolfson Diabetes & Endocrine Clinic
Cambridge, , United Kingdom
Centre for Clinical Research and Innovation
Darlington, , United Kingdom
King's College London, Diabetes Research Group
London, , United Kingdom
Imperial College London, Diabetes, Endocrinology and Metabolism Division
London, , United Kingdom
Manchester Royal Infirmary, University Hospital
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD002718
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.