Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System (PRO Solo)
Diabetes Mellitus, Type 1
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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)
Sites / Locations
- VIVIT Institut am LKH Felkirch
- LKH Graz, Medizinische Universität Graz
- Medizinische Universität Innsbruck
- Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
- Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
- Hietzing Hospital
- Diabetes Klinik Bad Mergentheim GmbH
- InnoDiab Forschung GmbH
- Gemeinschaftspraxis im Altstadt-Carree
- Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
- Diabeteszentrum am CKQ
- Diabendo Praxiszentrum
- Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
- Jagiellonian University
- Central Clinical Hospital of the MSWiA in Warsaw
- Bournemouth Diabetes and Endocrine Centre
- Wolfson Diabetes & Endocrine Clinic
- Centre for Clinical Research and Innovation
- King's College London, Diabetes Research Group
- Imperial College London, Diabetes, Endocrinology and Metabolism Division
- Manchester Royal Infirmary, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A: Accu-Chek® Solo
Group B: MDI, then Accu-Chek® Solo
Group C: mylife™ OmniPod®, then 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.
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.