Status:
COMPLETED
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2020
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT03478969
Start Date
May 17 2018
End Date
May 18 2020
Last Update
August 20 2021
Active Locations (21)
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1
VIVIT Institut am LKH Felkirch
Feldkirch, Austria, 6800
2
LKH Graz, Medizinische Universität Graz
Graz, Austria, 8036
3
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
4
Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
Salzburg, Austria, 5020