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Von Teilnehmenden beschriebene Ergebnisse mit dem Accu-Chek® Solo-Mikropumpensystem
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System (PRO Solo)
- Stoffwechselerkrankung
- Diabetes Mellitus Typ 1
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Bad Mergentheim
- Essen
- Fulda
- Lage
- Quakenbrück
- Rostock
Studien-ID:
NCT03478969 RD002718
Studienzusammenfassung
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.
Hoffmann-La Roche
Sponsor
N/A
Phase
NCT03478969,RD002718
Studien-ID
Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System, Multiple Daily Injections (MDI) therapy
Treatments
Diabetes Mellitus, Type 1
Condition
Official Title
Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes
Einschlusskriterien
All
Gender
≥ 18 Years & ≤ 65 Years
Age
No
Healthy Volunteers
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)
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