Clinical Trials Directory

Trials / Completed

CompletedNCT03478969

Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System

Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
181 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEAccu-Chek® Solo micropump systemMedical device for subcutaneous delivery of insulin in a personalized way.
DEVICEmylife™ OmniPod® Insulin Management SystemA patch pump system delivering insulin.
OTHERMultiple Daily Injections (MDI) therapyInjecting insulin as per participant's need.

Timeline

Start date
2018-05-17
Primary completion
2020-05-18
Completion
2020-05-18
First posted
2018-03-27
Last updated
2021-08-20
Results posted
2021-08-16

Locations

21 sites across 4 countries: Austria, Germany, Poland, United Kingdom

Source: ClinicalTrials.gov record NCT03478969. Inclusion in this directory is not an endorsement.