CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
Accu-Chek® Solo micropump system +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03478969
NCT03478969N/ACompleted
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Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes

Hoffmann-La Roche·interventional·Posted Mar 27, 2018·Updated Aug 20, 2021

In Brief

A clinical study evaluating Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 181 participants across 21 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesAustria, Germany, Poland, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartMay 17, 2018
Primary CompletionMay 18, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.3 years ago

Interventions

Accu-Chek® Solo micropump systemdevice

Medical device for subcutaneous delivery of insulin in a personalized way.

mylife™ OmniPod® Insulin Management Systemdevice

A patch pump system delivering insulin.

Multiple Daily Injections (MDI) therapyother

Injecting insulin as per participant's need.