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

NCT03478969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2021-08-20

Study results available
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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

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Accu-Chek® Solo micropump system

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

DEVICE

mylife™ OmniPod® Insulin Management System

A patch pump system delivering insulin.

OTHER

Multiple Daily Injections (MDI) therapy

Injecting insulin as per participant's need.

Sponsors & Collaborators

Principal Investigators

  • Iris Vesper · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2020-05-18
Completion
2020-05-18

Countries

  • Austria
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478969 on ClinicalTrials.gov