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A Study Evaluating the Perception of Insertion Pain With Accu-Chek FlexLink and FlexLink Plus Insulin Pump Devices Under Real Life Conditions in Diabetic Patients.

NCT02103595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-04-04

No results posted yet for this study

Summary

German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.

Conditions

  • Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

Interventions

DEVICE

Accu-Chek FlexLink

Insulin pump device used for 4-weeks under real life conditions

DEVICE

Accu-Chek FlexLink Plus

Insulin pump device used for 4-weeks under real life conditions

Sponsors & Collaborators

Principal Investigators

  • Linda Amstutz · Roche Diagnostics GmbH

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Germany

Study Locations

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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 NCT02103595 on ClinicalTrials.gov