An Evaluation of the FreeStyle Flash Glucose Monitoring System

February 27, 2017 updated by: Ingrid Arijs, Jessa Hospital

An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System

The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system in children will be evaluated by questionnaires, pictures of the insertion site and comparison of the glucose results with capillary blood glucose determinations.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with type 1 diabetes mellitis using the FreeStyle Libre Flash glucose monitoring system

Description

Inclusion Criteria:

  • type 1 diabetes mellitus
  • being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the FreeStyle glucose monitoring systeem
Time Frame: 0.5 year follow-up
The usability will be evaluated by a short questionnaire.
0.5 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin reactions to the sensor : e.g. allergic reaction, red mark, blister
Time Frame: 0.5 year follow-up
The skin reactions will be evaluated by a questionnaire and a picture will be taken when skin reactions are present.
0.5 year follow-up
Accuracy of the FreeStyle Libre glucose monitoring system
Time Frame: 0.5 year follow-up
0.5 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Investigators

  • Study Director: Guy Massa, MD, PhD, Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium
  • Principal Investigator: Renate Zeevaert, MD, PhD, Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B243201628915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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