An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System

January 19, 2018 updated by: Jessa Hospital

A Medium-term Evaluation of the Use, the Identified Problems, the Usability and the Effect on the Metabolic Control of the FreeStyle Flash Libre Glucose Monitoring System

Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

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:
          • Guy Massa, MD, PhD

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 (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitis
  • Being followed in the Pediatric Diabetes Unit of the Jessa Hospital

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

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: cases
children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care)
Device: FreeStyle Flash Libre glucose monitoring system
glucose monitoring system with sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the FreeStyle Flash Libre glucose monitoring system
Time Frame: 6-12 months follow up
Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire
6-12 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problems associated with the FreeStyle Flash Libre glucose monitoring system
Time Frame: 6-12 months follow up
Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire
6-12 months follow up
The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients
Time Frame: 6-12 months follow up
The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients by measurement of the HbA1c values
6-12 months 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

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 (ACTUAL)

March 10, 2017

Primary Completion (ANTICIPATED)

March 10, 2018

Study Completion (ANTICIPATED)

March 10, 2018

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (ACTUAL)

March 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JessaH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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