An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 10, 2018

Interventions

  • Device: FreeStyle Flash Libre glucose monitoring system
    • glucose monitoring system with sensors

Arms, Groups and Cohorts

  • Other: cases
    • children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Type 1 diabetes mellitis – Being followed in the Pediatric Diabetes Unit of the Jessa Hospital Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jessa Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Guy Massa, MD, PhD, Study Director, Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500
  • Overall Contact(s)
    • Guy Massa, MD, PhD, +32 11 30 96 34, guy.massa@jessazh.be

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