An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System

Metabolic Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03071159
• Other study ID #: JessaH
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2017
• Last updated: January 19, 2018
• Start date: March 10, 2017
• Est. completion date: March 10, 2018

Study information

• Verified date: February 2017
• Source: Jessa Hospital
• Contact: Guy Massa, MD, PhD
• Phone: +32 11 30 96 34
• Email: guy.massa[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 10, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitis

• Being followed in the Pediatric Diabetes Unit of the Jessa Hospital

Exclusion Criteria:

Related Conditions & MeSH terms

• Flash Glucose Monitoring
• Metabolic Control

Intervention

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

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of the FreeStyle Flash Libre glucose monitoring system	Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire	6-12 months follow up
Secondary	Problems associated with the FreeStyle Flash Libre glucose monitoring system	Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire	6-12 months follow up
Secondary	The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients	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