An Evaluation of the FreeStyle Flash Glucose Monitoring System

Flash Glucose Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824549
• Other study ID #: B243201628915
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2016
• Last updated: February 27, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• 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: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes mellitus

• being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis

Exclusion Criteria:

Related Conditions & MeSH terms

• Flash Glucose Monitoring
• Skin Reactions

Intervention

Device:
• FreeStyle Libre Flash Glucose Monitoring

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 glucose monitoring systeem	The usability will be evaluated by a short questionnaire.	0.5 year follow-up
Secondary	Skin reactions to the sensor : e.g. allergic reaction, red mark, blister	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
Secondary	Accuracy of the FreeStyle Libre glucose monitoring system		0.5 year follow-up