An Evaluation of the FreeStyle Flash Glucose Monitoring System

• Conditions: Skin Reactions; Flash Glucose Monitoring

• Registration Number: NCT02824549
• Lead Sponsor: Jessa Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-29
• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usability of the FreeStyle glucose monitoring systeem	0.5 year follow-up	The usability will be evaluated by a short questionnaire.

Secondary Outcome Measures

Name	Time	Method
Skin reactions to the sensor : e.g. allergic reaction, red mark, blister	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.
Accuracy of the FreeStyle Libre glucose monitoring system	0.5 year follow-up

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Belgium