Flash Glucose Monitoring Clinical Trial
Official title:
An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System
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.
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: |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Hospital | Hasselt |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital |
Belgium,
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 |
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