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An Evaluation of the FreeStyle Flash Glucose Monitoring System

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02824549
Enrollment
50
Registered
2016-07-06
Start date
2016-07-31
Completion date
2017-12-31
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flash Glucose Monitoring, Skin Reactions

Keywords

Flash glucose monitoring, skin reactions, usability, accuracy

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.

Interventions

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Usability of the FreeStyle glucose monitoring systeem0.5 year follow-upThe usability will be evaluated by a short questionnaire.

Secondary

MeasureTime frameDescription
Skin reactions to the sensor : e.g. allergic reaction, red mark, blister0.5 year follow-upThe 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 system0.5 year follow-up

Countries

Belgium

Contacts

Primary ContactGuy Massa, MD, PhD
guy.massa@jessazh.be+32 11 30 96 34
Backup ContactIngrid Arijs, PhD
ingrid.arijs@jessazh.be+3211 33 82 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026