An Evaluation of the FreeStyle Flash Glucose Monitoring System
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|ClinicalTrials.gov Identifier: NCT02824549|
Recruitment Status : Unknown
Verified July 2016 by Ingrid Arijs, Jessa Hospital.
Recruitment status was: Recruiting
First Posted : July 6, 2016
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment|
|Flash Glucose Monitoring Skin Reactions||Device: FreeStyle Libre Flash Glucose Monitoring|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
- Usability of the FreeStyle glucose monitoring systeem [ Time Frame: 0.5 year follow-up ]The usability will be evaluated by a short questionnaire.
- Skin reactions to the sensor : e.g. allergic reaction, red mark, blister [ Time Frame: 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 [ Time Frame: 0.5 year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824549
|Contact: Guy Massa, MD, PhD||+32 11 30 96 email@example.com|
|Contact: Ingrid Arijs, PhD||+3211 33 82 firstname.lastname@example.org|
|Hasselt, Belgium, 3500|
|Contact: Guy Massa, MD, PhD +32 11 30 98 66 email@example.com|
|Study Director:||Guy Massa, MD, PhD||Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium|
|Principal Investigator:||Renate Zeevaert, MD, PhD||Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium|