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
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Condition or disease | Intervention/treatment |
---|---|
Flash Glucose Monitoring Skin Reactions | Device: FreeStyle Libre Flash Glucose Monitoring |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 ]

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Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- type 1 diabetes mellitus
- being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis
Exclusion Criteria:
-

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 34 | guy.massa@jessazh.be | |
Contact: Ingrid Arijs, PhD | +3211 33 82 65 | ingrid.arijs@jessazh.be |
Belgium | |
Jessa Hospital | Recruiting |
Hasselt, Belgium, 3500 | |
Contact: Guy Massa, MD, PhD +32 11 30 98 66 guy.massa@jessazh.be |
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 |
Responsible Party: | Ingrid Arijs, Prof. dr. G. Massa, MD, PhD - Pediatric Endocrinologist, Jessa Hospital |
ClinicalTrials.gov Identifier: | NCT02824549 |
Other Study ID Numbers: |
B243201628915 |
First Posted: | July 6, 2016 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | July 2016 |
Flash glucose monitoring skin reactions usability accuracy |