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An Evaluation of the FreeStyle Flash Glucose Monitoring System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Ingrid Arijs, Jessa Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Flash Glucose Monitoring Skin Reactions Device: FreeStyle Libre Flash Glucose Monitoring

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Usability of the FreeStyle glucose monitoring systeem [ Time Frame: 0.5 year follow-up ]
    The usability will be evaluated by a short questionnaire.


Secondary Outcome Measures :
  1. 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.

  2. Accuracy of the FreeStyle Libre glucose monitoring system [ Time Frame: 0.5 year follow-up ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Children with type 1 diabetes mellitis using the FreeStyle Libre Flash glucose monitoring system
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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Belgium
Jessa Hospital Recruiting
Hasselt, Belgium, 3500
Contact: Guy Massa, MD, PhD    +32 11 30 98 66    guy.massa@jessazh.be   
Sponsors and Collaborators
Jessa Hospital
Investigators
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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
More Information
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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
Keywords provided by Ingrid Arijs, Jessa Hospital:
Flash glucose monitoring
skin reactions
usability
accuracy