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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
Sponsor:
Information provided by (Responsible Party):
Ingrid Arijs, Jessa Hospital

Tracking Information
First Submitted Date June 29, 2016
First Posted Date July 6, 2016
Last Update Posted Date February 28, 2017
Study Start Date July 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2016)
Usability of the FreeStyle glucose monitoring systeem [ Time Frame: 0.5 year follow-up ]
The usability will be evaluated by a short questionnaire.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Evaluation of the FreeStyle Flash Glucose Monitoring System
Official Title An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with type 1 diabetes mellitis using the FreeStyle Libre Flash glucose monitoring system
Condition
  • Flash Glucose Monitoring
  • Skin Reactions
Intervention Device: FreeStyle Libre Flash Glucose Monitoring
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 1, 2016)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02824549
Other Study ID Numbers B243201628915
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ingrid Arijs, Jessa Hospital
Study Sponsor Jessa Hospital
Collaborators Not Provided
Investigators
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
PRS Account Jessa Hospital
Verification Date July 2016