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An Evaluation of the FreeStyle Libre 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: NCT03071159
Recruitment Status : Unknown
Verified February 2017 by Jessa Hospital.
Recruitment status was:  Recruiting
First Posted : March 6, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jessa Hospital

Brief Summary:
Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.

Condition or disease Intervention/treatment Phase
Flash Glucose Monitoring Metabolic Control Device: FreeStyle Flash Libre glucose monitoring system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Medium-term Evaluation of the Use, the Identified Problems, the Usability and the Effect on the Metabolic Control of the FreeStyle Flash Libre Glucose Monitoring System
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : March 10, 2018
Estimated Study Completion Date : March 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
cases
children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care)
Device: FreeStyle Flash Libre glucose monitoring system
glucose monitoring system with sensors




Primary Outcome Measures :
  1. Usability of the FreeStyle Flash Libre glucose monitoring system [ Time Frame: 6-12 months follow up ]
    Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire


Secondary Outcome Measures :
  1. Problems associated with the FreeStyle Flash Libre glucose monitoring system [ Time Frame: 6-12 months follow up ]
    Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire

  2. The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients [ Time Frame: 6-12 months follow up ]
    The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients by measurement of the HbA1c values



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
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitis
  • Being followed in the Pediatric Diabetes Unit of the Jessa Hospital

Exclusion Criteria:

-


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): NCT03071159


Contacts
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Contact: Guy Massa, MD, PhD +32 11 30 96 34 guy.massa@jessazh.be
Contact: Ingrid Arijs, PhD +32(0)11 33 82 65 ingrid.arijs@jessazh.be

Locations
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Belgium
Jessa Hospital Recruiting
Hasselt, Belgium, 3500
Contact: Guy Massa, MD, PhD         
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
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Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT03071159    
Other Study ID Numbers: JessaH
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessa Hospital:
Flash Glucose Monitoring
Usability
Metabolic control