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An Evaluation of the FreeStyle Flash Glucose Monitoring System

NCT ID: NCT02824549

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Flash Glucose Monitoring Skin Reactions

Keywords

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Flash glucose monitoring skin reactions usability accuracy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FreeStyle Libre Flash Glucose Monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ingrid Arijs

Prof. dr. G. Massa, MD, PhD - Pediatric Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Massa, MD, PhD

Role: STUDY_DIRECTOR

Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium

Renate Zeevaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Guy Massa, MD, PhD

Role: CONTACT

Phone: +32 11 30 96 34

Email: [email protected]

Ingrid Arijs, PhD

Role: CONTACT

Phone: +3211 33 82 65

Email: [email protected]

Facility Contacts

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Guy Massa, MD, PhD

Role: primary

Other Identifiers

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B243201628915

Identifier Type: -

Identifier Source: org_study_id