NCT03071159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 10, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2018

Completed
Last Updated

January 23, 2018

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

March 1, 2017

Last Update Submit

January 19, 2018

Conditions

Flash Glucose MonitoringMetabolic Control

Keywords

Flash Glucose MonitoringUsabilityMetabolic control

Outcome Measures

Primary Outcomes (1)

  • Usability of the FreeStyle Flash Libre glucose monitoring system

    Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire

    6-12 months follow up

Secondary Outcomes (2)

  • Problems associated with the FreeStyle Flash Libre glucose monitoring system

    6-12 months follow up

  • The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients

    6-12 months follow up

Study Arms (1)

cases

OTHER

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

Interventions

FreeStyle Flash Libre glucose monitoring systemDEVICE

glucose monitoring system with sensors

cases

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

RECRUITING

Study Officials

  • Guy Massa, MD, PhD

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

    STUDY DIRECTOR

Central Study Contacts

Guy Massa, MD, PhD

CONTACT

+32 11 30 96 34guy.massa@jessazh.be

Ingrid Arijs, PhD

CONTACT

+32(0)11 33 82 65ingrid.arijs@jessazh.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 6, 2017

Study Start

March 10, 2017

Primary Completion

March 10, 2018

Study Completion

March 10, 2018

Last Updated

January 23, 2018

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)