FreeStyle Libre Glucose Monitoring System Paediatric Study

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

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-02-22

Brief Summary

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The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

FreeStyle Libre Flash Glucose Monitoring System

Group Type EXPERIMENTAL

FreeStyle Libre Flash Glucose Monitoring System

Intervention Type DEVICE

Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear.

During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase.

Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management.

Interventions

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FreeStyle Libre Flash Glucose Monitoring System

Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear.

During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase.

Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged ≥4 years and ≤17 years.
* Has an identified Caregiver of ≥18 years.
* Type 1 diabetes using insulin (administered by injections or CSII) for at least 1 year.
* Current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen.
* Currently testing BG, on average at least 2 times per day.

Exclusion Criteria

* Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
* Currently prescribed oral steroid therapy for any acute or chronic condition (or requires it during the study).
* Currently receiving dialysis treatment or planning to receive dialysis during the study.
* Female participant known to be pregnant.
* Participating in another device or drug study that could affect glucose measurements or glucose management.
* Currently using or planning to use FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device during the study.
* Has used the FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device in the previous 3 months.
* Known (or suspected) allergy to medical grade adhesives.
* In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No