NCT02821117

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
3 countries

10 active sites

Status
completed

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

June 27, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

June 30, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

June 27, 2016

Last Update Submit

April 20, 2017

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, PaediatricSensing Technology

Outcome Measures

Primary Outcomes (1)

  • Change in Time in Range

    Time in range (Sensor glucose 3.9-10.0 mmol/L \[70-180 mg/dL\]) in days 56-70 minus time in range at baseline (days 1-15).

    Baseline and days 56 to 70

Study Arms (1)

Intervention

EXPERIMENTAL

FreeStyle Libre Flash Glucose Monitoring System

Device: FreeStyle Libre Flash Glucose Monitoring System

Interventions

FreeStyle Libre Flash Glucose Monitoring SystemDEVICE

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

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kinder- und Jugendkrankenhaus

Hanover, 30173, Germany

Location

National Children's Hospital

Dublin, 24, Ireland

Location

Temple Street Children's University Hospital

Dublin, 7, Ireland

Location

Royal Belfast Hospital for Sick Children

Belfast, County Antrim, BT12 6BE, United Kingdom

Location

Antrim Area Hospital

Antrim, BT41 2RL, United Kingdom

Location

Ulster Hospital

Belfast, BT16, United Kingdom

Location

St. James University Hospital, Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Altnagelvin Hospital

Londonderry, BT47 6SB, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Southampton University Hospital NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 1, 2016

Study Start

June 30, 2016

Primary Completion

November 30, 2016

Study Completion

February 22, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

GB(7)IE(2)DE(1)