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FreeStyle Libre Glucose Monitoring System Paediatric Study (SELFY)

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: NCT02821117
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: FreeStyle Libre Flash Glucose Monitoring System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : February 22, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Device: 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.





Primary Outcome Measures :
  1. Change in Time in Range [ Time Frame: Baseline and days 56 to 70 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT02821117


Locations
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Germany
Kinder- und Jugendkrankenhaus
Hannover, Germany, 30173
Ireland
National Children's Hospital
Dublin, Ireland, 24
Temple Street Children's University Hospital
Dublin, Ireland, 7
United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, County Antrim, United Kingdom, BT12 6BE
Antrim Area Hospital
Antrim, United Kingdom, BT41 2RL
Ulster Hospital
Belfast, United Kingdom, BT16
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Altnagelvin Hospital
Londonderry, United Kingdom, BT47 6SB
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Southampton University Hospital NHS Trust
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Abbott Diabetes Care

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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02821117     History of Changes
Other Study ID Numbers: ADC-UK-PMS-16028
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Abbott Diabetes Care:
Diabetes Mellitus, Paediatric
Sensing Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases