FreeStyle Libre Glucose Monitoring System Paediatric Study

Diabetes Mellitus Clinical Trial

— SELFY  

Official title:

An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821117
• Other study ID #: ADC-UK-PMS-16028
• Status: Completed
• Phase: N/A
• First received: June 27, 2016
• Last updated: April 20, 2017
• Start date: June 30, 2016
• Est. completion date: February 22, 2017

Study information

• Verified date: April 2017
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 22, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Germany	Kinder- und Jugendkrankenhaus	Hannover
Ireland	National Children's Hospital	Dublin
Ireland	Temple Street Children's University Hospital	Dublin
United Kingdom	Antrim Area Hospital	Antrim
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	County Antrim
United Kingdom	Ulster Hospital	Belfast
United Kingdom	St. James University Hospital, Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Altnagelvin Hospital	Londonderry
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Southampton University Hospital NHS Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Countries where clinical trial is conducted

Germany,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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