Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatment freestyle libre flash glucose monitoring system
Sponsor Abbott Diabetes Care
Start date June 2016
End date December 2016
Trial size 76 participants
Trial identifier NCT02821117, ADC-UK-PMS-16028

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
FreeStyle Libre Flash Glucose Monitoring System
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 Outcomes

Measure
Change in Time in Range
time frame: Baseline and days 56 to 70

Eligibility Criteria

Male or female participants from 4 years up to 17 years old.

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).

Additional Information

Official title An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Abbott Diabetes Care.