Abbott Sensor Based Glucose Monitoring System Paediatric Study (BEAGLE)

July 11, 2016 updated by: Abbott Diabetes Care

Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)

To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS1 3NU
        • University Hospitals Bristol NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter NHS Foundation Trust
      • Harrogate, United Kingdom, HG2 7SX
        • Harrogate & District NHS FOUNDATION TRUST
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital, Leeds Teaching Hospitals NHS Trust
      • Northampton, United Kingdom, NNI 5BD
        • Northampton General Hospital NHS Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford Radcliffe Hospital NHS Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 4 years, ≤17 years
  • Each participant has an identified Caregiver of ≥18 years
  • Type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII)
  • Currently testing blood glucose, on average at least 2 times per day
  • In the investigator's opinion, technically capable of using device (participant and/or caregiver).

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
  • Currently receiving dialysis treatment or planning to receive dialysis during the study
  • Female participant known to be pregnant
  • Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
  • Currently using a continuous glucose monitoring (CGM) device
  • Known (or suspected) allergy to medical grade adhesives
  • In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Device: FreeStyle Libre Flash Glucose Monitoring System

Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.

During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Accuracy
Time Frame: 14 days

Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.

The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences.

Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-UK-VAL-14022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on FreeStyle Libre Flash Glucose Monitoring System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe