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Abbott Sensor Based Glucose Monitoring System Paediatric Study (BEAGLE)

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: NCT02388815
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : April 12, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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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:

  • 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)
Contacts and Locations
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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): NCT02388815


Locations
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United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Harrogate & District NHS Foundation Trust
Harrogate, United Kingdom, HG2 7SX
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Northampton General Hospital NHS Trust
Northampton, United Kingdom, NNI 5BD
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital NHS Trust
Oxford, United Kingdom, OX3 9DU
Southampton University Hospital NHS Trust
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Abbott Diabetes Care
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02388815    
Other Study ID Numbers: ADC-UK-VAL-14022
First Posted: March 17, 2015    Key Record Dates
Results First Posted: April 12, 2016
Last Update Posted: August 11, 2016
Last Verified: July 2016
Keywords provided by Abbott Diabetes Care:
Diabetes Mellitus
Sensing Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases