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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: FreeStyle Libre Flash Glucose Monitoring System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|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|
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.
- 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.
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
|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|