Abbott Sensor Based Glucose Monitoring System Paediatric Study (BEAGLE)
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ClinicalTrials.gov Identifier: NCT02388815 |
Recruitment Status :
Completed
First Posted : March 17, 2015
Results First Posted : April 12, 2016
Last Update Posted : August 11, 2016
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Sponsor:
Abbott Diabetes Care
Information provided by (Responsible Party):
Abbott Diabetes Care
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Tracking Information | |||
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First Submitted Date ICMJE | March 10, 2015 | ||
First Posted Date ICMJE | March 17, 2015 | ||
Results First Submitted Date ICMJE | March 14, 2016 | ||
Results First Posted Date ICMJE | April 12, 2016 | ||
Last Update Posted Date | August 11, 2016 | ||
Study Start Date ICMJE | March 2015 | ||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Abbott Sensor Based Glucose Monitoring System Paediatric Study | ||
Official Title ICMJE | Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE) | ||
Brief Summary | To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) |
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Condition ICMJE | Diabetes Mellitus | ||
Intervention ICMJE | 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. |
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Study Arms ICMJE | Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Intervention: Device: FreeStyle Libre Flash Glucose Monitoring System
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Publications * | Edge J, Acerini C, Campbell F, Hamilton-Shield J, Moudiotis C, Rahman S, Randell T, Smith A, Trevelyan N. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Arch Dis Child. 2017 Jun;102(6):543-549. doi: 10.1136/archdischild-2016-311530. Epub 2017 Jan 30. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
89 | ||
Original Estimated Enrollment ICMJE |
90 | ||
Actual Study Completion Date ICMJE | July 2015 | ||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 4 Years to 17 Years (Child) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United Kingdom | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02388815 | ||
Other Study ID Numbers ICMJE | ADC-UK-VAL-14022 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Abbott Diabetes Care | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Abbott Diabetes Care | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Abbott Diabetes Care | ||
Verification Date | July 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |