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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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 |
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 |

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. |
- 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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Ages Eligible for Study: | 4 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
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 |
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 |
Diabetes Mellitus Sensing Technology |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |