Abbott Sensor Based Glucose Monitoring System Paediatric Study
BEAGLE
Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)
1 other identifier
interventional
89
1 country
9
Brief Summary
To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Mar 2015
Shorter than P25 for not_applicable diabetes-mellitus
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
April 12, 2016
CompletedAugust 11, 2016
July 1, 2016
3 months
March 10, 2015
March 14, 2016
July 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Point Accuracy
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
Study Arms (1)
Intervention
EXPERIMENTALFreeStyle Libre Flash Glucose Monitoring System
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
Harrogate & District NHS Foundation Trust
Harrogate, HG2 7SX, United Kingdom
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Northampton General Hospital NHS Trust
Northampton, NNI 5BD, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Oxford Radcliffe Hospital NHS Trust
Oxford, OX3 9DU, United Kingdom
Southampton University Hospital NHS Trust
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 28137708DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jolyon Bugler, Snr Director Clinical Development & Regulatory Affairs
- Organization
- Abbott Diabetes Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
August 11, 2016
Results First Posted
April 12, 2016
Record last verified: 2016-07