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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

Tracking Information
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
 (submitted: June 9, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
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
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)
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.

Study Arms  ICMJE Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Intervention: Device: FreeStyle Libre Flash Glucose Monitoring System
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2015)
89
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2015)
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:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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