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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Diabetes Mellitus
Intervention Device: FreeStyle Libre Flash Glucose Monitoring System
Enrollment 89
Recruitment Details  
Pre-assignment Details A total of 89 subjects consented and were enrolled into the study.
Arm/Group Title FreeStyle Libre Flash Glucose Monitoring System
Hide Arm/Group Description

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.
Period Title: Overall Study
Started 89
Completed 85
Not Completed 4
Arm/Group Title FreeStyle Libre Flash Glucose Monitoring System
Hide Arm/Group Description

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.
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
<=18 years
89
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
44
  49.4%
Male
45
  50.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 89 participants
89
1.Primary Outcome
Title Point Accuracy
Hide Description

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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew prior to having a sensor applied, another did not perform any blood glucose tests on the FreeStyle Libre. Neither subject could be included in the accuracy analysis, both are included in the safety analysis.
Arm/Group Title FreeStyle Libre Flash Glucose Monitoring System
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of glucose results in zone A
83.8
(82.5 to 86.3)
Time Frame Adverse Events collected from enrolment to completion by last subject (2.5 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FreeStyle Libre Flash Glucose Monitoring System
Hide Arm/Group Description

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.
All-Cause Mortality
FreeStyle Libre Flash Glucose Monitoring System
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
FreeStyle Libre Flash Glucose Monitoring System
Affected / at Risk (%) # Events
Total   1/89 (1.12%)    
Musculoskeletal and connective tissue disorders   
Painful right leg *  1/89 (1.12%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FreeStyle Libre Flash Glucose Monitoring System
Affected / at Risk (%) # Events
Total   15/89 (16.85%)    
General disorders   
Common cold *  9/89 (10.11%)  9
Headache *  6/89 (6.74%)  8
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jolyon Bugler, Snr Director Clinical Development & Regulatory Affairs
Organization: Abbott Diabetes Care
Phone: 01993863164
EMail: joe.bugler@abbott.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02388815    
Other Study ID Numbers: ADC-UK-VAL-14022
First Submitted: March 10, 2015
First Posted: March 17, 2015
Results First Submitted: March 14, 2016
Results First Posted: April 12, 2016
Last Update Posted: August 11, 2016