Trial Outcomes & Findings for Abbott Sensor Based Glucose Monitoring System Paediatric Study (NCT NCT02388815)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

89 participants

Primary outcome timeframe

14 days

Results posted on

2016-08-11

Participant Flow

A total of 89 subjects consented and were enrolled into the study.

Participant milestones

Participant milestones
Measure	FreeStyle Libre Flash Glucose Monitoring System 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 Study STARTED	89
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abbott Sensor Based Glucose Monitoring System Paediatric Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FreeStyle Libre Flash Glucose Monitoring System n=89 Participants 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.
Age, Categorical <=18 years	89 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United Kingdom	89 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	FreeStyle Libre Flash Glucose Monitoring System n=87 Participants 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	83.8 percentage of glucose results in zone A Interval 82.5 to 86.3

Adverse Events

FreeStyle Libre Flash Glucose Monitoring System

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FreeStyle Libre Flash Glucose Monitoring System n=89 participants at risk 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.
Musculoskeletal and connective tissue disorders Painful right leg	1.1% 1/89 • Number of events 1 • Adverse Events collected from enrolment to completion by last subject (2.5 months)

Other adverse events

Other adverse events
Measure	FreeStyle Libre Flash Glucose Monitoring System n=89 participants at risk 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.
General disorders Common cold	10.1% 9/89 • Number of events 9 • Adverse Events collected from enrolment to completion by last subject (2.5 months)
General disorders Headache	6.7% 6/89 • Number of events 8 • Adverse Events collected from enrolment to completion by last subject (2.5 months)

Additional Information

Jolyon Bugler, Snr Director Clinical Development & Regulatory Affairs

Abbott Diabetes Care

Phone: 01993863164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60