Abbott Sensor Based Glucose Monitoring… | Clinical Trial

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Freestyle LIbre Flash Glucose Monitoring System

Device

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)

Acronym: BEAGLE

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Mar 17, 2015
Registry last updated: Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed