Abbott Sensor Based Glucose Monitoring System Paediatric Study

Study Overview
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Brief Summary
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To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: FreeStyle Libre Flash Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>FreeStyle Libre Flash Glucose Monitoring System | Device: FreeStyle Libre Flash Glucose Monitoring System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Sensing Technology