Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

Study Overview
=================
Brief Summary
-----------------
Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.

Official Title
-----------------
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System - an Accuracy Evaluation

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Abbott Sensor Based Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 4-17 years (inclusive). Have type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII). Currently testing blood glucose levels at least twice per day. Each participant has an identified Caregiver aged ≥18 years. 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 real-time or professional use continuous glucose monitoring (CGM) or FreeStyle Libre device or is planning to use one during the study, and unwilling to stop use of the device during the study. 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
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Abbott Sensor Based Glucose Monitoring System | Device: Abbott Sensor Based Glucose Monitoring System<br>* Subjects will wear the Abbott Sensor Based Glucose Monitoring System and will be asked to perform 4 blood glucose tests per day (pre-meal and before bedtime). Subjects will be asked to scan the sensor when each blood glucose test is performed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Accuracy Determined as % within Consensus Error Grid Zone A | Point accuracy of Sensor based glucose values compared to capillary fingerstick blood glucose, determined as % within Consensus Error Grid Zone A. | Up to 35 days |