Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-16

Study Completion Date

2018-05-11

Brief Summary

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Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Abbott Sensor Based Glucose Monitoring System

Group Type EXPERIMENTAL

Abbott Sensor Based Glucose Monitoring System

Intervention Type DEVICE

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.

Interventions

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Abbott Sensor Based Glucose Monitoring System

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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No