Abbott Sensor Based Glucose Monitoring System Paediatric Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

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.

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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

Blinding Strategy

NONE

Study Groups

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Intervention

FreeStyle Libre Flash Glucose Monitoring System

Group Type EXPERIMENTAL

FreeStyle Libre Flash Glucose Monitoring System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No