Abbott Sensor Based Glucose Monitoring System Paediatric Study (BEAGLE)

Abbott

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: FreeStyle Libre Flash Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388815

ADC-UK-VAL-14022

Details and patient eligibility

About

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

Enrollment: 89 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

89 participants in 1 patient group

Intervention

Experimental group

Description:

FreeStyle Libre Flash Glucose Monitoring System

Treatment:

Device: FreeStyle Libre Flash Glucose Monitoring System