Abbott Sensor Based Glucose Monitoring System Paediatric Study

Diabetes Mellitus Clinical Trial

— BEAGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388815
• Other study ID #: ADC-UK-VAL-14022
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: October 8, 2015
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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 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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter
United Kingdom	Harrogate & District NHS Foundation Trust	Harrogate
United Kingdom	St. James University Hospital, Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Northampton General Hospital NHS Trust	Northampton
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford Radcliffe Hospital NHS Trust	Oxford
United Kingdom	Southampton University Hospital NHS Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point Accuracy	Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A	14 days	No