Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

Diabetes Mellitus Clinical Trial

— PUGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433573
• Other study ID #: ADC-UK-VAL-17032
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: May 11, 2018

Study information

• Verified date: August 2018
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool
United Kingdom	Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	Northampton General Hospitals NHS Trust	Northampton
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Salisbury NHS Foundation Trust	Salisbury
United Kingdom	Southampton University Hospitals NHS Trust	Southampton
United Kingdom	Great Western Hospitals NHS Foundation Trust	Swindon
United Kingdom	Taunton and Somerset NHS Foundation Trust	Taunton
United Kingdom	St George's Healthcare NHS Trust	Tooting
United Kingdom	Royal Cornwall Hospitals NHS Trust	Truro

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 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