Clinical trial NCT03433573: Paediatric Use of the Abbott Sensor Based Glucose Monitoring System
Official title: Paediatric Use of the Abbott Sensor Based Glucose Monitoring System - an Accuracy Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 103
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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).

Primary outcomes:
measure: Point Accuracy Determined as % within Consensus Error Grid Zone A
timeFrame: Up to 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Northampton
country: United Kingdom
facility: Northampton General Hospitals NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals NHS Trust
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
city: Tooting
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
Study officials:
References: