Clinical trial NCT02388815: Abbott Sensor Based Glucose Monitoring System Paediatric Study
Official title: Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Sensing Technology
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 89
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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


Eligibility criteria: 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)

Primary outcomes:
measure: Point Accuracy
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Harrogate
country: United Kingdom
facility: Harrogate & District NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: St. James University Hospital, Leeds Teaching Hospitals NHS Trust
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospital NHS Trust
Study officials:
References:
citation: Edge J, Acerini C, Campbell F, Hamilton-Shield J, Moudiotis C, Rahman S, Randell T, Smith A, Trevelyan N. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Arch Dis Child. 2017 Jun;102(6):543-549. doi: 10.1136/archdischild-2016-311530. Epub 2017 Jan 30.