Status:
COMPLETED
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief Summary
Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2018
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03433573
Start Date
February 16 2018
End Date
May 11 2018
Last Update
August 29 2018
Active Locations (11)
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1
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
2
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L14 5AB
3
Pennine Acute Hospitals NHS Trust
Manchester, United Kingdom, M8 5RB
4
Northampton General Hospitals NHS Trust
Northampton, United Kingdom, NN1 5BD