Paediatric Use of the Abbott Sensor Based Glucose Monitoring System
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Abbott Sensor Based Glucose Monitoring System
- Registration Number
- NCT03433573
- Lead Sponsor
- Abbott Diabetes Care
- Brief Summary
Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Abbott Sensor Based Glucose Monitoring System Abbott Sensor Based Glucose Monitoring System
- Primary Outcome Measures
Name Time Method Point Accuracy Determined as % within Consensus Error Grid Zone A Up to 35 days Point accuracy of Sensor based glucose values compared to capillary fingerstick blood glucose, determined as % within Consensus Error Grid Zone A.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Alder Hey Children's NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Pennine Acute Hospitals NHS Trust
🇬🇧Manchester, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Northampton General Hospitals NHS Trust
🇬🇧Northampton, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Southampton University Hospitals NHS Trust
🇬🇧Southampton, United Kingdom
Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
Great Western Hospitals NHS Foundation Trust
🇬🇧Swindon, United Kingdom
St George's Healthcare NHS Trust
🇬🇧Tooting, United Kingdom
Salisbury NHS Foundation Trust
🇬🇧Salisbury, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, United Kingdom