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Completed
NCT02821117
FreeStyle Libre Glucose Monitoring System Paediatric Study
Conditions: Diabetes Mellitus
Sex: All
Ages: 4 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: Abbott Diabetes Care
Location: Kinder- und Jugendkrankenhaus Hanover
Summary
The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.
Eligibility Criteria
Inclusion Criteria:
* Aged ≥4 years and ≤17 years.
* Has an identified Caregiver of ≥18 years.
* Type 1 diabetes using insulin (administered by injections or CSII) for at least 1 year.
* Current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen.
* Currently testing BG, on average at least 2 times per day.
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 (or requires it during the study).
* Currently receiving dialysis treatment or planning to receive dialysis during the study.
* Female participant known to be pregnant.
* Participating in another device or drug study that could affect glucose measurements or glucose management.
* Currently using or planning to use FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device during the study.
* Has used the FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device in the previous 3 months.
* Known (or suspected) allergy to medical grade adhesives.
* In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).
Source: ClinicalTrials.gov (NCT02821117). StuddyBuddy aggregates publicly available trial information.