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Clinical Trial Summary

To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.


Clinical Trial Description

This is a non-pivotal , non-randomized, single-arm, multi-center, prospective, non-significant risk study to evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels. Up to approximately 600 subjects will be enrolled who will have fourteen (14) study visits over the course of approximately six (6) months. During each visit the subject will have blood samples drawn for documentation of their HbA1c level. Subjects will also be required to wear Professional FreeStyle Libre Flash Glucose Monitoring System(s) to record blood glucose levels through the duration of the study. During Visits 1 and 14, Venous sample for CBC, biochemistry, haemoglobinopathy screen, hematology, liver function and iron panels will be collected. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05189938
Study type Observational
Source Abbott Diabetes Care
Contact Mohamed Nada, PhD
Phone 5107495416
Email [email protected]
Status Recruiting
Phase
Start date December 20, 2021
Completion date December 2022

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