NCT05189938

HbA1c Variation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 488 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HBA1c data and glucose levels	All subjects will wear the professional FreeStyle Libre Pro for glucose data and HbA1c data will be collected at different time points over the participation period.

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-01-13
• Last updated: 2025-05-25

Locations

22 sites across 2 countries: United States, United Kingdom