At a glance
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Clinical Study of the Apollo Evolution BGMS With Tatsu Blood Glucose Test Strips
In Brief
A clinical study evaluating Apollo Evolution Investigational BG Monitoring System for Diabetes. Completed, enrolled 207 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Study Details
Timeline
Interventions
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.