NCT01466075

Study of an Investigational Glucose Meter System

Clinical Study of the Apollo Evolution BGMS With Tatsu Blood Glucose Test Strips

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Apollo Evolution Investigational BG Monitoring System	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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-11-07
• Last updated: 2016-02-29
• Results posted: 2013-01-30

Locations

1 site across 1 country: United States