Clinical Test of Blood Glucose Test Strips

Diabetes Clinical Trial

Official title:

Clinical Test of Blood Glucose Test Strips

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976924
• Other study ID #: AndonMedical1
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 14, 2009
• Start date: July 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Andon Medical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Blood glucose test strips are tested with the test meters to test the accuracy of the blood pressure monitoring function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 78 Years

Eligibility

Inclusion Criteria:

• The patients with blood glucose within the range of ISO15197

Exclusion Criteria:

• The patients with blood glucose out of the range of ISO15197

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.

Locations

Country	Name	City	State
China	Tianjin Medical University general hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Andon Medical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose value		5 seconds	No