AST Clinical Investigation

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268345
• Other study ID #: AndonMedical2
• Status: Completed
• Phase: N/A
• First received: December 29, 2010
• Last updated: December 29, 2010
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• 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 monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 78 Years

Eligibility

Inclusion Criteria:

• people ( disbetes people)with at least 8 hours of limosis

Exclusion Criteria:

• After meal(when doing the test)

• take Hypoglycemic Drugs(when doing the test)

• with insulin(when doing the test)

• after strenuous exercise(when doing the test)

• Pregnant women

• neonates

• patients in a hyperglycemic-hyperosmolur state, with or without ketosis.

• patients who are dehydrated, hypertensive, hypotensive or in shock.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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
• 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 Hexi Ruijing metabolism 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