AST Clinical Investigation

Andon Health

Status: Completed

Conditions: Diabetes

Treatments: Device: blood glucose monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268345

AndonMedical2

Details and patient eligibility

About

Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.

Enrollment: 63 patients

Sex: All

Ages: 21 to 78 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Andon

Experimental group

Description:

Andon blood glucose test strips with test meter

Treatment:

Device: blood glucose monitor

Device: blood glucose monitor

Lifescan

Active Comparator group

Treatment:

Device: blood glucose monitor

Device: blood glucose monitor