Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Contour Link Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328717

R&D-2010-2011.09

Details and patient eligibility

About

Subjects with diabetes and study staff used an investigational blood glucose monitoring system.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 years of age and above
• Diagnosed as having type 1 or type 2 diabetes
• Currently self-testing blood glucose at home for at least three months
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion criteria

• Gestational Diabetes
• Hemophilia or any other bleeding disorder
• Employee of competitive medical device company

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

78 participants in 1 patient group

Intended Users of the System

Experimental group

Description:

Subjects with diabetes used Contour Link Investigational Blood Glucose Monitoring System

Treatment:

Device: Contour Link Investigational Blood Glucose Monitoring System