Performance of a New Glucose Meter System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01264016

CTD-2010-004-01

Details and patient eligibility

About

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or 2 diabetes
• Age 18 years or older
• Routinely performs blood glucose self testing at home, at least once per day
• Able to speak, read, and understand English.
• Is willing to complete all study procedures

Exclusion criteria

• Currently pregnant
• Hemophilia or any other bleeding disorder
• Taking prescription anticoagulants or has clotting problems that may prolong bleeding. Taking aspirin daily is not excluded
• Subject employee of competitive medical device company
• Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

96 participants in 1 patient group

Intended Users of the Monitoring System

Experimental group

Description:

Untrained subjects with diabetes use an investigational blood glucose monitoring system.

Treatment:

Device: Investigational Blood Glucose Monitoring System