Study of an Investigational Glucose Meter System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: G3 Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474317

CTD-PRO-2010-009-01

Details and patient eligibility

About

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 years of age and older
• Type 1 or type 2 diabetes
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion criteria

• Pregnancy
• Hemophilia or any other bleeding disorder
• Previously participated in a study using the G3 system
• Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
• A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
• Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 1 patient group

Intended Users of the Monitoring System

Experimental group

Description:

Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.

Treatment:

Device: G3 Investigational Blood Glucose Monitoring System