User Study of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Tatsu/Tradewind Investigational BG Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447121

CTD-PRO-2011-005-01

Details and patient eligibility

About

This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previously participated in a study using this investigational system
• Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
• Pregnancy
• Hemophilia or any other bleeding disorder
• 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
• 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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

Intended Users of the System

Experimental group

Description:

Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.

Treatment:

Device: Tatsu/Tradewind Investigational BG Monitoring System