Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Karajishi TS Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02041377

GCA-2013-002-01

Details and patient eligibility

About

The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Hemophilia or any other bleeding disorder
• Pregnancy
• Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
• Previously participated in a BG monitor study using the Karajishi TS BGMS (or used a Bayer Contour TS meter)
• Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
• Working for a competitive medical device company, or having an immediate family member who works for such a company
• A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

134 participants in 1 patient group

Intended Users of the Monitoring System

Experimental group

Description:

Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes

Treatment:

Device: Karajishi TS Investigational Blood Glucose Monitoring System