Evaluation of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: NINJA 3 Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859494

CTD-2012-009-01

Details and patient eligibility

About

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

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Hemophilia or any other bleeding disorder
2. Pregnancy
3. Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
4. Previously participated in a BG monitor study using the Ninja 3 BGMS
5. Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
6. Working for a competitive medical device company, or having an immediate family member who works for such a company
7. A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk.

The enrollment criteria for the study population:

1. At least 60% of subjects will be younger than age 65
2. At least 20% of subjects will have type 1 diabetes
3. At least 50% of subjects with type 2 diabetes wil be insulin users.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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219 participants in 1 patient group

Users of the Monitoring System

Experimental group

Description:

Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.

Treatment:

Device: NINJA 3 Investigational Blood Glucose Monitoring System