Evaluation of an Investigational Blood Glucose Monitoring System

NCT ID: NCT01859494

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-05-31

Brief Summary

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.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Users of the Monitoring System

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

Group Type: EXPERIMENTAL

NINJA 3 Investigational Blood Glucose Monitoring System

Intervention Type: DEVICE

Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.

Interventions

NINJA 3 Investigational Blood Glucose Monitoring System

Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Leslie J Klaff, MD

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research Center

Locations

AMCR Institute

Escondido, California, United States

Rainier Clinical Research Center

Renton, Washington, United States

Countries

United States

Other Identifiers

CTD-2012-009-01

Identifier Type: -

Identifier Source: org_study_id