Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

NCT ID: NCT01575080

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-04-30

Brief Summary

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

Conditions

Diabetes

Study Design

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

Study Groups

Intended Users of the Monitoring System

Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.

Group Type: EXPERIMENTAL

Contour TS Blood Glucose Monitoring System

Intervention Type: DEVICE

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.

Interventions

Contour TS Blood Glucose Monitoring System

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Have a diagnosis of diabetes
• Be 18 years of age or older
• Be able to speak, read and understand English and understand the Informed Consent document.
• Be willing to complete study procedures

Exclusion Criteria

• Pregnancy
• Infections or skin disorders at the puncture site (at the discretion of the site professional staff).
• Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
• Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
• A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
• Previously participated in a blood glucose monitoring study using Contour TS system or use the Contour TS for personal use when monitoring blood glucose.
• 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
• Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors

• 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

David Simmons, MD

Role: PRINCIPAL_INVESTIGATOR

Ascensia Diabetes Care

Locations

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, United States

Countries

United States

Other Identifiers

R&D-2011-2012-0.20

Identifier Type: -

Identifier Source: org_study_id