Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

Ascensia Diabetes Care

Status

Completed

Conditions

Diabetes

Treatments

Device: Contour TS Blood Glucose Monitoring System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01575080

R&D-2011-2012-0.20

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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