Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

Completed · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01575080

Run by

Ascensia Diabetes Care

People needed

102

Starts

2012-04-01

Expected to finish

2012-04-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bayer HealthCare LLC, Diabetes Care — Mishawaka, Indiana, United States

Full record on ClinicalTrials.gov

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