Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

NCT ID: NCT01614613

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of this study was to test the performance of an investigational Bayer Blood Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was to obtain glucose samples from subjects with diabetes across the meter operating ranges. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). All lancings and testing were performed by study staff.

Conditions

Diabetes

Study Design

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

Study Groups

Intended BGM Users

Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips

Group Type: EXPERIMENTAL

Bayer G3 / Tatsu System

Intervention Type: DEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips

Intervention Type: DEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Freestyle Lite® Meter and Test Strips with ZipwikTM tabs

Intervention Type: DEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips

Intervention Type: DEVICE

Study staff performed Blood Glucose (BG) tested with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

One Touch® VerioTM Pro/One Touch® VerioTM Test Strips

Intervention Type: DEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Truetrack® Meter/Truetrack® Test Strips

Intervention Type: DEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Interventions

Bayer G3 / Tatsu System

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Intervention Type: DEVICE

Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Intervention Type: DEVICE

Freestyle Lite® Meter and Test Strips with ZipwikTM tabs

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Intervention Type: DEVICE

OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips

Study staff performed Blood Glucose (BG) tested with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Intervention Type: DEVICE

One Touch® VerioTM Pro/One Touch® VerioTM Test Strips

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Intervention Type: DEVICE

Truetrack® Meter/Truetrack® Test Strips

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of type 1 or type 2 diabetes mellitus
• 18 years of age or older
• Willing to follow all study procedures

Exclusion Criteria

• Received an investigational drug or device within the last 30 days
• Current use or recent exposure to any prescription medication within 24 hours prior to screening that in the opinion of the investigator could have an influence on the subject's ability to participate in the study or on the performance on the test device
• Positive pregnancy test obtained at screening (test performed for females only, except if surgically sterile or three years past menopause)
• Hematocrit <32% or >55%
• Inadequate veins (in the opinion of the investigator or designated study staff) for venous blood withdrawal or intravenous catheter insertion
• Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g. percutaneous transluminal coronary angioplasty [PTCA], stent placement) or coronary artery bypass graft (CABG) within the past 6 months
• Cerebrovascular accident within the past 6 months
• Diagnosis of the following diabetic autonomic neuropathies: symptomatic orthostatic hypotension, heart rate anomalies, gastroparesis
• Being treated for malignancy, except basal cell or squamous cell skin cancers
• Major surgical operation within 30 days prior to screening
• Active alcohol abuse or substance abuse (as judged by the principal investigator)
• Severe mental illness, mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation (as judged by principal investigator)
• Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity, as judged by principal investigator (reason for exclusion will be clearly documented by investigator or designee)
• 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

• 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

Leslie J Klaff, MD

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research Center Inc

Locations

Rainier Clinical Research Center Inc

Renton, Washington, United States

Countries

United States

Other Identifiers

CTD-2010-009-02

Identifier Type: -

Identifier Source: org_study_id