Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

NCT01614613 | Completed Results

• 1 other identifier: CTD-2010-009-02
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)

  Using samples with BG \< 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.

  6 hours

Secondary Outcomes (4)

• MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL

  6 hours

• MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL

  6 hours

• Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)

  6 hours

• Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements

  1 hour

Study Arms (1)

Intended BGM Users

EXPERIMENTAL

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

Device: Bayer G3 / Tatsu System; Device: Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Device: Freestyle Lite® Meter and Test Strips with ZipwikTM tabs; Device: OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips; Device: One Touch® VerioTM Pro/One Touch® VerioTM Test Strips; Device: Truetrack® Meter/Truetrack® Test Strips

Interventions

Bayer G3 / Tatsu System 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).

Intended BGM Users

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

Intended BGM Users

Freestyle Lite® Meter and Test Strips with ZipwikTM tabs 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).

Intended BGM Users

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

Intended BGM Users

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

Intended BGM Users

Truetrack® Meter/Truetrack® Test Strips 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).

Intended BGM Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Rainier Clinical Research Center Inc

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Carmine Greene
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

574-257-3040

Study Officials

• Leslie J Klaff, MD

  Rainier Clinical Research Center Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: June 8, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 29, 2016
• Results First Posted: September 9, 2013

Record last verified: 2016-01

Locations

US (1)