NCT01714232

Brief Summary

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 27, 2013

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

October 23, 2012

Results QC Date

November 8, 2013

Last Update Submit

January 29, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range

    Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \|(BG meter)-(BG reference)\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.

    8 hours

Secondary Outcomes (2)

  • MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)

    8 hours

  • MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)

    8 hours

Study Arms (1)

Study Staff Test BGMSs

EXPERIMENTAL

All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.

Device: Contour® PLUS BGMSDevice: OneTouch® SelectSimple™ BGMSDevice: Accu-Chek® Performa BGMSDevice: Accu-Chek® Active BGMSDevice: Freestyle Freedom® BGMS

Interventions

Contour® PLUS BGMSDEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Study Staff Test BGMSs
OneTouch® SelectSimple™ BGMSDEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Study Staff Test BGMSs
Accu-Chek® Performa BGMSDEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Study Staff Test BGMSs
Accu-Chek® Active BGMSDEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Study Staff Test BGMSs
Freestyle Freedom® BGMSDEVICE

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Study Staff Test BGMSs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, 18 years of age or older
  • Willing to complete all study procedures

You may not qualify if:

  • Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
  • Hemophilia or any other bleeding disorder
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, 46544, United States

Location

Related Publications (2)

  • Pardo S, Dunne N, Simmons DA. A comparison of bolus insulin dose errors based on results of a clinical trial of five blood glucose monitoring systems. Ther Deliv. 2019 Dec;10(12):793-799. doi: 10.4155/tde-2019-0047. Epub 2019 Dec 2.

    PMID: 31789119DERIVED

  • Dunne N, Viggiani MT, Pardo S, Robinson C, Parkes JL. Accuracy Evaluation of CONTOUR((R))PLUS Compared With Four Blood Glucose Monitoring Systems. Diabetes Ther. 2015 Sep;6(3):377-88. doi: 10.1007/s13300-015-0121-3. Epub 2015 Jul 14.

    PMID: 26169192DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Jane Wallace
Organization
Ascensia Diabetes Care
jane.wallace@ascensia.com
574-257-3063

Study Officials

  • David Simmons, MD

    Ascensia Diabetes Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
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

October 23, 2012

First Posted

October 25, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 29, 2016

Results First Posted

December 27, 2013

Record last verified: 2016-01

Locations

US(1)