Performance Evaluation of an Investigational Blood Glucose Monitoring System

NCT01598610 | Completed Results

• 1 other identifier: CTD-2012-002-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method

  Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.

  1 hour

Secondary Outcomes (5)

• Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method

  1 hour

• Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method

  1 hour

• Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method

  1 hour

• Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff

  1 hour

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

  1 hour

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.

Device: CONTOUR® PLUS Investigational BG Monitoring System

Interventions

CONTOUR® PLUS Investigational BG Monitoring System DEVICE

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.

Intended Users of the Monitoring System

Eligibility Criteria

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

You may qualify if:

• Males and females, 18 years of age and older
• Type 1 or type 2 diabetes
• Able to speak, read, and understand English
• Willing to complete all study procedures

You may not qualify if:

• Pregnancy
• Hemophilia or any other bleeding disorder
• Previously participated in a study using the CONTOUR PLUS system
• Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
• 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 (2)

Midwest Institute For Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Consumer Product Testing Co.

Fairfield, New Jersey, 07004, 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

• Phillip D Toth, MD, FACP

  Midwest Institute For Clinical Research

  PRINCIPAL INVESTIGATOR

• Michael Caswell, PhD

  Consumer Product Testing Co.

  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: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 29, 2016
• Results First Posted: July 30, 2013

Record last verified: 2016-01

Locations

US (2)