Blood Glucose Testing and You

February 21, 2013 updated by: Ascensia Diabetes Care
The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92101
        • TCOYD at San Diego Convention Center
    • Florida
      • Tampa, Florida, United States, 33602-5331
        • TCOYD Conference at Tampa Convention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females, 18 years of age and above
  2. Type 2 diabetes
  3. Able to speak, read, and understand English
  4. Willing to complete all study procedures

Exclusion Criteria:

  1. Type 1 diabetes
  2. Currently a user of continuous glucose monitoring system
  3. Currently pregnant
  4. Hemophilia or any other bleeding disorder
  5. Employee of competitive medical device company
  6. Cognitive disorder or other condition which, in the opinion of the investigator (or designee), would put the person at risk or seriously compromise the integrity of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: People with type 2 diabetes
People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on a Blood Glucose meter, subjects were informed of their BG value.
Other: Blood Glucose meter
Staff tested subject Blood Glucose using a Blood Glucose meter.
Other Names:
  • Contour® Blood Glucose Meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
Time Frame: 1 visit 15-20 minutes
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.
1 visit 15-20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
Time Frame: 1 visit 15-20 minutes
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.
1 visit 15-20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascensia Diabetes Care

Investigators

  • Principal Investigator: Steven Edelman, MD, Founder TCOYD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

September 30, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (ESTIMATE)

October 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CTD PRO 2011-003-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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