- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466075
Study of an Investigational Glucose Meter System
January 29, 2016 updated by: Ascensia Diabetes Care
Clinical Study of the Apollo Evolution BGMS With Tatsu Blood Glucose Test Strips
The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
207
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
-
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Indiana
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Mishawaka, Indiana, United States, 46544
- Bayer HealthCare LLC, Diabetes Care
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-
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:
- Have a diagnosis of diabetes or pre-diabetes.
- Be 18 years of age or older
- Be able to speak, read and understand English and understand the Informed Consent document.
- Be willing to complete study procedures
Exclusion Criteria:
- Pregnancy
- Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
- Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
- Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
- A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
- Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
- 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
- Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intended Users of the Monitoring System
Untrained subjects with diabetes use the Apollo Evolution Investigational BG Monitoring System.
|
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution meter and an investigational sensor.
Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method.
Untrained subjects complete basic tasks using the User Guide and provide feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Time Frame: 1 hour
|
Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS).
BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
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).
Site staff tested in parallel after subjects.
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1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 1 hour
|
Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).
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1 hour
|
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Time Frame: 1 hour
|
Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS).
Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma).
|
1 hour
|
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction
Time Frame: 1 hour
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After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.
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1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 28, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (Estimate)
November 6, 2011
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
January 29, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- R&D-2011-2012-0.03
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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