Study of an Investigational Glucose Meter System

NCT ID: NCT01466075

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intended Users of the Monitoring System

Untrained subjects with diabetes use the Apollo Evolution Investigational BG Monitoring System.

Group Type: EXPERIMENTAL

Apollo Evolution Investigational BG Monitoring System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Simmons, MD

Role: PRINCIPAL_INVESTIGATOR

Ascensia Diabetes Care

Locations

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, United States

Countries

United States

Other Identifiers

R&D-2011-2012-0.03

Identifier Type: -

Identifier Source: org_study_id