Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

NCT01268488 | Completed Results

• 1 other identifier: CTD-2010-008-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method

  Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.

  2 hours

Secondary Outcomes (3)

• Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method

  2 hours

• Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)

  2 hours

• Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method

  2 hours

Study Arms (1)

Intended Users of the System

EXPERIMENTAL

Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor. This BG monitoring system will not proceed to marketed product.

Device: Ninja 2 Investigational Blood Glucose Meter

Interventions

Ninja 2 Investigational Blood Glucose Meter DEVICE

Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.

Intended Users of the 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 above
• Type 1 or type 2 diabetes
• Currently self-testing blood glucose at home at least twice daily
• Able to speak, read, and understand English
• Willing to complete all study procedures

You may not qualify if:

• Currently Pregnant
• Hemophilia or any other bleeding disorder
• Employee of competitive medical device company
• Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Consumer Product Testing Company

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

Limitations and Caveats

It was decided that this investigational BG monitoring system would not be part of a regulatory submission. It will not proceed to market.

Results Point of Contact

• Title: Carmine Greene, Senior Clinical Research Scientist
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

914-333-6280

Study Officials

• Michael Caswell, PhD

  Consumer Product Testing Company

  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: December 29, 2010
• First Posted: December 31, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 3, 2016
• Results First Posted: October 16, 2012

Record last verified: 2016-09

Locations

US (1)