User Performance Evaluation of an Investigational Blood Glucose Monitoring System

NCT01410773 | Completed Results

• 1 other identifier: R&D-2010-2011.32
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

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

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

  1 hour

Secondary Outcomes (1)

• Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method

  1 hour

Study Arms (1)

Intended Users of the System

EXPERIMENTAL

Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.

Device: Ninja 2 Investigational Blood Glucose Monitoring System

Interventions

Ninja 2 Investigational Blood Glucose Monitoring System DEVICE

The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.

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
• Diagnosed as having type 1 or type 2 diabetes
• Currently self-testing blood glucose at home
• Able to speak, read, and understand English
• Willing to complete all study procedures

You may not qualify if:

• Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
• Hemophilia or any other bleeding disorder
• Employee of competitive medical device company,immediate family member of such, or living within the household of such
• Pregnancy

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, 46544, 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: Jane Wallace
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

574-257-3063

Study Officials

• David Simmons, MD

  Ascensia Diabetes Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: 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: August 3, 2011
• First Posted: August 5, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 29, 2016
• Results First Posted: August 31, 2012

Record last verified: 2016-01

Locations

US (1)