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

NCT01268267 | Completed Results

• 1 other identifier: CTD-2010-008-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the performance and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/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 monitoring system (BGMS), which included an investigational meter and sensor. 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 20 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 20 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 20 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 an investigational blood glucose monitoring system (development name Ninja 2).

Device: Ninja 2 Investigational Blood Glucose Monitoring System

Interventions

Ninja 2 Investigational Blood Glucose Monitoring System 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 and an investigational sensor. 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)

AMCR Institute

Escondido, California, 92026, 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: Carmine Greene
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

574-257-3040

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  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 28, 2010
• First Posted: December 30, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 29, 2016
• Results First Posted: May 31, 2012

Record last verified: 2016-01

Locations

US (1)