Evaluation of an Investigational Blood Glucose Monitoring System

NCT01859494 | Completed Results

• 1 other identifier: CTD-2012-009-01
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to determine if untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma).

  1 hour

Secondary Outcomes (5)

• Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method

  1 hour

• Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method

  1 hour

• Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method

  1 hour

• Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff

  1 hour

• Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements

  1 hour

Study Arms (1)

Users of the Monitoring System

EXPERIMENTAL

Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.

Device: NINJA 3 Investigational Blood Glucose Monitoring System

Interventions

NINJA 3 Investigational Blood Glucose Monitoring System DEVICE

Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.

Users of the Monitoring 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 older
• People with type 1 or type 2 diabetes
• Able to speak, read, and understand English
• Willing to complete all study procedures

You may not qualify if:

• Hemophilia or any other bleeding disorder
• Pregnancy
• Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
• Previously participated in a BG monitor study using the Ninja 3 BGMS
• Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
• Working for a competitive medical device company, or having an immediate family member who works for such a company
• A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk.
• The enrollment criteria for the study population:
• At least 60% of subjects will be younger than age 65
• At least 20% of subjects will have type 1 diabetes
• At least 50% of subjects with type 2 diabetes wil be insulin users.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (2)

AMCR Institute

Escondido, California, 92026, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, 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, Deputy Director for Global Clinical Affairs
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

574-257-3063

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

• Leslie J Klaff, MD

  Rainier Clinical Research Center

  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: May 19, 2013
• First Posted: May 22, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 10, 2017
• Results First Posted: October 31, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)