Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

NCT02150109 | Completed Results

• 1 other identifier: GCA-2014-002-01
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Untrained subjects WITH diabetes (329) 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 +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).

  1 hour

Secondary Outcomes (8)

• Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

  1 hour

• Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff

  1 hour

• Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements

  1 hour

• Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range

  1 hour

• Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range

  1 hour

Study Arms (2)

Persons With Diabetes

EXPERIMENTAL

Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Device: Subjects WITH Diabetes Use Karajishi Contour BGMS

Persons With and Without Diabetes

EXPERIMENTAL

Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS

Interventions

Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS DEVICE

Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Persons With and Without Diabetes

Subjects WITH Diabetes Use Karajishi Contour BGMS DEVICE

Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Persons With Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18 years of age and older
• 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 Karajishi Contour BGMS (or used a Bayer Contour meter)
• Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
• Work 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
• General enrollment guidelines:
• Most subjects will be persons with type 1 or type 2 diabetes
• At least 10% of subjects with diabetes will have type 1 diabetes
• Approximately 10% of subjects will be persons without diabetes
• At least 60% of subjects will be younger than age 65

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 Clinical Trials
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

574-257-3063

Study Officials

• Leslie J Klaff, MD

  Rainier Clinical Research Center

  PRINCIPAL INVESTIGATOR

• 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: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 29, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 29, 2016
• Results First Posted: July 21, 2015

Record last verified: 2015-06

Locations

US (2)