Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

NCT02041377 | Completed Results

• 1 other identifier: GCA-2013-002-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid 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

  Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. 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 (4)

• 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 Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

  1 hour

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

  1 hour

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes

Device: Karajishi TS Investigational Blood Glucose Monitoring System

Interventions

Karajishi TS Investigational Blood Glucose Monitoring System DEVICE

Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Intended 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 Karajishi TS BGMS (or used a Bayer Contour TS meter)
• 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

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

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

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 29, 2016
• Results First Posted: February 16, 2015

Record last verified: 2016-01

Locations

US (2)