Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

Diabetes Clinical Trial

Official title:

Performance Evaluation of the Contour TS BGMS Using ISO/DIS 15197:2011 Section 8 Study Design and Performance Criteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575080
• Other study ID #: R&D-2011-2012-0.20
• Status: Completed
• Phase: N/A
• First received: April 9, 2012
• Last updated: January 29, 2016
• Start date: April 2012
• Est. completion date: April 2012

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a diagnosis of diabetes

• Be 18 years of age or older

• Be able to speak, read and understand English and understand the Informed Consent document.

• Be willing to complete study procedures

Exclusion Criteria:

• Pregnancy

• Infections or skin disorders at the puncture site (at the discretion of the site professional staff).

• Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.

• Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).

• A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.

• Previously participated in a blood glucose monitoring study using Contour TS system or use the Contour TS for personal use when monitoring blood glucose.

• Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company

• Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Contour TS Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.

Locations

Country	Name	City	State
United States	Bayer HealthCare LLC, Diabetes Care	Mishawaka	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method	Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).	1 hour	No
Secondary	Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method	Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).	1 hour	No
Secondary	Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method	Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).	1 hour	No
Secondary	Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements	Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.	1 hour	No