User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)

NCT03730480 | Completed Results FDA Device

• 1 other identifier: GCA-PRO-2018-006-01
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 2

Brief Summary

This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, using a fingerstick(s) to collect meter samples. Meter results will be compared to standardized test system to assess the accuracy of the meters' results. Additionally, a blood sample will be drawn from the subject's arm by a trained healthcare professional for testing on both BGMS. Subjects will also be asked to complete a questionnaire to rate their experience using the meters and to evaluate the meter's Instructions for Use. After all testing and the first questionnaire have been completed, the study staff will demonstrate only to subjects with diabetes several features of the meters that would not necessarily be experienced during the meter testing. These subjects will then answer questions about the features in a second questionnaire.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer

  Number of Participants with self fingerstick results from the Contour Next BGMS and Contour TV3 BGMS that are within 15% of results from the Reference Analyzer. Results from the two meter systems will not be compared to each other.

  1 day

Secondary Outcomes (1)

• Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS

  1 day

Study Arms (1)

Subjects with and without Diabetes test Contour Next and Contour TV3

EXPERIMENTAL

All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS

Device: Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes

Interventions

Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes DEVICE

Using the first blood glucose monitoring system (BGMS), which is either Contour Next or Contour TV3, subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Using the second BGMS, the palm, self test and staff tests are performed. Subjects with diabetes get a venipuncture and staff tests using both BGMS using the venous blood.

Subjects with and without Diabetes test Contour Next and Contour TV3

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
• Ability to speak, read and understand English. Subjects must demonstrate ability to read a paragraph from the first page of the User Guide to qualify for the study.
• Willing to complete all study procedures.

You may not qualify if:

• Hemophilia or any other bleeding disorder.
• Pregnancy (self-reported).
• Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS.
• Previous participation in a blood glucose monitoring study using the Ascensia CONTOUR NEXT or CONTOUR TV3 BGMS.
• Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose monitors.
• 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.
• 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
• Regulatory and Clinical Research Institute Inc: collaborator

Study Sites (2)

AMCR Institute

Escondido, California, 92025, United States

Location

Ranier Clinical Research Center, Inc.

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: Pragathi Shelat
• Organization: Ascensia Diabetes Care

pragathi.shelat@ascensia.com

1 (862) 229-6679

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

• Leslie J Klaff, MD

  Ranier Clinical Research Center, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: September 6, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: January 18, 2022
• Results First Posted: January 5, 2022

Record last verified: 2022-01

Locations

US (2)