User Performance of the Thunder Plus BGMS

Diabetes Mellitus Clinical Trial

Official title:

User Performance of the T-Plus Blood Glucose Monitoring Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008836
• Other study ID #: GCA-PRO-2019-001-01
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2024
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

T-PLUS (Thunder PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and CONTOUR PLUS test strips. The meter can wirelessly transmit BG results using Bluetooth® Low Energy technology to the meter mobile application that will be available on specified versions of the iOS and Android mobile platforms.

This clinical trial will assess the performance (accuracy) of the T-PLUS meters by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).

Description:

This study is designed to satisfy both the FDA SMBG:2018 and the ISO 15197:2013, Section 8 requirements. Besides different analysis criteria, the main difference between these regulations is that FDA SMBG:2018 requires that both naïve users (people without diabetes) and people with diabetes to be included in the study population. The ISO 15197:2013 standard states that the study population shall only include people with diabetes.

The study will be conducted at one clinical site and enroll approximately 370 lay users. Ten to fifteen percent (10-15%) of the enrolled subjects will be people without diabetes and twenty percent (20%) of subjects enrolled with diabetes will have Type 1 diabetes.

Each subject will make one visit, lasting approximately 1 hour at the clinical site. Study sessions will be conducted by study staff members who have been trained on all aspects of the protocol.

PROCEDURES: Subjects will be assigned to use the T-PLUS meter and use one lot of Contour Plus test strip lots throughout the visit.

• Additional Procedures for Subjects with Diabetes: Subjects with diabetes will be given a venipuncture. The venous blood will be tested by the study staff using the T-PLUS system, and the YSI lab analyzer.

After all self-testing is completed, subjects with diabetes will be given a questionnaire to provide feedback about the new features of the system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 UG to qualify for the study.

• Willing to complete all study procedures

Exclusion Criteria:

• 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 TV3 or Thunder V3 and Thunder PLUS BGMS.

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

• Being in this trial during or soon after xylose absorption testing (Xylose in the blood is known to cause interference). However, subjects can be enrolled as soon as 2 days after the test is performed (25 gms of oral xylose administered during this test is cleared within 480 mins or 8 hours).

• 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.

• Immediate family members are the subject's parents, spouse, children, and siblings, including the parent's spouse; step-children and adopted children and their spouses.

• A competitive medical device company is a company that provides a medical device or components of a device that is related to diabetes.

• A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk. The reason for exclusion will be clearly documented by investigator or designee on the subject disposition form.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• T-PLUS Meter
Blood Glucose Monitoring System (BGMS)

Locations

Country	Name	City	State
United States	Diablo Clinical Research (DCR)	Walnut Creek	California

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 Participants With Accurate BGMS Fingerstick Results	Number of participants with results within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations =100 mg/dL	One day
Secondary	Number of Participants With Accurate BGMS Palm (AST) Results.	Count of BGMS Palm (AST) from persons with diabetes within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations =100 mg/d results	One day
Secondary	Number of Responses to Questionnaire 1 That Are Within Specified Criteria.	A Labeling evaluation (Ease of Use) was performed by the subjects who answered a survey to evaluate the ease of use of the test and the instructions in the package insert. A numerical score or rating will be reported by subjects for statement. The allowed response are 1) Strongly Disagree, 2) Disagree, 3) Neutral, 4) Agree, or 5) Strongly Agree. The number of responses for each statement that is 3,4, or 5 will be reported; 3,4, and 5 are considered favorable responses.	One day
Secondary	Number of Participants With Accurate BGMS Venous Blood Results	Number of participant's results from venous blood that are within 15% of the reference analyzer.	One day