User Performance of the Thunder Plus BGMS

NCT04008836 | Completed Results FDA Device

• 1 other identifier: GCA-PRO-2019-001-01
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Mellitus

Keywords

diabetes; BGMS; blood glucose monitoring system; YSI Glucose Analyzer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Accurate BGMS Palm (AST) Results.

  One day

• Number of Responses to Questionnaire 1 That Are Within Specified Criteria.

  One day

• Number of Participants With Accurate BGMS Venous Blood Results

  One day

Study Arms (1)

Untrained Subjects WITH Diabetes use the T-PLUS BGMS

EXPERIMENTAL

Untrained subjects WITH Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the T-PLUS BGMS. All blood glucose results are compared to reference method results. Also, study staff test subject's venous blood and the blood glucose results are compared to the reference method results.

Device: T-PLUS Meter

Interventions

T-PLUS Meter DEVICE

Blood Glucose Monitoring System (BGMS)

Untrained Subjects WITH Diabetes use the T-PLUS BGMS

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 UG 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 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.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Diablo Clinical Research (DCR)

Walnut Creek, California, 94598, 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
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

5748501467

Study Officials

• Mark Christiansen, MD

  Diablo Clinical Research

  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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be assigned to use the T-PLUS meter

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: June 10, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 17, 2024
• Results First Posted: February 5, 2024

Record last verified: 2024-02

Locations

US (1)