N/A
Completed N=384
User Performance of the Thunder Plus BGMS
Source: ClinicalTrials.gov NCT04008836 ↗Enrolled (actual)
384
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Accurate BGMS Fingerstick Results — 373 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Accurate BGMS Fingerstick Results |
373 | — |
| SECONDARY Number of Participants With Accurate BGMS Palm (AST) Results. |
344 | — |
| SECONDARY Number of Responses to Questionnaire 1 That Are Within Specified Criteria. |
327 | — |
| SECONDARY Number of Participants With Accurate BGMS Venous Blood Results |
327 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04008836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.