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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-PLUS Meter | Device | Blood Glucose Monitoring System (BGMS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Responses to Questionnaire 1 That Are Within Specified Criteria. |
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Inclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Christiansen, MD | Diablo Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research (DCR) | Walnut Creek | California | 94598 | United States |
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Recruitment was from 10Jun2019 to 31Jul2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | 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. T-PLUS Meter: Blood Glucose Monitoring System (BGMS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subject Fingerstick Self Testing | Each subject performs fingerstick testing using the Thunder Plus meter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | count of number of subjects within an age range |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | One day |
|
Only collected on the day of the study
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | 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. T-PLUS Meter: Blood Glucose Monitoring System (BGMS) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Diabetes Care | 5748501467 | jane.wallace@ascensia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol and Statistical section | May 9, 2019 | Feb 4, 2023 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis plan | Apr 23, 2019 | Mar 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Subjects will be assigned to use the T-PLUS meter
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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 |
| 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 |
| Count of Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| 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 | Posted | Count of Participants | Participants | One day |
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| 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. | Posted | Count of Participants | Participants | One day |
|
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| 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. | Posted | Count of Participants | Participants | One day |
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| 0 |
| 384 |
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| 384 |
| 0 |
| 384 |
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