Diabetes Mellitus
Conditions
Keywords
diabetes, BGMS, blood glucose monitoring system, YSI Glucose Analyzer
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).
Detailed 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.
Interventions
DEVICET-PLUS Meter
Blood Glucose Monitoring System (BGMS)
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Subjects will be assigned to use the T-PLUS meter
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Accurate BGMS Fingerstick Results | One day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Accurate BGMS Palm (AST) Results. | One day | 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 |
| Number of Responses to Questionnaire 1 That Are Within Specified Criteria. | One day | 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. |
| Number of Participants With Accurate BGMS Venous Blood Results | One day | Number of participant's results from venous blood that are within 15% of the reference analyzer. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from 10Jun2019 to 31Jul2019.
Participants by arm
| Arm | Count |
|---|---|
| Subject Fingerstick Self Testing Each subject performs fingerstick testing using the Thunder Plus meter. | 384 |
| Total | 384 |
Baseline characteristics
| Characteristic | Subject Fingerstick Self Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 115 Participants |
| Age, Categorical Between 18 and 65 years | 269 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 14.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 331 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 38 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 260 Participants |
| Region of Enrollment United States | 384 participants |
| Sex: Female, Male Female | 224 Participants |
| Sex: Female, Male Male | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 384 |
| other Total, other adverse events | 0 / 384 |
| serious Total, serious adverse events | 0 / 384 |
Outcome results
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
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | Number of Participants With Accurate BGMS Fingerstick Results | 373 Participants |
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
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | Number of Participants With Accurate BGMS Palm (AST) Results. | 344 Participants |
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.
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | Number of Participants With Accurate BGMS Venous Blood Results | 327 Participants |
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.
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | Number of Responses to Questionnaire 1 That Are Within Specified Criteria. | 327 Participants |