Diabetes MellitusNCT04008836
User Performance of the Thunder Plus BGMS
A study testing T-PLUS Meter in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- T-PLUS Meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diablo Clinical Research (DCR)
Walnut Creek, California, 94598
About this study
Official title: User Performance of the T-Plus Blood Glucose Monitoring Systems
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).
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- T-PLUS Meter
- Keywords
- diabetes, BGMS, blood glucose monitoring system, YSI Glucose Analyzer
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PLUS MeterDevice
Blood Glucose Monitoring System (BGMS)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: T-PLUS Meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day
Secondary outcomes (3)
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
Measured: One day
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.
Measured: 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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start10 Jun 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be assigned to use the T-PLUS meter
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Christiansen, MD, Principal investigator, Diablo Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008836
- Sponsor's protocol ID
- GCA-PRO-2019-001-01
- Status last verified
- Feb 2024
- First submitted
- 1 Jul 2019
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance of the T-Plus Blood Glucose Monitoring Systems
- ClinicalTrials.gov ID
- NCT04008836
- Acronym / sponsor ID
- GCA-PRO-2019-001-01
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, BGMS, blood glucose monitoring system, YSI Glucose Analyzer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be assigned to use the T-PLUS meter
| Arm | Type | Receives |
|---|---|---|
| Untrained Subjects WITH Diabetes use the T-PLUS BGMS | Experimental | Device: T-PLUS MeterUntrained 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-PLUS MeterBlood Glucose Monitoring System (BGMS) | Device | Untrained Subjects WITH Diabetes use the T-PLUS BGMS |
Primary outcome
Number of Participants With Accurate BGMS Fingerstick Results
Time frame: 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
3 secondary outcomes
Number of Participants With Accurate BGMS Palm (AST) Results.
Time frame: One day
Number of Responses to Questionnaire 1 That Are Within Specified Criteria.
Time frame: One day
Number of Participants With Accurate BGMS Venous Blood Results
Time frame: One day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Christiansen, MD principal investigator
Diablo Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-PLUS Meter in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Accurate BGMS Fingerstick Results (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.