Diabetes MellitusNCT05647824
User Performance of the TV4 BGMS
An observational study of Diabetes Mellitus, run by Ascensia Diabetes Care at 3 sites in United States.
Trial summary
Thunder V4 (TV4) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and new Contour FIT test strips. This clinical trial will assess the performance (accuracy) of the TV4 meter by lay users enrolled as subjects in the study, and by health care professionals (also called study staff). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Capillary Testing, Alternative Site Testing (AST) and Venous Testing
- Type of treatment
- Medical device
- How many people
- 402 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Feb 2020to 23 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: The following population criteria are study goals, with each site recruiting to meet these goals: 1. Enrollment: A total of at least 402 subjects across the sites, or it can also be 134 per clinical site. 2. At least 70% of all subjects will be younger than age 65 (across all the sites). 3. Ten to fifteen % (10-15%) of naïve users (naïve to SMBG's and may include people without diabetes) (across all the sites). 4. At least 20% of non-naïve users (subjects with diabetes) will have type 1 diabetes (across all the sites). 5. Sites will also recruit subjects of Chinese descent according to the site's ability. (One or both of the subject's parents can be of Chinese descent.)
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 the ability to read a paragraph from the first page of the User Guide (UG) to qualify for the study.
- Willing to complete all study procedures
Who cannot join
- Subjects without diabetes that are not naïve to Blood Glucose Monitoring System.
- 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 use of the Ascensia Contour Thunder V3 (TV3), or Thunder PLUS (T-PLUS), or Thunder V4 (TV4) BGMS.
- Working for a medical laboratory, hospital or another clinical setting that involves training on, or clinical use of blood glucose monitors.
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- 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).
- 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.
- 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.
- For example, people who are not eligible are those who work for companies that create or manufacture the following (or a company that is in a partnership with a company that provides such devices): lancing devices, blood glucose monitoring systems, continuous glucose monitoring systems, insulin pens, or systems related to the measurement of HbA1c.
- People who are eligible are those who work for companies associated with products such as wound dressings, medications or dietary products.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Clinical Research, LLC
Idaho Falls, Idaho, 83404
Rainier Clinical Research Center Inc
Renton, Washington, 98057
Diablo Clinical Research (DCR)
Walnut Creek, California, 94598
About this study
Official title: User Performance of the TV4 Blood Glucose Monitoring System
Thunder V4 (TV4) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and new Contour FIT test strips. This clinical trial will assess the performance (accuracy) of the TV4 meter by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).
Read the detailed description
The study will be conducted at three clinical sites and enroll a total of approximately 402 lay users. Ten to fifteen percent (10 - 15%) of the enrolled subjects will be naïve users (naïve to SMBG's and may include people without diabetes). At least twenty percent (20%) of subjects enrolled with diabetes will have Type 1 diabetes. At least 70% of subjects will be younger than age 65. Sites will also enroll subjects of Chinese descent.
This clinical investigation will be conducted within the US.
- Conditions
- Diabetes Mellitus
- Being tested
- Capillary Testing, Alternative Site Testing (AST), Venous Testing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary TestingDevice
Also called Contour Fit BGMS
Testing Contour Fit BGMS with capillary blood
Alternative Site Testing (AST)Device
Also called Contour Fit BGMS
Testing Contour Fit BGMS using blood from alternative site
Venous TestingDevice
Also called Contour Fit BGMS
Testing Contour Fit BGMS with venous blood
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Consists of people with Diabetes and people without Diabetes Receives: Device: Capillary Testing; Device: Alternative Site Testing (AST); Device: Venous Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fingerstick Test: Obtain TV4 BGMS performance data in the hands of lay users with diabetes using fingerstick capillary blood obtained with Microlet NEXT® lancing device.
Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL
Measured: 4 weeks
Secondary outcomes (3)
Alternative Site Test (AST): Obtain TV4 BGMS performance data in the hands of lay users with diabetes using capillary blood from the palm site obtained with Microlet NEXT lancing device with the AST endcap.
Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL
Measured: 4 weeks
Venous Blood Test: Obtain TV4 BGMS performance data using venous blood from lay users with diabetes.
Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL
Measured: 4 weeks
Subject Questionnaire on the Usability of TV4 BGMS
Number of results with scores of 3 or higher to statements concerning instructions for use or ease of use. Scores of 3 or greater (on a scale of 0 to 5) are more favorable to usability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start5 Feb 2020
- Primary completion20 Mar 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark P Christiansen, MD, Principal investigator, Diablo Clinical Research (DCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647824
- Sponsor's protocol ID
- GCA-PRO-2019-006-01
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Protection of laboratory workers from occupationally acquired infections; approved guideline - third edition. CLSI document M29-A3. ISBN1-56238-567-4.
Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008. CDC.
FDA, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance of the TV4 Blood Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT05647824
- Acronym / sponsor ID
- GCA-PRO-2019-006-01
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thunder V4 (TV4) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and new Contour FIT test strips. This clinical trial will assess the performance (accuracy) of the TV4 meter by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).
Detailed description
The study will be conducted at three clinical sites and enroll a total of approximately 402 lay users. Ten to fifteen percent (10 - 15%) of the enrolled subjects will be naïve users (naïve to SMBG's and may include people without diabetes). At least twenty percent (20%) of subjects enrolled with diabetes will have Type 1 diabetes. At least 70% of subjects will be younger than age 65. Sites will also enroll subjects of Chinese descent.
This clinical investigation will be conducted within the US.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | Device: Capillary Testing, Device: Alternative Site Testing (AST), Device: Venous TestingConsists of people with Diabetes and people without Diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The following population criteria are study goals, with each site recruiting to meet these goals: 1. Enrollment: A total of at least 402 subjects across the sites, or it can also be 134 per clinical site. 2. At least 70% of all subjects will be younger than age 65 (across all the sites). 3. Ten to fifteen % (10-15%) of naïve users (naïve to SMBG's and may include people without diabetes) (across all the sites). 4. At least 20% of non-naïve users (subjects with diabetes) will have type 1 diabetes (across all the sites). 5. Sites will also recruit subjects of Chinese descent according to the site's ability. (One or both of the subject's parents can be of Chinese descent.)
Key inclusion criteria (3 listed)
- Males and females, 18 years of age and older
- Ability to speak, read and understand English. Subjects must demonstrate the ability to read a paragraph from the first page of the User Guide (UG) to qualify for the study.
- Willing to complete all study procedures
Key exclusion criteria (13 listed)
- Subjects without diabetes that are not naïve to Blood Glucose Monitoring System.
- 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 use of the Ascensia Contour Thunder V3 (TV3), or Thunder PLUS (T-PLUS), or Thunder V4 (TV4) BGMS.
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 |
|---|---|---|
| Capillary TestingAlso: Contour Fit BGMSTesting Contour Fit BGMS with capillary blood | Device | All Subjects |
| Alternative Site Testing (AST)Also: Contour Fit BGMSTesting Contour Fit BGMS using blood from alternative site | Device | All Subjects |
| Venous TestingAlso: Contour Fit BGMSTesting Contour Fit BGMS with venous blood | Device | All Subjects |
Primary outcome
Fingerstick Test: Obtain TV4 BGMS performance data in the hands of lay users with diabetes using fingerstick capillary blood obtained with Microlet NEXT® lancing device.
Time frame: 4 weeks
Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL
3 secondary outcomes
Alternative Site Test (AST): Obtain TV4 BGMS performance data in the hands of lay users with diabetes using capillary blood from the palm site obtained with Microlet NEXT lancing device with the AST endcap.
Time frame: 4 weeks
Venous Blood Test: Obtain TV4 BGMS performance data using venous blood from lay users with diabetes.
Time frame: 4 weeks
Subject Questionnaire on the Usability of TV4 BGMS
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- BackgroundProtection of laboratory workers from occupationally acquired infections; approved guideline - third edition. CLSI document M29-A3. ISBN1-56238-567-4.
- BackgroundRutala W, Weber D, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008. CDC.
- BackgroundFDA, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2, 2011.
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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 P Christiansen, MD principal investigator
Diablo Clinical Research (DCR)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Ascensia Diabetes Care at 3 sites 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 13 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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fingerstick Test: Obtain TV4 BGMS performance data in the hands of lay users with diabetes using fingerstick capillary blood obtained with Microlet NEXT® lancing device. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647824, which also lists 3 linked publications.
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 2 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.