Cardiovascular DiseasesNCT05237271
Clinical Utility Trial for the SomaLogic CVD-T2D Test
A study testing Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) and Educational Materials on the CVD-T2D and Bundled Metabolic Panel in people with Cardiovascular Diseases and Type 2 Diabetes, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
QURE will use its CPV technology in a randomized controlled trial to measure how SomaLogic's diagnostic test (the Cardiovascular Disease in Type 2 Diabetes) changes clinical practice and improves patient outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Type 2 Diabetes
- What is being tested?
- Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) and Educational Materials on the CVD-T2D and Bundled Metabolic Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 15 Aug 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Board-certified primary care physicians or cardiologist for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Routinely evaluate patients with diabetes mellitus in their practice
- Practicing in the U.S.
- English speaking
- Access to the internet
- Informed, signed and voluntarily consented to be in the study
Who cannot join
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
- Previous exposure to the CVD-T2D test
- Do not voluntarily consent to be in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for SomaLogic's Cardiovascular Disease in Type 2 Diabetes Test: A CPV® Randomized Controlled Trial
QURE will use its CPV technology in a randomized controlled trial to measure how SomaLogic's diagnostic test (the Cardiovascular Disease in Type 2 Diabetes) changes clinical practice and improves patient outcomes.
Read the detailed description
SomaLogic has developed a pioneering technology, the SomaScan® Platform, the first and only platform, that simultaneously measures 7,000 proteins. The company's technology is based on proprietary aptamers, called SOMAmers®, which can measure these unique proteins with high sensitivity and specificity across a large dynamic range. Using over 60,000 samples, artificial intelligence and machine learning powered bioinformatics algorithms have created 12 SomaSignal™ tests. The Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) Test result produces risk score for developing cardiovascular events such as heart attacks, strokes, heart failure, or cardiovascular death within 4 years, with median time to event of 1.7 years across the different risk categories. SomaSignal™ testing has the potential to effectively risk-stratify patients, determine disease prognosis, and elucidate disease drivers for clinicians. Analytic and clinical validity findings, using this patented technology, have already been published by the company or collaborators in scientific and clinical manuscripts.
SomaLogic is looking to understand if the test, when used by practitioners, helps clinicians determine cardiovascular risk status and achieve better care for patients with diabetes. To achieve this goal, SomaLogic is looking for an established, innovative approach to gather high-quality prospective clinical utility data in as short a time as possible. Determining the clinical utility of the SomaSignal tests will be essential to increase access to the test and is required to gain coverage and reimbursement.
Accordingly, this study will collect high-quality randomized controlled data from a nationally representative sample of practicing primary care physicians and cardiologists. To first determine how these physicians currently manage cardiovascular risk factors in patients with Type 2 Diabetes (T2DM) and then to determine if introducing the test results of the CVD-T2D test will change their clinical decision making. Data from this study will better illuminate which use case is best served by SomaSignal testing (and thus the greatest clinical utility) and what physician characteristics (e.g., age, practice setting, training) are associated with these practice changes.
This study uses simulated patient cases, called Clinical Performance and Value vignettes (CPVs), a proven methodology that is widely used to rapidly measure physician care decisions. CPVs are a unique and scalable tool that standardizes practice measurement by having all providers care for the same (virtual) patients. With all providers caring for the same patients, the CPVs generate unbiased data that yields powerful insights into clinical decision making and how these decisions change with the introduction of a new product or solution. Data from the CPVs demonstrates the presence or absence of the clinical utility of a diagnostic test. The results, positive or negative, are published in peer-reviewed literature and if they are positive, favorably impact coverage and reimbursement decisions.
The primary goal will be to determine whether informing clinicians of the CVD-T2D test results leads to changes in prescriptions and/or medical management of virtual participants with T2D in concordance with CVD in Type 2 Diabetes results compared with virtual participants whose physicians are not informed of the test results.
- Conditions
- Cardiovascular Diseases, Type 2 Diabetes
- Being tested
- Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D), Educational Materials on the CVD-T2D and Bundled Metabolic Panel
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D)Other
Educational Materials will detail the diagnostic tests in question. This CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years.
Educational Materials on the CVD-T2D and Bundled Metabolic PanelOther
Educational Materials will detail the diagnostic tests in question.his CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years. The bundled metabolic scores will provide insight into the patient's current metabolic conditions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group treats their simulated patients using standard practice and have no introduction to the new SomaLogic test. |
| Intervention Group 1 | Experimental | Intervention group 1 will receive educational materials on the single cardiovascular disease in type 2 diabetes risk score. They will then be forced to used the risk score for their simulated patients, which will allow us to assess how the risk score may improve clinical practice and reduce variation. Receives: Other: Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) |
| Intervention Group 2 | Experimental | Intervention group 2 will receive educational materials on the cardiovascular disease in type 2 diabetes (CVD-T2D) risk score as well as the panel of metabolic scores. They will then be forced to used the CVD-T2D score and the metabolic panel scores for their simulated patients, which will allow us to assess how the risk score may improve clinical practice and reduce variation. Receives: Other: Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D); Other: Educational Materials on the CVD-T2D and Bundled Metabolic Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPV-measured clinical score difference
Difference-in-differences regression analysis between the control and the intervention groups' physicial exam, workup, diagnosis, and treatment cardiovascular risk in patients with type 2 diabetes, as measured by the participants diagnostic and treatment CPV case domain scores. In each CPV, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes. We will measure the overall change in the evidence-based physician behavior including referrals, utilization of cardioprotective medications, right heart catherization and echocardiography, in the CPV patient simulations.
Measured: 12 Months
CPV-measured cost difference
Change in cost of related care for cardiovascular risks in patients with diabetes mellitus when comparing the control to the intervention group. (This cost is modeled in part by measuring differential rates of medical interventions selected by each arm and multiplying by average Medicare reimbursement rates for these interventions. The cost is also modeled by examining average per annum costs for patients suffering from diabetes mellitus and multiplying by the percent of patients whose workup and interventions for cardiovascular risks are significantly reduced following the intervention.)
Measured: 12 Months
Secondary outcomes (2)
CPV-measured baseline clinical variation levels
Participants completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types. We will measure the baseline levels of variation in the assessment, recognition, and management of cardiovascular risks in patients with diabetes mellitus among all participants.
Measured: 12 Months
CPV-measured Assessment of use case types
Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is a average score of the subcategory scores (percent correct). This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Mar 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SomaLogic, Inc.
- Responsible party
- Sponsor
- Investigators
- John W Peabody, MD, PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237271
- Sponsor's protocol ID
- Pro00058735
- Status last verified
- Aug 2022
- First submitted
- 2 Feb 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peabody JW, Paculdo D, de Belen E, Ganesan D, Cooney I, Trujillo N. Clinical utility of a novel test for assessing cardiovascular disease risk in type 2 diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2023 Jul 13;15(1):155. doi: 10.1186/s13098-023-01122-w.
PubMed 37438853
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for SomaLogic's Cardiovascular Disease in Type 2 Diabetes Test: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05237271
- Acronym / sponsor ID
- Pro00058735
- Conditions
- Cardiovascular Diseases, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SomaLogic, Inc.
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 14 Feb 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.
QURE will use its CPV technology in a randomized controlled trial to measure how SomaLogic's diagnostic test (the Cardiovascular Disease in Type 2 Diabetes) changes clinical practice and improves patient outcomes.
Detailed description
SomaLogic has developed a pioneering technology, the SomaScan® Platform, the first and only platform, that simultaneously measures 7,000 proteins. The company's technology is based on proprietary aptamers, called SOMAmers®, which can measure these unique proteins with high sensitivity and specificity across a large dynamic range. Using over 60,000 samples, artificial intelligence and machine learning powered bioinformatics algorithms have created 12 SomaSignal™ tests. The Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) Test result produces risk score for developing cardiovascular events such as heart attacks, strokes, heart failure, or cardiovascular death within 4 years, with median time to event of 1.7 years across the different risk categories. SomaSignal™ testing has the potential to effectively risk-stratify patients, determine disease prognosis, and elucidate disease drivers for clinicians. Analytic and clinical validity findings, using this patented technology, have already been published by the company or collaborators in scientific and clinical manuscripts.
SomaLogic is looking to understand if the test, when used by practitioners, helps clinicians determine cardiovascular risk status and achieve better care for patients with diabetes. To achieve this goal, SomaLogic is looking for an established, innovative approach to gather high-quality prospective clinical utility data in as short a time as possible. Determining the clinical utility of the SomaSignal tests will be essential to increase access to the test and is required to gain coverage and reimbursement.
Accordingly, this study will collect high-quality randomized controlled data from a nationally representative sample of practicing primary care physicians and cardiologists. To first determine how these physicians currently manage cardiovascular risk factors in patients with Type 2 Diabetes (T2DM) and then to determine if introducing the test results of the CVD-T2D test will change their clinical decision making. Data from this study will better illuminate which use case is best served by SomaSignal testing (and thus the greatest clinical utility) and what physician characteristics (e.g., age, practice setting, training) are associated with these practice changes.
This study uses simulated patient cases, called Clinical Performance and Value vignettes (CPVs), a proven methodology that is widely used to rapidly measure physician care decisions. CPVs are a unique and scalable tool that standardizes practice measurement by having all providers care for the same (virtual) patients. With all providers caring for the same patients, the CPVs generate unbiased data that yields powerful insights into clinical decision making and how these decisions change with the introduction of a new product or solution. Data from the CPVs demonstrates the presence or absence of the clinical utility of a diagnostic test. The results, positive or negative, are published in peer-reviewed literature and if they are positive, favorably impact coverage and reimbursement decisions.
The primary goal will be to determine whether informing clinicians of the CVD-T2D test results leads to changes in prescriptions and/or medical management of virtual participants with T2D in concordance with CVD in Type 2 Diabetes results compared with virtual participants whose physicians are not informed of the test results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group treats their simulated patients using standard practice and have no introduction to the new SomaLogic test. |
| Intervention Group 1 | Experimental | Other: Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D)Intervention group 1 will receive educational materials on the single cardiovascular disease in type 2 diabetes risk score. They will then be forced to used the risk score for their simulated patients, which will allow us to assess how the risk score may improve clinical practice and reduce variation. |
| Intervention Group 2 | Experimental | Other: Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D), Other: Educational Materials on the CVD-T2D and Bundled Metabolic PanelIntervention group 2 will receive educational materials on the cardiovascular disease in type 2 diabetes (CVD-T2D) risk score as well as the panel of metabolic scores. They will then be forced to used the CVD-T2D score and the metabolic panel scores for their simulated patients, which will allow us to assess how the risk score may improve clinical practice and reduce variation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Board-certified primary care physicians or cardiologist for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Routinely evaluate patients with diabetes mellitus in their practice
- Practicing in the U.S.
- English speaking
Key exclusion criteria (7 listed)
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
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 |
|---|---|---|
| Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D)Educational Materials will detail the diagnostic tests in question. This CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years. | Other | Intervention Group 1, Intervention Group 2 |
| Educational Materials on the CVD-T2D and Bundled Metabolic PanelEducational Materials will detail the diagnostic tests in question.his CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years. The bundled metabolic scores will provide insight into the patient's current metabolic conditions. | Other | Intervention Group 2 |
Primary outcome
CPV-measured clinical score difference
Time frame: 12 Months
Difference-in-differences regression analysis between the control and the intervention groups' physicial exam, workup, diagnosis, and treatment cardiovascular risk in patients with type 2 diabetes, as measured by the participants diagnostic and treatment CPV case domain scores. In each CPV, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes. We will measure the overall change in the evidence-based physician behavior including referrals, utilization of cardioprotective medications, right heart catherization and echocardiography, in the CPV patient simulations.
CPV-measured cost difference
Time frame: 12 Months
Change in cost of related care for cardiovascular risks in patients with diabetes mellitus when comparing the control to the intervention group. (This cost is modeled in part by measuring differential rates of medical interventions selected by each arm and multiplying by average Medicare reimbursement rates for these interventions. The cost is also modeled by examining average per annum costs for patients suffering from diabetes mellitus and multiplying by the percent of patients whose workup and interventions for cardiovascular risks are significantly reduced following the intervention.)
2 secondary outcomes
CPV-measured baseline clinical variation levels
Time frame: 12 Months
CPV-measured Assessment of use case types
Time frame: 12 Months
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 22 Aug 2022.
- Derived from this study: PubMed 37438853Peabody JW, Paculdo D, de Belen E, Ganesan D, Cooney I, Trujillo N. Clinical utility of a novel test for assessing cardiovascular disease risk in type 2 diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2023 Jul 13;15(1):155. doi: 10.1186/s13098-023-01122-w.
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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.
John W Peabody, MD, PhD principal investigator
QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) and Educational Materials on the CVD-T2D and Bundled Metabolic Panel in people with Cardiovascular Diseases and Type 2 Diabetes, run by Qure Healthcare, LLC 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 7 inclusion and 7 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 22 Aug 2022. 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?
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?
CPV-measured clinical score difference (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 NCT05237271, which also lists 1 linked publication.
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 22 Aug 2022.