Clinical Utility Trial for the SomaLogic CVD-T2D Test

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237271
• Other study ID #: Pro00058735
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Qure Healthcare, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Board-certified primary care physicians or cardiologist for at least two years

2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months

3. Routinely evaluate patients with diabetes mellitus in their practice

4. Practicing in the U.S.

5. English speaking

6. Access to the internet

7. Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

1. Non-English speaking

2. Practicing in an academic setting

3. Unable to access the internet

4. Not practicing in the U.S.

5. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months

6. Previous exposure to the CVD-T2D test

7. Do not voluntarily consent to be in the study

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 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.
• Educational Materials on the CVD-T2D and Bundled Metabolic Panel
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.

Locations

Country	Name	City	State
United States	QURE Healthcare	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Qure Healthcare, LLC	SomaLogic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Months
Primary	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.)	12 Months
Secondary	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.	12 Months
Secondary	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.	12 Months