Clinical trial NCT05237271: Clinical Utility Trial for the SomaLogic CVD-T2D Test
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Type 2 Diabetes
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: SomaLogic, Inc.
First posted: 2022-02-14
Enrollment: 251
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CPV-measured clinical score difference
timeFrame: 12 Months
measure: CPV-measured cost difference
timeFrame: 12 Months
Secondary outcomes:
measure: CPV-measured baseline clinical variation levels
timeFrame: 12 Months
measure: CPV-measured Assessment of use case types
timeFrame: 12 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
affiliation: QURE Healthcare
name: John W Peabody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: