Clinical Utility Trial for the SomaLogic CVD-T2D Test
Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for SomaLogic's Cardiovascular Disease in Type 2 Diabetes Test: A CPV® Randomized Controlled Trial
1 other identifier
interventional
251
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Mar 2022
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2022
CompletedAugust 22, 2022
August 1, 2022
5 months
February 2, 2022
August 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
CPV-measured baseline clinical variation levels
12 Months
CPV-measured Assessment of use case types
12 Months
Study Arms (3)
Control Group
NO INTERVENTIONControl group treats their simulated patients using standard practice and have no introduction to the new SomaLogic test.
Intervention Group 1
EXPERIMENTALIntervention 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
EXPERIMENTALIntervention 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qure Healthcare, LLClead
- SomaLogic, Inc.collaborator
Study Sites (1)
QURE Healthcare
San Francisco, California, 94133, United States
Related Publications (1)
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.
PMID: 37438853DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John W Peabody, MD, PhD
QURE Healthcare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 14, 2022
Study Start
March 15, 2022
Primary Completion
August 15, 2022
Study Completion
August 15, 2022
Last Updated
August 22, 2022
Record last verified: 2022-08