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NCT05256706 · ClinicalTrials.gov registry record · NA

SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes

A NA study of Diabetes Mellitus, Type 2, sponsored by Emory University.

Completed
Registry status
NA
Development phase
143
Enrollment target
5
Study locations

NCT05256706 is a NA study of Diabetes Mellitus, Type 2 that has completed, run by Emory University. The registered enrollment target is 143 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 1 state.

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The verdict

NCT05256706, a NA study of Diabetes Mellitus, Type 2, has completed, sponsored by Emory University.

COMPLETED
Registry status
NA
Development phase
143 participants
Enrollment target
5
Study locations

Study Summary

Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It has been proposed that such low uptake is more related to insurance type and coverage than to risk assessment. While it can be easy to blame prescribing deficiencies on complacent physicians and/or over-frugal payors, SomaLogic believes there is more likely to be a fundamental problem with the cost and risk-effective allocation of such therapies, which are neither low in cost nor free of adverse events. As current clinical trials and guidelines tend to "bundle" participants together, there is an absence of individualized assessment of residual cardiovascular risk. This leads to physicians, participants, and payors being relatively uninformed as to the need for and/or likely benefits of such therapies in an individual. Simply giving every eligible participant a drug regardless of residual risk would be unaffordable and would create adverse effects and costs for people at low residual risk who might not actually benefit from the drugs. To resolve this lack of precision in risk assessment, SomaLogic has performed the largest ever proteomic program to date with over 36,000 samples from 26,000 participants in eleven clinical studies, for a total of over 180,000,000 protein measurements, to develop and validate a surrogate proteomic endpoint for cardiovascular outcomes. The SomaSignal Cardiovascular Risk (SSCVR) test, a 27-protein model encompassing ten biological systems.

Conditions Studied

Interventions

  • OTHER Standard of Care
  • DIAGNOSTIC_TEST SomaSignal Informed Medical Management SSCVD

Study Locations (5)

Georgia

  • Grady Health System - Atlanta
  • Emory Hospital Midtown - Atlanta
  • Emory Clinic, Emory University Hospital - Atlanta
  • Emory Hospital - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2022-02-03
Est. Completion 2023-12-09
Phase NA

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT05256706

The ClinicalTrials.gov registry entry for NCT05256706 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT05256706 reports 5 study locations spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT05256706 about?

NCT05256706 is a clinical study titled "SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes". Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It ...

What is the current status of trial NCT05256706?

This trial is currently completed. It is a NA study. The enrollment target is 143 participants. The study started on 2022-02-03. Estimated completion is 2023-12-09.

What conditions does trial NCT05256706 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT05256706?

The interventions under investigation include: Standard of Care (OTHER), SomaSignal Informed Medical Management SSCVD (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05256706?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05256706 being conducted?

This trial has 5 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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