Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 5:48 AM
Study NCT ID:
NCT05182359
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PORTRAIT-DM
Brief Summary:
Single-center, prospective, 2:1 randomized controlled parallel-group study, with an open label extension to evaluate SomaSignal Informed Medical Management (informed) versus Standard of Care (uninformed).
Detailed Description:
Primary Aim: To determine whether risk stratification from SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test leads to riskconcordant changes in prescriptions and/or medical management in patients with diabetes.
Secondary Aims:
Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical practice.
Secondary Aim 2: To enable future health economic analyses of the impact of precision risk-stratified treatment.
Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D)) on medical management of the previously uninformed group at the end of the study.
Secondary Aims:
Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical practice.
Secondary Aim 2: To enable future health economic analyses of the impact of precision risk-stratified treatment.
Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D)) on medical management of the previously uninformed group at the end of the study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: