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Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications

Primary Purpose

Type 2 Diabetes, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes focused on measuring Proteomics, T2D, Type 2 diabetes mellitus, CVD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provider

  • Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes

Inclusion Criteria: Patient

  • Patients receiving care at a UC Health system
  • Age 40 years or older
  • Type 2 Diabetes
  • Eligible for (per drug label/guidelines) at least one of the following classes: SGLT2i, PCSK9i, GLP-1 RA
  • Able to provide consent

Exclusion Criteria:

  • Use of SGLT2i , GLP1RA and PCSK9i within the 3 months prior to enrollment
  • Systemic Lupus Erythematous (SLE)*
  • Pregnancy (as determined by self report)
  • Intolerance or contraindication for use of both GLP1RA and SGLT2i

  • History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening

    • Samples provided by patients with SLE may fail to produce results or may produce inaccurate results because autoantibodies in the patient plasma may interact with the DNA-based reagents used in the assay

Sites / Locations

  • Aanchal Gupta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)

Group 2: Standard of Care (CVDT2D test, uninformed)

Arm Description

Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit.

Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.

Outcomes

Primary Outcome Measures

Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline
Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.

Secondary Outcome Measures

Change in protein predicted risk: SomaLogic CVDT2D test
Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months
Change in protein predicted risk: biomarkers
Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months
Standard of care risk assessment: body mass index (BMI) at baseline
Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.
Standard of care risk assessment: body mass index (BMI) at 6 months
Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline
The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months
The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.

Full Information

First Posted
December 8, 2021
Last Updated
June 9, 2023
Sponsor
University of Colorado, Denver
Collaborators
SomaLogic, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05166382
Brief Title
Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications
Official Title
Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
SomaLogic, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to learn more about using a proteomic test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Cardiovascular Diseases
Keywords
Proteomics, T2D, Type 2 diabetes mellitus, CVD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Providers will be randomized into informed vs uninformed groups. The randomization will occur at each clinic individually to assure equal distribution of informed vs uninformed providers in each clinic. Patients will be assigned a group based on their providers randomization.
Masking
ParticipantCare Provider
Masking Description
Providers and participants in the uninformed arm will not receive CVD-T2D test results until the second research visit in the study.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)
Arm Type
Experimental
Arm Description
Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit.
Arm Title
Group 2: Standard of Care (CVDT2D test, uninformed)
Arm Type
Placebo Comparator
Arm Description
Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
Other Intervention Name(s)
Informed
Intervention Description
Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their first research visit.
Intervention Type
Behavioral
Intervention Name(s)
Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
Other Intervention Name(s)
Uninformed
Intervention Description
Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their second research visit.
Primary Outcome Measure Information:
Title
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline
Description
Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.
Time Frame
Baseline
Title
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
Description
Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in protein predicted risk: SomaLogic CVDT2D test
Description
Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months
Time Frame
Baseline, 6 months
Title
Change in protein predicted risk: biomarkers
Description
Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months
Time Frame
Baseline, 6 months
Title
Standard of care risk assessment: body mass index (BMI) at baseline
Description
Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.
Time Frame
Baseline
Title
Standard of care risk assessment: body mass index (BMI) at 6 months
Description
Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.
Time Frame
6 months
Title
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline
Description
The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.
Time Frame
Baseline
Title
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months
Description
The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provider Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes Inclusion Criteria: Patient Patients receiving care at a UC Health system Age 40 years or older Type 2 Diabetes Eligible for (per drug label/guidelines) at least one of the following classes: SGLT2i, PCSK9i, GLP-1 RA Able to provide consent Exclusion Criteria: Use of SGLT2i , GLP1RA and PCSK9i within the 3 months prior to enrollment Systemic Lupus Erythematous (SLE)* Pregnancy (as determined by self report) Intolerance or contraindication for use of both GLP1RA and SGLT2i History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening Samples provided by patients with SLE may fail to produce results or may produce inaccurate results because autoantibodies in the patient plasma may interact with the DNA-based reagents used in the assay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neda Rasouli, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aanchal Gupta
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications

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