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

Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients With Type 2 Diabetes at Higher Risk of Cardiovascular Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05256706

Enrollment

143

Registered

2022-02-25

Start date

2022-02-03

Completion date

2023-12-09

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

cardiovascular risk

Brief 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.

Detailed description

This study is being done to evaluate the use of a new test for the management and treatment of patients who are at high risk of heart disease. The test, called a SomaSignal Test, makes use of personalized proteomics. Proteomes refer to a set of proteins produced in the body. Proteins can affect the function of our bodies and can regulate disease, behavior, and drug treatments. The research team's hypothesis is that the SomaSignal Test can study these proteins and provide results that can help in the management of heart disease. Potential benefits include increased participant engagement and satisfaction from increased personalized medical knowledge and improved participant outcomes through personalized risk stratification, more precise clinical care, and improvements in the triage of medical interventions and education. There may be improved health outcomes in the subset of participants who have a residual risk based on the SomaSignal Test test that they were previously unaware of, and who may receive treatment with a drug or additional lifestyle intervention they were previously eligible for but were not undertaking at the start of the study. All participating providers will be provided education and training on SomaSignal testing including how to interpret and educate participants on the results. There will be two study visits. Participants will be randomized into one of 2 arms. Blood samples and information collected for this study will be shared with SomaLogic Inc., the company where sample testing and analysis will be done.

Interventions

DIAGNOSTIC_TESTSomaSignal Informed Medical Management SSCVD

For participants randomized to the Informed arm, the SSCVD test results will be provided to the participant's clinicians approximately 2-4 weeks after the baseline blood draw. Clinicians will discuss results with the participant and make adjustments to the care plan as needed based on the SSCVD test results within 50 days of receiving results. Clinicians may advise participants to (i) either change the doses of existing medications within existing guidelines, (ii) prescribe additional guideline-based medications, (iii) advise additional lifestyle interventions, or (iv) advise no change. This information will be documented in the case report forms. This test is neither intended to diagnose cardiovascular disease (CVD) nor replace the standard of care protocols for this disease. The physician should not rely solely on this information to make a decision on the best course of action for this patient.

OTHERStandard of Care

Clinicians will provide the standard of care based on routine test results and without the SSCVD results. The SSCVD and SomaSignal Metabolic Factor Panel results from participants from both the baseline and 6-month period will be provided to the study team at the 6-month study visit. The SomaSignal Metabolic Factor tests include evaluation of Liver Fat, Glucose Tolerance, Kidney Function, Alcohol Impact, Cardiorespiratory Fitness/oxygen consumption (VO2) max, Resting Energy Rate, Body Fat Percentage, Visceral Fat, and Lean Body Mass. Any recommendations made to the participant by the physicians, based on obtaining the aforementioned test results will be collected.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female participants 40 years and older * Diagnosis of type 2 diabetes (T2D) \[according to American Diabetes Association (ADA) guidelines\] * Able to provide consent * Eligible for (per drug label/guidelines) at least one of the following drug classes: sodium-glucose cotransporter 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 (PCSK9i), glucagon-like peptide receptor agonists (GLP-1 RA) but not currently prescribed any of these classes of drugs, or only prescribed PCSK9i

Exclusion criteria

* Systemic Lupus Erythematous (SLE) * Pregnancy * Intolerance or contraindication for use of GLP-1 RA, SGLT2i, and PCSK9i * 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 * Inability to understand English (currently, SomaSignal testing information, guides, educational materials, and reports are only available in English.)

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results	6 months and 12 months after baseline	The number of participants with type 2 diabetes (T2D) who had changes in prescriptions aligned with SSCVD results at baseline will be reported for the informed group. For the uninformed group, this represents the number of participants who had prescription changes, even though the healthcare provider (HCP) was not informed of the results. SSCVD results from participants at both the baseline and 6-month periods will be provided to the study team during the 6-month study visit. Any recommendations made by physicians to participants, after these test results, will be collected. Medical records will be reviewed to assess any changes in treatment strategies.

Secondary

Measure	Time frame	Description
Changes in Low-density Lipoprotein (LDL)	6 months and 12 months	A blood sample to measure LDL will be drawn during the baseline and follow-up visits. Electronic medical records (EMR) will also be reviewed.
Changes in High-density Lipoprotein (HDL)	6 months and 12 months	A blood sample to measure HDL will be drawn during the baseline and follow-up visits. EMR Records will also be reviewed
Changes in Triglycerides (TG) Levels	6 months and 12 months	A blood sample to measure TG will be drawn during the baseline and follow-up visits. EMR Records will also be reviewed.
Changes in Glucose Levels	6 months and 12 months	A blood sample to measure glucose will be drawn during the baseline and follow-up visits. EMR records will also be reviewed.
Changes in Glycated Hemoglobin Test (HbA1C)	6 months and 12 months	A blood sample to measure HbA1C will be drawn during the baseline and follow-up visits.
Changes in Weight	6 months and 12 months	Weight will be measured in kilograms (kg) during baseline and follow-up visits. EMR records will also be reviewed.
Number of Participants With Changes in the SSCVD Results	Baseline and 6 months	During the baseline and follow-up visits, participants will have blood samples drawn for the SSCVD test.
Number of Participants Who Experienced Changes in Tobacco Exposure	6 months and 12 months	Participants will complete a questionnaire on personal tobacco use and exposure to second-hand smoke at both the baseline and follow-up visits. Responses are provided as categorical, multiple-choice options, and no summary score will be calculated for tobacco exposure. Data will also be extracted from the EMR.
Number of Participants Who Experienced a Change in Physical Activity	6 months and 12 months	A questionnaire will be provided at baseline and follow-up visit asking about physical activity habits. The questionnaire asks respondents how active they are during leisure time and has four response options: * Mainly sedentary (e.g. sitting, reading, watching television) * Mild exercise, minimal effort (eg. yoga, archery, sport fishing, easy walking at least 3 times per week) * Moderate exercise (eg. walking, bicycle riding, or light gardening at least 4 hours per week) * Strenuous exercise (heart beats rapidly e.g. running/jogging, football, vigorous swimming at least 3 times per week) A summary score is not calculated for this assessment. Data will also be extracted from EMR.
Number of Participants Who Changed Their Dietary Habits	6 months and 12 months	Dietary habits will be assessed with a 5-item asking about consumption of salty foods, deep fried foods, fruits, vegetables, and meat/poultry. Responses are given as yes or no. There is not a summary score generated for this questionnaire.
Physician Experience Questionnaire	At 6 months	The physician questionnaire will ask 6 to 8 open ended and multiple choice questions regarding changes to treatment plans, identification of unexpected higher risk patients patients, and frequency of testing preferences. There is not a summary score generated for this qualitative questionnaire.
Change in Medication Possession Ratio	Baseline and 6 months	Participant adherence to medications will be quantified using the medication possession ratio which is the number of prescriptions filled divided by the number of months participants are prescription eligible.
Changes in Body Mass Index (BMI)	6 months and 12 months	Height will be measured in meters (m) during the baseline visit, and weight will be measured during the baseline and follow-up visits. BMI will be calculated at each visit using the formula: weight (kg) / \[height (m)\]\^2. EMR will also be reviewed.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began February 03, 2022, and all follow-up was complete by December 9, 2023.

Participants by arm

Arm	Count
SomaSignal Informed Medical Management SSCVD Blood draw for SSCVD test at baseline and 6 months (±50 days). SomaSignal Cardiovascular Risk (SSCVD) results will be sent to the providers and participants approximately 2-4 weeks after testing. SomaSignal Informed Medical Management SSCVD: For participants randomized to the Informed arm, the SSCVD test results will be provided to the participant's clinicians approximately 2-4 weeks after the baseline blood draw. Clinicians will discuss results with the participant and make adjustments to the care plan as needed based on the SSCVD test results within 50 days of receiving results. Clinicians may advise participants to (i) either change the doses of existing medications within existing guidelines, (ii) prescribe additional guideline-based medications, (iii) advise additional lifestyle interventions, or (iv) advise no change. This information will be documented in the case report forms. This test is neither intended to diagnose cardiovascular disease (CVD) nor replace the standard of care protocols for this disease. The physician should not rely solely on this information to make a decision on the best course of action for this patient.	73
Standard of Care (Uninformed Arm) Blood draw for SSCVD test at baseline and 6 months (±50 days). SomaSignal Cardiovascular Risk (SSCVD) results will not be provided to the provider or participant until the 6-month visit. Standard of Care: Clinicians will provide the standard of care based on routine test results and without the SSCVD results. The SSCVD and SomaSignal Metabolic Factor Panel results from participants from both the baseline and 6-month period will be provided to the study team at the 6-month study visit. The SomaSignal Metabolic Factor tests include evaluation of Liver Fat, Glucose Tolerance, Kidney Function, Alcohol Impact, Cardiorespiratory Fitness/oxygen consumption (VO2) max, Resting Energy Rate, Body Fat Percentage, Visceral Fat, and Lean Body Mass. Any recommendations made to the participant by the physicians, based on obtaining the aforementioned test results will be collected.	70
Total	143

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	9	3
Overall Study	Screen Failures	3	0
Overall Study	Withdrawal by Subject	7	11

Baseline characteristics

Characteristic	Standard of Care (Uninformed Arm)	Total	SomaSignal Informed Medical Management SSCVD
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	48 Participants	96 Participants	48 Participants
Age, Categorical Between 18 and 65 years	22 Participants	47 Participants	25 Participants
Age, Continuous	67.66 years STANDARD_DEVIATION 9.79	68.15 years STANDARD_DEVIATION 9.96	68.63 years STANDARD_DEVIATION 10.16
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	9 Participants	16 Participants	7 Participants
Race (NIH/OMB) Black or African American	31 Participants	65 Participants	34 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	29 Participants	60 Participants	31 Participants
Region of Enrollment United States	70 participants	143 participants	73 participants
Sex: Female, Male Female	32 Participants	67 Participants	35 Participants
Sex: Female, Male Male	38 Participants	76 Participants	38 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 73	0 / 70
other Total, other adverse events	0 / 73	0 / 70
serious Total, serious adverse events	1 / 73	0 / 70

Outcome results

Primary

Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results

The number of participants with type 2 diabetes (T2D) who had changes in prescriptions aligned with SSCVD results at baseline will be reported for the informed group. For the uninformed group, this represents the number of participants who had prescription changes, even though the healthcare provider (HCP) was not informed of the results. SSCVD results from participants at both the baseline and 6-month periods will be provided to the study team during the 6-month study visit. Any recommendations made by physicians to participants, after these test results, will be collected. Medical records will be reviewed to assess any changes in treatment strategies.

Time frame: 6 months and 12 months after baseline

Population: Participants with valid data who completed study visits.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
SomaSignal Informed Medical Management SSCVD	Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results	Six months after baseline	45 Participants
SomaSignal Informed Medical Management SSCVD	Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results	Twelve months after baseline	8 Participants
Standard of Care (Uninformed Arm)	Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results	Six months after baseline	13 Participants
Standard of Care (Uninformed Arm)	Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results	Twelve months after baseline	35 Participants

Secondary

Change in Medication Possession Ratio

Participant adherence to medications will be quantified using the medication possession ratio which is the number of prescriptions filled divided by the number of months participants are prescription eligible.

Time frame: Baseline and 6 months

Population: Data not collected

Secondary

Changes in Body Mass Index (BMI)

Height will be measured in meters (m) during the baseline visit, and weight will be measured during the baseline and follow-up visits. BMI will be calculated at each visit using the formula: weight (kg) / \[height (m)\]\^2. EMR will also be reviewed.