SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes (NCT05256706), a randomized na study. The primary outcome is Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results.

2. Clinical Question

The question concerns the relationship between risk information and medical management, rather than a direct comparison of clinical events such as cardiovascular disease or death. The primary measure is a count of participants with prescription changes, assessed at 6 months and 12 months after baseline. The record describes the informed group’s changes as aligned with baseline SSCVD results. In the uninformed group, it counts prescription changes made while the healthcare provider was not informed of the results.

The trial rationale in the registry record is that individual variation in residual cardiovascular risk could be relevant to treatment decisions. The comparison therefore tests whether making SSCVD results available is associated with prescription decisions that correspond to those results. It does not, by itself, establish whether a prescription change improves health outcomes, nor does it show whether a test-guided decision is more beneficial than a decision made without the results. The registry record does not report the primary outcome findings.

3. Trial Design

The registry record describes a randomized, parallel-group study with no masking. Emory University is listed as the sponsor. The condition is type 2 diabetes, and the official title describes the target population as having higher risk of cardiovascular disease. Enrollment is listed as 143. The trial is marked completed; its listed start date is 2022-02-03 and its primary completion date is 2023-12-09. Phase is recorded as NA.

Both groups underwent SSCVD blood testing at baseline and 6 months. In the SomaSignal-informed medical-management group, results were sent to providers and participants approximately 2-4 weeks after testing. In the standard-of-care, uninformed group, results were not to be provided to the provider or participant until the 6-month visit. Thus, the randomized contrast is principally about access to the SSCVD result during medical management, not whether blood testing occurred.

The primary outcome description gives assessment time points of 6 months and 12 months after baseline. It describes collecting physician recommendations after test results and reviewing medical records for changes in treatment strategies. The description also states that results from baseline and the 6-month period would be provided to the study team during the 6-month study visit. These details specify the intended outcome context, but the registry record does not report outcome values or clarify how the timing of result disclosure relates to every measurement point.

Secondary outcomes include changes in SSCVD results, LDL, HDL, triglycerides, glucose, HbA1C, weight, and BMI. The record lists 14 outcome measures overall. It does not report a detailed statistical analysis plan, allocation procedures beyond randomization, or the handling of deviations from the assigned information strategy.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants with valid data who completed study visits.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results, measured over 6 months and 12 months after baseline.

The primary endpoint is the number of participants with type 2 diabetes who had prescription changes described as concordant with SSCVD results. Its timeframe is 6 months and 12 months after baseline. The registry record says the informed-group count concerns prescription changes aligned with baseline SSCVD results. For the uninformed group, the count concerns prescription changes even though the healthcare provider was not informed of the results. Recommendations made by physicians after test results were to be collected, and medical records were to be reviewed for changes in treatment strategies.

This endpoint is used to examine whether access to individualized risk information corresponds to changes in prescribing. A count is a direct way to describe how many participants met the stated prescription-change criterion in each group. However, a count alone does not express the size of a between-group difference, its uncertainty, or whether the observed pattern could be compatible with chance variation. Those interpretations require comparative estimates and an analysis method, which are not reported in the registry record.

The endpoint is a measure of medical-management activity, not a clinical outcome. A prescription change may be consistent with a risk result without demonstrating that the decision improved cardiovascular health. The record also limits the stated population to participants with valid data who completed study visits. It does not report how many participants contributed to each endpoint time point or how unavailable data affected the counts.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on the type of outcome, the comparison being made, and the uncertainty around the estimate. The primary measure in this study is a count of participants meeting a prescription-change description. The registry record does not provide the observed counts or a statistical comparison, so the concepts below explain how such evidence is generally interpreted rather than describing analyses reported for this trial.

What does randomization contribute?

In general, randomization assigns participants to study groups by chance. Its purpose is to reduce systematic differences between groups at the start of a study, including differences that could influence outcomes. A randomized design makes a between-group comparison more interpretable, but it does not guarantee that groups are identical in every characteristic, ensure adherence to assigned procedures, or address missing outcome data. The registry record states that allocation was randomized, but does not describe the randomization sequence, concealment procedures, or baseline balance.

How should a participant count be understood?

A count reports the number of participants who meet a stated outcome definition. In general, a count is easiest to interpret alongside the number of participants assessed and the rule used to decide who qualifies. The primary outcome description specifies participants with valid data who completed study visits, but the actual endpoint counts and time-specific denominators are not reported in the registry record. It is therefore not possible to determine from the record how many participants contributed to each assessment or to compare the count with the number assessed.

For a comparison between groups, analysts commonly express the contrast using an effect estimate and an interval that conveys uncertainty. A confidence interval is a range of values compatible with the data under the assumptions of the analysis; it helps readers judge both the plausible magnitude and precision of an estimated effect. A narrow interval generally indicates greater precision than a wide interval. Neither a confidence interval nor another comparative estimate is reported for the primary endpoint in the registry record.

What does a hypothesis test add?

In general, a hypothesis test evaluates how compatible observed data are with a specified null hypothesis, under an analysis model. A p-value does not measure the probability that the null hypothesis is true, nor does it convey the size or clinical importance of an effect. It is most informative when considered with the effect estimate, its uncertainty, the design, and the analysis plan. The registry record does not report a primary-outcome p-value or other inferential result. A result cannot be called statistically significant or nonsignificant on the basis of the available record.

Why do outcome definitions matter?

The informed-arm outcome is described as prescription changes aligned with baseline SSCVD results. The uninformed-arm outcome is described as prescription changes despite the provider not being informed of the results. A clear and consistent definition is essential because group counts are only comparable if the criteria and ascertainment process are sufficiently aligned. The record says that physician recommendations would be collected and medical records reviewed, but does not report detailed coding rules, how concordance was judged, or whether outcome assessors were masked. The study itself is listed as having no masking.

What can secondary outcomes tell readers?

Secondary outcomes can describe other dimensions of the study, including changes in laboratory measures and body measurements. The registry lists outcomes for LDL, HDL, triglycerides, glucose, HbA1C, weight, BMI, and SSCVD results. In general, each outcome requires a defined analysis, a time point, and a clear approach to comparing groups. Testing multiple outcomes raises multiplicity concerns: the more comparisons considered, the greater the chance that some findings may appear unusual by chance. Whether the investigators adjusted for multiplicity or prioritized outcomes in a prespecified hierarchy is not reported in the registry record.

The registry record lists 14 outcome measures but zero analyses. That listing does not provide evidence of a particular model, adjustment strategy, or statistical test. No analysis method for repeated measurements, no covariate-adjustment plan, and no approach to multiple testing are reported. These omissions mean that numerical findings, if encountered outside this record, would need their analysis context before their strength and precision could be evaluated.

How should planning illustrations be read?

In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, allocation, and error rates. It is not a result observed in participants and should not be described as observed power. The registry record states that its planning illustration uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and a stated fraction of the observed effect. For time-to-event tables, the stated convention is total events; for other outcomes, it is participants per arm. Those assumptions describe an illustration and not necessarily the trial’s original design. The registry record does not report the trial’s own sample-size justification. The primary outcome is also flagged as having several categories or time points and is not reduced to one comparison, so a single planning comparison should not be inferred from it.

Recalculated results, when available, are unadjusted calculations from posted summary statistics and are not a replacement for the sponsor’s own analysis. If a discrepancy is identified, the sponsor’s own analysis takes precedence. No recalculated primary endpoint comparison is reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 14 outcome measures, including the primary prescription-change measure and secondary measures involving SSCVD results, laboratory values, weight, and BMI. Considering multiple outcomes can be useful for describing different aspects of a study, but it also creates multiple opportunities for chance findings. Statistical methods may address this through prespecified outcome hierarchies or adjustments to inference. Whether any such approach was planned or used is not reported in the registry record.

The record lists zero analyses. It therefore does not provide a detailed account of which comparisons were performed, how repeated time points were handled, or whether any reported analyses were adjusted for other variables. No interim analysis plan is reported in the registry record. These omissions do not establish that such procedures were absent; they mean they cannot be described from the available registry information.

The primary population is described as participants with valid data who completed study visits. The registry record does not report the number excluded for invalid data, the number who did not complete visits, or the amount and pattern of missing outcome data. It also does not report whether participants were analyzed according to randomized assignment, whether missing values were imputed, or how withdrawals were handled. These details matter because an analysis restricted to participants with complete data can differ from an analysis that retains all randomized participants.

Without outcome-specific denominators and a missing-data strategy, readers cannot assess how representative the analyzed population was of the randomized population. The listed enrollment and adverse-event denominators do not supply the missing primary endpoint denominators. The registry record does not report enough information to judge the potential influence of missingness or multiplicity on the primary comparison.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: non related hospital admission (1.4%).

The registry lists serious adverse events by group. In the SomaSignal-informed medical-management group, 1 of 73 participants at risk had a serious adverse event; the standard-of-care group lists 0 of 70. The listed serious event term is non related hospital admission, reported as 1.4%. The record lists 0 other adverse events in each group and 0 deaths in both groups.

These figures are descriptive counts and registry classifications. They do not show whether the event was caused by the test, a treatment decision, or another factor. The listed term explicitly describes the admission as non related, but the registry information does not give further details about the event or the method used to assess relatedness. A group with no recorded event is not proof that the risk is absent.

Comparisons based on sparse event counts are imprecise. In general, a safety comparison should be interpreted with its uncertainty, follow-up context, event definitions, and completeness of reporting. The registry record does not provide a comparative safety estimate or confidence interval. It also does not describe the duration of safety surveillance beyond the event information reported. The counts should therefore be read as the adverse-event entries recorded, not as conclusive evidence of a difference in safety between groups.

12. What the Result Does, and Does Not, Mean

The trial addresses a specific statistical question: whether making SSCVD results available to providers and participants is associated with prescription changes that correspond to those results. Randomization provides a design for comparing an informed management strategy with standard care in which results were withheld until the 6-month visit. The registry record also identifies laboratory and body-measure outcomes that were intended to provide additional descriptions of change.

What the registry record does not provide is the primary outcome result. There are no reported prescription-change counts, comparative effect estimate, confidence interval, or inferential test. As a result, the record cannot establish the direction or size of any difference in prescribing between groups. It also cannot show how precisely a possible difference was estimated.

Even a reported difference in prescribing would address medical-management activity, not necessarily health benefit. Concordance with a risk result is not itself proof that the prescription decision improves cardiovascular outcomes, and a prescription change alone does not establish a favorable balance of benefits and harms. The registry record does not report a primary endpoint based on cardiovascular events or mortality. It lists 0 deaths in both groups in the adverse-event information, but those entries do not substitute for a reported comparative clinical-outcome analysis.

The record’s completion status indicates that the study is marked completed, but completion status is not evidence that every planned outcome was reported or that findings were positive or negative. The registry record does not provide the detailed analysis plan, missing-data handling, or a complete account of the primary endpoint population. Those gaps limit interpretation of both the design and any conclusions drawn from it.

The appropriate conclusion is narrow: the registry describes a randomized test of disclosing individualized risk results as part of medical management, but does not report the primary results needed to judge the observed prescribing pattern. The serious adverse-event entries are descriptive and sparse. Neither the intervention’s clinical value nor a comparative safety effect can be determined from these registry data alone.

13. Why This Trial Matters Statistically

This trial is statistically relevant because it examines an information strategy rather than simply comparing two medications. Both groups underwent SSCVD testing, while access to results differed. That design focuses attention on whether information changes medical management, a pathway that can be studied separately from whether a treatment ultimately changes clinical outcomes.

The distinction between a process measure and a health outcome is central. Prescription changes can show that clinical decisions differ, but they do not establish whether those decisions improve health or reduce harm. The registry’s primary endpoint is a count tied to prescription changes and result concordance; it is not a reported measure of cardiovascular events. Keeping that distinction clear prevents an observed change in clinical behavior from being mistaken for evidence of clinical benefit.

The record also illustrates why outcome definitions and reporting matter. The informed and uninformed groups are described using different language for the prescription-change count. Readers need operational criteria, denominators, and comparative estimates to understand how the two counts relate. Without those details, randomization alone cannot answer the substantive question.

Finally, the listing of multiple secondary measures makes transparent statistical reporting especially important. The registry record lists 14 outcome measures but zero analyses, and does not describe multiplicity procedures or missing-data handling. These details affect how readers assess the credibility, precision, and scope of any findings. The record therefore provides a useful account of the intended comparison, while leaving the primary statistical evidence unavailable for evaluation.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation of the registry record for interpretation is that it does not report primary outcome results. The endpoint is described, but there are no group counts, comparative estimate, confidence interval, or test result. It is therefore not possible to assess the observed prescribing pattern or its precision.

The primary endpoint description does not fully specify how concordance was judged or how equivalent criteria were applied to the two groups. The informed group is described in terms of alignment with baseline SSCVD results, whereas the uninformed group is described in terms of prescription changes while providers were not informed. The record also does not report whether endpoint assessment was blinded or provide detailed coding procedures.

The stated primary outcome timeframe includes 6 months and 12 months after baseline, while the intervention description specifies testing at baseline and 6 months and disclosure timing tied to those tests. The record does not explain how all outcome assessments align with disclosure and follow-up. It also does not report endpoint-specific denominators, attrition, or the amount and handling of missing data, despite defining the population as participants with valid data who completed study visits.

Other interpretive details are not reported in the registry record, including a detailed statistical analysis plan, multiplicity handling, the original sample-size justification, and interim analyses. The study is listed as randomized and unmasked, but the record does not describe allocation concealment, adherence, or baseline characteristics. The adverse-event data are limited to the listed counts and term, without a comparative estimate or further event detail. These limitations concern what can be assessed from the registry information and do not establish that the unreported procedures were not conducted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes — NCT05256706.
• Registry record last updated 2025-01-09; status last verified 2024-12.
• Results first posted 2025-01-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes a completed randomized, unmasked, parallel-group study sponsored by Emory University, with enrollment listed as 143. It compares SomaSignal-informed medical management with standard care in which SSCVD results were withheld until the 6-month visit. Both groups were tested at baseline and 6 months. The listed dates are a start date of 2022-02-03 and a primary completion date of 2023-12-09.

The primary endpoint counts participants with prescription changes described in relation to SSCVD results, at 6 months and 12 months after baseline. Secondary outcomes include SSCVD results, LDL, HDL, triglycerides, glucose, HbA1C, weight, and BMI. The record lists 14 outcome measures and zero analyses. It does not report primary outcome findings, a statistical analysis plan, or missing-data handling.

For serious adverse events, the record lists 1 affected participant in the informed group and 0 in standard care, with 0 deaths in both groups. The listed serious term is non related hospital admission. These entries are descriptive and do not establish a comparative safety effect.