This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM (NCT04502212), a na na study. The primary outcome is Change From Baseline in Glucose Disposal Rate: Insulin Ratio During Steady State (M/I).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04502212 |
| Phase | NA |
| Condition | Type 2 Diabetes |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | General Electric Research |
| Results posted | Yes |
2. Clinical Question
Population
People with Type 2 Diabetes. The registry records an enrollment of 16 and identifies the safety population as 16 participants. Further eligibility details and characteristics of the enrolled participants are not reported in the registry record.
Intervention
Hepatic ultrasound insonification targeting the portis hepatis (liver). The arm description states that all enrolled subjects receive a 3-day course, with 15 minute per day of insonification.
Comparator
There is no separate control group in this single-group study. Allocation is listed as NA, and the registry identifies the study as open-label with no masking. Changes from baseline are assessed within the treated group, not against a concurrent untreated or alternative-treatment group.
Primary question
The primary question is whether hepatic ultrasound insonification is associated with a change from baseline in glucose disposal rate divided by insulin concentration during steady state (M/I), used as a measure of whole-body insulin sensitivity. The registry specifies measurement from Day 2 (Baseline) to Day 17. Numerical results for this primary endpoint are not reported in the registry record.
3. Trial Design
This is an open-label, pilot, single-group study of hepatic ultrasound insonification in subjects with Type 2 Diabetes. The registry lists allocation as NA and masking as NONE. All enrolled subjects are assigned to the Insonification arm; there is no randomized or like-for-like control comparison. Accordingly, the design can describe changes observed over time among participants who received the intervention, but it cannot by itself separate an intervention-associated change from changes related to time, measurement conditions, or other influences.
The intervention is described as a 3-day, 15 minute per day ultrasound insonification targeting the portis hepatis (liver). The registry lists enrollment of 16. Study status is COMPLETED, with a start date of 2020-07-30 and primary completion on 2021-05-24. The phase is listed as NA. Generalizability beyond the enrolled study population cannot be assessed from the record because participant characteristics and detailed eligibility criteria are not reported in the registry record.
The stated purpose includes evaluating whole-body insulin sensitivity, safety and tolerability, glucose tolerance, insulin secretion, and glucose metabolism. The primary endpoint is the change from baseline in glucose disposal rate: insulin ratio during steady state (M/I), measured during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer. Secondary outcomes include adverse device effects, clinically significant laboratory abnormalities, physical examination findings, and vital-sign measures. The registry lists 38 outcome measures, but numerical results for the primary endpoint and the listed secondary outcomes are not reported in the registry record.
The registry identifies General Electric Research as the sponsor. Its brief summary says the device is cleared by the United States Food and Drug Administration for ultrasound diagnostic exams, but has not been tested or approved specifically for modulation of metabolism in people with diabetes; its use for that purpose in this study is investigational. Protocol details beyond those stated, including a fuller schedule of assessments, are not reported in the registry record.
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
| Stage | Ultrasound Insonification Effect Population |
|---|---|
| STARTED | 16 |
| COMPLETED | 14 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Ultrasound Insonification Effect Population |
|---|---|
| Unevaluable data; excluded from Ultrasound Insonification Effect Pop; included in Safety Pop | 1 |
| Clamp protocol deviation; excluded from Ultrasound Insonification Effect Pop; included in Safety Pop | 1 |
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.
Population: Demographic characteristics by subject for all enrolled subjects.
| Characteristic | Unit | Ultrasound Insonification Effect Population |
|---|---|---|
| Participants analysed | 16 | |
| Age, Continuous | years | 61.9 (SD 5.39) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 11 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 2 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 12 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Glucose Disposal Rate: Insulin Ratio During Steady State (M/I), measured over Day 2 (Baseline) to Day 17.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/kg/min per microU/ml |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in glucose disposal rate divided by insulin concentration during steady state, denoted M/I. The registry gives the unit as mg/kg/min per microU/ml and identifies the measure as a mean with standard deviation. The listed timeframe is Day 2 (Baseline) to Day 17. The endpoint is assessed during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer.
As a general statistical and physiological explanation, glucose disposal rate reflects the rate at which glucose is taken up and used or stored, while insulin concentration provides context for the insulin exposure during the clamp. Relating the glucose disposal rate to insulin concentration produces a measure used to characterize insulin sensitivity under the test conditions. A change-from-baseline endpoint compares the participant’s later measurement with their baseline measurement, so the main quantity of interest is the within-participant change rather than a comparison between separate randomized groups.
The registry describes the endpoint as evaluating the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity. The endpoint is a physiological measure taken under a controlled metabolic test; it is not itself a direct measure of longer-term clinical outcomes. The registry record does not report the mean change, its standard deviation, a confidence interval, or a statistical test result. It also does not report the number of participants with usable measurements at both time points. Consequently, the magnitude and precision of any observed change cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant physiological question: whether whole-body insulin sensitivity changes after hepatic ultrasound insonification. Its primary measure is M/I during steady state, with change assessed from Day 2 (Baseline) to Day 17. However, the registry record does not report numerical results for this endpoint. No primary-endpoint mean, standard deviation, confidence interval, or p-value is listed. The direction, magnitude, and precision of an observed change therefore cannot be described.
The study enrolled 16 participants and used a single-group, open-label design. In a before-and-after study, each participant’s baseline can serve as a reference for their later measurement. This can be useful for characterizing within-person change, but without a concurrent control group it does not establish that any change was caused by the intervention. General considerations include natural fluctuation, differences in measurement conditions, concurrent changes in care or behavior, and regression toward a participant’s usual level. The registry does not report information that would quantify or rule out these possibilities.
The record lists 38 outcome measures, including safety outcomes and measures related to glucose handling, insulin secretion, and vital signs. Yet numerical results for the primary outcome and the listed secondary outcomes are not reported in the registry record. The adverse-event summary does include counts: in the Safety Population, 16 participants were at risk for serious events and 0 were recorded as affected; the count of deaths is 0. The summary also records 7 affected participants in the other adverse-event category among 16 at risk. Those counts do not supply the missing primary endpoint results or establish how outcomes were assessed over time.
Statistical precision cannot be evaluated without an estimate of the primary change and its variability. A confidence interval, when reported, indicates a range of values compatible with the data under the analysis assumptions; its width communicates precision. No such interval is reported for the primary endpoint. Nor does the registry report an analysis method, handling of missing observations, or the number of participants contributing to the primary analysis. Those omissions prevent a detailed assessment of statistical uncertainty and analysis choices.
The record contains a planning-illustration description based on the observed effect and assumptions for a two-arm calculation. Such an illustration is not the trial’s own sample-size justification, and it does not turn this single-group study into a controlled comparison. The registry record does not report the numerical planning estimates. Overall, the posted information describes the design and selected safety counts, but does not permit an estimate of the primary endpoint’s observed change or a conclusion about its statistical precision.
9. Statistical Methods Explained
The registry describes the primary endpoint as a mean of a continuous measure, with standard deviation as its dispersion measure. A continuous measure can take values along a scale rather than being restricted to event categories. For a change-from-baseline outcome, each participant’s follow-up value is related to their own baseline value, and a group mean can describe the average change among participants included in the analysis. The standard deviation describes how spread out participant measurements or changes are around that mean. It is not the same as the uncertainty around the estimated mean.
General: A confidence interval communicates statistical uncertainty around an estimate. A narrower interval indicates greater precision under the analysis assumptions, while a wider interval indicates less precision. The interval’s interpretation depends on the method and the data used. The registry record does not report a confidence interval, an estimate of change, or the variability of the primary endpoint, so precision cannot be evaluated for this study’s primary result.
What does M/I represent?
The primary measure is glucose disposal rate divided by insulin concentration during steady state, expressed in mg/kg/min per microU/ml. The registry says the assessment uses a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer. In general, a clamp is a controlled test intended to assess glucose and insulin physiology under specified conditions. The glucose disposal rate captures glucose handling during the test, and the insulin concentration is part of the context for interpreting that rate. M/I is used as an indicator of whole-body insulin sensitivity in this setting. It is a physiological endpoint measured under test conditions, not a direct substitute for every aspect of glucose metabolism or later clinical outcomes.
How should a before-and-after result be read?
General: A within-participant comparison can account for stable differences between participants because each person’s baseline is their own reference. But the design does not include a concurrent control group. A change over time may reflect the intervention, other changes over time, measurement variability, or a combination. Open-label status also means participants and study personnel are not masked to the intervention, although the registry does not state how this may have affected measurement or conduct. These are design considerations, not evidence that bias occurred in this study.
The registry lists the primary timeframe as Day 2 (Baseline) to Day 17. It does not report the actual results at either time point, the mean change, the standard deviation, the analysis population for the primary endpoint, or the method used to estimate the change. Thus, the basic interpretation of a posted mean change cannot be applied to this record: there is no numerical primary estimate to interpret.
What does the sample-size illustration mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect; for time-to-event tables, the illustration uses total events, and for other outcomes, participants per arm. These are planning assumptions, not evidence that the trial enrolled randomized arms or used that design. The actual study is single-group, and the registry record does not report numerical planning estimates or a sample-size justification from the trial protocol. A planning illustration is not observed power, and it cannot establish how likely the study was to detect an effect.
General: Over-dispersion means that observed variability is greater than a model’s assumptions would anticipate. When it is present, standard errors and confidence intervals based on an under-dispersed model can be too small, making results appear more precise than they are. The registry does not report a model for the primary endpoint or information that would establish whether over-dispersion is relevant; no specific model assumption should be attributed to this study.
In general, a p-value is a measure of how compatible data are with a specified null hypothesis under a statistical model; it is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The registry record does not report a primary-endpoint p-value or identify the statistical test used. An estimate with an uncertainty interval would be needed to assess the observed magnitude and precision directly, but those primary results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 38 outcome measures. When a study examines many outcomes, the chance of obtaining at least one apparently notable result by chance can increase if each is tested without an appropriate strategy. General approaches include identifying a small set of primary hypotheses in advance, adjusting inference for multiple comparisons, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among the secondary outcomes, or a statistical analysis plan. It also lists 0 analyses, which describes what is entered in the record and does not establish whether analyses were or were not conducted outside it.
Missing data can affect a change-from-baseline analysis if participants lack a measurement at either the baseline or follow-up time point. General methods may use only participants with the required observations, or may use model-based approaches under stated assumptions. The appropriate interpretation depends on why data are missing and how the analysis handles them. The registry does not report missingness for the primary endpoint, reasons for missing measurements, an imputation method, or a sensitivity analysis. The number of participants contributing data to the primary analysis is therefore not reported in the registry record.
The registry identifies a Safety Population of 16 for the adverse-event summary, but the primary endpoint population field is blank. It does not specify whether primary analyses used all enrolled participants, participants who received the intervention, participants with complete endpoint data, or another population definition. The analysis populations and missing-data procedures are not reported in the registry record. These gaps limit assessment of whether the analysis set matches the enrolled group and how incomplete follow-up may affect the results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Safety Population | 0 | 16 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Safety Population | 0 of 16 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Safety Population | 7 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Safety Population |
|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | 2 of 16 |
| Erythema | Skin and subcutaneous tissue disorders | 1 of 16 |
| Abdominal pain | Gastrointestinal disorders | 1 of 16 |
| Dyspepsia | Gastrointestinal disorders | 1 of 16 |
| Vomiting | Gastrointestinal disorders | 1 of 16 |
| Infusion site haemorrhage | General disorders | 1 of 16 |
| Vessel puncture site swelling | General disorders | 1 of 16 |
| Hypoglycaemia | Metabolism and nutrition disorders | 1 of 16 |
| Dizziness | Nervous system disorders | 1 of 16 |
| Thrombophlebitis | Vascular disorders | 1 of 16 |
The adverse-event summary lists 16 participants at risk for serious adverse events and 0 affected by a serious adverse event. It records 0 deaths. The other adverse-event category lists 16 participants at risk and 7 affected. These are counts in the registry’s safety summary; the record does not provide further numerical detail about event timing or the number of events per affected participant.
The registry also lists planned safety outcomes covering adverse device effects with a severity score of 1, treatment-emergent adverse events by system organ class and preferred term, clinically significant laboratory abnormalities, physical examination findings, and changes or clinically significant changes in vital signs. Numerical results for those listed outcomes are not reported in the registry record. No serious adverse-event terms are listed in the summary.
General: A count of zero recorded serious events describes what the registry reports for the stated safety population. It does not demonstrate that an event is impossible, and it does not establish the absence of every type of harm. Interpretation depends on the number followed, the duration and completeness of follow-up, event definitions, and how events were collected. The record does not provide enough detail to assess those aspects fully. These safety counts should be read separately from the unreported primary insulin-sensitivity results.
12. What the Result Does, and Does Not, Mean
The study addresses whether hepatic ultrasound insonification is associated with a change in a physiological measure of whole-body insulin sensitivity in people with Type 2 Diabetes. It is a completed, open-label, single-group pilot study with enrollment of 16. The intervention is described as a 3-day course of 15 minute per day insonification targeting the liver. The registry lists a primary assessment from Day 2 (Baseline) to Day 17 and provides counts for selected safety summaries.
The registry record does not report numerical results for the primary endpoint. Therefore, the posted information does not establish the size or direction of any change in M/I, how variable participant responses were, or how precise an estimate might be. It also does not report the numerical results for the listed secondary outcomes. The safety summary records 0 serious adverse events among 16 at risk and 0 deaths, along with 7 affected participants in the other adverse-event category among 16 at risk; those counts are not a substitute for detailed reporting of all planned safety measures.
General: A single-group before-and-after design can describe what happened to a measured outcome among participants receiving an intervention. Without a concurrent control group, it cannot determine whether an observed change was caused by the intervention rather than by other influences over time. A pilot study can contribute information about feasibility, measurement, and the range of outcomes to examine, but its interpretation depends on the data and methods reported.
The device is described in the registry as cleared by the United States Food and Drug Administration for ultrasound diagnostic exams, but not tested or approved specifically for modulation of metabolism in people with diabetes. The study’s use for that purpose is described as investigational. The available record does not support a conclusion about whether the intervention changes insulin sensitivity or other metabolic outcomes. It supports a description of the research question, design, intervention, and limited safety counts; fuller interpretation would require the missing outcome results and analysis details.
13. Why This Trial Matters Statistically
This trial is statistically notable for the contrast between a clearly defined physiological endpoint and the limited results available in the registry record. The primary measure, M/I during steady state, is tied to a specified clamp procedure and a stated baseline-to-follow-up timeframe. Such specification helps readers understand what is being measured. But without the estimated change and its variability, the central statistical questions—magnitude, direction, and precision—remain unanswered in the registry record.
The single-group design matters for causal interpretation. A baseline measurement offers a within-participant reference, but there is no concurrent comparator to show what would have happened over the same period without insonification or under another condition. This limits the ability to distinguish an intervention-associated change from other influences. The open-label structure is another design feature relevant to interpretation, though the record does not establish that it altered any measurement.
The pilot scale, with enrollment of 16, also makes transparent reporting of participant-level availability and uncertainty important. A mean alone would not convey how consistently participants changed; a dispersion measure and confidence interval would help readers assess variability and precision. Those primary endpoint results are not reported in the registry record. In the safety summary, event counts are available, but most listed safety outcome results are not.
The record lists 38 outcome measures and 0 analyses. That makes clear why access to the analysis plan and outcome-level results matters: readers need to know how many comparisons were assessed, which outcomes were prioritized, and how missing observations were handled. These details are not reported in the registry record. The study remains a useful example of how design information and a registered endpoint can frame a research question, while incomplete results and absent analysis details constrain what can be inferred statistically.
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.
Several limitations are specific to interpreting this registry record. It describes a single-group study with no randomized comparator, so any within-participant change cannot be separated from other time-related influences using a concurrent control. The open-label design is stated, but the record does not describe masking of outcome assessors or safeguards against measurement influence; those details are not reported in the registry record.
The enrollment is 16, but the record does not report how many participants contributed paired measurements to the primary endpoint. It does not provide participant characteristics, detailed eligibility criteria, baseline values, follow-up completeness, or reasons for missing data. The primary endpoint population field is blank. As a result, readers cannot assess the representativeness of the sample or determine how missing endpoint observations may affect the estimate.
Most importantly, numerical results for the primary endpoint and the listed secondary outcomes are not reported in the registry record. The primary change, standard deviation, confidence interval, and p-value are absent. The record also does not report the statistical analysis plan, the method used for the primary analysis, or a strategy for handling the 38 outcome measures. The listed 0 analyses should be understood as a registry entry, not evidence about whether analyses occurred elsewhere.
The adverse-event summary reports counts but does not provide the detailed event descriptions, follow-up context, or results for the other listed safety measures. The registry does not report further detail about the duration or completeness of safety observation. The sample-size description is a planning illustration and is not a reported design justification for this single-group trial; numerical illustration results are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM — NCT04502212.
- Registry record last updated 2022-06-02; status last verified 2022-03.
- Results first posted 2022-06-02.
- 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.
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18. Record Summary
The registry describes an open-label, single-group pilot study of hepatic ultrasound insonification in subjects with Type 2 Diabetes. Enrollment is 16; status is COMPLETED. The intervention is described as a 3-day course with 15 minute per day targeting the portis hepatis (liver). The primary endpoint is change from baseline in glucose disposal rate: insulin ratio during steady state (M/I), measured from Day 2 (Baseline) to Day 17 during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer.
The record lists 38 outcome measures and 0 analyses. Numerical primary and secondary outcome results are not reported in the registry record. The safety summary lists 0 serious adverse events among 16 participants at risk and 0 deaths; 7 participants are recorded as affected in the other adverse-event category among 16 at risk. A concurrent control group is not part of the registered design, and the analysis plan, missing-data methods, and primary analysis population are not reported in the registry record.