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 Helius in Hypertension-I: The UK Hypertension Registry (NCT02553512), a registered phase not stated study. The primary outcome is Frequency of Medication-taking (% Taking Adherence).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02553512 |
| Phase | Phase not stated |
| Condition | Essential Hypertension |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 151 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Proteus Digital Health, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 151 people with essential hypertension. The brief summary describes persistent hypertension during chronic antihypertensive treatment as the context. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The intervention was an ingestible sensor and wearable sensor, named Helius. The study purpose was to demonstrate use of a digital health offering in the management of persistent hypertension during chronic antihypertensive treatment. Details of how participants used the sensors are not reported in the registry record.
Comparator
A comparator group is not described. Allocation is not stated, and the study is not a randomized comparison. The record therefore does not establish a like-for-like control comparison for interpreting outcomes.
Primary question
The primary outcome was the frequency of medication-taking, expressed as percentage taking adherence over 2 weeks. The measure concerns timing adherence derived from sensor detections relative to prescribed ingestion sensors. The posted result for this endpoint is not reported in the registry record.
The registry record also lists outcomes concerning blood pressure control on existing treatment, change in systolic and diastolic blood pressure, and blood pressure management after use of the digital health offering. These are outcome topics, not evidence that a particular change occurred. Results for those outcomes are not reported in the registry record.
In statistical terms, the primary question concerns measurement of adherence during use of the digital offering. Without a reported result and without a comparator, the record cannot support a comparative estimate of the offering relative to another approach. It also does not establish whether measured adherence corresponded to a change in blood pressure. The purpose and outcomes define what the study set out to examine; they do not by themselves answer those questions.
3. Trial Design
The registry record identifies this as a completed study titled Helius in Hypertension-I: The UK Hypertension Registry. It lists Proteus Digital Health, Inc. as sponsor and essential hypertension as the condition. Enrollment was 151. The recorded study start was 2013-09, and primary completion was 2014-12.
The intervention is described as an ingestible sensor and wearable sensor, with the intervention name Helius. The study kind is recorded as other. Allocation is not stated, and the record explicitly indicates that this is not a randomized comparison and that arms are not a like-for-like control comparison. A comparator, control condition, or allocation procedure is not reported in the registry record.
The primary outcome was frequency of medication-taking, measured as percentage taking adherence over 2 weeks. The registry describes the planned summary as a median with full range. It defines timing adherence using the number of ingestion sensors detected by the wearable monitor divided by the total number prescribed for the 2-week timeframe. The outcome value itself is not reported in the registry record.
The record lists five outcome measures and includes secondary outcomes concerning blood pressure control on existing treatment, changes in systolic and diastolic blood pressure, and blood pressure management after use of the digital offering. Detailed results for these outcomes are not reported in the registry record. The registry record also lists 0 analyses, so it does not provide a posted statistical analysis result for the outcomes described.
Further design information, including eligibility criteria, participant characteristics, recruitment procedures, treatment duration beyond the stated primary endpoint timeframe, and the statistical analysis plan, is not reported in the registry record. Consequently, the design can be described as a completed study of a digital offering with an adherence endpoint, but not as a controlled estimate of comparative effectiveness.
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 | Helius |
|---|---|
| STARTED | 167 |
| COMPLETED | 144 |
| NOT COMPLETED | 23 |
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.
| Characteristic | Unit | Helius |
|---|---|---|
| Participants analysed | 151 | |
| Age, Continuous | Years | 68 (SD 9) |
| Sex: Female, Male: Female | Participants | 63 |
| Sex: Female, Male: Male | Participants | 88 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 151 |
| 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 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 151 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United Kingdom | Participants | 151 |
| Blood Pressure: Systolic | mm Hg | 154 (125 to 207) |
| Blood Pressure: Diastolic | mm Hg | 88 (47 to 110) |
| Diabetes | Participants | 45 |
| Anti-Hypertensives (Type): Generic | Participants | 136 |
| Anti-Hypertensives (Type): Generic and Branded | Participants | 15 |
| Anti-Hypertensives (Type): Branded | Participants | 0 |
| Anti-Hypertensives (Number): 1 | Participants | 0 |
| Anti-Hypertensives (Number): 2 | Participants | 93 |
| Anti-Hypertensives (Number): 3-5 | Participants | 58 |
| Anti-Hypertensives (Class): ACE inhibitor | Participants | 82 |
| Anti-Hypertensives (Class): Angiotensin receptor blocker | Participants | 57 |
| Anti-Hypertensives (Class): Beta-blocker | Participants | 43 |
| Anti-Hypertensives (Class): Calcium channnel antagonist | Participants | 93 |
| Anti-Hypertensives (Class): Diuiretic | Participants | 72 |
| Anti-Hypertensives (Class): Fixed-dose combination | Participants | 3 |
| Anti-Hypertensives (Class): Other | Participants | 29 |
6. Primary Endpoint
The registry lists the primary outcome as Frequency of Medication-taking (% Taking Adherence), measured over 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | percentage of taking adherence |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is frequency of medication-taking, expressed as percentage taking adherence. It covers 2 weeks. The registry describes the measure as timing adherence: ingestion sensors detected by a wearable monitor are counted relative to the total number of ingestion sensors prescribed during the timeframe. The registry specifies a median and full range as the summary format.
As a general statistical concept, an adherence measure can describe whether recorded medication-taking aligns with a prescribed schedule. A sensor-based measure offers an observable record of detection events, but the meaning of that record depends on the measurement process. A detected sensor event is the recorded signal used in this endpoint; the registry description does not establish other details about medication ingestion or the accuracy of detection.
The endpoint is relevant to the study purpose because the brief summary concerns use of a digital health offering during chronic antihypertensive treatment, and the stated primary measure concerns medication-taking. It is distinct from the secondary outcomes concerning blood pressure control and blood pressure change. A measure of adherence alone does not establish a blood pressure response or a comparative treatment effect.
The numerical median and full range, along with any analysis of the endpoint, are not reported in the registry record. Thus, the endpoint definition is available, but the posted information does not show the observed distribution or its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record states the study purpose, population size, intervention, endpoint definition, and outcome topics, but it does not report the primary endpoint result. It specifies a median and full range for percentage taking adherence over 2 weeks; neither summary value is reported in the registry record. Consequently, the degree of observed adherence and the spread across participants cannot be described from the posted results.
The registry also lists secondary outcomes related to blood pressure control on existing treatment, changes in systolic and diastolic blood pressure, and blood pressure management. Their numerical results are not reported in the registry record. The study description therefore does not establish whether blood pressure changed, how much it changed, or how consistently any change was observed.
The design information limits interpretation of any outcome as a comparative effect. Allocation is not stated, and the record identifies the study as not a randomized comparison, with arms that are not a like-for-like control comparison. A comparator result is not described. Without a suitable comparison, a change observed over time could not, on this record alone, be attributed to the digital offering rather than to other influences. This is a general limitation of interpreting uncontrolled observations, not a claim that any particular influence occurred in this study.
The record indicates enrollment of 151 participants, but enrollment alone does not reveal how many contributed data to a particular endpoint. The number analyzed, missing observations, and analysis population are not reported in the registry record. The listed count of 0 analyses means the record does not include a posted analysis result. It is therefore not possible to assess the endpoint estimate, its uncertainty, or whether analysis choices affected the findings.
There is no confidence interval or other measure of precision reported for the primary endpoint. As a general statistical concept, a confidence interval describes the range of values compatible with the data and method under stated assumptions. Without an estimate and interval, statistical precision cannot be judged. No statistical significance conclusion can be drawn from the absence of a reported analysis.
The adverse-event figures are separate from evidence about efficacy or blood pressure outcomes. The record lists 0 participants with serious adverse events, 18 with other adverse events, and 0 deaths among the listed group of 151 at risk. The serious adverse event terms are not listed. These counts should be read as registry-recorded safety summaries, not as evidence about the primary adherence outcome or comparative safety.
Overall, the registry record supports a description of what was studied and how the primary measure was defined. It does not supply the results required to quantify adherence or blood pressure outcomes. Any interpretation should preserve that distinction between an outcome being specified and an outcome having a posted result.
9. Statistical Methods Explained
The statistical information in the registry record is limited. It identifies a median and full range as the intended summary for the primary outcome and describes the adherence measure and timeframe. It does not report an analysis result, an analysis population, or a statistical plan. The explanations below describe general statistical concepts and do not imply that a particular unreported method was used.
What does a median and full range describe?
The median is the middle value when observations are ordered. It can describe a typical value without being pulled as strongly by extreme observations as a mean may be. The full range describes the lowest and highest observed values. These summaries can be useful when a distribution is skewed or when values are bounded, as a percentage measure is. They do not show the shape of the full distribution, how many observations cluster near the median, or the uncertainty around the median.
For this study, the registry specifies the median and full range for percentage taking adherence over 2 weeks, but the values are not reported in the registry record. The reader therefore cannot assess the observed central value or spread. The registry does not state whether the summary was calculated from all enrolled participants or from a subset with endpoint data.
What does the sensor-based definition capture?
The endpoint definition uses detected ingestion sensors divided by the total number prescribed during the 2-week timeframe. In general, a measurement definition should be distinguished from the underlying behavior it is intended to represent. Here, the registry describes timing adherence based on sensor detections. The record does not report details about sensor performance, missed detections, adherence to wearing the monitor, or procedures for handling incomplete data. Those matters could affect how a recorded sensor measure is interpreted, but their occurrence in this study is not established.
What can be inferred without a comparator?
In general, a single-group observation can describe outcomes among participants observed in that group. A comparator can help distinguish changes associated with an intervention from changes that might occur over time or under other conditions. The registry states that this was not a randomized comparison, that allocation is not stated, and that the arms are not a like-for-like control comparison. A comparator-based causal estimate is therefore not established by the record. The record does not describe a control group or comparative analysis.
What does uncertainty mean?
General statistical interpretation considers both the observed estimate and its uncertainty. A confidence interval is one way to express uncertainty around an estimate, under the assumptions of the method used. A narrow interval usually indicates more precision than a wide interval, while neither interval by itself addresses bias from study design or measurement. No confidence interval, standard error, or other uncertainty measure for the primary result is reported in the registry record. Since the estimate itself is also not reported, its magnitude and precision cannot be assessed.
How should planning illustrations be read?
The registry record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect, and distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. These are planning assumptions, not results from a randomized comparison and not observed power. The actual observed effect and numerical planning outputs are not reported in the registry record. The record also does not report the study's own sample-size justification, so the planning description should not be treated as evidence of the original design rationale.
More generally, sample-size planning asks how much information a future study might need under specified assumptions. The result depends on the target effect, variability, significance threshold, allocation, and analysis method. If the assumed effect is uncertain or does not match the effect a future study seeks to detect, the illustration may not match that study's needs. These are general considerations; the registry record does not provide enough information to assess the suitability of its planning assumptions.
Why does over-dispersion matter?
General explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model underestimates variability, uncertainty intervals can be too narrow and tests can appear more decisive than warranted. The registry record does not report a model for the primary outcome, a dispersion assessment, or an analysis method that would permit an evaluation of this issue. It would therefore be inappropriate to claim that over-dispersion was present or addressed.
Finally, the registry lists 0 analyses. This means there is no posted statistical analysis result to evaluate for model choice, adjustment, handling of repeated observations, or sensitivity analysis. Those methodological details are not reported in the registry record. The endpoint's definition and summary format are available, but they are not substitutes for an analysis result or a complete statistical plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures, including a primary adherence endpoint and secondary outcomes related to blood pressure control, systolic and diastolic blood pressure change, and blood pressure management. It does not describe how these outcomes were prioritized beyond identifying the primary outcome, or how multiple statistical tests were handled. A multiplicity adjustment or prespecified hierarchy is not reported in the registry record.
As a general statistical concept, assessing several outcomes can increase the chance of finding an apparently notable result by chance if each is tested separately. Adjustment methods or a clearly prespecified hierarchy can address some of this concern. Since no outcome analyses or numerical results are posted, it is not possible to determine whether multiplicity affected interpretation in this study. No claim about false-positive findings is supported by the record.
Missing-data procedures are not reported in the registry record. The enrollment count is 151, but the number with usable observations for the primary endpoint or each secondary outcome is not stated. Reasons for missing measurements, any imputation, and any sensitivity analyses are also not reported. The record does not specify whether all enrolled participants were included in an analysis or define an analysis population.
These omissions matter because the interpretation of a summary depends on which observations contribute to it and how incomplete data are handled. This is a general principle, not evidence that data were missing or that any particular analysis population was used. The registry lists 0 analyses, so it does not provide results that could resolve these questions.
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 |
|---|---|---|---|
| Helius | 0 | 151 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Helius | 0 of 151 |
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 |
|---|---|
| Helius | 18 of 151 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Helius |
|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | 12 of 151 |
| Gastrointestinal complaint | Gastrointestinal disorders | 6 of 151 |
The registry lists one group, Helius, with 151 participants at risk for serious adverse events and 0 participants affected. It also lists 151 at risk for other adverse events and 18 affected. The death count is 0. These are the safety figures recorded for the listed group.
The registry does not list serious adverse event terms. It also does not provide descriptions, severity categories, timing, duration, or individual event counts for the other adverse events in the information available. The figure of 18 refers to participants affected in the other-adverse-event category; it should not be interpreted as a count of distinct event types or as a rate calculated by combining categories.
As a general statistical point, adverse-event counts describe what was recorded in a defined group and observation period. A count of 0 serious adverse events does not prove that the risk is absent, particularly when details about ascertainment and follow-up are not reported. Likewise, the other-event count cannot be interpreted comparatively without a suitable comparator and fuller information about event definitions and observation.
The record does not provide a like-for-like control comparison. These safety figures should therefore be read as descriptive registry entries rather than evidence that the digital offering is safer or less safe than another approach. They do not answer the primary adherence question.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed study enrolled 151 participants and examined a digital health offering involving an ingestible sensor and wearable sensor. Its stated purpose concerned management of persistent hypertension during chronic antihypertensive treatment. The primary endpoint was defined as percentage taking adherence over 2 weeks, based on detected ingestion sensors relative to sensors prescribed.
Those details describe the question and measurement, but the primary endpoint result is not reported in the registry record. The numerical summaries for the secondary blood pressure outcomes are not reported either. The posted information therefore does not quantify medication-taking adherence, blood pressure control, or change in systolic or diastolic blood pressure.
The study is not identified as a randomized comparison, allocation is not stated, and a like-for-like control comparison is not described. The record therefore does not establish a comparative effect of the digital offering. Even if an outcome had been reported for the study group, interpreting a change as caused by the offering would require careful consideration of the design and other possible explanations. That is a general caution, not a statement that a specific alternative explanation occurred.
The record does not provide a statistical analysis result, a confidence interval, or information about missing observations and analysis populations. The uncertainty and robustness of any outcome estimate consequently cannot be assessed. A stated endpoint and a completed study status are not substitutes for numerical outcome results.
The safety entries report 0 participants with serious adverse events, 18 with other adverse events, and 0 deaths among 151 at risk in the listed group. These are descriptive counts, not a comparison with another treatment or group. The record does not supply enough detail to characterize the events further.
In short, the registry supports a factual account of the study's purpose, design features, endpoint definition, and recorded safety counts. It does not establish whether the offering changed adherence or blood pressure, how large any change was, or whether such a change was attributable to the offering.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between a clearly stated measurement question and the absence of a posted numerical result. The registry defines a sensor-based adherence endpoint over 2 weeks and specifies a median with full range, but does not report those values. For readers, that distinction is essential: knowing what an outcome measures is not the same as knowing what the study found.
The record also illustrates why study design shapes interpretation. It identifies no randomized comparison, leaves allocation unstated, and does not describe a like-for-like control comparison. These features limit what can be concluded about comparative effects. A descriptive outcome in one group, even when available, would not by itself separate an intervention effect from other changes over time. This is a general statistical principle, not a claim about unreported events in this study.
The study's stated context links a digital health offering with medication-taking and blood pressure outcomes. These are related but distinct questions. Sensor-based adherence measures describe recorded medication-taking behavior; blood pressure outcomes address a different endpoint. One cannot substitute for the other. The registry lists both kinds of outcomes but does not report their numerical results.
The safety entries also show why counts need context. The record reports participants affected in serious and other adverse-event categories, but provides no serious-event terms and no comparative safety estimate. Descriptive counts are informative as registry entries, yet they do not establish relative risk or a causal relationship.
More broadly, this record emphasizes the value of reporting estimates, uncertainty, analysis populations, missing-data handling, and prespecified approaches to multiple outcomes. Their absence leaves readers unable to assess precision or robustness. The statistical importance lies as much in recognizing these limits as in describing the study's stated measures.
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 registry record does not report the primary endpoint value or its full range, despite defining the adherence measure and summary format. It also does not report numerical results for the secondary blood pressure outcomes. This prevents assessment of the size, direction, distribution, or precision of the outcomes.
The study is not described as a randomized comparison. Allocation is not stated, and the registry notes that arms are not a like-for-like control comparison. A comparator and comparative analysis are not reported. This limits causal and comparative interpretation, irrespective of whether descriptive changes were observed.
The record gives enrollment but not the number of participants contributing data to each outcome. Participant characteristics, eligibility criteria, follow-up details beyond the primary endpoint timeframe, and the analysis population are not reported in the registry record. Missing-data frequency, reasons for missingness, and handling procedures are also not reported.
The registry lists 0 analyses and does not describe a statistical analysis plan, confidence intervals, adjustment for multiple outcomes, or sensitivity analyses. It is therefore not possible to evaluate model assumptions or robustness. The numerical planning illustrations are described through assumptions, but the original sample-size justification and numerical planning outputs are not reported in the registry record.
The adherence measure relies on sensor detections, but details about measurement performance, sensor use, and procedures for incomplete monitoring are not reported. The serious adverse event terms are not listed, and the record does not provide details that would characterize other adverse events. These limitations are specific to what is documented in this study record; they do not establish that any particular problem occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Helius in Hypertension-I: The UK Hypertension Registry — NCT02553512.
- Registry record last updated 2017-06-16; status last verified 2017-04.
- Results first posted 2017-06-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed study of Helius involving an ingestible sensor and wearable sensor for people with essential hypertension. Enrollment was 151. The recorded start was 2013-09, and primary completion was 2014-12. The study purpose concerned use of a digital health offering during chronic antihypertensive treatment.
The primary endpoint was frequency of medication-taking, expressed as percentage taking adherence over 2 weeks and summarized as a median with full range. Its numerical result is not reported in the registry record. The record lists five outcome measures, including secondary blood pressure outcomes, but their numerical results are also not reported. It lists 0 analyses.
The record identifies the study as not a randomized comparison; allocation is not stated, and a like-for-like control comparison is not described. The safety entries list 0 participants with serious adverse events, 18 with other adverse events, and 0 deaths among 151 at risk in the Helius group. Serious adverse event terms are not listed.