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 One Touch VerioIQ US Clinical Outcomes Study (NCT01627899), a na na study. The primary outcome is Change in A1C From Baseline to Week 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01627899 |
| Phase | NA |
| Condition | Diabetes |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | LifeScan |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned subjects with diabetes. Enrollment was 5. Further eligibility criteria, participant characteristics, and details about the analysis population are not reported in the registry record. The primary outcome description states that the study was terminated early by the sponsor and no analysis was completed.
Intervention
The intervention was the One Touch VerioIQ Blood Glucose Monitor, described as a device. Subjects replaced their own blood glucose monitoring system with VerioIQ. The record does not report additional details about how participants used the device or how adherence was assessed.
Comparator
No separate comparator arm is listed. The record identifies a single-group study, and the listed arm is VerioIQ. Allocation is recorded as NA. A like-for-like control comparison is not available in the record.
Primary question
The planned primary question was how A1C changed from baseline to week 24 after participants replaced their own monitoring system with VerioIQ. The outcome description gives a 24-week timeframe, but no primary outcome estimate or completed analysis is reported in the registry record.
These details define the question the study was set up to examine, rather than an answer to that question. A single-group design can describe change within participants over time if measurements and analyses are completed, but without a separate comparator it cannot by itself distinguish change associated with the device from change associated with other influences over the same period. That is a general limitation of interpreting before-and-after results, not a reported finding about these participants.
The record lists secondary outcomes concerning change in A1C, fasting plasma glucose, the proportion with A1C less than or equal to 7.0%, and 30-day mean glucose. Their stated timeframes include week 12 and week 24. No secondary outcome analysis is reported. The intended study question therefore remains unanswered by the posted results: the record describes the planned measurements but supplies no analyzed change estimate for the primary outcome or the listed secondary outcomes.
3. Trial Design
The registry record identifies the One Touch VerioIQ US Clinical Outcomes Study as a single-group study of a device. Its status is terminated, enrollment is 5, and allocation is recorded as NA. Masking is recorded as none. The listed group is VerioIQ, and its description says subjects replaced their own blood glucose monitoring system with VerioIQ. There is no separate control group in the record.
The listed start date is 2012-10-01, and the primary completion date is 2013-05-01. The primary outcome was change in A1C from baseline to week 24. Its description states that the study terminated early by sponsor and that no analysis was completed. Thus, the registry record presents a planned outcome and timeframe but no outcome result.
In general, a single-group before-and-after design follows participants under one assigned study condition and compares measurements over time. Such a design can describe observed within-group change when appropriate measurements and analyses are available. It does not create a concurrent untreated or alternative-treatment comparison. Without that comparison, a change over time cannot alone establish that the study device caused the change. This is a general design consideration; it is not a claim that any change occurred in this study.
The record lists five outcome measures and zero analyses. It does not report a completed primary analysis, a statistical analysis plan, or results for the secondary outcomes. Further design details, including eligibility criteria, visit procedures, and the intended method for handling participants who did not complete follow-up, are not reported in the registry record. The reason for termination beyond the statement that termination was early by the sponsor is not reported in the registry record. These omissions restrict what can be inferred about implementation and what analyses, if any, were intended.
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 | OneTouch VerioIQ BGMS |
|---|---|
| STARTED | 5 |
| COMPLETED | 0 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | OneTouch VerioIQ BGMS |
|---|---|
| Study terminated early by sponsor. | 5 |
Analysis population for the primary outcome, as defined in the registry: Study terminated early by sponsor, no analysis completed.
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: No data was analysed including demographics as study was terminated early before any data was collected.
| Characteristic | Unit | OneTouch VerioIQ BGMS |
|---|---|---|
| Participants analysed | 5 | |
| Age, Customized: Unknown | Participants | 5 |
| Sex/Gender, Customized: Unknown | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Change in A1C From Baseline to Week 24, measured over 24 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was change in A1C from baseline to week 24. The registry record gives the measure and timeframe, but its unit, parameter, and dispersion are not reported in the registry record. Most importantly, the outcome description says that the study was terminated early by the sponsor and no analysis was completed. There is therefore no posted estimate of change, uncertainty interval, or test result for this endpoint.
As a general statistical concept, a change endpoint compares a participant’s follow-up measurement with that participant’s baseline measurement. It is used to express how the measured outcome differs over a specified period, rather than reporting only a follow-up value. A baseline-to-follow-up change is interpretable only when the relevant observations are collected and an analysis specifies how the changes are summarized and how incomplete observations are handled. Those analysis details are not reported in the registry record.
In a single-group study, change in an endpoint can describe the pattern among the participants with usable measurements. It does not by itself separate an intervention-associated change from time trends, co-occurring care, measurement variation, or other influences. This is a general interpretation point, not evidence that any such influence affected this study. Because the posted record has no completed analysis, even a descriptive within-group estimate is unavailable.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the registry record reports no completed analysis of the primary outcome. The planned outcome was change in A1C from baseline to week 24, but no numerical change estimate, uncertainty measure, or inferential result is reported in the registry record. The primary result therefore cannot be characterized as an increase, a decrease, or no change. An absence of an analysis is not an estimate of zero change and is not evidence that the planned outcome was unchanged.
The record reports enrollment of 5 and a terminated status. Its primary outcome description says the study was terminated early by the sponsor and no analysis was completed. This makes it important to distinguish the planned design from observed results: a target measure and follow-up time are not outcome findings. Likewise, the registry lists secondary outcomes, but listing them does not establish that the measures were collected, analyzed, or met any criterion. Results for those outcomes are not reported in the registry record.
No confidence interval or p-value for the primary endpoint is reported in the registry record. In general, a confidence interval communicates the range of values compatible with an estimate under the analysis assumptions; without an estimate and its uncertainty, there is no interval to interpret. A p-value, in general, assesses how compatible data are with a specified null hypothesis under a statistical model. No such test result is available, so the record cannot support a statement about statistical significance or a lack of statistical significance.
The single-group design also limits the kind of conclusion that could be drawn even if an analysis were available. In general, a within-group change describes what happened between measurements among observed participants, whereas a causal comparison requires a suitable reference group or other defensible design and assumptions. The record lists no separate comparator group. It would therefore be inappropriate to describe a hypothetical change as proof of an effect attributable to the monitor. In this study, the stronger limitation is that the primary outcome was not analyzed at all.
The enrollment figure is a description of study enrollment, not the number with complete week-24 outcome data. The number of participants with baseline and follow-up A1C measurements is not reported in the registry record. The analysis population and handling of missing measurements are not reported in the registry record. Consequently, the record does not establish how many participants contributed to any endpoint analysis; it explicitly states that no analysis was completed for the primary outcome.
The registry record also includes planning assumptions for sample-size illustrations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with an effect to detect expressed as a fraction of an observed effect. These are planning assumptions, not outcomes from this single-group study. The numerical planning estimates are not reported in the registry record, and an observed primary effect is unavailable because the primary analysis was not completed. Planning illustrations cannot replace a completed analysis or be interpreted as observed power.
9. Statistical Methods Explained
What does a change endpoint mean?
As a general statistical concept, a change endpoint is formed by relating a follow-up measurement to a baseline measurement for the same participant. The result can then be summarized across participants. The summary might describe a typical change or estimate an average change, depending on the prespecified analysis. Those are general possibilities, not methods reported for this study. The registry record names change in A1C from baseline to week 24 as the primary endpoint but does not report the parameter or dispersion used to summarize it.
A complete change analysis needs both outcome measurements and a rule for including participants. For example, analysis choices may differ according to whether only participants with both measurements are included or whether a model uses available measurements under stated assumptions. This is a general explanation of analysis options. The record does not state which approach was planned, how missing observations would be treated, or whether baseline and follow-up measurements were available for any particular participant. It also states that no analysis was completed.
What does uncertainty add?
In general, an estimate alone does not show how precisely the study has estimated the outcome. A standard error or confidence interval can convey uncertainty around an estimate, conditional on the analysis and its assumptions. A narrow interval indicates greater precision than a wide interval for the same kind of quantity, while neither interval width nor the point estimate alone establishes clinical importance. These concepts cannot be applied to a primary result when the registry record contains no estimate or uncertainty measure. A confidence interval and standard error for the primary endpoint are not reported in the registry record.
Hypothesis tests are another general statistical tool. A test compares observed data with a specified null hypothesis through a chosen model and test statistic. Its interpretation depends on the hypothesis, the analysis population, and the assumptions of the method. The registry record does not report a test for the primary outcome, a p-value, or a statistical analysis plan. No conclusion about statistical significance can be drawn from a result that was not analyzed.
Why does the design affect interpretation?
In a single-group study, each participant may contribute measurements at different times, and the analysis can describe within-participant change. In general, that comparison does not provide the counterfactual information about what would have happened over the same period under another condition. Time effects, changes in concurrent care, and other influences can affect before-and-after measurements. Without a separate comparator or another justified design, the observed change cannot be attributed solely to the intervention. The registry record lists a single-group model and no separate comparator. Since there is no completed analysis, it reports no observed within-group change either.
Masking is recorded as none. As a general methods point, knowledge of the assigned intervention can sometimes affect behavior, reporting, or measurement processes, depending on the outcome and its collection. That is a possible design consideration, not a claim that bias occurred in this study. The registry record does not describe measurement procedures or safeguards that would allow those issues to be assessed.
How should planning assumptions be read?
The registry record specifies assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of an observed effect. In general, sample-size planning asks how many participants an imagined study design would need to attain a stated operating characteristic under specified assumptions. It is prospective planning, not a result from participants already enrolled.
The listed planning assumptions describe a two-arm calculation, while the registered study is single-group and allocation is NA. The record's general note says the assumptions are not the trial's own design. No numerical planning estimates are reported in the registry record. The observed effect needed to anchor those illustrations is also not reported for the primary endpoint, because the outcome description states that no analysis was completed. Therefore, no planning estimate can be treated as evidence about the precision or findings of this study. Sample-size illustrations are not observed power; observed power is not a substitute for an effect estimate and its uncertainty.
General sample-size calculations depend on the assumed effect, variability, significance level, allocation, and statistical method. If those inputs differ from what actually occurs, the calculated planning requirement may not describe the resulting study. The registry record does not provide numerical estimates for alternative assumed effects, and no values should be inferred from the assumptions alone.
What do the listed outcomes tell us?
The registry record lists five outcome measures and names secondary outcomes relating to A1C, fasting plasma glucose, the proportion of subjects with A1C less than or equal to 7.0% at week 24, and 30-day mean glucose comparing the first month with the last month after 24 weeks. These descriptions identify planned outcome topics and timeframes. They do not report estimates, methods of analysis, or uncertainty. The number of analyses is listed as 0. A reader should distinguish an outcome listed in a registry from an outcome with posted results: only the latter can support statistical interpretation of the observed data.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names a primary outcome and several secondary outcomes, but it does not report an analysis plan describing how those outcomes would be tested or interpreted together. It does not report whether any multiplicity adjustment was planned. The number of analyses is listed as 0, and the primary outcome description says no analysis was completed. Thus, there are no reported outcome tests whose family-wise error or false-discovery properties can be evaluated.
As a general statistical concept, multiplicity arises when several hypotheses or outcomes are examined. Without an adjustment or an interpretation plan, repeated testing can increase the chance of at least one apparently notable result under a collection of null hypotheses. This general concern does not imply that any result was obtained in this study. The registry record gives no analyzed results from which to assess such a pattern.
Missing-data methods and analysis populations are not reported in the registry record. Enrollment was 5, but the number with baseline and week-24 measurements, the number completing follow-up, and the number included in any analysis are not reported in the registry record. The record states that no primary analysis was completed. It does not describe how incomplete observations would have been handled or whether any imputation or sensitivity analysis was planned.
In general, the consequences of missing outcome data depend on why measurements are absent and on the assumptions used by the analysis. Those details cannot be assessed from enrollment alone. The registry record does not report reasons for missing measurements or participant-level follow-up status. Accordingly, neither the completeness of endpoint data nor the robustness of a hypothetical estimate can be evaluated.
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 |
|---|---|---|---|
| OneTouch VerioIQ BGMS | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| OneTouch VerioIQ BGMS | 0 of 5 |
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 |
|---|---|
| OneTouch VerioIQ BGMS | 0 of 5 |
The registry record lists the OneTouch VerioIQ BGMS safety group with 5 at risk for serious adverse events and 0 affected. It also lists 5 at risk for other adverse events and 0 affected, and reports 0 deaths. These are the posted counts; they do not describe an analyzed comparison with another group because no comparator group is listed.
As a general statistical point, a count of zero affected participants in a small group does not establish that an event is impossible or that the underlying risk is zero. Counts describe what is recorded among the participants at risk; they do not, by themselves, provide a precise estimate of the frequency that might occur in a broader population. No uncertainty interval for the safety figures is reported in the registry record.
The record lists no top serious adverse event terms. The serious and other adverse event counts should not be read as a statement that no event of any kind occurred: the posted figures are specifically the numbers affected for the listed categories. Further details about event definitions, collection procedures, severity, or relatedness are not reported in the registry record. The safety figures are descriptive registry counts, not evidence from a controlled safety comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a small, single-group device study was registered and later terminated. It identifies the One Touch VerioIQ Blood Glucose Monitor as the intervention and states that subjects replaced their own blood glucose monitoring system with VerioIQ. The planned primary outcome was change in A1C from baseline to week 24. These details describe the study question and its design; they do not establish what happened to A1C.
The record explicitly says the study terminated early by the sponsor and that no primary analysis was completed. No numerical estimate for change in A1C, no uncertainty interval, and no test result are reported in the registry record. It is therefore not possible to say from the posted results whether the primary measure increased, decreased, or remained similar. It is also not possible to characterize the size or precision of a change.
The absence of a result should not be interpreted as a null finding. A null finding would require analyzed data and a result that can be evaluated against a defined question. Here, the registry record reports no analysis. Likewise, the fact that secondary outcomes are listed does not show that they were measured or analyzed, and it does not establish whether any planned threshold or comparison was met.
Even if a within-group change estimate were available, the single-group design would limit causal interpretation. In general, a before-and-after difference cannot by itself distinguish a device-associated change from changes that might have occurred over time for other reasons. The record does not list a separate comparator arm, and no like-for-like control comparison is available.
The safety counts are limited descriptive information: 0 of 5 were affected by a serious adverse event, 0 of 5 by other adverse events, and 0 deaths were reported. These counts do not provide a controlled comparison, and their precision cannot be fully assessed without additional detail. Overall, the registry record documents a planned study question, a terminated study, and a lack of completed outcome analysis; it does not provide evidence that answers the primary efficacy question.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between a registered outcome and an analyzed result. The registry record specifies a primary endpoint and follow-up timeframe: change in A1C from baseline to week 24. Yet the outcome description states that the study terminated early by the sponsor and no analysis was completed. A planned endpoint provides context for what investigators intended to measure, but without an estimate it cannot answer the research question.
The record also distinguishes the study's design from the assumptions used for planning illustrations. It identifies a single-group model, while the planning note refers to equal allocation between two arms and says the illustrations are not the trial's own design. This is a useful reminder that hypothetical sample-size calculations depend on assumed designs and effects. They do not become evidence about an enrolled study simply because planning estimates are available. No numerical planning estimates are reported in the registry record.
A second statistical lesson concerns interpretation of zero event counts in a small enrolled group. The record reports no affected participants for the listed serious and other adverse event categories and no deaths. Those counts are informative descriptions of what is posted, but they do not establish a precise underlying event rate or support a comparison with an unobserved control group. This is a general limitation of sparse event data, not a claim about what occurred beyond the recorded counts.
Finally, a single-group design and an incomplete analysis create distinct constraints. The design would limit causal inference even if a within-group estimate were available; the absence of an analysis means that such an estimate is not available in the first place. Keeping those limitations separate prevents an absent result from being mistaken for evidence of no change, and prevents a planned outcome from being mistaken for a finding.
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 most direct limitation is that the primary outcome was not analyzed. The registry record states that the study terminated early by the sponsor and no analysis was completed. It gives no change estimate for A1C from baseline to week 24, and no uncertainty measure or inferential result. The listed secondary outcomes also have no reported analyses.
Enrollment was 5, but the number with complete baseline and follow-up measurements is not reported in the registry record. Participant characteristics, eligibility criteria, and the analysis population are not reported in the registry record. The reason for early termination beyond the sponsor's decision is not reported in the registry record. These omissions prevent a fuller assessment of who contributed data and why the study stopped.
The single-group design has no listed concurrent comparator. As a general design limitation, within-group change alone cannot rule out alternative explanations for changes over time. Masking is recorded as none, while details about outcome measurement procedures and safeguards are not reported in the registry record.
The registry record does not report the statistical analysis plan, the method for summarizing change, the approach to missing data, or any multiplicity strategy. It also does not report a rationale for the enrollment or numerical sample-size planning outputs. The record's planning assumptions concern a two-arm illustration and are explicitly not the trial's own design. Together, these limitations mean that neither outcome magnitude, precision, robustness, nor causal interpretation can be evaluated from the posted results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: One Touch VerioIQ US Clinical Outcomes Study — NCT01627899.
- Registry record last updated 2018-08-02; status last verified 2018-07.
- Results first posted 2018-08-02.
- 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.
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 One Touch VerioIQ US Clinical Outcomes Study (NCT01627899) was a single-group device study sponsored by LifeScan. The record lists 5 enrolled participants, no masking, and a terminated status. Subjects replaced their own blood glucose monitoring system with the One Touch VerioIQ Blood Glucose Monitor.
The primary outcome was change in A1C from baseline to week 24. The record states that the study terminated early by the sponsor and no analysis was completed. Although several secondary outcomes are listed, their results are not reported in the registry record. Serious adverse events affected 0 of 5 at risk, other adverse events affected 0 of 5 at risk, and 0 deaths are listed. The registry record therefore documents the study design and planned outcomes but does not provide an analyzed result for the primary question.