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 Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp (NCT01874392), a na na study. The primary outcome is Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01874392 |
| Phase | NA |
| Condition | Type 1 Diabetes Mellitus |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sansum Diabetes Research Institute |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 21–65 years with type 1 diabetes for at least one year, using an insulin infusion pump with rapid-acting insulin for at least six months. The registry record lists an enrollment of 9.
Intervention
An artificial pancreas device using the APS platform, combined with investigational Technosphere inhaled insulin. The study description places inhaled insulin before meals and describes conventional subcutaneous insulin for basal management and second-phase meal-related insulin.
Comparator
There is no separate control group in the registry record. The study is listed as single-group, and allocation is recorded as NA. It therefore does not provide a like-for-like randomized comparison between treatment strategies.
Primary question
Under close medical supervision in a clinical research center, what percentage of time does glucose remain within 70–180 mg/dL during the 5 hours after a meal when the artificial pancreas device is used with inhaled insulin? The registry frames the objective as testing device safety in challenging situations, including meals, exercise, and the nocturnal period. The listed endpoint is a glucose-range measure, not a direct count of safety events.
3. Trial Design
This was a completed, single-group feasibility study sponsored by Sansum Diabetes Research Institute. The registry lists the study start as 2012-10 and primary completion as 2013-06. Enrollment is recorded as 9. The phase is listed as NA, allocation is NA, and masking is listed as NONE. The record does not describe a randomized allocation or a separate control arm.
Participants were described as adults aged 21–65 years with type 1 diabetes mellitus for at least one year who had used an insulin infusion pump with rapid-acting insulin for at least six months. The interventions listed are an investigational Technosphere inhaled insulin product and an artificial pancreas device using the APS platform. The study rationale was to explore multiple insulin delivery routes: rapid-acting inhaled insulin for part of meal coverage and subcutaneous insulin for basal management and second-phase meal-related insulin.
The study description emphasizes testing the system in a clinical research center under close medical supervision and subjecting it to challenging situations, including meals, exercise, and the nocturnal period. The record identifies a five-hour post-meal glucose-range endpoint. It also lists two secondary-outcome entries with the same title, “Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System.” The registry lists 7 outcome measures but no analysis records. Further details about the protocol, participant flow, intervention schedule, and conduct 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 | T1DM |
|---|---|
| STARTED | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
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 | T1DM |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 49 (SD 10) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 3 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting., measured over 5 hours.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | percentage time in range (70 - 180 mg/dL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of time glucose remains within the target range of 70–180 mg/dL during the 5 hours after a meal. The registry describes assessing the artificial pancreas device combined with Technosphere inhaled insulin under challenging circumstances, including meals, exercise, and the nocturnal period. The endpoint’s stated unit focuses on the post-meal period.
Time in range expresses how much of a monitored period glucose measurements fall within a prespecified interval. As a general statistical concept, it can summarize glucose patterns across a period rather than relying on a single measurement. It is not itself a count of serious adverse events, and a value for this endpoint would not by itself describe every aspect of safety or device performance.
The record specifies the median as the summary parameter and the interquartile range as the dispersion measure. These summaries describe the center and spread of participant-level measurements without requiring a normal distribution. However, the registry record does not report the observed median, interquartile range, or individual participant results. The endpoint’s numerical outcome and its precision therefore cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the study’s purpose and the endpoint it intended to evaluate, but it does not provide an observed value for the primary endpoint. There is no reported median percentage of time in range or interquartile range for the 5 hours after a meal. Consequently, the posted results do not quantify how much time participants spent in the target glucose range, how variable that measure was, or how precisely it was estimated.
The study is listed as single-group, with allocation recorded as NA. Without a separate control group, the record cannot support a randomized between-group estimate of the effect of the combined system relative to another treatment strategy. The feasibility design is relevant to whether the approach could be studied under the described clinical research center conditions, but the registry record does not report enough outcome information to characterize its performance.
The primary objective is worded as testing safety under close medical supervision, while the named primary endpoint is percentage time in a glucose range. These represent related but different kinds of information: a glucose-range measure describes glucose observations over time, whereas safety-event summaries count reported adverse events. Neither type of measure should be substituted for the other. The adverse-event record reports zero serious adverse events and zero other adverse events in the listed group, but the small recorded enrollment and absence of additional event details limit interpretation. Deaths are not reported in the registry record.
The registry lists 7 outcome measures and 0 analysis records. It does not report inferential results, confidence intervals, a statistical comparison, or an analysis population. The result is therefore not merely an imprecise estimate: the endpoint’s observed summary is absent from the record. No conclusion about the size, direction, or statistical uncertainty of the glucose-range outcome can be drawn from the posted results.
The record supports a descriptive account of the intended feasibility question, population, interventions, and measurement period. It does not establish whether the planned endpoint was achieved, whether any observed pattern was attributable to the intervention, or whether results would generalize beyond the described participants and clinical research center setting. Any stronger interpretation would require outcome and analysis information not reported in the registry record.
9. Statistical Methods Explained
The registry record identifies the primary summary as a median with an interquartile range. These are descriptive statistics. The median is the middle of an ordered set of measurements, while the interquartile range describes the spread of the middle portion of those measurements. As a general statistical explanation, these summaries can be useful when data are skewed or contain values that would strongly affect a mean. Their use does not, by itself, establish that the data are skewed or that any particular analysis was performed.
The endpoint is a percentage of time in the 70–180 mg/dL range during the 5 hours after a meal. To interpret such an endpoint fully, a reader would need to know how glucose observations were collected and converted into time in range, how missing or unusable observations were handled, and how participant-level values were summarized. Those procedural details are not reported in the registry record. The listed median and interquartile range indicate the intended form of summary, but the numerical summaries themselves are absent.
What can a median and interquartile range show?
As a general concept, the median describes the central location of participant measurements, and the interquartile range describes their spread. Together they give information about a typical observation and variability across observations. They do not convey the full distribution, and they do not automatically provide a confidence interval for the population value. The record does not report a confidence interval or another measure of inferential uncertainty for the primary endpoint.
What does the single-group structure imply?
A single-group study can describe outcomes observed among participants receiving the study intervention, but it does not provide a concurrent control-group contrast. A control comparison can help separate treatment-related differences from changes over time, measurement conditions, or other influences. Without that comparison, this record cannot estimate a randomized treatment contrast. This is a general limitation of interpreting an uncontrolled intervention study, not evidence that a particular source of bias occurred in this trial.
The registry describes a feasibility objective and a closely supervised clinical research center setting. Such a setting can support evaluation under controlled conditions, but it does not by itself answer how results would vary in other settings. The record does not describe procedures for comparing outcomes across participants or challenging situations, so no such analysis should be assumed.
What is known about the analysis plan?
The record lists the median and interquartile range for the primary endpoint, but the statistical analysis plan is not reported in the registry record. The record lists 0 analysis records. It does not specify a hypothesis test, model, adjustment strategy, confidence-interval method, treatment of repeated measurements, or prespecified analysis population. No inferential method should be attributed to the investigators based solely on the endpoint summary format.
The record includes assumptions for a separate planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of an observed effect. Those are planning assumptions, not a description of this single-group study’s allocation or its analysis. They do not show that the trial used two arms, and they do not constitute observed power. The registry record does not report the numerical planning results or the observed effect needed to evaluate such an illustration.
Why does over-dispersion matter in general?
Over-dispersion occurs when the variability in data exceeds what a chosen statistical model assumes. If an analysis ignores over-dispersion, its estimated uncertainty can be too small, which can make findings appear more precise than the data warrant. This is a general consideration for statistical modeling, not a reported feature of this study. The registry does not report a model or enough outcome data to assess whether over-dispersion was relevant.
Overall, the available methodological detail permits a limited description of the endpoint and its planned descriptive summary. It does not permit reconstruction of an analysis, evaluation of model assumptions, or assessment of statistical precision. The observed endpoint summary and the statistical analysis methods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures and two secondary-outcome entries with the same title. It does not report how these outcomes were prioritized beyond identifying the primary objective, nor does it describe a strategy for controlling multiplicity. Multiplicity refers, in general, to the increased chance of obtaining apparently notable findings when many outcomes or statistical tests are examined. Whether that concern affected this study cannot be determined from the registry record because no analysis records are listed and no testing strategy is reported.
Missing-data procedures are not reported in the registry record. The record does not say whether any endpoint measurements were missing, how incomplete monitoring periods would be handled, or whether any participants were excluded from particular summaries. The absence of these details does not establish that data were missing; it means the record does not describe their status or handling.
The record does not define an analysis population, such as a population based on enrollment, intervention exposure, or endpoint availability. It also does not report participant-level outcome data or the number contributing to the primary endpoint summary. Therefore, the extent to which the endpoint analysis reflects all enrolled participants cannot be evaluated. The registry’s enrollment figure alone does not establish the denominator for any outcome analysis.
These omissions limit assessment of selective outcome reporting, the handling of incomplete observations, and the relationship between enrollment and analysis. The missing analysis and population details should not be filled in by assumption.
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 |
|---|---|---|---|
| T1DM | 0 | 9 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 4% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| T1DM | 0 of 9 |
The adverse-event record lists the T1DM group with 9 at risk for serious adverse events and 0 affected. It also lists 9 at risk for other adverse events and 0 affected. These are the posted counts for the categories recorded; they should be read as descriptive event information, not as proof that risk was absent.
The record does not provide event terms for serious adverse events, and it lists no top serious-event terms. Deaths are not reported in the registry record. The absence of a reported death count is not the same as a reported count of zero. Further details about event definitions, observation time, severity, relatedness, and participant-level event patterns are not reported in the registry record.
The adverse-event counts and the primary glucose-range endpoint measure different things. Zero reported adverse events in the listed categories does not supply the missing median or interquartile range for time in range, and the glucose-range measure does not replace adverse-event monitoring. Because the study is single-group and the recorded enrollment is 9, the event counts are descriptive; they do not provide a comparative estimate of safety against another intervention.
12. What the Result Does, and Does Not, Mean
This record describes a feasibility study of an artificial pancreas device used with inhaled insulin and an intended post-meal glucose-range endpoint. It reports a single-group design, an enrollment of 9, the target glucose range of 70–180 mg/dL, and a measurement period of 5 hours after a meal. It also records zero affected participants for the listed serious and other adverse-event categories.
However, the registry record does not report the observed primary endpoint median or interquartile range. It therefore does not show the amount or variability of time in range achieved by participants. It also provides no analysis records, confidence intervals, or inferential results. The endpoint’s precision and any statistical evidence about its value cannot be assessed.
The study design does not include a separate control group, so the record cannot establish a comparative treatment effect. Even if an outcome summary were available, a single-group result would describe participants under the study conditions rather than isolate a causal effect through a randomized comparison. The study’s close-supervision clinical research center setting also limits what can be inferred about other contexts.
The safety counts are limited descriptive information. They do not establish that no adverse events occurred outside the recorded categories or observation period, and deaths are not reported in the registry record. The glucose-range endpoint likewise should not be interpreted as a complete safety assessment.
In short, the registry record documents the feasibility question and some design and event-count information, but it does not include the primary outcome result needed to characterize the observed glucose-range performance. The record does not establish a benefit, lack of benefit, or comparative safety conclusion.
13. Why This Trial Matters Statistically
Statistically, the record illustrates the distinction between a study question and an interpretable study result. The endpoint is defined in terms of time within a glucose range during a specified post-meal period, and the planned descriptive summary is identified as a median and interquartile range. Yet the observed summary is not reported. Without it, a reader cannot assess the central outcome, its variability, or its precision.
The single-group feasibility design also matters. It is suited to describing an intervention experience in the enrolled group, but it does not create a randomized contrast against a control condition. Statistical interpretation must therefore distinguish descriptive observation from comparative evidence. The record’s separate planning assumptions involving equal allocation between two arms do not change the listed single-group design.
The record also places a glucose-range measure under a primary objective framed around safety. This makes clear why endpoint definitions matter: a measure of glucose patterns and a count of adverse events address different questions. Reporting each outcome with its own definition and analysis is important for readers to understand what evidence it can support.
Finally, the registry lists no analysis records and does not describe missing-data or multiplicity procedures. Those omissions make it difficult to assess how outcome summaries were generated or how multiple outcomes were handled. The main statistical lesson is not a conclusion about the intervention, but the need for complete outcome reporting, transparent analysis methods, and careful matching of claims to the design and endpoint.
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 primary limitation for interpretation is that the observed primary endpoint summary is not reported in the registry record. Although the record specifies a median and interquartile range, neither value appears in the posted results. The glucose-range outcome therefore cannot be quantified or evaluated for precision.
The study is listed as single-group, with no separate control group. The registry record cannot support a randomized comparison or isolate an intervention effect relative to another strategy. The enrollment is recorded as 9, and the population description is limited to adults aged 21–65 years with specified diabetes and insulin-pump history. The extent to which findings might apply beyond that described group is not established.
The endpoint covers the 5 hours after a meal, while the study description also refers to exercise and the nocturnal period. Results for those circumstances are not reported in the registry record. The registry does not provide participant-level data, outcome denominators, measurement procedures, or the handling of missing observations.
Further limitations include the absence of analysis records and a reported statistical analysis plan, including details on multiplicity and analysis populations. The adverse-event record gives counts for affected participants but does not report deaths, event timing, relatedness, or detailed event terms. These omissions constrain interpretation of both efficacy-related measurements and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp — NCT01874392.
- Registry record last updated 2021-11-11; status last verified 2021-10.
- Results first posted 2021-11-11.
- 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 record describes a completed, single-group feasibility study sponsored by Sansum Diabetes Research Institute, with enrollment of 9. It lists adults aged 21–65 years with type 1 diabetes and prior use of an insulin infusion pump with rapid-acting insulin. The interventions are an artificial pancreas device using the APS platform and investigational Technosphere inhaled insulin.
The primary endpoint is percentage time in the 70–180 mg/dL range during the 5 hours after a meal, with the median and interquartile range specified as summaries. The observed endpoint values are not reported in the registry record. The record lists 7 outcome measures and 0 analysis records. It reports zero participants affected by serious adverse events and zero affected by other adverse events in the listed group; deaths are not reported in the registry record.