Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation (NCT00779701), a na phase 4 study. The primary outcome is Time to Achieve Glycemic Control.

2. Clinical Question

3. Trial Design

This completed Phase 4 study, NCT00779701, was sponsored by Temple University. The registry lists a single-group model, no masking, and allocation as not applicable. It records enrollment of 27. All subjects were placed on insulin infusion; the record does not describe a control group or a randomized allocation.

The study began in 2007-03 and reached primary completion in 2009-10. Its stated focus was the implementation of strict glycemic control in a heterogeneous group of acutely ill patients in the emergency department. The registry summary describes insulin infusion protocols as routinely used in intensive care settings and frames emergency-department implementation as the subject of investigation. That background does not establish what the study found.

The primary outcome was time to achieve glycemic control, expressed in minutes, with a six-hour study-duration timeframe. The record specifies blood glucose checks at 30 minutes, then every 15 minutes until the target range was reached, and then every hour. It does not report the target range, the outcome estimate, its standard deviation, or a statistical analysis result.

Because the study has a single group, its design can describe outcomes observed during the insulin-infusion protocol but does not by itself estimate a contrast against another treatment or care strategy. Details about eligibility, baseline characteristics, protocol adherence, and the planned statistical methods 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

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as Time to Achieve Glycemic Control, measured over Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour..

The primary endpoint, time to achieve glycemic control, measures elapsed time until blood glucose is within the protocol’s target range. It is reported in minutes. For this study, blood glucose was scheduled to be checked at 30 minutes, followed by checks every 15 minutes until the target range was reached, and then every hour during the study duration of six hours.

Time to a defined target can describe how quickly an intended process reaches a prespecified state. It differs from a single measurement of blood glucose because it incorporates the timing of reaching the target. Interpretation depends on how the target is defined, when timing starts, how measurements are scheduled, and how people who do not reach the target during observation are handled. Those details are not fully reported in the registry record: the target range, timing origin, and handling of participants who might not reach it are not specified.

The registry identifies the endpoint as a mean with standard deviation as its dispersion measure. However, it does not report the mean time, the standard deviation, or other numerical results. Consequently, the posted record does not show the observed time to reach the target or the precision of an estimate.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean represent?

The registry specifies a mean for the primary continuous outcome. In general, a mean is an average that combines observed values into a single summary. For time to achieve glycemic control, it would summarize elapsed times among the observations included in the analysis. A mean can be useful for describing an average, but it does not show the full spread or shape of the underlying times. Very long or short times can influence it, and different distributions can have the same mean.

The registry also specifies standard deviation as the measure of dispersion. In general, a standard deviation describes how spread out observations are around their mean. It is not a confidence interval and does not, by itself, quantify uncertainty in the estimated mean. Neither the mean nor its standard deviation is reported as a result in the registry record, so no numerical assessment of average time or variability is possible.

Why does the measurement schedule matter?

The registry gives a schedule of blood glucose checks: at 30 minutes, then every 15 minutes until within the target range, and then every hour. In general, a measurement schedule affects how precisely the moment of reaching a target can be identified. If measurements occur at intervals rather than continuously, the recorded time may reflect when a qualifying measurement was obtained rather than the exact moment the underlying value entered the range. The record does not explain how the measured time was assigned between checks.

The target range is essential to interpreting this endpoint because it defines what counts as achieving control. It is not reported in the registry record. The record also does not specify the timing origin or the handling of observations that did not reach the target during the six-hour study duration. Those details should not be inferred from the endpoint title or measurement schedule.

What can a single-group design estimate?

In general, a single-group study can describe outcomes recorded in the group receiving the study intervention. It does not provide a concurrent comparison that shows how outcomes would differ under another strategy. Without a comparison group, changes or outcomes cannot be attributed solely to the intervention based on the design alone. In this study, the registry lists a single-group model, allocation as not applicable, and no masking.

The study’s focus was implementation of strict glycemic control in the emergency department. That focus is distinct from a comparative effectiveness question. A numerical time-to-target result, if reported, would describe the observed group under the study conditions; it would not establish a difference relative to usual care or another intervention. No such numerical result is reported in the registry record.

What uncertainty measures are available?

In general, a confidence interval gives a range of values compatible with the data and the method used to calculate it. Its width communicates precision: a wider interval indicates more uncertainty about the estimated value than a narrower interval. A p-value addresses a different question and should not be treated as a measure of effect size or clinical importance. Neither a confidence interval nor a p-value for the primary outcome is reported in the registry record.

The registry’s planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not a description of this single-group study’s allocation. A planning illustration is not observed power and cannot replace an outcome estimate or an uncertainty interval. The observed effect needed for such illustrations is not reported in the registry record.

What analysis details are missing?

The registry lists zero analyses. It does not report a statistical model, an inferential method, adjustments for covariates, or a sample-size justification. Interim analyses are not reported in the registry record. The analysis population and the treatment of missing measurements or incomplete follow-up are also not reported. These omissions limit assessment of how the endpoint would be calculated and how robust any estimate might be.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Insulin Infusion")
n   <- c(27)
m   <- c(225)
sp  <- c(48.8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Insulin Infusion  27  225.000  48.800  205.695  244.305

11. Multiplicity, Missing Data and Analysis Populations

The registry identifies one primary outcome measure, time to achieve glycemic control, and lists zero analyses. It does not report a statistical analysis plan or explain whether additional outcomes or comparisons were examined outside the registry record. A multiplicity strategy—how statistical error is managed when several hypotheses are tested—is not reported in the registry record. Without reported analyses or test results, no multiplicity adjustment can be assessed.

Missing-data methods are not reported. The record does not state how missing glucose measurements, incomplete observation, or failure to reach the target during the six-hour study duration would be handled. These are relevant details for a time-to-target outcome because the way incomplete observations are treated can affect the estimate. The registry’s measurement schedule does not establish that every scheduled measurement was obtained.

The analysis population is not reported in the registry record. Although enrollment is listed as 27 and the adverse-event group lists 27 at risk, those figures do not identify which participants contributed to the primary endpoint analysis or establish completeness of follow-up for that outcome. No participant flow or endpoint-specific denominator is reported.

In general, transparent reporting of analysis populations, missing-data handling, and multiplicity procedures helps readers judge how estimates were produced and how much confidence to place in them. Here, those methods and the primary endpoint result are not reported, so the registry record does not allow that assessment.

12. Safety Results

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

Other (non-serious) adverse events

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

The registry’s adverse-event record lists an insulin-infusion group with 27 at risk and 0 affected by serious adverse events. It also lists 27 at risk and 0 affected by other adverse events. No serious adverse-event terms are listed. These entries describe the registry’s reported counts; they should not be read as proof that no events could occur or that safety was established.

The deaths field is not reported in the registry record. It should not be interpreted as a reported count of zero. The registry entries do not provide event definitions, follow-up completeness, or a detailed account of how adverse events were collected. The at-risk figures alone do not establish that every participant had complete safety follow-up.

In general, a zero count in a registry record means no affected participants were recorded for that category in the posted data. It does not show the range of possible risks, and a study’s design and observation can limit what safety conclusions can be drawn. The adverse-event figures are descriptive and do not compare insulin infusion with another group, since the registry describes a single-group study.

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

The record establishes that this was a completed, single-group study of insulin infusion in the emergency-department setting, with time to achieve glycemic control named as the primary outcome. It also gives a measurement schedule and reports adverse-event counts. These details describe the study’s intended focus and some registry entries.

The record does not report the numerical primary outcome, its standard deviation, or an inferential result. It therefore does not show how long participants took to reach the target, how variable those times were, or how precise an estimate might be. The target range itself is not reported, further limiting interpretation of what counted as achieving control.

The single-group design does not provide a concurrent control comparison. Even if a group-level outcome estimate were available, this design would not by itself establish how outcomes would have differed under another care strategy. The registry record also does not report enough information to assess participant-level variation, missing measurements, or the analysis population.

The adverse-event entries list zero affected for serious and other adverse events among the listed at-risk group, while the deaths field is not reported. These are registry entries, not a comparative safety analysis, and they do not establish the absence of risk.

Overall, the posted record supports a description of the research question, design, endpoint, and reported safety counts. It does not support a conclusion about the magnitude or precision of the time-to-control outcome, or a causal comparison of insulin infusion with another approach. Those distinctions are important when separating a study’s stated aim from results that are actually reported.

14. Why This Trial Matters Statistically

This study is statistically notable for posing an implementation question in an emergency-department setting while using a single-group design. The registry summary describes the intended population as a heterogeneous group of acutely ill patients. A single-group design can document what was observed during a protocol, but it cannot supply a concurrent estimate of what would have happened under another approach.

The endpoint also illustrates why outcome definitions matter. Time to achieve glycemic control depends on the definition of the target range, the timing origin, and how measurements are used to assign the time. The registry reports a schedule of checks but not the target range or the method for assigning the endpoint time. Readers therefore cannot fully evaluate the operational meaning of the measure.

Reporting the mean and standard deviation as the planned summary would give information about average time and dispersion if the results were posted. In this record, those numerical results are absent. The distinction between a defined endpoint and a reported endpoint is central: a measure can be specified without the evidence needed to assess its observed value or precision.

The registry’s planning assumptions also illustrate the difference between design planning and trial findings. Assumptions for a hypothetical two-arm planning illustration do not describe the allocation of this single-group study, and a planning calculation is not evidence of observed power. With no reported primary result or analysis, the record is most useful for understanding the question and design rather than drawing a statistical conclusion about outcomes.

15. 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 registry record does not report the numerical result for the primary endpoint. It specifies a mean and standard deviation but gives neither value, and it reports no inferential result. The endpoint’s target blood glucose range is also not stated, making it difficult to determine precisely what qualified as glycemic control.

The single-group design has no like-for-like control comparison. It can describe outcomes in the insulin-infusion group but cannot provide a direct estimate of a difference from another treatment or care strategy. The record also describes the intended population as heterogeneous without reporting participant characteristics or eligibility criteria, so the applicability of any result to specific groups cannot be assessed from the registry information.

Details needed to evaluate the endpoint are not reported, including the timing origin, how a time was assigned from scheduled measurements, and how observations that did not reach the target during the study duration were handled. The analysis population, missing-data approach, and completeness of outcome follow-up are also not reported.

The registry lists no analyses and does not report a statistical plan, sample-size justification, or interim analyses. Its adverse-event entries do not include detailed event definitions or follow-up information, and the deaths field is not reported. These limitations mean the posted information supports a description of the design and registry counts, but not a complete assessment of outcome precision, analytic choices, or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation — NCT00779701.
• Registry record last updated 2017-03-16; status last verified 2017-02.
• Results first posted 2015-06-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT00779701 is a completed Phase 4, single-group study sponsored by Temple University. The registry lists enrollment of 27, allocation as not applicable, and no masking. All subjects were placed on insulin infusion. The study began in 2007-03 and reached primary completion in 2009-10.

The primary outcome was mean time to achieve glycemic control in minutes, with standard deviation specified as the dispersion measure. Blood glucose checks were scheduled at 30 minutes, then every 15 minutes until the target range was reached, and then every hour during the six-hour study duration. The target range and numerical outcome result are not reported in the registry record.

The adverse-event record lists 0 affected by serious adverse events and 0 affected by other adverse events, with 27 at risk in each category. The deaths field is not reported. The registry lists zero analyses, and statistical methods and missing-data handling are not reported.