Risk Identification of the GlucoTab System in Routine Use: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Risk Identification of the GlucoTab System in Routine Use (NCT02053077), a registered phase not stated study. The primary outcome is Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week.

2. Clinical Question

The clinical question is therefore descriptive in scope: what glucose measurements and safety events were recorded while the GlucoTab system was used in the stated ward setting? The record does not establish a randomized treatment contrast. Without a clearly described comparator and allocation procedure, any differences between groups, if groups were used, could reflect differences in participants, care, or measurement rather than an effect attributable to the system.

The title and official title frame the setting as glycaemic management for non-critically ill patients with type 2 diabetes on general wards. The registry lists Diabetes Mellitus as the condition; it does not provide detailed eligibility criteria or a fuller account of the enrolled population. The answer to the primary question cannot be quantified from the posted outcome information because the primary endpoint result is not reported in the registry record.

3. Trial Design

This was a completed study sponsored by the Medical University of Graz. Its title describes risk identification of the GlucoTab system in routine use, and its official title specifies glycaemic management in non-critically ill patients with type 2 diabetes on general wards. The registry records enrollment of 150 participants, a start in 2014-02, and primary completion in 2016-06.

The record does not describe a randomized comparison. Allocation is not stated, and it cautions that arms are not a like-for-like control comparison. A comparator and the basis for any division into groups are not reported in the registry record. Consequently, the study should not be read as a randomized trial establishing a causal contrast between GlucoTab and another care strategy.

The primary outcome was mean daily blood glucose during hospital stay, with the expected stay described as an average of 1 week. The record also lists secondary outcomes concerning blood glucose during the hospital stay and coverage of the GlucoTab system. It lists 3 outcome measures in total, but does not report their measured results in the posted record.

Although the status is COMPLETED, that status does not itself establish that outcome data or statistical results were posted. The registry lists 0 analyses. Details of the statistical analysis plan, including planned estimands, adjustment variables, handling of repeated measurements, and inferential procedures, are not reported in the registry record.

The description of routine use is relevant to the intended context, but the record does not give implementation details sufficient to characterize the exact care process. Recruitment procedures, eligibility criteria, follow-up completeness, and analysis populations are not reported in the registry record. These omissions limit assessment of representativeness and of how the observed measurements, if available, would relate to routine ward practice.

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 Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week, measured over participants will be followed for the duration of hospital stay, an expected average of 1 week.

The primary endpoint is the mean daily blood glucose during the hospital stay. It is a continuous measure, reported in mg/dl, with the parameter specified as a mean and the dispersion specified as a standard deviation. Follow-up is described as the duration of the hospital stay, expected to average 1 week. The endpoint description likewise refers to mean daily blood glucose during that stay.

A mean can describe the central level of repeated glucose measurements over a defined period. The standard deviation describes how spread out measurements are around that mean; it does not express the precision of the estimated mean. These are general statistical interpretations of the measures named in the record. The registry does not explain the exact calculation of a participant’s daily value, how multiple measurements were combined, or whether the reported mean was intended to be calculated at the participant or group level.

Such an outcome can be used to describe glucose levels during inpatient care. It does not, by itself, establish comparative benefit or harm. Interpretation of a mean depends on the population, measurement schedule, duration of observation, and handling of missing measurements. Those details, as well as the primary endpoint result, are not reported in the registry record. Therefore, the endpoint’s value and variability cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical details that can be interpreted from the registry are limited. The primary measure is continuous, and its parameter is a mean with standard deviation as the stated measure of dispersion. The registry lists 0 analyses and does not report the primary outcome result. The explanations below describe general statistical concepts relevant to this kind of outcome; they are not claims about procedures used in this study.

What does a mean describe?

In general, a mean summarizes the central level of a set of numeric observations. For glucose measured during a hospital stay, the meaning of the mean depends on how observations were collected and combined. A mean across all measurements can give greater influence to participants with more recorded measurements. A mean of participant-level averages gives each participant a different role in the summary. The registry record does not specify which approach was used, how daily measurements were formed, or how observations across the hospital stay were summarized.

The outcome description says mean daily blood glucose during hospital stay and names the unit mg/dl. That description sets out the intended quantity, but does not resolve the calculation details. For example, the measurement schedule and rules for handling measurements taken at different times are not reported in the registry record. Those details matter because a summary can depend on which observations contribute and how they are weighted.

What does standard deviation describe?

In general, standard deviation describes the spread of observations around their mean. A large spread indicates more variability among the measured values; a smaller spread indicates that the values are more tightly clustered. Standard deviation is not the same as uncertainty about the mean. Uncertainty in an estimated mean is commonly expressed with a standard error or a confidence interval, but neither is reported in the registry record for this endpoint.

A confidence interval is a statistical range intended to convey the precision of an estimate under a specified method and assumptions. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. No interval for the primary outcome is reported in the registry record, so the estimate’s precision cannot be judged. The record also does not report a hypothesis test or a p-value for the primary outcome.

Why does the comparison structure matter?

General statistical interpretation of a treatment contrast requires knowing what groups are being compared and how participants entered them. Random assignment can help make groups comparable in expectation, while a non-randomized comparison can be affected by differences in participant characteristics, care, or observation. The registry states that allocation is not stated and that arms are not a like-for-like control comparison. It therefore does not support interpreting an unspecified group contrast as a randomized estimate of a causal effect.

Adjustment can sometimes account for measured differences between groups, but it cannot automatically address unmeasured differences. The variables to adjust for, the model, and any adjusted estimates are not reported in the registry record. A specific statistical plan or method should not be inferred from the outcome’s continuous scale alone.

How should repeated measurements be considered?

In general, glucose values collected repeatedly from the same participant are related observations rather than independent observations. Methods that account for this within-participant relationship can be important when estimating group-level patterns or comparing groups. If repeated measurements are treated as independent when they are correlated, uncertainty can be understated. The registry record does not describe the measurement schedule, whether repeated observations were analyzed, or what model, if any, accounted for within-participant correlation.

The record names an expected average hospital stay of 1 week, but individual follow-up durations can differ in hospital-based data. In general, different observation durations can lead to different numbers of measurements per participant. The registry does not report how unequal observation time was addressed, whether the endpoint was calculated for each participant before summarization, or whether any participants had insufficient measurements for an endpoint value.

What do the adverse-event counts establish?

In general, an adverse-event count describes events or affected participants as defined and collected in a study. The registry’s wording distinguishes participants affected from those at risk, and lists 1 serious adverse event affected participant and 3 participants affected by other adverse events in the intervention group, each among 150 at risk. The record does not explain event definitions, attribution, collection procedures, or whether the counts refer to unique participants across event categories. A count alone does not establish causation or permit a reliable comparison without a suitable comparator and aligned observation.

Can the listed design support a causal conclusion?

General causal interpretation is strongest when a comparison is designed to make groups comparable and the analysis follows a clearly stated plan. Here, allocation is not stated and the record warns that arms are not a like-for-like control comparison. The statistical analyses are not listed. Consequently, readers cannot evaluate whether the analysis accounted for potential confounding, repeated measures, missing observations, or other design features. The record supports describing the study’s aim and listed outcomes, but the posted information does not support a quantified causal conclusion.

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("Intervention")
n   <- c(150)
m   <- c(159)
sp  <- c(32)
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  Intervention  150  159.000  32.000  153.837  164.163

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures, including the primary measure of mean daily blood glucose during the hospital stay and secondary outcomes concerning blood glucose during the stay and coverage of the GlucoTab system. It does not report the statistical analyses or a plan for prioritizing, testing, or interpreting multiple outcomes. Any multiplicity adjustment, outcome hierarchy, or prespecified decision rule is not reported in the registry record.

In general, evaluating several outcomes or performing several tests can increase the chance of finding an apparently notable result by chance. A prespecified analysis plan can clarify which outcomes are primary and how secondary findings should be interpreted. The registry identifies a primary outcome but does not provide results or details of a multiplicity strategy. No claim about whether adjustment was used is justified from the record.

Missing-data handling is also not reported in the registry record. The record does not describe how missing glucose measurements, incomplete hospital stays, withdrawals, or missing safety follow-up were handled. It does not state whether any imputation, complete-case approach, or sensitivity analysis was used. These are general analysis choices that can affect the interpretation of an endpoint, particularly when repeated measurements or different follow-up durations are involved.

Analysis populations are not described. The registry does not state whether analyses included all enrolled participants, only participants with usable measurements, or another defined group. Although enrollment is listed as 150, that does not establish how many participants contributed to each outcome analysis. No analysis denominators for the primary outcome are reported in the registry record.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia and cardiac decompensation requiring treatment in intensive care unit (0.7%).

The registry lists the intervention group with 150 participants at risk for serious adverse events and 1 serious adverse event affected participant. For other adverse events, it lists 150 participants at risk and 3 affected participants. The most frequent serious event term listed is Pneumonia and cardiac decompensation requiring treatment in intensive care unit, with 0.7%. The registry does not report deaths.

These are descriptive registry counts, not a comparison of event rates between randomized groups. Allocation is not stated, and the record cautions that arms are not a like-for-like control comparison. It also does not report the event collection method, the period over which each participant was observed for safety, or whether events were judged related to the system. The number of affected participants should not be interpreted as proof that an event was caused by, or unrelated to, GlucoTab.

The record does not clarify whether participants could contribute to both serious and other adverse-event categories, or how multiple events in one participant were handled. Its serious-event term and percentage should therefore be read as the registry’s listed summary rather than as a complete account of event patterns. Without comparable groups and fuller ascertainment details, these counts cannot establish a comparative safety effect.

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

The record describes a completed study intended to identify risks during routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes on general wards. It identifies mean daily blood glucose during the hospital stay as the primary outcome and lists adverse-event information for an intervention group. These registry entries clarify the study’s focus and setting.

The posted record does not report the primary glucose mean or standard deviation, any primary-outcome comparison, or a confidence interval. It also lists 0 analyses. Therefore, the record does not permit a quantitative judgment about the glucose measurements or the precision of an estimated mean. It does not establish whether glucose values differed from another care approach, since a comparator and like-for-like comparison are not described.

The adverse-event counts provide limited descriptive information: 1 serious adverse event affected participant and 3 participants affected by other adverse events, each among 150 at risk in the intervention group. The listed serious-event term and 0.7% give additional registry detail, but neither establishes causation. The record does not report deaths. These data should not be interpreted as proof of safety or harm, especially without a comparator, complete event definitions, and a clear account of follow-up.

In general, a study’s completion status and enrollment do not substitute for reported outcome analyses. The results needed to assess the primary endpoint, missing data, and analysis populations are not reported in the registry record. The appropriate reading is therefore limited: the registry documents the study’s purpose, setting, intended outcome, and certain adverse-event counts, but leaves the principal statistical results unavailable. It does not support a conclusion that the system did or did not improve glucose outcomes or cause or prevent adverse events.

14. Why This Trial Matters Statistically

This study is statistically relevant because it frames a real-world implementation question rather than a clearly randomized treatment comparison. Its stated focus is risk identification during routine use of a glucose-management system on general wards. Such a setting raises practical questions about what is measured, how consistently it is measured, and how outcomes are summarized across participants with hospital stays of potentially different duration.

The primary outcome is a continuous glucose measure summarized as a mean, with standard deviation named for dispersion. That pairing illustrates an important distinction: describing the center and spread of measurements is not the same as quantifying the precision of an estimate. A confidence interval or another inferential result would be needed to assess precision, but none is reported in the registry record.

The record also illustrates why design details matter for interpretation. Allocation is not stated, and the record cautions that arms are not a like-for-like control comparison. Without a suitable comparator and analysis details, even a numerical difference would not necessarily identify an effect attributable to the system. The registry lists 0 analyses, so the posted record does not offer the results needed to evaluate the primary outcome statistically.

Finally, the safety information emphasizes the distinction between event reporting and causal inference. Counts can document that events were recorded, but attribution and comparative risk require context about definitions, follow-up, and a valid comparison. Those details are not reported in the registry record. The study’s stated risk-identification purpose makes clear why safety surveillance is relevant, while the limitations of the posted information show why descriptive counts alone have a narrow interpretation.

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 outcome result is not reported in the registry record. Without the mean and standard deviation, readers cannot assess the observed glucose level or its variability. The record lists 0 analyses and does not report an estimate of effect, confidence interval, or p-value. Statistical precision and the strength of any outcome pattern therefore cannot be evaluated from the posted information.

The comparison structure is a further limitation. Allocation is not stated, and the record says the arms are not a like-for-like control comparison. A comparator is not reported in the registry record. Thus, the study description does not support treating any group contrast as randomized or as a clean estimate of a causal effect.

Several details needed to assess the outcome are absent. The registry does not describe the measurement schedule, the calculation of participant-level daily glucose, or how observations across the hospital stay were combined. It does not report missing-data methods, analysis populations, eligibility criteria, participant characteristics, or the completeness of follow-up. It also does not describe statistical models or adjustment for repeated observations.

The safety summary is limited to listed counts and a serious-event term. Event definitions, attribution, ascertainment procedures, and individual follow-up duration are not reported in the registry record. The absence of a reported death count is also not evidence that no deaths occurred; the registry does not report deaths.

Finally, the study’s routine-use setting does not by itself establish how broadly the findings apply. The record lacks detailed information about implementation, care processes, and the enrolled population. Combined with the absence of primary outcome results, these omissions constrain both statistical interpretation and assessment of generalizability.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Risk Identification of the GlucoTab System in Routine Use — NCT02053077.
• Registry record last updated 2023-05-12; status last verified 2023-05.
• Results first posted 2021-02-08.
• 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

The registry record describes a completed study of risk identification for the GlucoTab system in routine use for glycaemic management among non-critically ill patients with type 2 diabetes on general wards. The sponsor is the Medical University of Graz. The study started in 2014-02, reached primary completion in 2016-06, and lists enrollment of 150 participants.

The primary outcome is mean daily blood glucose during the hospital stay, in mg/dl, with standard deviation specified as the measure of dispersion and an expected average hospital stay of 1 week. The registry lists 3 outcome measures and 0 analyses. The primary outcome result is not reported in the registry record.

The intervention group listing records 1 serious adverse event affected participant and 3 participants affected by other adverse events, each among 150 at risk. The most frequent serious event term is listed as Pneumonia and cardiac decompensation requiring treatment in intensive care unit, with 0.7%. The record does not report deaths. Allocation is not stated, and the registry cautions that arms are not a like-for-like control comparison.