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 Two Bag System for Hydration in Diabetes (NCT01631929), a randomized na study. The primary outcome is Time to Achieve Patient Stabilization.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01631929 |
| Phase | NA |
| Condition | Diabetes, Ketoacidosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Hospital General de Niños Pedro de Elizalde |
| Results posted | Yes |
2. Clinical Question
Population
Children with diabetic ketoacidosis receiving initial treatment. The registry describes the condition and the pediatric population, but the participants’ ages, eligibility criteria, and other baseline characteristics are not reported in the registry record.
Intervention
The two-bag system used two solutions with the same electrolyte content and different dextrose concentrations, 0% and 10%, administered simultaneously through the same intravenous line.
Comparator
The one-bag system delivered fluids, electrolytes, and dextrose using one bag. The registry describes this as the classic system, in which a change in glucose administration requires a bag change.
Primary question
How much time was needed to reach patient stabilization with each system? Stabilization required plasmatic glucose < 250 mg/dl, blood pH > 7.3, and plasmatic bicarbonate > 15 mmol/L.
The clinical question concerns the time required to reach a combined biochemical target during treatment of diabetic ketoacidosis. The registry’s description links the systems to the practical task of adjusting intravenous glucose administration in response to hourly glucose measurements. With one bag, a change in the administered glucose concentration requires a bag change. With two bags, the two solutions can be delivered together through the same line, allowing the glucose concentration to be adjusted by changing their delivery.
The trial’s primary outcome captures the time to a defined stabilization state, rather than a single laboratory value or a broader measure of recovery. Its answer, as recorded, is a mean for each group. The registry record does not post a direct estimate of the between-group difference, a confidence interval for that difference, or a statistical test comparing the systems. The reported group means therefore describe the observed times in the two arms but do not by themselves establish how precisely the systems differ.
3. Trial Design
This was a randomized, parallel-group trial comparing the one-bag system with the two-bag system. The record lists no masking. It reports enrollment of 12 participants, with 6 in the One Bag arm and 6 in the Two Bags arm. The trial status is terminated. The reason for termination is not reported in the registry record.
The registered start was 2012-08, and primary completion was 2014-05. The phase is listed as NA. The sponsor was Hospital General de Niños Pedro de Elizalde. These registry entries describe the administrative and structural features of the study; they do not establish why recruitment stopped or whether any particular feature affected the results.
The brief description places the comparison in the initial treatment of children with diabetic ketoacidosis. It describes fast infusion of isotonic saline solution at 20 ml/kg to prevent shock, followed by maintenance fluids and insulin therapy. The planned comparison concerns the time needed to reach the study’s stabilization criteria while using either fluid-delivery system. The detailed protocol, including the timing and conduct of randomization, is not reported in the registry record.
A parallel design assigns participants to one system or the other, with each participant contributing to the group to which they were assigned. The registry labels the trial randomized, but does not report the sequence-generation method, allocation concealment, or whether assignment was stratified. Those details matter for judging how randomization was implemented, but cannot be inferred from the label alone. The record also does not report participant flow, withdrawals, adherence to assigned systems, or the number completing outcome assessment. The 12 enrolled participants and the 6 participants shown in each outcome arm describe the registered results; further details about analysis populations 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 | One Bag | Two Bags |
|---|---|---|
| STARTED | 6 | 6 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 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 | One Bag | Two Bags | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 6 | 12 | |
| Age, Categorical: <=18 years | Participants | 6 | 6 | 12 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 8.83 (SD 1.7) | 9.67 (SD 2.7) | 9.2 (SD 3.4) |
| Gender: Female | Participants | 5 | 5 | 10 |
| Gender: Male | Participants | 1 | 1 | 2 |
| Disease debuted: Yes | participants | 4 | 2 | 6 |
| Disease debuted: Not | participants | 2 | 4 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Achieve Patient Stabilization, measured over Participants were followed for the duration of ketoacidosis (an expected average of 12 hours).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Hours |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is time to achieve patient stabilization, measured in hours. Stabilization was defined by meeting all three stated criteria: plasmatic glucose < 250 mg/dl, blood pH > 7.3, and plasmatic bicarbonate > 15 mmol/L. The endpoint therefore represents the time until the specified combination of biochemical thresholds is reached, rather than the time until any one threshold is met.
A time-based endpoint is relevant to the registry’s clinical question because the trial compares approaches to delivering fluids and adjusting dextrose during treatment. Measuring time to a defined target can describe the pace at which participants reached that target under each system. It also gives a concrete outcome for a comparison whose stated rationale involves making glucose infusion adjustments in less time. The registry describes follow-up as lasting for the duration of ketoacidosis, with an expected average of 12 hours. That is an expected duration, not a report that every participant was followed for that length of time.
The endpoint uses a combined definition, so reaching one threshold alone would not meet the stated stabilization criteria. The record does not explain how measurements were scheduled for pH or bicarbonate, how the event time was assigned when laboratory measurements were intermittent, or how a participant who did not reach all criteria was handled. Those operational details are not reported in the registry record. The posted outcome is summarized as a mean, with a 95% confidence interval, for each treatment group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a mean time to stabilization of 13.3 hours in the One Bag arm, with a 95% confidence interval from 10.5 to 16.1 hours. In the Two Bags arm, the reported mean is 9.8 hours, with a 95% confidence interval from 8.64 to 10.96 hours. Each arm includes 6 participants. These figures describe the observed group summaries and their reported uncertainty; they are not a direct estimate of the difference between the systems.
The confidence intervals are given for each arm separately. They indicate uncertainty around the estimated mean for that group, under the statistical procedure used to construct the intervals. The registry record does not describe the interval-construction method. A reader should not substitute a visual comparison of two separate intervals for a formal comparison of the group means. No confidence interval for the treatment contrast, p-value, or other inferential comparison is reported in the registry record.
Numerically, the posted mean is lower for the Two Bags arm than for the One Bag arm. This is a descriptive statement about the means recorded for these small groups. The registry does not provide a sponsor-reported analysis of whether the observed group contrast is compatible with chance variation under a specified null hypothesis, nor does it report an adjusted or unadjusted effect estimate. Accordingly, the results do not establish the precision of the between-group contrast. No recalculated treatment comparison is reported in the registry record.
The small number of participants is important when reading these summaries. With 6 participants in each arm, each individual observation can have substantial influence on a group mean. The confidence intervals communicate uncertainty in the estimated means, but their interpretation depends on the analysis and assumptions used. The registry does not report individual times, a measure of within-group dispersion beyond the confidence intervals, or a description of the distribution of observed times. It is therefore not possible from the record to assess whether the means represent the typical participant’s experience or whether observations were particularly variable.
The trial is marked terminated, but the reason and the relationship, if any, between termination and the outcome data are not reported in the registry record. The reported means should consequently be read as the outcome information available in the record, not as a complete account of study conduct. The record contains one outcome measure and no secondary outcomes. It does not report a formal conclusion from the investigators. The appropriate statistical reading is descriptive: the recorded group means differ, while the precision and inferential meaning of that contrast are not established by a posted between-group analysis.
9. Statistical Methods Explained
The posted endpoint is continuous: time to stabilization is measured in hours, and the outcome is summarized using the mean. A mean is the arithmetic average of the observed values in a group. It gives a concise description of the group’s center, but it can be influenced by unusually short or long observations. When group sizes are small, a single participant’s value can have a noticeable effect on that average. The registry does not provide the individual observations or a separate measure of spread, so the shape and variability of the times cannot be assessed from the record.
What does a confidence interval describe?
A confidence interval expresses uncertainty around an estimated quantity. The posted 95% confidence intervals apply to the mean within each arm: 10.5 to 16.1 hours for One Bag, and 8.64 to 10.96 hours for Two Bags. In general statistical terms, a confidence interval is generated by a procedure that, under its assumptions, would cover the target quantity at the stated rate over repeated applications. It is not a range containing a specified proportion of individual participants’ times, and it is not a direct probability statement about the particular fixed mean after the data have been observed.
These are arm-specific intervals, not an interval for the difference between the arms. A treatment comparison ordinarily needs an estimate of the contrast and a measure of uncertainty around that contrast, or a suitable statistical test. Neither is posted in the registry record. The interval method and the assumptions used to calculate these arm-specific intervals are also not reported in the registry record. Thus, the intervals help describe uncertainty in the group means, but cannot alone answer how precisely the two systems differ.
Why does the analysis scale matter?
Time is a continuous outcome, and reporting a mean treats the numerical distance between times as meaningful. This fits the registry’s stated outcome and summary measure. General statistical considerations still apply: if times are strongly skewed, the mean and methods that rely on symmetric uncertainty can be sensitive to the distribution. Some time outcomes may also be censored when participants do not reach the endpoint during observation. The registry does not say whether censoring occurred or how it would have been handled. It would be inappropriate to assume that a time-to-event analysis was used merely because the endpoint is expressed as time.
In general, confidence intervals for means may be affected by small sample sizes and by departures from the assumptions of the method used. This study has 6 participants in each arm, but the record does not describe the analysis method, distributional checks, or adjustments. It is therefore not possible to determine whether these considerations were addressed. The reported intervals should be read as registry results, without attributing a particular calculation method to them.
What comparison is available?
The record provides the group means and their confidence intervals, but does not post a direct treatment-effect estimate. A difference between group means would be a distinct statistic, and no such number is reported. No new contrast, standard error, or p-value should be inferred from the arm summaries. The record reports no analyses. The fact that the trial was randomized describes its design; it does not replace the need for an analysis of the randomized comparison.
When a trial reports no direct contrast, the descriptive group summaries can still be read as the observed results, but they do not quantify uncertainty in the contrast itself. Interpretation should also consider whether the analysis followed randomized assignment, how missing outcomes were handled, and which participants were included. Those details are not reported in the registry record. The available outcome counts correspond to 6 participants in each arm, but the registry does not state whether that represents all randomized participants or a particular analysis population.
How should planning illustrations be read?
General sample-size calculations are planning exercises: they estimate the number of participants needed under stated assumptions to detect a target effect with a chosen error rate and power. The registry’s planning assumptions describe an illustration based on the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation; the target effect is expressed as a stated fraction of the observed effect. Such an illustration is not the original trial’s sample-size justification unless the record explicitly says so. The original justification is not reported in the registry record.
Any planning illustration based on the observed effect is especially uncertain when the observed sample is small. The effect used for planning may itself be imprecisely estimated, so the resulting participant counts should not be interpreted as evidence that the trial had a particular probability of finding a result. They are not observed power. The record’s planning assumptions also do not establish which analysis was actually conducted. No specific planning counts are reported in the registry record.
What role does over-dispersion play?
General explanation: over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make standard errors too small and intervals too narrow if a model does not account for the extra variability. This concept is most often discussed for outcomes modeled as counts or proportions, whereas this trial’s primary outcome is a continuous time summarized by a mean. A related concern for a continuous outcome is whether the assumed distribution and variability model adequately describe the data. The registry does not report model checks or a method addressing unusual variability, so no claim can be made about how this was handled.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no secondary outcomes. With one registered outcome, there is no set of multiple posted endpoints whose results need to be interpreted together in the record. However, the registry does not report a multiplicity plan, including whether there were additional outcomes or analyses considered outside those posted. Whether any multiplicity adjustment was planned or used is not reported in the registry record.
The record does not report an analysis plan or the statistical methods used for the primary outcome. It gives arm-level means and confidence intervals, but no direct comparison analysis. The population used for the primary analysis is not specified. Although 12 participants were enrolled and 6 participants are listed in each outcome arm, the record does not explain whether all randomized participants were included, whether the analysis followed assignment, or whether any participants were excluded from the outcome summary.
Missing data handling is also not reported in the registry record. The entry does not state whether any stabilization times were unavailable, whether any participants failed to reach the criteria during follow-up, or how incomplete observations would affect the analysis. These omissions matter because the outcome is time to a defined event: a participant without a recorded event time could require a distinct handling rule. The expected average follow-up duration of 12 hours does not specify the observed follow-up for each participant or resolve how incomplete follow-up was treated.
The record also does not report interim analyses, stopping rules, or a protocol-based sample-size justification. The terminated status alone does not establish that the trial stopped for a particular reason or at a particular analysis point. These details are not reported in the registry record. In the absence of this information, the posted group summaries can be described, but the analysis population, missingness assumptions, and prespecified inferential strategy cannot 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 |
|---|---|---|---|
| One Bag | 0 | 6 | 0.0% |
| Two Bags | 0 | 6 | 0.0% |
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 |
|---|---|
| One Bag | 0 of 6 |
| Two Bags | 0 of 6 |
The registry lists 0 serious adverse events among 6 participants at risk in the One Bag arm and 0 among 6 participants at risk in the Two Bags arm. It also lists 0 other adverse events among 6 participants at risk in each arm. These are the recorded counts for the groups and categories shown in the registry record.
A zero count in a small group means that no event in that category was recorded for those listed participants; it does not establish that the risk is absent or that the systems have equivalent safety. The results do not provide enough information to estimate rare-event rates precisely. The registry record does not give event timing, definitions beyond the serious and other categories, surveillance procedures, or a comparison analysis of adverse events.
Deaths are listed as null for both groups. That is not the same as a recorded count of zero: death information is not reported in the registry record. The entry also lists no top serious adverse-event terms. This should be read as no terms listed, not as detailed evidence that every possible event was actively assessed and ruled out. Safety counts in this record are therefore descriptive, limited to the recorded categories, participant counts, and reporting available.
12. What the Result Does, and Does Not, Mean
The posted results show that the mean time to the defined stabilization endpoint was 13.3 hours in the One Bag arm and 9.8 hours in the Two Bags arm. The associated 95% confidence intervals are 10.5 to 16.1 hours and 8.64 to 10.96 hours, respectively. Each mean is based on 6 participants. These figures provide a descriptive account of the outcome among the participants represented in the registry results.
They do not, by themselves, establish the size or precision of a treatment effect. The registry does not report a direct between-group estimate, an interval for that estimate, or a statistical test. The fact that the two reported means are different does not answer whether the difference would persist across a larger group or under a formal comparison. The small arm sizes also mean that the group summaries may be sensitive to individual observations, whose values are not reported.
The endpoint has a specific biochemical definition, and the result concerns time to satisfy all stated thresholds. It does not describe every aspect of care, all possible clinical outcomes, or later outcomes beyond the recorded follow-up. The registry does not report a secondary outcome or additional measures of recovery. Nor does the result establish how the systems performed in settings or populations not represented by this small trial.
The two-bag description offers a practical rationale related to adjusting glucose delivery without changing a single bag. The recorded means address time to stabilization, not directly the time needed for a bag change, the frequency of adjustments, or staff workload. Those measures are not reported in the registry record. The trial status is terminated, and the reason is not reported. Consequently, the record supports a narrow descriptive reading of the posted primary outcome, while leaving important questions about the comparison, conduct, and generalizability unresolved.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it pairs a clinically concrete endpoint with very small groups and reports arm-level summaries without a direct treatment contrast. Readers can see the means and their confidence intervals, but still need to distinguish those summaries from evidence about the difference between randomized groups. That distinction is central to interpreting clinical trial results: the precision of each group mean is not the same as the precision of a comparison.
The endpoint also illustrates how outcome definitions shape interpretation. Stabilization requires three biochemical conditions, so the time recorded represents reaching a combined target. A report of time to that target does not automatically explain which component determined the timing, whether measurements were made at consistent intervals, or how the event time was assigned. Those details can affect how a time-based outcome is understood, yet they are not reported in the registry record.
The entry also highlights the value of transparency about analysis populations and missing data. The arm counts are shown, but the record does not say whether they correspond to everyone randomized or how participants without a recorded endpoint would be treated. For a time-to-event outcome, those choices can influence estimates. The record further lacks a posted comparison analysis and does not describe the original sample-size justification.
Finally, the terminated status makes clear why status information should not be treated as an explanation. The record establishes that the trial was terminated, but not why. A careful statistical reading separates what is recorded—design, group summaries, and event counts—from what remains unknown. That approach avoids overstating what a small randomized study’s descriptive results can establish.
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 principal limitation for interpretation is the small enrolled sample: 12 participants, with 6 listed in each arm. With so few observations, group means may be sensitive to individual times, and the available confidence intervals do not substitute for a direct interval around the between-group contrast. The registry record does not provide individual data or a dispersion measure that would allow the observed variation to be examined.
The record does not report the reason for termination, participant flow, withdrawals, adherence, or whether the outcome counts include every randomized participant. It also does not report baseline characteristics, detailed eligibility criteria, or the ages of the children. Without these details, it is difficult to assess the composition of the analyzed groups or how broadly the results might apply.
Key methodological information is absent: the randomization procedure, allocation concealment, outcome-assessment procedures, statistical analysis plan, analysis population, missing-data approach, and method used to calculate the confidence intervals are not reported in the registry record. The primary endpoint requires several laboratory thresholds, but the record does not specify measurement schedules or the rule for assigning event time. It also does not report a direct treatment comparison or a prespecified sample-size justification.
Safety reporting is limited to the listed counts. Death information is null, and event definitions, surveillance methods, and timing are not reported. The registry contains no secondary outcomes or posted analyses. These limitations do not erase the reported group summaries, but they restrict the conclusions that can be drawn about comparative precision, completeness, and wider relevance.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Two Bag System for Hydration in Diabetes — NCT01631929.
- Registry record last updated 2017-02-09; status last verified 2016-12.
- Results first posted 2015-10-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a randomized, unmasked, parallel-group comparison of one-bag and two-bag fluid systems during initial treatment of children with diabetic ketoacidosis. Enrollment was 12, with 6 participants in each arm. The trial is listed as terminated; the reason is not reported in the registry record.
The primary outcome was mean time to stabilization, defined using plasmatic glucose, blood pH, and plasmatic bicarbonate thresholds. The recorded means were 13.3 hours for One Bag and 9.8 hours for Two Bags, with arm-specific 95% confidence intervals. No direct between-group analysis, secondary outcome, or analysis method is reported. Serious and other adverse-event counts were 0 in each arm; death information is not reported in the registry record.