The Breakfast Rise, Education and Knowledge Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Breakfast Rise, Education and Knowledge Study (NCT05698875), a na na study. The primary outcome is Mean Glucose (mmol/l).

2. Clinical Question

3. Trial Design

The BREAK Study is listed as a completed, single-group study sponsored by the University of Stirling. Its registry enrollment is 48. The brief summary says the study proposes to recruit 90 children and young people; the registry record does not explain the difference between that proposed recruitment figure and the recorded enrollment. The study start is listed as 2023-02-14 and primary completion as 2023-12-31.

The intervention is listed as breakfast meals. Participants were to receive three test meals and a usual-breakfast control meal in an individual randomized order using Latin square randomization, according to the study summary. The meal descriptions identify high glycaemic load, high glycaemic load with 10g added protein, and medium glycaemic load conditions. The arm description states that there was no washout period. The registry allocation field is listed as NA, and masking is listed as NONE. Thus, the registry describes randomized meal order within a single-group study, not a conventional comparison of separately allocated parallel groups.

Dietitians were asked to provide baseline demographic and clinical information, treatment details, and anthropometric information. The summary also says dietitians were asked to optimize insulin doses before the test meals. Participants were asked to provide access to Dexcom CGM data and to complete a questionnaire for each test and control meal period. Questionnaire topics included diabetes management, food and fluid intake, and activities during the postprandial period.

The registry describes statistical analysis using univariate, bivariate, and multivariate analysis, but further details of the analysis plan are not reported in the registry record. The listed secondary outcomes include glucose excursion, peak excursion, time to peak, area under the glucose curve, coefficient of variation, and measures of time in glucose ranges. The record lists 15 outcome measures and 90 analyses, without giving the full analysis specifications in the information.

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.

Before assignment: Following recruitment participants were allocated to a randomised sequence for testing the meals. Randomisation was in a block of four. Of the participants who tested the meals this resulted in 18 different sequences of meal order.

Overall Study

Analysis population for the primary outcome, as defined in the registry: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

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 Mean Glucose (mmol/l), measured over three-hour postprandial breakfast period.

The primary endpoint is mean glucose in mmol/l over the three-hour postprandial breakfast period. The registry defines it as the mean of CGM readings recorded every 5 minutes during that period. It is a continuous measure: each participant’s glucose readings contribute to a numerical average rather than to a category such as an event occurring or not occurring.

As a general statistical matter, a mean can describe the central level of a continuous measurement over a defined observation window. Here, the postprandial window anchors the measurement to the period after breakfast, allowing the study to describe glucose patterns associated with each meal condition. The standard deviation is the stated measure of dispersion. It describes how spread out the observed measurements are around their mean, rather than the precision of the estimated mean itself.

The primary-outcome population description says CGM data were available for 25 participants who consumed test and control meals on two occasions, while also noting incomplete meal testing and repetition. It gives meal-level counts for Test Meal 1, Test Meal 2, and Test Meal 3, but the final part of the population description is truncated. The registry record does not report the primary endpoint means or standard deviations, nor does it report an estimated contrast between test meals and the usual breakfast. The results therefore cannot be interpreted for the size or precision of meal-related differences.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome: mean glucose in mmol/l over the three-hour postprandial breakfast period. CGM readings were taken every 5 minutes. A mean condenses the readings during an observation window into a measure of central level. The stated standard deviation describes the spread of values around that mean. It is not itself a confidence interval and does not directly show how precisely a group or condition mean has been estimated.

What does a comparison of means represent?

In general, a comparison of means expresses the difference in average outcome between conditions. For a within-participant meal study, a natural comparison may use observations from the same participants under different conditions. That approach can account for stable characteristics shared by a participant’s observations. However, the registry information does not specify the exact estimator, model, or whether the reported analyses used paired observations. The record’s reference to univariate, bivariate, and multivariate analysis does not identify which methods were used for the primary comparison.

In general, a confidence interval gives a range of values compatible with the data under a specified statistical model and method. It communicates the uncertainty around an estimate, complementing the point estimate itself. A narrow interval indicates more precise estimation than a wide interval, while the interpretation still depends on the design and assumptions. The primary outcome’s confidence interval is not reported in the registry record. Nor are the primary means, standard deviations, or a contrast between meal conditions reported.

Why does the study structure matter?

The study is listed as a single-group study, and the arm description says all participants received the breakfast conditions in an individual randomized order. This is different from assigning separate groups to different breakfasts. In a repeated-condition design, observations from the same participant are related rather than independent. As a general statistical principle, an analysis should account for that relationship when estimating uncertainty. The registry does not report whether a repeated-measures method, a mixed model, or another approach was used.

Randomized meal order can help prevent a systematic ordering of conditions from being inseparable from the meal comparison. The summary specifically describes Latin square randomization. The arm description also states there was no washout period. In general, a washout period is intended to reduce carryover from an earlier condition before a later condition is assessed. Whether carryover was plausible for these meal periods, and whether order or carryover was included in the analysis, is not reported in the registry record.

What is over-dispersion, and why might it matter?

General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It is especially relevant to outcomes modeled as counts or event rates, where a simple model may assume a particular relationship between the mean and variance. The primary endpoint in this study is a continuous mean glucose measure, not a count outcome. The registry does not report an over-dispersion assessment or a model that would make it relevant to the primary endpoint.

The listed secondary outcomes include several summaries of glucose patterns, such as mean glucose excursion, mean peak glucose excursion, mean time to peak, area under the glucose curve, percentage coefficient of variation, and time in glucose ranges. These outcomes describe different features of postprandial glucose data. The registry lists 15 outcome measures and 90 analyses, but the full mapping of measures to analyses and the corresponding statistical methods are not reported in the registry record. Their results are also not reported in the information available for this analysis.

What do the sample-size assumptions mean?

The registry describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. This is a planning framework, not evidence about the precision of the completed study. The registry record does not report a sample-size justification for the study’s own design. It also does not report the calculated sample-size values or the observed primary effect needed to interpret such an illustration. Sample-size planning values, where reported, describe hypothetical planning scenarios and are not observed power.

Because the registry record does not report the primary effect estimate or inferential results, the statistical methods can be described only at the level of the outcome definition and broad analysis labels. The exact model, covariates, treatment of repeated readings, handling of missing observations, and uncertainty estimates are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures and 90 analyses. It identifies a primary outcome, mean glucose over the three-hour postprandial breakfast period, and lists multiple secondary glucose measures. Conducting many analyses can increase the chance of finding an apparently notable result by chance if each analysis is interpreted independently. General approaches to this issue include defining a hierarchy of outcomes, adjusting significance thresholds, or treating secondary analyses as exploratory. Which approach, if any, was used is not reported in the registry record.

The information available does not state whether the 90 analyses were planned in advance, how they were grouped across outcomes and meal conditions, or whether multiplicity adjustments were applied. It also does not report a statistical analysis plan with decision rules for interpreting multiple comparisons. Therefore, the registry description does not support an assessment of how the study controlled or interpreted multiplicity.

Incomplete meal testing and repetition are explicitly noted. The primary-outcome description refers to CGM data for 25 participants who consumed test and control meals on two occasions, then gives meal-specific counts and says not all participants tested all meals or repeated meals. This indicates that observations were not complete across all planned meal conditions and repetitions. The registry record does not report why observations were missing, how missing CGM readings or meal periods were handled, or whether any imputation or sensitivity analyses were used.

The full definition of the primary analysis population is not available in the registry description, which is truncated after the meal-specific information. It is not reported whether analyses used all available observations, a defined subset, or another analysis population. These omissions limit assessment of how missingness and analysis-population choices could affect comparisons.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry reports safety information for the Breakfast Meals group. It lists 26 participants at risk for serious adverse events and 0 serious adverse events. For other adverse events, it also lists 26 at risk and 0 events. Deaths are listed as 0, and no top serious adverse event terms are listed.

These figures describe what was entered in the registry for the stated group and categories. They are not a comparison between separate treatment arms, since the study is listed as single-group. The registry record does not provide further detail about the event-collection procedures, the period covered by the safety reporting, or whether all events were actively solicited. It also does not give a narrative explanation of the recorded counts.

A count of zero in the registry indicates that no events were reported in that category for the group as recorded; it does not establish that an event could not occur or that the study can rule out uncommon harms. The safety figures should be read alongside the limited size of the reported group and the registry’s lack of additional safety detail. They do not determine the interpretation of the primary glucose outcome.

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

The registry record establishes what the study set out to measure: mean CGM glucose over the three-hour period after breakfast, comparing test breakfasts with a usual-breakfast condition. It also describes randomized meal order, the use of Dexcom CGM, questionnaires, and several secondary measures of glucose patterns. These design details help define the intended research question.

The registry information does not include the primary endpoint results. Without reported means, variability, comparison estimates, or confidence intervals, the observed direction and magnitude of any differences are unknown. The record therefore cannot establish whether mean glucose differed across meal conditions, how precise an estimate would be, or whether an observed difference would be statistically distinguishable from chance variation.

The record also does not support a conclusion that there was no difference. A missing result is not a finding of equivalence. Establishing equivalence or non-inferiority generally requires a prespecified margin and an analysis designed to assess it; neither is reported in the registry record. No medical advice or treatment conclusion follows from the design description alone.

The study’s single-group structure and within-participant meal sequence mean that any results would need to be interpreted in light of repeated observations, meal order, the absence of a washout period, and incomplete testing or repetition. The registry does not report how these issues were handled analytically. The recorded safety counts provide limited descriptive information but do not quantify the possibility of unreported or uncommon events.

In short, the posted information describes the study’s aims, measurements, and some participation counts, but it does not provide the statistical results necessary to interpret the primary comparison. The registry record should not be read as evidence for or against a particular breakfast’s effect on glucose.

13. Why This Trial Matters Statistically

This study raises a useful statistical question about measuring a short-term response under different meal conditions in the same population. CGM provides repeated readings during a defined postprandial period, while the primary outcome reduces those readings to a mean. The study also lists measures that characterize other aspects of the glucose profile, including excursions, timing, variability, and time in ranges. These outcomes illustrate that a single summary may not capture every feature of a response.

The randomized order of meals is relevant because the order in which conditions are experienced can be entangled with condition effects. At the same time, a single-group, repeated-condition design creates statistical dependence: observations from one participant are related. Analysis methods need to reflect that structure if they are to estimate uncertainty appropriately. The registry does not report the specific methods used, making the design a useful example of why clear analysis reporting matters.

Incomplete testing and repetition also make the analysis population important. The registry notes that not all participants tested all meals or repeated them, and gives meal-level counts for some conditions. Transparent reporting of which observations contributed to each estimate, how missing observations were handled, and how repeated measurements were modeled would help readers assess the reliability and scope of any comparison.

Finally, a registry may describe an outcome and planned analyses without displaying the outcome estimates needed for interpretation. Distinguishing a defined research question from reported evidence is essential. In this record, the design and measurement information is available, but the primary results and their uncertainty are not reported in the registry record.

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.

Several limitations are specific to interpreting the registry description. The primary outcome results are not reported in the registry record: means, standard deviations, contrasts, confidence intervals, and p-values are absent. Consequently, the effect’s direction, magnitude, and precision cannot be evaluated. This is a limitation of the available record, not evidence about the underlying observations.

The registry gives a proposed recruitment figure of 90 in the study summary and an enrollment of 48 in the record. The reason for that difference is not reported in the registry record. The primary-outcome description refers to CGM data for 25 participants who consumed test and control meals on two occasions, and it lists different meal-level counts. It also states that not all participants tested all meals or repeated meals. The final meal-specific participant detail is truncated, and the full analysis-population definition is not reported.

The arm description states there was no washout period. The record does not explain the rationale for that choice or report whether carryover was considered. It also does not report how meal order was represented in the analysis or how the dependence among repeated observations was addressed. Although the summary names univariate, bivariate, and multivariate analysis, it does not specify the models or their assumptions.

The registry lists many outcome measures and analyses, but does not report the multiplicity strategy, missing-data method, or detailed statistical analysis plan. The safety figures are limited to the recorded counts and do not include further information on event ascertainment or reporting periods. These gaps restrict assessment of both the results and the methods used to produce them.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Breakfast Rise, Education and Knowledge Study — NCT05698875.
• Registry record last updated 2025-03-11; status last verified 2025-01.
• Results first posted 2025-03-11.
• 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.

18. Record Summary

The Breakfast Rise, Education and Knowledge Study is listed as completed and sponsored by the University of Stirling. It is a single-group study of breakfast meals among children and young people with type 1 diabetes. Participants were to consume three test breakfasts and a usual-breakfast control in randomized order, with CGM used to measure glucose responses. The registry lists enrollment of 48, while the study summary describes a proposal to recruit 90.

The primary outcome is mean glucose in mmol/l over the three-hour postprandial breakfast period, based on CGM readings taken every 5 minutes. The registry describes incomplete meal testing and repetition and gives some meal-specific observation counts. It does not report the primary outcome estimates or their uncertainty. The record also does not specify the detailed analysis methods, missing-data approach, or multiplicity strategy. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in the Breakfast Meals group.