Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults (NCT05923827), a randomized na study. The primary outcome is Change in HbA1c (%).

2. Clinical Question

3. Trial Design

The registry describes a randomized, controlled, parallel-group trial with no masking. The study is marked completed, and its phase is listed as NA. The recorded enrollment is 189. The sponsor is Insulet Corporation. The start date is 2023-09-11, and the primary completion date is 2024-08-16.

The intervention group used the Omnipod 5 System with FreeStyle Libre 2. The control group used multiple daily injections of insulin with FreeStyle Libre 2. Because both groups are described as using the same continuous glucose monitor, the stated contrast is between the insulin-delivery approaches alongside that monitor. The registry does not report additional details about treatment adherence, protocol deviations, or how treatment use was monitored.

The primary endpoint timeframe is the 13-week study phase. The record also lists extension groups: an intervention extension with continued Omnipod 5 and a control extension involving crossover to Omnipod 5. The duration and analysis details for those extension groups are not reported in the registry record. Their safety counts should therefore be read as separate registry group entries, not substituted for the primary randomized comparison.

The registry record does not report the rationale for the enrollment target, a sample-size justification, or a detailed statistical analysis plan. Although it identifies randomization and a parallel design, details such as the randomization procedure and allocation concealment 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.

Before assignment: A total of 189 participants were enrolled; however, one participant was withdrawn prior to randomization, resulting in 188 participants started and assigned to study arms - 125 for intervention and 63 for control.

Main Study

Reasons for not completing this period:

13-week Extension

Analysis population for the primary outcome, as defined in the registry: Subjects are included in the Primary Endpoint Analysis even if data for one period is missing.

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 Change in HbA1c (%), measured over Comparing intervention group with control group during the 13-week study phase.

The primary endpoint is change in HbA1c, measured as a percentage, from baseline to 13 weeks. The registry specifies that the comparison is between the intervention and control groups during the 13-week study phase. It describes the endpoint as a mean and identifies standard deviation as the measure of dispersion. The numerical group means, standard deviations, and between-group estimate are not reported in the registry record.

Comparing change from baseline focuses on how the measure shifts during the study, rather than comparing only the final measurements. In general, a change score can account for participants’ starting values in the description of the treatment contrast. The interpretation still depends on how the change was estimated and on the uncertainty around the comparison; those numerical details are not reported in the registry record.

HbA1c is the registry’s chosen primary measure, but no claim about the size or direction of its change can be made from the endpoint description alone. The record states that participants remain in the primary endpoint analysis even if data for one period are missing. It does not explain how missing observations were handled in the calculation, so inclusion in the analysis should not be taken to mean that missing values were observed or replaced in any particular way.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the trial as randomized, controlled, unmasked, and parallel-group. These design labels describe how participants were allocated and how treatment groups were organized; they do not replace a report of the statistical methods used to estimate the primary contrast. The detailed analysis plan, including model choice, covariate adjustment, and handling of protocol deviations, is not reported in the registry record.

What does a mean change represent?

The primary endpoint is a continuous measure: change in HbA1c percentage from baseline. A mean summarizes the average change within a group. Comparing group means is one way to describe the average difference associated with the randomized treatment assignment. For the result to be interpretable, readers would ordinarily need the group summaries and the between-group estimate, together with a measure of uncertainty. Those numerical results are not reported in the registry record.

The listed standard deviation describes variability among individual observations around a group mean. It is not interchangeable with a standard error or confidence interval. In general, uncertainty in an estimated group contrast depends on the amount of variability, the amount of observed information, and the analysis method. Since the primary outcome numbers and analysis details are absent, no recalculation of the contrast or its uncertainty is possible from this record.

How should a confidence interval be read?

As a general statistical concept, a confidence interval communicates the precision of an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while the interval’s location communicates which effect sizes are compatible with the data and method. No primary confidence interval is reported in the registry record. It is therefore not possible to assess whether the primary estimate is compatible with a range of clinically important effects.

A p-value, when reported, addresses compatibility between the observed data and a specified null model under the analysis assumptions. It does not describe the size or clinical importance of an effect. The record does not report a primary p-value. A significance conclusion cannot be reconstructed from the endpoint description or the safety counts.

What do the design labels establish?

Random allocation is intended, in general, to support a fair comparison by assigning treatment independently of participants’ measured or unmeasured characteristics. The registry says the study was randomized, but it does not report the method used to generate or conceal the allocation sequence. No masking was used, according to the record. The registry does not describe how awareness of treatment assignment was addressed in outcome collection or analysis.

The parallel design indicates that the initial comparison is between groups assigned to different approaches. The record separately lists extension groups, including continued Omnipod 5 and crossover to Omnipod 5. The extension counts should not be treated as if they were an additional result from the initial randomized contrast. Details of extension timing and statistical analysis are not reported in the registry record.

What do the planning assumptions mean?

The stated planning assumptions describe illustrations using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They define the effect to detect as a stated fraction of the observed effect. For outcomes other than time-to-event outcomes, the stated planning quantity is participants per arm; time-to-event planning uses the total number of events. These assumptions describe planning calculations, not an observed trial result. Any sample-size illustrations are planning illustrations, never observed power. The registry record does not report that these assumptions were the trial’s own design justification.

Over-dispersion is a general issue when observed variability exceeds what a statistical model assumes. If present, it can make standard errors and uncertainty intervals based on an overly restrictive model too small. The registry record does not report whether over-dispersion was assessed or whether a model requiring such an assessment was used. No model-specific diagnostic or correction is reported.

The record’s outcome descriptions and design labels are not enough to reproduce the analysis. The primary result, its uncertainty, the detailed statistical model, and the treatment of missing observations are not reported in the registry record. Accordingly, a recalculated estimate cannot be presented, and no sponsor analysis can be compared with a recalculation from posted summary statistics.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 19 outcome measures, including the primary HbA1c change and secondary glucose-range and age-specific outcomes. It reports 0 analyses. Listing multiple outcomes raises a general multiplicity issue: when many hypotheses are examined, the chance of at least one apparently unusual result can increase unless the analysis plan addresses that possibility. The registry record does not report whether multiplicity adjustments were planned or used, or how the primary and secondary outcomes were prioritized beyond identifying the primary endpoint.

The primary endpoint description says participants are included in the primary endpoint analysis even if data for one period are missing. This describes the intended analysis population in broad terms, but it does not explain the missing-data method. Imputation, likelihood-based estimation, complete-case analysis, or sensitivity analyses are not reported in the registry record. The description does not establish how many observations were missing or how missingness affected the result.

The registry does not report a detailed definition of the analysis population, such as how randomized participants with treatment changes or other protocol deviations were handled. Nor does it provide a statistical analysis plan specifying the model, estimand, covariates, or sensitivity analyses. These omissions limit assessment of whether the reported outcome would correspond to treatment assignment, treatment received, or another target of inference. The primary numerical result is also not reported, so the effect of these choices cannot be evaluated.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: diabetic ketoacidosis (dka) (1.6%), other (0.8%), severe hypoglycemia (0.8%), prolonged hyperglycemia (0.8%).

The registry lists serious and other adverse-event counts separately for the initial intervention and control groups and for the extension groups. In the initial intervention group, 2 serious adverse events were listed among 125 at risk, and 26 other adverse events were listed among 125 at risk. In the initial control group, 0 serious adverse events were listed among 63 at risk, and 3 other adverse events were listed among 63 at risk.

For the intervention extension with continued Omnipod 5, the record lists 3 serious and 13 other adverse events among 124 at risk. For the control extension involving crossover to Omnipod 5, it lists 1 serious and 15 other adverse events among 63 at risk. Deaths are listed as 0 for each of the four groups. These are separate entries; the extension groups should not be combined with the initial groups to describe the randomized comparison.

The registry lists Diabetic Ketoacidosis (DKA) at 1.6%, and Other, Severe Hypoglycemia, and Prolonged Hyperglycemia at 0.8% each among the top serious terms. The record does not report enough detail to identify the denominators or event-level overlap for these percentages. Counts alone do not establish comparative risk, causality, or the overall safety profile.

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

The registry record establishes that a randomized, controlled comparison was conducted between Omnipod 5 with FreeStyle Libre 2 and multiple daily insulin injections with FreeStyle Libre 2. It also identifies change in HbA1c at 13 weeks as the primary endpoint and describes the measure as a mean with standard deviation. These registry entries explain what the trial was designed to compare, but they do not show the numerical result.

The record does not report the primary group means, the between-group estimate, or its confidence interval. As a result, it cannot establish from the information recorded whether the mean HbA1c change favored either group, how large any difference was, or how precise an estimate might be. It also does not provide a primary p-value. Statistical significance, if assessed elsewhere, would not on its own communicate the magnitude or practical importance of an effect.

The listed secondary outcomes and adverse-event entries give additional context about what was assessed and what events were recorded in the listed groups. They do not fill the gap in the primary efficacy result. Likewise, extension-group safety counts describe the registry’s extension entries, not the initial randomized comparison. The safety counts do not, by themselves, establish that an event was caused by a treatment or indicate comparative risk.

In general, trial results are interpreted in light of the estimate, its uncertainty, the analysis population, missing-data handling, and the study design. Several of those details are not reported in the registry record, and the numerical primary result is absent. The appropriate reading is therefore limited: the record describes the comparison and endpoint but does not permit an evidence-based statement about the observed primary effect or its precision.

13. Why This Trial Matters Statistically

This trial is statistically notable for comparing two insulin-delivery approaches while naming the same continuous glucose monitor in both groups. The randomized, parallel-group design provides a framework for comparing assigned groups, and the registry identifies a specific primary measure and timeframe: change in HbA1c during the 13-week study phase. Clear definition of the comparison and endpoint is important for interpreting any eventual estimate.

The registry also illustrates why an endpoint description is not a substitute for outcome results. Knowing that an outcome is a mean change and that standard deviation is the stated dispersion measure does not reveal the estimated treatment contrast or its uncertainty. Without those values, readers cannot assess precision or distinguish a small estimate from a large one.

The number of listed outcome measures also makes transparent reporting of the analysis plan important. In general, multiple outcomes can complicate interpretation unless their roles and any multiplicity approach are clear. The record lists 19 outcome measures but reports 0 analyses; details about multiplicity handling are not reported in the registry record.

Finally, the extension entries and safety counts require attention to group labels and analysis context. Continued treatment and crossover are distinct from the initial intervention-control assignments. The record’s design and outcome descriptions can orient readers, but the missing primary estimate and analysis details limit statistical interpretation of the trial’s main question.

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 central limitation for interpreting this trial from the registry record is that numerical primary outcome results are not reported. The record identifies change in HbA1c as the primary endpoint and specifies the 13-week study phase, but provides no group means, between-group estimate, confidence interval, or p-value. The magnitude, direction, and precision of the primary comparison therefore remain unknown from the recorded information.

The registry identifies randomization, parallel allocation, and no masking, but does not report the randomization procedure, allocation concealment, or detailed statistical model. It does not provide the analysis plan, multiplicity approach, or a detailed account of how missing observations were handled. Although the primary analysis description includes participants with data missing for one period, it does not state how such data enter the estimate.

The record lists secondary outcomes and safety entries, but numerical results for the secondary outcomes are not reported in the information. The extension groups have different treatment descriptions from the initial groups, and extension timing and analysis details are not reported. Safety counts and listed event terms lack the detail needed to determine event overlap, attribution, or comparative risk.

Finally, the registry does not report the rationale for enrollment or establish that the stated planning assumptions were the trial’s own design basis. The trial status is completed, but completion alone does not resolve these reporting gaps. These limitations concern what can be interpreted from the registry record, rather than proving that additional information does not exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults — NCT05923827.
• Registry record last updated 2026-11-03; status last verified 2026-10.
• Results first posted 2026-04-14.
• 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 registry record describes NCT05923827, titled “Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults.” It is a completed, randomized, controlled, unmasked, parallel-group study with enrollment of 189. The sponsor is Insulet Corporation. The recorded start date is 2023-09-11, and the primary completion date is 2024-08-16.

The intervention was Omnipod 5 with FreeStyle Libre 2; the control was multiple daily insulin injections with FreeStyle Libre 2. The primary endpoint was mean change in HbA1c from baseline during the 13-week study phase. The registry record does not report the numerical primary comparison or its precision. It lists 19 outcome measures and 0 analyses. Separate safety entries are reported for the initial groups and extension groups, with no deaths listed in any group.