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 The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus (NCT04120974), a na na study. The primary outcome is Change in Glycemic Control.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04120974 |
| Phase | NA |
| Condition | Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Lipohypertrophy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 90 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Becton, Dickinson and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants had Type 1 or Type 2 diabetes mellitus, with or without lipohypertrophy. The registry lists an enrollment of 90. The primary endpoint analysis is described as including only participants who completed the study, but the number of completers is not reported in the registry record.
Intervention
Participants received instruction in optimal insulin injection technique. The study description specifies personal training by the investigator and online video training modules delivered through a web-based platform. It also describes use of disposable BD Micro-Fine Plus 32G pen needles.
Comparator
The study is recorded as a single-group investigation with no masking and no randomized allocation. It does not describe a separate control group or a like-for-like comparator. Changes are framed as within-participant comparisons from baseline to follow-up, rather than as differences between assigned groups.
Primary question
The primary outcome is change in glycemic control, expressed as HbA1c percentage, from baseline to 6 months. The registry describes the outcome as HbA1c levels at baseline and 6 months, but does not report the values or a calculated change. The central question is therefore whether the recorded participants’ HbA1c changed over the stated follow-up; the direction and size of that change cannot be assessed from the registry record.
This is a question about outcomes observed after an intervention in a single group. Without a concurrent control group, any change over time cannot be separated from changes that might have occurred for other reasons. The study also includes secondary outcomes concerning insulin total daily dose, hypoglycemic events, and blood glucose levels. The registry describes quality of life in its study summary, but detailed results for that measure are not reported in the registry record.
3. Trial Design
This was a prospective, post-marketing, single-arm clinical investigation. The registry lists the study model as single group, allocation as not applicable, and masking as none. It records the study as completed, with an enrollment of 90. The recorded start date is 2019-10-01 and the primary completion date is 2021-04-26. The phase is listed as not applicable.
Participants with Type 1 or Type 2 diabetes mellitus, with or without lipohypertrophy, were to receive training in insulin injection technique. The intervention description combines personal instruction from the investigator with online video modules on a web-based platform. The study summary also describes the intervention in conjunction with disposable Becton Dickinson Micro-Fine Plus 32G pen needles. The registry does not describe an alternative intervention or a separate control group.
The primary outcome is change in HbA1c, expressed as a percentage of glycated hemoglobin, over a timeframe of up to 6 months. The description says the assessment concerns participants’ baseline and 6-month HbA1c levels. Only study completers are described as analyzed for this outcome. The number of participants who completed the study and the handling of participants without a follow-up measurement are not reported in the registry record.
The listed secondary outcomes are change in insulin total daily dose, incidence of hypoglycemic events, and change in blood glucose levels. The registry reports eight outcome measures overall, but does not provide a complete outcome-by-outcome account of results in the record. It lists no statistical analyses. Details such as the planned statistical model, how within-participant measurements were to be compared, or whether any interim analyses were planned are not reported in the registry record.
Because this is a single-group study, its structure supports description of outcomes before and after training but does not provide a randomized comparison with usual care or another technique. A change observed over follow-up would not, by itself, identify the effect of the training separately from other influences over time.
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 | Optimal Insulin Injection Technique |
|---|---|
| STARTED | 90 |
| COMPLETED | 82 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Optimal Insulin Injection Technique |
|---|---|
| Death | 1 |
| Physician Decision | 1 |
| Lost to Follow-up | 6 |
Analysis population for the primary outcome, as defined in the registry: Only participants who completed the study have been analyzed
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.
Population: Only the participants who completed the study have been analyzed and are reported on. 90 Participants included, but 82 completed the study.
| Characteristic | Unit | Optimal Insulin Injection Technique |
|---|---|---|
| Participants analysed | 82 | |
| Age, Continuous | years | 48.2 (SD 13.3) |
| Sex: Female, Male: Female | Participants | 26 |
| Sex: Female, Male: Male | Participants | 56 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Russia | Participants | 82 |
| BMI, average | kg/m^2 | 26.7 (SD 5.1) |
| Baseline HbA1c (%), average | % of glycated hemoglobin | 9.2 (SD 1.4) |
| Diabetes Type: Type I, Type II: Type I Diabetes Mellitus | Participants | 57 |
| Diabetes Type: Type I, Type II: Type II Diabetes Mellitus | Participants | 25 |
| Insulin therapy duration, average (years) | years | 13.2 (SD 11.4) |
| Baseline Lipohypertrophy: Yes, No: Lipohypertrophy present | Participants | 46 |
| Baseline Lipohypertrophy: Yes, No: Lipohypertrophy absent | Participants | 36 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Glycemic Control, measured over up to 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | % of glycated hemoglobin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in glycemic control, measured using HbA1c as a percentage of glycated hemoglobin. The registry describes the measurement at baseline and at 6 months, within a timeframe of up to 6 months, and specifies a mean with standard deviation as the planned summary. It also states that only participants who completed the study were analyzed for this endpoint.
As general statistical context, HbA1c is a continuous measure, so a mean can describe the group’s average level or average change. A standard deviation describes how dispersed participant measurements are around that mean. These summaries answer different questions: the mean characterizes the group average, while the standard deviation characterizes variation among participants. Neither alone indicates how precisely the group mean has been estimated; that requires an uncertainty measure such as a confidence interval.
The registry description calls the endpoint a change but specifies the HbA1c levels at baseline and 6 months. The numerical levels, mean change, standard deviation, and confidence interval are not reported in the registry record. It is therefore not possible to quantify the size or direction of the primary endpoint from the reported record. Nor does the record clarify the exact calculation used to define change, beyond the baseline-to-follow-up description.
HbA1c is used in this study as an indicator of glycemic control. Its selection makes the primary outcome a laboratory measure rather than a report of symptoms or treatment experience. However, interpreting an endpoint requires the actual values, the analysis population, and information about missing follow-up measurements. Those details are not all available in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a relevant clinical outcome and a defined follow-up period, but it does not report the primary endpoint results. In particular, there are no baseline or 6-month HbA1c values, no mean change, and no reported uncertainty estimate. The record therefore does not establish the direction, magnitude, or precision of any observed change in glycemic control.
The intervention was evaluated in a single group. In general, a before-and-after comparison can describe how measurements changed among participants over time. It cannot alone show that the intervention caused the change, because the design has no separate comparison group to represent what would have happened over the same period without the intervention. Other influences may coincide with the intervention and follow-up. The registry does not report a design feature that would address this limitation.
The primary analysis is described as restricted to study completers. That makes the number of completers and the reasons for non-completion important for interpreting the result. Neither is reported in the registry record. If follow-up availability differs in relation to participants’ outcomes or circumstances, results among completers may not represent all enrolled participants. The record does not state whether missing measurements were imputed, whether sensitivity analyses were conducted, or whether a broader analysis population was used.
The registry reports that there were eight outcome measures and lists secondary outcomes involving insulin total daily dose, hypoglycemic events, and blood glucose levels. It does not report results for those outcomes in the record. The number of analyses is listed as zero, and inferential results such as p-values, confidence intervals, or estimates from an adjusted model are not reported. A statistical plan, including any plan for handling multiple outcomes, is also not reported in the registry record.
The safety record lists 4 serious adverse events among 90 participants at risk and 5 other adverse events among 90 participants at risk in the optimal insulin injection technique group. It also lists 1 death. These counts describe events recorded in the group; the registry information does not establish whether any event was caused by the intervention. The listed serious-event terms each carry a reported value of 1.1%, but the record does not clarify whether event terms refer to distinct participants or whether categories overlap.
Overall, the record permits a description of the study design and some safety counts, but not an evaluation of the primary endpoint’s observed result. Even if numerical before-and-after results were available, the single-group design would limit causal interpretation. Conclusions about the intervention would need to account for that design, the completer-only analysis, and the absence of reported endpoint estimates and uncertainty.
9. Statistical Methods Explained
The registry describes the primary outcome as a mean continuous measure with standard deviation. The outcome is HbA1c, and the stated comparison is from baseline to 6 months. No statistical analysis is listed, so the following concepts explain how such data are commonly interpreted in general; they do not identify methods used in this study.
What a mean and standard deviation describe
For a continuous measurement, a mean gives the average across the participants included in the calculation. If the endpoint is change, the mean change represents the average of the participant-level changes, provided that is how the endpoint was calculated. A standard deviation describes how much individual values vary around the mean. A small or large standard deviation is about spread among observations, not whether the mean is statistically significant or clinically important.
Repeated measurements on the same participant are related. In general, analyzing within-participant changes can account for the fact that the baseline and follow-up measurements come from the same people. A comparison that treats those measurements as independent would not reflect that pairing. The registry record does not report which calculation or model was used, nor does it give enough endpoint results to reproduce an analysis.
What uncertainty measures add
A confidence interval is a range of values compatible with the data and the assumptions of the analysis, expressed at a stated confidence level. It conveys uncertainty about an estimate, whereas a standard deviation describes variation in the measured participants. For an intervention estimate, the interval’s width is affected by the amount of information and variability in the data, as well as the analysis method. No confidence interval for the primary endpoint is reported in the registry record.
A p-value, when reported, describes how unusual data at least as incompatible with a specified null model would be if that model and the test assumptions held. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of a change. The record does not report a p-value or name a hypothesis test for the primary outcome. Statistical significance, if it had been reported, would not by itself resolve the limitations of a single-group design.
Why a comparator matters
In a randomized comparison, assignment to groups can support an estimate of the contrast between intervention and comparator, subject to the trial’s conduct and analysis. This study is recorded as single group, with allocation not applicable and no masking. Its baseline-to-follow-up framing can describe change in participants who were measured, but there is no concurrent group to account for changes over time that are unrelated to the training. General causal interpretation therefore requires caution. The registry does not report an alternative comparison strategy.
How missing observations affect interpretation
The primary outcome description specifies analysis of participants who completed the study. A completer analysis uses available outcomes from those who finished, but its representativeness depends in part on why other participants did not complete follow-up and whether their outcomes differ. General approaches to missing data include analyzing available observations under explicit assumptions, modeling missingness, or conducting sensitivity analyses. The choice depends on the design and the missingness process. No missing-data method or sensitivity analysis is reported in the registry record, and the number of completers is not stated.
Multiple outcomes and analysis choices
The registry lists eight outcome measures and identifies a primary outcome alongside secondary outcomes. When researchers test or estimate many outcomes, the chance of highlighting an apparently notable result by chance can increase, depending on the analysis plan. A prespecified hierarchy, adjustment procedure, or emphasis on estimation can help clarify interpretation. The registry record does not report a multiplicity strategy, the full statistical analysis plan, or any inferential analyses. It is not possible to determine whether results were adjusted or how outcome reporting was prioritized.
What can be concluded from the record
The design and endpoint description identify what was intended to be measured, while the registry’s result details do not give the HbA1c values or an estimated change. General statistical principles cannot substitute for those observed results. Without an estimate and an uncertainty measure, the magnitude and precision of the primary outcome are unknown. Without a comparator, a change over time would not isolate the effect of the intervention. These are separate limitations: more complete reporting could improve understanding of the observed change, but it would not turn the single-group design into a randomized comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures, including change in HbA1c as the primary outcome and secondary outcomes concerning insulin total daily dose, hypoglycemic events, and blood glucose levels. It lists zero analyses. A multiplicity adjustment, outcome hierarchy beyond the primary designation, and statistical analysis plan are not reported in the registry record. As a general matter, considering multiple outcomes can increase the opportunity for chance findings if each is tested separately. Without the analysis plan and results, the impact of multiple outcomes on interpretation cannot be assessed.
The primary endpoint population is described as participants who completed the study. The enrolled number is 90, but the number who completed follow-up is not reported. The record does not state how many participants had usable baseline and follow-up HbA1c measurements, why any participants did not complete, or how missing endpoint values were handled. Imputation, sensitivity analyses, and alternative analysis populations are not reported in the registry record.
These omissions matter because a completer-only result may differ from the experience of all enrolled participants if completion is associated with outcomes or participant characteristics. This is a general concern, not evidence that such a difference occurred in this study. The absence of reported missing-data methods means the assumptions behind any endpoint estimate cannot be evaluated. Since no primary endpoint estimate is reported either, the record does not permit assessment of how missingness may have affected the result.
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 |
|---|---|---|---|
| Optimal Insulin Injection Technique | 4 | 90 | 4.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Optimal Insulin Injection Technique | 1 of 90 |
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 |
|---|---|
| Optimal Insulin Injection Technique | 5 of 90 |
Most frequent serious adverse event terms
| Event term | Organ system | Optimal Insulin Injection Technique |
|---|---|---|
| COVID-19 | Infections and infestations | 1 of 90 |
| COVID-19 pneumonia | Infections and infestations | 1 of 90 |
| Death | General disorders | 1 of 90 |
| Coronary artery disease | Cardiac disorders | 1 of 90 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Optimal Insulin Injection Technique |
|---|---|---|
| Visual impairment | Eye disorders | 1 of 90 |
| Hypotension | Vascular disorders | 1 of 90 |
| Skin ulcer | Skin and subcutaneous tissue disorders | 1 of 90 |
| Nasopharyngitis | Infections and infestations | 1 of 90 |
| Respiratory tract infection viral | Infections and infestations | 1 of 90 |
Serious events with the highest arm-level rate: covid-19 (1.1%), covid-19 pneumonia (1.1%), death (1.1%), coronary artery disease (1.1%).
For the optimal insulin injection technique group, the registry lists 90 participants at risk for serious adverse events and 4 affected, and 90 participants at risk for other adverse events and 5 affected. It also records 1 death. These are reported counts; they should be read as safety information recorded for the study group, not as evidence that the intervention caused an event.
The listed serious adverse event terms are COVID-19, COVID-19 pneumonia, Death, and Coronary artery disease, each reported as 1.1%. The registry does not explain whether these terms describe distinct participants, whether a participant could contribute more than one term, or how the percentage for each term was calculated. The record also does not provide a comparison group’s safety experience. Without such a comparator, the counts do not estimate an excess risk attributable to the intervention.
Interpretation is further limited by the absence of event timing, event-level descriptions, and reported assessments of relatedness in the registry record. The count of deaths is not, by itself, a determination of cause. These safety figures are descriptive records for the study group and should not be treated as a causal comparison.
12. What the Result Does, and Does Not, Mean
The record establishes that a prospective, post-marketing, single-group study evaluated training in insulin injection technique among participants with Type 1 or Type 2 diabetes, with or without lipohypertrophy. Its primary outcome was HbA1c change from baseline to 6 months, and its summary describes personal instruction and online video training. It also identifies secondary outcomes related to insulin dose, hypoglycemic events, and blood glucose.
The main primary result cannot be interpreted from the registry record because the baseline and follow-up HbA1c values, estimated change, and uncertainty are not reported. Consequently, the record does not show whether HbA1c increased or decreased, how large any change was, or how variable or precise an estimate may have been. The same limitation applies to the listed secondary outcomes, for which outcome results are not reported in the record.
Even with complete numerical before-and-after findings, a single-group study cannot distinguish an intervention-associated change from other changes occurring during follow-up. The lack of a randomized comparator is therefore important for causal claims. The completer-only primary analysis description adds another interpretive issue because the number of completers and the handling of missing measurements are not reported.
The safety counts describe events recorded among participants in the study group. They do not establish that an event was caused by training or needle use, and the registry does not provide a control group for comparison. The serious-event terms and percentages also do not clarify whether categories overlap.
The appropriate reading is narrow: the registry describes a study design and planned clinical outcomes, along with selected safety counts, but does not report the primary efficacy estimate needed to assess the observed HbA1c change. These limitations do not establish that no change occurred; they mean that the magnitude, precision, and causal interpretation of a change cannot be determined from the registry record.
13. Why This Trial Matters Statistically
This study raises a statistical question that often arises when a clinical intervention is assessed in routine practice: how should change over time be described when all participants receive the intervention? A single-group design can document measurements before and after training and can show the pattern among participants with observed follow-up. It cannot, without a suitable comparator or other design strategy, determine how much of that pattern is attributable to the intervention.
The distinction between describing change and estimating an intervention effect is central. A mean change would summarize the observed group experience, while an uncertainty interval would communicate how precisely that change had been estimated. Neither would, on its own, resolve confounding by time-varying influences. The registry record does not report the HbA1c estimate or its uncertainty, so even the descriptive change cannot be evaluated.
The completer-only analysis description also highlights why the analysis population matters. A result based on participants with completed follow-up can be informative, but interpreting it requires knowing how many completed and how missing observations were handled. Those details are not reported in the registry record. Such reporting helps readers distinguish the enrolled group from the participants contributing to the endpoint estimate.
Finally, the record lists several outcome measures but no analyses. Clear reporting of the primary estimate, uncertainty, secondary results, missing-data approach, and multiplicity strategy would help readers understand both the observed data and the limits of inference. In this case, the registry’s design information and adverse event counts can be described, but the primary outcome result and its statistical precision cannot be assessed.
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 primary limitation for interpreting the main outcome is that the registry record does not report the baseline or 6-month HbA1c values, a mean change, or an uncertainty estimate. The outcome is described as a change over a timeframe of up to 6 months, but the record does not clarify the precise calculation used beyond identifying the baseline and follow-up measurements. Without the results, the direction and magnitude of the observed outcome are unknown.
The single-group design has no randomized comparator. It can describe what happened among participants with measurements but cannot isolate the intervention’s effect from other influences during follow-up. Masking is recorded as none, and the record does not report a separate control group or another comparison method.
The primary endpoint analysis is described as including only participants who completed the study. Although enrollment is listed as 90, the number of completers and the reasons for incomplete follow-up are not reported. Missing-data handling and sensitivity analyses are also not reported, limiting assessment of whether the endpoint population represents all enrolled participants.
The registry lists eight outcome measures but no analyses. A statistical analysis plan, approach to multiple outcomes, inferential tests, and adjusted analyses are not reported. The record also does not report results for the listed secondary outcomes. These omissions prevent a fuller assessment of outcome estimates and their statistical uncertainty.
Safety interpretation is limited by the absence of a comparator and by limited detail on event timing, relatedness, and whether serious-event terms overlap. The counts are descriptive and do not establish causation. These limitations are specific to the information recorded and do not establish what the unreported analyses or results would have shown.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus — NCT04120974.
- Registry record last updated 2024-02-22; status last verified 2023-07.
- Results first posted 2024-02-22.
- 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.
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18. Record Summary
The registry records a completed, prospective, post-marketing, single-group study of optimal insulin injection technique in participants with Type 1 or Type 2 diabetes, with or without lipohypertrophy. Enrollment was 90. The study began on 2019-10-01, and primary completion was recorded as 2021-04-26. Allocation is listed as not applicable, masking as none, and phase as not applicable.
The primary outcome was change in HbA1c from baseline to 6 months, expressed as a percentage of glycated hemoglobin. Only participants who completed the study are described as analyzed for this endpoint. The registry record does not report the endpoint values, the number of completers, or the statistical analysis. Secondary outcomes include change in insulin total daily dose, incidence of hypoglycemic events, and change in blood glucose levels.
The safety record lists 4 serious adverse events and 5 other adverse events among 90 participants at risk, along with 1 death. These counts are descriptive and do not establish a relationship to the intervention. The registry record does not report the primary endpoint estimate or its precision.