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 Simplified Insulin Regimen for the Elderly (NCT03660553), a randomized phase 4 study. The primary outcome is Hemoglobin A1c (HbA1c).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03660553 |
| Phase | Phase 4 |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Miami |
| Results posted | Yes |
2. Clinical Question
Population
The intended population was older adults age >65 years with type 2 diabetes. The registry record reports enrollment of 7 participants in total. It does not report participant-level characteristics or a more detailed description of the enrolled population, so the extent to which the participants represent the intended population cannot be assessed from the record.
Intervention
The Basal Insulin (BI) group was assigned one morning injection of insulin glargine each day. The study summary describes this as a simplified regimen and frames the comparison around whether it could provide glycemic control with less treatment-management burden. Actual adherence, injection burden experienced by participants, and treatment errors are not reported in the registry record.
Comparator
The Multiple Subcutaneous Injection (MSI) group was assigned four insulin injections each day: long-acting insulin and short-acting insulin, with the short-acting insulin identified as insulin aspart or insulin lispro. The registry record describes this as the usual basal-bolus regimen. It does not report how consistently participants followed the assigned regimen.
Primary question
The primary outcome was mean hemoglobin A1c (HbA1c), measured as a percentage of HbA1c at 6 months. The registry description states that the mean in the BI group would be compared with the mean in the MSI group. The posted results give a mean of 7.8 for BI and 8.5 for MSI. No estimated between-group contrast, confidence interval, or statistical test is reported in the registry record.
3. Trial Design
This was a Phase 4, randomized, parallel-group trial with no masking reported. The study was sponsored by the University of Miami. The registry record lists the study start as 2018-10-10, primary completion as 2022-06-30, and status as terminated. Enrollment was 7. The reason for termination and the timing or circumstances of the decision are not reported in the registry record.
Participants were assigned to one of two insulin regimens. The MSI group description specifies four daily injections, including long-acting and short-acting insulin. The BI group description specifies one morning injection of insulin glargine. The registry record does not report the randomization sequence method, allocation concealment, or the procedures used to assign participants. It also does not state whether other aspects of care were standardized between groups.
The primary outcome was mean HbA1c at 6 months. The registry also lists incidence of any hypoglycemia and incidence of severe hypoglycemia as secondary outcomes. Although the record lists 3 outcome measures, it reports results for the primary HbA1c outcome and gives safety figures separately. Results for the listed hypoglycemia outcomes are not reported in the registry record.
The record lists 0 statistical analyses. It does not report a statistical analysis plan, a protocol for handling missing observations, an intention-to-treat definition, or a per-protocol definition. It also does not report the number of participants randomized to each arm separately from the outcome counts. The reported outcome counts are 3 for MSI and 4 for BI, totaling the stated enrollment. This description does not establish whether all participants completed follow-up or whether the outcome counts reflect a prespecified analysis population.
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 | Multiple Subcutaneous Injection (MSI) | Basal Insulin (BI) |
|---|---|---|
| STARTED | 3 | 4 |
| COMPLETED | 3 | 4 |
| 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 | Multiple Subcutaneous Injection (MSI) | Basal Insulin (BI) | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 4 | 7 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 3 | 4 | 7 |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 3 | 4 | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| HbA1c | % | 9.9 (7.5 to 12.4) | 7.9 (7 to 8.7) | 8.6 (7 to 12.4) |
6. Primary Endpoint
The registry lists the primary outcome as Hemoglobin A1c (HbA1c), measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | percentage of HbA1c |
| Endpoint classification | not reduced to a single comparison |
HbA1c was the primary endpoint, expressed as a percentage of HbA1c, with the registry specifying a mean value and a 6-month timeframe. The registry description says the mean in the BI group would be compared with the mean in the MSI group. The posted results report a mean of 7.8 for BI and 8.5 for MSI. The reported full ranges are 7.6 to 8.0 for BI and 7.4 to 9.7 for MSI.
As a general statistical concept, a continuous outcome such as a mean can summarize the central level of a measurement in each group. The mean alone does not show how individual participants’ measurements are distributed. A measure of variability or the participant-level observations can help describe that distribution; the record reports full ranges but does not report standard deviations or individual values.
The endpoint is relevant to the stated study question because the trial description focuses on glycemic control and specifies HbA1c as its primary measure. The registry record does not provide further details about the rationale for selecting the 6-month assessment or how measurements were collected. The endpoint values therefore describe the posted group summaries at that assessment, but do not by themselves establish the precision or statistical significance of a difference between groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted HbA1c summaries are a mean of 7.8 in the BI group, with a reported range of 7.6 to 8.0 among 4 participants, and a mean of 8.5 in the MSI group, with a reported range of 7.4 to 9.7 among 3 participants. These are descriptive group summaries. The registry record does not report a between-group effect estimate, confidence interval, or test result, so the precision of the comparison and the degree of compatibility between the data and different possible effects cannot be quantified from the posted results.
The group summaries should be read in light of the very small outcome counts. With only 3 participants in MSI and 4 in BI, each participant’s measurement can have a substantial influence on the group summary. The ranges also indicate that the observed measurements were not identical within either group. In particular, the MSI range is broad relative to the BI range, but ranges from such small groups are unstable descriptions of the underlying population distribution. A range does not indicate how values are distributed between its endpoints.
There is no reported analysis to determine whether the observed means differ beyond what could plausibly arise from sampling variability. A numerical difference between reported means is not, on its own, evidence of a statistically reliable treatment contrast. No contrast should be inferred as a sponsor-reported result because the registry gives only arm-level means and does not provide an estimated comparison or its uncertainty.
General statistical context: a confidence interval for a group contrast would describe the range of effects reasonably compatible with the observed data under the model used. A narrow interval would indicate greater precision than a wide interval. No such interval is reported in the registry record. A p-value, if reported, would address compatibility with a specified null hypothesis under stated assumptions; it would not measure the probability that a treatment is effective. No p-value or hypothesis test is reported.
The registry identifies the trial as terminated, but does not state why. The limited enrollment and absence of reported analyses constrain interpretation, but the record does not establish that termination caused the small enrollment, that the reported outcomes are incomplete, or that any particular analysis was planned. The posted results describe outcomes for the participants counted in each group; they do not support broad conclusions about the comparative effects in the intended population. Results for the two listed hypoglycemia outcomes are not reported in the registry record.
9. Statistical Methods Explained
General: statistical methods connect observed participant data to a question about differences between groups. In a randomized parallel-group design, the intended comparison is between outcomes in participants assigned to each group. The registry record describes the allocation as randomized and the model as parallel, but does not report the randomization procedure, the analysis model, or a formal estimate of the group contrast. The posted HbA1c figures are group means and ranges, not a reported inferential analysis.
What do the group means describe?
A mean is a measure of central tendency: it summarizes the values in a group using a single number. The posted mean is 7.8 for BI and 8.5 for MSI. These means describe the observed participants counted in each arm, subject to the registry’s reporting. The registry does not specify whether the means are adjusted for other variables, whether values were transformed, or whether the calculation followed a particular statistical model. The record labels the measure as a mean and gives no adjustment details, so it is not appropriate to attribute an adjusted analysis to these values.
A mean is not the same as an individual participant’s outcome. Nor does it reveal whether most observations cluster near the mean or whether a small number of observations influence it. The reported full ranges give the lowest and highest reported values in each group, but not the distribution within the range. Standard deviations, standard errors, and individual observations are not reported in the registry record.
Why does uncertainty matter?
General: an estimate based on a sample is subject to sampling variability. A confidence interval is a way of expressing uncertainty around an estimate, conditional on the assumptions of the method used. For a comparison, the most informative interval would concern the between-group contrast rather than separate intervals around each group mean. The registry record reports neither a contrast nor a confidence interval. Consequently, it does not show how precisely the difference between regimens was estimated.
General: a hypothesis test evaluates data against a stated null hypothesis using a statistical procedure. Its result depends on the estimated effect, the variability, the sample size, and the test’s assumptions. A test result cannot be reconstructed responsibly from the arm summaries alone without choosing methods and assumptions that are not specified in the registry record. The record reports 0 statistical analyses, so there is no reported sponsor analysis to interpret or compare with a recalculation.
What can ranges and small groups tell us?
General: a range conveys the span of observed values, not the uncertainty of a mean or contrast. It can be strongly affected by extreme observations and changes as additional participants are observed. With 3 MSI participants and 4 BI participants contributing to the posted outcome summaries, the observed ranges should not be treated as stable estimates of the range expected in a broader population. The small counts also mean that the group means are sensitive to each included value.
General: over-dispersion refers to variability greater than a chosen model expects. It can make standard errors and inferential conclusions unreliable when the model does not account for the extra variability. The registry does not report a model or evidence of over-dispersion for this outcome, and the available summaries do not permit an assessment of it. The principle is relevant when selecting a model for variable outcomes, but it does not establish that over-dispersion occurred in this trial.
How should the planning assumptions be read?
The registry describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. These are planning assumptions, not observed trial results. The record does not report the trial’s own sample-size justification, and the illustrations must not be interpreted as observed power or as evidence that the trial was adequately sized. The actual outcome counts were 3 in MSI and 4 in BI, whereas the planning description assumes equal allocation.
General: a planning sample size is conditional on assumptions about the target effect, variability, error rate, allocation, and analysis method. Changing those assumptions can change the number of participants needed. A calculation based on an effect observed in a very small trial can be especially uncertain because that observed effect may be unstable. Planning illustrations cannot repair the lack of a reported inferential comparison and do not establish the reliability of the group means.
The record does not report covariate adjustment, repeated-measures methods, a missing-data method, or an approach to account for multiple outcomes. Those methods cannot be inferred from the endpoint description or from the arm summaries. In general, a statistical model should be matched to the outcome, design, and estimand, and its assumptions should be stated so readers can assess whether its estimate is credible. Here, the registry record does not include the analysis details needed to evaluate such choices.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists HbA1c as the primary outcome and lists incidence of any hypoglycemia and incidence of severe hypoglycemia as secondary outcomes. It reports 3 outcome measures, but does not report results for the two listed hypoglycemia outcomes. The record lists 0 statistical analyses. It does not describe a multiplicity strategy, such as an ordering of tests or an adjustment to account for examining multiple outcomes. It is therefore not possible to determine how the investigators intended to control the chance of false-positive findings across outcomes.
General: multiplicity arises when several outcomes or hypotheses are examined. If each is tested separately, the chance of at least one apparently notable result can increase. A prespecified testing strategy can clarify which outcome is primary and how secondary results should be interpreted. Naming a primary outcome helps distinguish the principal question, but the registry record does not state a broader statistical plan.
The record does not report missing-data counts, reasons for missingness, imputation, or other methods for handling missing observations. Although the posted HbA1c counts are 3 for MSI and 4 for BI, the record does not explain whether these counts represent all randomized participants, all participants with available measurements, or a specified analysis population. It does not report an intention-to-treat population or a per-protocol population.
General: missing-data methods rely on assumptions about why observations are missing and how missingness relates to outcomes and participant characteristics. Different assumptions can lead to different estimates. Without a reported missing-data description and analysis approach, readers cannot assess how missing observations may have affected the summaries. This uncertainty is distinct from sampling variability and cannot be resolved using the reported group means and ranges alone.
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 |
|---|---|---|---|
| Multiple Subcutaneous Injection (MSI) | 0 | 3 | 0.0% |
| Basal Insulin (BI) | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Multiple Subcutaneous Injection (MSI) | 0 of 3 |
| Basal Insulin (BI) | 0 of 4 |
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 |
|---|---|
| Multiple Subcutaneous Injection (MSI) | 0 of 3 |
| Basal Insulin (BI) | 0 of 4 |
The registry reports serious adverse event figures by group. In MSI, 3 participants were at risk, 0 were affected by a serious adverse event, and deaths were 0. In BI, 4 participants were at risk, 0 were affected by a serious adverse event, and deaths were 0. The record lists no serious adverse event terms. These figures describe the posted counts; they do not establish that no unreported or unrecorded events occurred.
General: an observed count of zero in a small group does not demonstrate that the underlying risk is zero. When few participants are observed, uncommon events may not appear during the study even if they could occur in a larger population or over a different period of observation. The number at risk is important context because it indicates how many participants contributed to the safety count, but it does not provide a precise estimate of event risk.
The registry does not report the observation duration for these safety counts, detailed event definitions, event ascertainment procedures, or non-serious adverse event results. It lists incidence of any hypoglycemia and severe hypoglycemia as secondary outcomes, but their results are not reported in the registry record. The serious adverse event figures should therefore be read narrowly as the recorded counts, not as a complete assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The posted results establish that the registry contains HbA1c summaries at 6 months for participants assigned to BI and MSI. The mean was 7.8 among 4 BI participants and 8.5 among 3 MSI participants. The respective reported ranges were 7.6 to 8.0 and 7.4 to 9.7. These values describe the recorded group summaries and are not accompanied by a reported contrast or measure of uncertainty.
The results do not establish the size or precision of a treatment effect. The registry reports no statistical analysis, confidence interval, or p-value for the primary comparison. Because the group counts are small, the summaries may be sensitive to individual observations, and the ranges do not provide a substitute for a model-based assessment of uncertainty. Readers should not treat a difference between two means as proof of a reliable difference between the assigned regimens.
The registry record also does not provide enough information to assess whether the findings apply to a wider population of older adults with type 2 diabetes. The reason for termination, participant characteristics, adherence, and analysis populations are not reported. The record does not state whether the observed participants represent the original randomized population or whether there were missing outcome measurements.
These results do not show whether the regimens differed in hypoglycemia outcomes: those secondary results are not reported in the registry record. Likewise, the serious adverse event counts of zero in both groups do not show that the regimens have no serious risks. The available safety counts are based on 3 participants in MSI and 4 in BI, with no event terms listed.
General: a trial’s result is best understood by considering the estimated contrast, its uncertainty, the study design, and the completeness of outcome reporting together. In this record, the group summaries are useful descriptive information, but the missing inferential analysis and limited counts leave substantial uncertainty. The registry results should not be interpreted as a definitive comparative conclusion.
13. Why This Trial Matters Statistically
This trial raises a statistical question about how to compare two assigned regimens when a study enrolls very few participants. Randomization supports a structured comparison in principle, but it does not make an imprecise estimate precise. The reported outcome counts are 3 for MSI and 4 for BI, so the group means and ranges are summaries of a small amount of observed data.
The record is also an example of why descriptive results and inferential results answer different questions. Group means describe the observed participants. An estimated contrast and uncertainty interval would address how much the groups differed and how precisely that contrast was estimated. The registry reports the means and full ranges, but no contrast, confidence interval, or statistical test. This distinction is important whenever readers encounter arm-level outcome summaries without an analysis of the comparison.
The study’s stated question includes both glycemic control and potential differences in treatment-management burden. HbA1c is the named primary outcome, while hypoglycemia outcomes are listed as secondary. The registry does not report results for the secondary outcomes or measures of burden, adherence, or treatment errors. This makes outcome completeness a central interpretive issue: a posted primary result cannot answer every part of the broader rationale for the study.
The terminated status and small enrollment also draw attention to the difference between a planned study and the results that are available for interpretation. The record does not report why the trial was terminated or its sample-size justification. Statistical readers should avoid filling those gaps with assumptions. The planning assumptions described in the record are illustrations, not evidence of the trial’s original design basis or observed power.
Overall, the record illustrates the value of transparent reporting of analysis plans, participant flow, missing data, and uncertainty. Without those details, even a clearly identified outcome and randomized design can leave the main comparative question unresolved.
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 interpreting the primary comparison is the very small number of participants with reported outcome summaries: 3 in MSI and 4 in BI. With few observations, group means and ranges can be strongly influenced by individual values. The record does not provide participant-level data or standard deviations, making it difficult to evaluate the distribution of HbA1c values beyond the reported full ranges.
No estimated between-group contrast, confidence interval, p-value, or other statistical test is reported. The registry lists 0 statistical analyses. Thus, the uncertainty around the comparison is not quantified, and the results cannot be assessed against a reported analysis plan. The record also does not report whether the means are adjusted or unadjusted, although it gives no details suggesting an adjusted model.
The study is marked terminated, but the reason for termination is not reported in the registry record. Participant characteristics, randomization procedures, allocation concealment, adherence, and follow-up completeness are also not reported. The posted arm counts match the stated total enrollment, but that alone does not establish the analysis population or rule out missing data at other stages.
The two listed secondary outcomes concern hypoglycemia, yet their results are not reported in the registry record. Detailed adverse event definitions, observation duration, and safety ascertainment methods are also not reported. The serious adverse event counts therefore offer limited information about safety, especially with small numbers at risk.
Finally, the record does not report a protocol-level sample-size justification, a statistical analysis plan, a multiplicity approach, or missing-data methods. The planning assumptions described in the record should not be treated as the study’s own design justification. These reporting gaps limit assessment of the reliability, completeness, and generalizability of the posted results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Simplified Insulin Regimen for the Elderly — NCT03660553.
- Registry record last updated 2023-12-12; status last verified 2023-11.
- Results first posted 2023-12-12.
- 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 record describes NCT03660553, titled “Simplified Insulin Regimen for the Elderly,” as a Phase 4 randomized parallel-group trial with no masking. It was sponsored by the University of Miami, began on 2018-10-10, had primary completion on 2022-06-30, and is listed as terminated. Enrollment was 7.
The trial compared one morning injection of insulin glargine in the BI group with four daily injections in the MSI group, including long-acting and short-acting insulin. The primary outcome was mean HbA1c at 6 months. The reported means were 7.8 for BI and 8.5 for MSI; the reported ranges were 7.6 to 8.0 and 7.4 to 9.7, respectively. The outcome counts were 4 for BI and 3 for MSI.
The registry lists incidence of any hypoglycemia and incidence of severe hypoglycemia as secondary outcomes, but their results are not reported in the registry record. No statistical analyses are listed, and no between-group estimate or uncertainty interval is reported. The registry gives zero serious adverse events and zero deaths in each group, among 4 BI participants and 3 MSI participants at risk.