Satisfaction of Treatment Among Elderly Patients With Insulin Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Satisfaction of Treatment Among Elderly Patients With Insulin Therapy (NCT01240200), a randomized phase 4 study. The primary outcome is Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score.

2. Clinical Question

This is a comparison of two ways to deliver the same named basal insulin, not a comparison of different insulin drugs. The study also listed HbA1c, fasting blood glucose, dosing errors and hypoglycemic events as secondary outcomes. The registry record does not report numerical results for these outcomes, so this page cannot describe whether they differed between delivery methods. It also does not report a numerical primary-outcome comparison or a statistical test for satisfaction. The record therefore establishes the intended question and the measure used, but not the estimated answer to that question.

3. Trial Design

The registry record describes a phase 4, randomized, unmasked, crossover trial sponsored by Emory University. Enrollment was 49. The listed study dates are 2011-01 for the start and 2012-08 for primary completion, and the record lists the study status as completed.

In a crossover design, participants receive more than one study condition in a sequence. Here, the two conditions were insulin glargine delivered by vial and syringe and insulin glargine delivered by SoloSTAR pen. The record lists one sequence as vial and syringe in Period 1 followed by pen in Period 2, and another as pen in Period 1 followed by vial and syringe in Period 2. Randomization assigned participants to a sequence. Thus, the comparison was intended to involve both delivery methods within the crossover, while the order of use differed between randomized groups.

The record says masking was none. It does not describe a masking procedure, and the device types are distinct in the sequence descriptions. The registry record does not report the duration of each period, any washout interval, the procedures for switching devices, or whether treatment conditions were otherwise held constant. Those details should not be inferred from the word “crossover.”

The primary outcome is listed as a mean DTSQs score, with assessments at baseline and week 12. The record describes the analysis population for that measure as participants who completed both assessments. It does not report the number of such participants, the exact comparison used to estimate the treatment effect, or the statistical model. The registry record reports zero analysis entries, so the trial design can be described, but a sponsor-reported primary-outcome analysis cannot be summarized from this 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: Of the 56 individuals who consented to take part in the study, 7 were removed prior to being randomized to a group (2 did not meet eligibility criteria and 5 withdrew consent prior to group assignment). Those who were not randomized were not considered to be enrolled in the study as group assignment was never determined.

12-week Crossover Phase - Period 1

Reasons for not completing this period:

12-week Crossover Phase - Period 2

Analysis population for the primary outcome, as defined in the registry: This analysis includes participants who completed the baseline and week 12 assessments.

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: The baseline analysis includes the 46 participants who completed the trial (23 in Vial \& Syringe to Pen group and 23 in Pen to Vial \& Syringe group).

6. Primary Endpoint

The registry lists the primary outcome as Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score, measured over Baseline, Week 12.

The primary endpoint was the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) score, a measure of satisfaction with diabetes treatment. The registry record describes eight questionnaire items, each scored on a seven-point scale from 0, “very dissatisfied,” to 6, “very satisfied.” The total satisfaction score sums responses to questions 1, 4, 5, 6, 7, and 8 and can range from 0 to 36. Higher scores indicate higher satisfaction with diabetes treatment.

This questionnaire is used to capture a patient-reported experience of treatment rather than a laboratory measure of glucose or a count of treatment-related events. That distinction matters: satisfaction describes how participants rated their treatment, while HbA1c and fasting blood glucose were listed separately as secondary outcomes. A satisfaction score alone does not establish a change in glucose control or explain why a participant gave a particular rating.

The primary endpoint is reported as a mean with standard deviation, and its timeframe is listed as baseline and week 12. The analysis population is described as participants who completed both assessments. The registry record does not report the observed mean scores, standard deviations, or a numerical comparison between delivery methods. It therefore does not allow the magnitude or precision of any satisfaction difference to be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is described as randomized and crossover. Randomization concerns assignment to a sequence: the registry record lists a vial-and-syringe-then-pen sequence and a pen-then-vial-and-syringe sequence. A crossover design allows a participant to use both conditions, with the sequence varying across randomized groups. In general, this can support a within-participant comparison, but analysis must account for the sequence and the fact that measurements from the same participant are related. The registry record does not report how the primary analysis handled these features.

What does “mean with standard deviation” convey?

The primary outcome is specified as a mean DTSQs score with standard deviation. In general, the mean summarizes the central level of scores in a group, while the standard deviation describes how dispersed individual scores are around that mean. The standard deviation is not the uncertainty of the mean and is not a confidence interval. The registry record gives the score range and direction but does not report means or standard deviations for the treatment conditions.

Why does the crossover structure matter?

General statistical explanation: observations from one participant are usually more alike than observations from different participants. A crossover analysis may therefore use the paired information from each participant, rather than treating every observation as independent. The period of treatment and its order may also be relevant. A suitable analysis needs to specify how those aspects are handled. The registry record does not report the statistical model, whether the primary comparison was paired, or whether period or sequence terms were included. It also does not describe washout procedures, so no assumptions about carryover or its handling can be made.

What is the role of the confidence interval?

General statistical explanation: a confidence interval expresses uncertainty around an estimated treatment contrast, conditional on the data and the analysis assumptions. Its width is informative about precision; a narrow interval indicates more precise estimation than a wide interval. A confidence interval also helps readers consider which values remain reasonably compatible with the data under the method used. No estimate or confidence interval for the primary outcome is reported in the registry record, so the precision of the satisfaction comparison cannot be judged.

What can a p-value show?

General statistical explanation: a p-value is calculated relative to a statistical model and a null hypothesis. It is not the probability that the null hypothesis is true, and it does not tell readers whether a difference is important. Interpreting a p-value requires the test, analysis population, and underlying estimate to be understood. The record reports no primary analysis entry or p-value. It would therefore be inappropriate to characterize the primary comparison as statistically significant or nonsignificant.

Why can over-dispersion matter?

General statistical explanation: for count outcomes, over-dispersion means that observed variability is greater than a simple model's assumptions would predict. If present and not accounted for, uncertainty estimates from an overly restrictive count model can be unreliable. This is a general consideration for outcomes such as event counts, not a claim about this trial. The registry record does not report the distribution of hypoglycemic events, an analysis model for that outcome, or any assessment of over-dispersion.

The sample-size material on the page is explicitly a planning illustration rather than a description of the original trial design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. The record says that non-time-to-event illustrations are expressed as participants per arm. Such calculations help illustrate how planning depends on an assumed effect and analysis framework; they are not observed power and do not establish what the trial was designed to detect. The registry record does not report the original sample-size justification or the assumptions used when the trial was planned.

The record lists a continuous primary outcome and several secondary outcomes, but the analysis entries count is zero. No details of a statistical analysis plan, interim analyses, covariate adjustment, multiplicity procedure, or missing-data method are reported in the registry record. Those omissions prevent a more specific account of how the sponsor intended to analyze the trial.

10. Multiplicity, Missing Data and Analysis Populations

The primary-outcome analysis population is described as participants who completed the baseline and week 12 assessments. The registry record does not report how many participants met that definition, how many were missing either assessment, or why any assessments might be missing. It also does not report whether missing values were imputed, whether a sensitivity analysis was conducted, or how participants who did not complete both assessments were handled. Therefore, the effect of missing data on the primary result cannot be assessed.

The record lists one primary outcome and several secondary outcomes: HbA1c, fasting blood glucose, dosing errors, and hypoglycemic events. It does not report a multiplicity strategy for interpreting results across outcomes, time points, or treatment sequences. The presence of multiple measures does not by itself show that a particular adjustment was required or applied; the planned testing strategy is not reported in the registry record.

The outcome timeframe includes baseline and week 12, but the registry record does not explain whether the primary comparison used change from baseline, week 12 scores, or another contrast. It also does not report a statistical analysis population beyond the completion-based description for the primary measure, or how protocol deviations were handled. The registry record reports zero analysis entries, so the posted material does not support an assessment of analysis exclusions, missing-data assumptions, or multiplicity control.

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 non-serious adverse event terms

The registry record lists serious adverse event counts of 0 for Vial and Syringe and 0 for SoloSTAR Pen. It lists deaths of 0 in both groups. For other adverse events, it reports 22 in the Vial and Syringe group and 15 in the SoloSTAR Pen group. The corresponding numbers at risk are 48 and 47, respectively. These are the counts as recorded; this summary does not calculate rates or compare them.

The groups are named by delivery method in the registry record, while the study design is crossover. The record does not explain how these safety counts were assigned across treatment periods or how repeated exposure was handled. It also does not give the types, timing, seriousness criteria for the other events, or statistical comparisons. The absence of serious events and deaths in these listed groups is a descriptive finding in the posted results, not evidence that the risk is zero. The other-event counts should likewise be read as counts, not as proof of a difference between methods.

Safety counts can be affected by the amount of time participants are observed, how events are collected, and whether a participant can contribute events under both conditions. The registry record does not provide enough detail to resolve those issues for this comparison. It also lists no serious adverse-event terms, so specific serious event types cannot be described.

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

This record establishes that investigators randomized participants to use insulin glargine through two delivery methods in a crossover study. It identifies treatment satisfaction, measured by the DTSQs, as the primary outcome and describes how that score is constructed and interpreted. It also lists other clinical and treatment-related outcomes and gives counts for adverse events and deaths.

What it does not establish is the size or direction of the primary satisfaction comparison. Numerical DTSQs results and a sponsor-reported statistical analysis are not present in the registry record. The record therefore cannot support a conclusion that one method produced higher satisfaction, that the methods were similar, or that any observed contrast was precise. A completed study status and a defined outcome are not substitutes for a reported result.

The design also shapes what can be concluded. Participants were assigned to sequences and used both delivery methods, but the record does not report the analysis model or the handling of period, sequence, or within-participant correlation. The effect of missing primary assessments is also not reported. Without these details, even a reader who had access to a simple group summary would not have enough information to assess the full analysis.

The safety figures show zero serious adverse events and zero deaths in each listed group, plus counts of other adverse events. These counts describe what the registry record posts, but they do not by themselves establish comparative safety. The record does not describe the events or report an inferential comparison, and the crossover design complicates treating the named groups as independent parallel groups.

General statistical explanation: absence of a reported difference is not the same as evidence of equivalence. An equivalence claim typically requires a prespecified margin and an analysis designed to evaluate whether the plausible treatment difference falls within that margin. Neither an equivalence margin nor such an analysis is reported in the registry record. The appropriate interpretation is therefore limited: the trial's question and measurement approach are identifiable, while its numerical primary-outcome answer and the precision of that answer are not available in the posted results.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why study design and result reporting must be considered together. The crossover structure means that participants used both delivery methods, with randomization determining the order. That design raises questions about within-participant dependence, treatment period, sequence, and missing assessments. A clear report of the analysis model would help readers understand how those features informed the estimated comparison. The registry record does not report that model.

The primary outcome is a patient-reported satisfaction score, while the listed secondary measures include laboratory outcomes and treatment-related events. These measures address different aspects of treatment and should not be treated as interchangeable. A satisfaction result would describe participants' reported experience; it would not, on its own, answer whether glucose measures or event counts differed. The record's distinction among these outcomes helps define the scope of the trial question, but the numerical results are not available.

The record also illustrates the difference between a completed trial and a fully interpretable results entry. It gives the enrollment, sequence descriptions, outcome definition, and some safety counts, yet reports no analysis entries and no numerical primary-outcome comparison. Without an estimate and an indication of its precision, readers cannot distinguish a small estimated difference from a larger but uncertain one, or judge how compatible the data are with different possible effects.

Finally, a sample-size calculation based on an observed effect is a planning illustration, not evidence that the study had a particular probability of finding a result. That distinction matters when interpreting post-study calculations. The original sample-size justification and statistical plan are not reported in the registry record. Together, these features make this record useful for identifying the methodological questions a reader should ask, but insufficient for drawing a statistical conclusion about satisfaction differences.

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 this trial from the registry record is that numerical results for the primary DTSQs outcome are not reported. The record gives the outcome definition and the assessment timeframe, but not the observed scores, treatment contrast, uncertainty interval, or test result. The number of participants in the primary analysis population is also not reported, despite the completion-based population description.

Important analysis details are unavailable. The record does not report the model used for the crossover comparison, how within-participant correlation or period and sequence were handled, or whether a carryover assessment was considered. It does not describe the period durations or any washout interval. These are not details that can be inferred simply from the crossover label.

The registry record does not report a missing-data strategy, reasons for missing assessments, or sensitivity analyses. It also does not state a multiplicity approach for the primary and secondary outcomes. Although multiple secondary measures are named, their numerical results are not included. The absence of these details limits assessment of the robustness and scope of any potential findings.

For safety, the record posts event counts but does not describe the other events, the observation periods used to compile the counts, or an analysis that accounts for the crossover structure. The study is listed as unmasked, which is a design characteristic relevant to interpreting a subjective satisfaction measure, but the record does not report procedures intended to address this or other sources of measurement influence. These limitations concern what can be assessed from the registry record; they do not establish that a particular bias occurred.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy — NCT01240200.
• Registry record last updated 2018-10-31; status last verified 2018-10.
• Results first posted 2014-10-30.
• 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

This is a phase 4, randomized, unmasked crossover trial sponsored by Emory University, with enrollment of 49 and status listed as completed. It compared insulin glargine delivered by vial and syringe with delivery by SoloSTAR pen, using randomized sequences in which participants used both methods.

The primary outcome was the mean DTSQs score at baseline and week 12 among participants completing both assessments. The registry record explains the scoring scale but does not report numerical primary-outcome results or a statistical analysis. HbA1c, fasting blood glucose, dosing errors, and hypoglycemic events are listed as secondary outcomes without numerical results.

The record lists zero serious adverse events and zero deaths in both delivery-method groups, with other adverse event counts of 22 and 15. It does not report details of those events or a comparative safety analysis. The original sample-size justification, statistical analysis plan, and missing-data methods are not reported in the registry record.