OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy (NCT01182493), a randomized na study. The primary outcome is Between Group Difference in HbA1c When Comparing CSII to MDI.

2. Clinical Question

The primary outcome is a between-group comparison of change in HbA1c, rather than a comparison of the groups’ HbA1c values at a single time point. Change is defined as the 6-month value minus the baseline value, so a negative change represents a decrease from baseline. The posted group means are -1.1 for insulin pump treatment and -0.4 for insulin treatment with MDI. The posted difference is expressed as the MDI mean minus the pump mean.

This question is a comparative-effectiveness question within the population and treatment context described by the registry. It does not by itself establish how the groups would compare in other populations, under other treatment regimens, or over a different follow-up period. The registry record describes a randomized, open-label, parallel-group trial with enrollment of 331 participants. Other details that might clarify eligibility, treatment management, or the intended interpretation of a meaningful HbA1c change are not reported in the registry record.

3. Trial Design

The registry identifies this as a randomized, parallel-group study with no masking. Participants were allocated to insulin pump treatment or treatment with multiple daily injections. The pump arm is described as receiving an insulin pump; the MDI arm is described as receiving basal/bolus therapy with rapid- and long-acting analogs and at least 3 injections per day. The study evaluated these strategies in people with type 2 diabetes who were taking insulin and were suboptimally controlled with MDI, according to the registry summary.

Enrollment was 331. The posted primary outcome includes 168 participants in the pump group and 163 in the MDI group. The record lists the study status as completed, a start date of 2010-12, and primary completion in 2014-02. The listed sponsor is Medtronic MiniMed, Inc. The phase is recorded as NA.

Random allocation is intended, in general, to help balance both measured and unmeasured participant characteristics between groups at assignment. The registry’s randomized designation does not establish how allocation was generated or concealed: those procedures are not reported in the registry record. With no masking, participants and study personnel were not described as blinded. That design feature may be relevant to outcomes that depend on experience or reporting, including treatment satisfaction, while HbA1c is a laboratory measure.

The primary endpoint is specified as change in HbA1c from baseline to 6 months. Several secondary outcomes are listed, including glycemic variability, treatment satisfaction, body weight, and safety outcomes. The registry record does not report detailed methods for handling adherence, treatment changes, missing observations, or the analysis population. The reported study design therefore identifies the broad comparison and follow-up, but not all procedures needed to reconstruct the trial’s statistical analysis.

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

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 Between Group Difference in HbA1c When Comparing CSII to MDI, measured over baseline and 6 months.

The primary endpoint measures change in HbA1c, expressed as a percentage, between baseline and 6 months. HbA1c is used as a measure of glycemic control over time. A change score is calculated as the 6-month HbA1c minus the baseline HbA1c: negative values indicate that the measured value was lower at follow-up than at baseline, while positive values indicate a higher follow-up value.

The registry’s primary question compares the mean change between the pump and MDI groups. The posted mean change is -1.1 in the pump group and -0.4 in the MDI group. The posted mean difference, defined as MDI minus pump, is 0.7. Read together, the group means show a larger average decrease from baseline in the pump group in this trial. This is a description of the posted endpoint results, not a conclusion about the clinical importance of that difference.

Mean change is a useful summary because it describes the average direction and size of change within each randomized group and permits a direct comparison between groups. It does not show how much individual participants varied, whether the change was similar across participant subgroups, or whether the magnitude is important to patients. Those questions require additional context or analyses, and such information is not reported in the registry record.

7. Results Posted in the Registry

• Insulin Treatment With MDI: mean -0.40 versus -1.10 on control; difference 0.70 (95% CI 0.45 to 0.95), standardized effect d = 0.61; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Insulin Treatment With MDI: mean -0.10 versus 0.00 on control; difference -0.10 (95% CI -0.30 to 0.10), standardized effect d = -0.13; z-test p = 0.333.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Insulin Treatment With MDI and the control. The interval gives the range of effects that remain compatible with the data.

Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Insulin Treatment With MDI: mean -2.60 versus -11.00 on control; difference 8.40 (95% CI 2.54 to 14.26), standardized effect d = 0.38; z-test p = 0.005.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Insulin Treatment With MDI than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Insulin Treatment With MDI: mean -0.26 versus 4.75 on control; difference -5.01 (95% CI -6.62 to -3.40), standardized effect d = -0.73; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Insulin Treatment With MDI than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcomes cover related but distinct domains: glycemic variability, treatment satisfaction, body weight, and safety. Group summaries and recalculated comparisons are posted for glycemic variability in hypo and hyper ranges and for the Diabetes Treatment Satisfaction Questionnaire. Although the registry lists seven outcome measures, six secondary outcomes are posted; complete comparative results for every listed secondary outcome are not present in the registry record.

Across the secondary outcomes with summaries, the numerical pattern is not uniform. Some comparisons have intervals that include zero, while others do not. That variability is not inherently inconsistent with the primary HbA1c result: the outcomes measure different constructs, use different scales, and have different participant counts. A measure of glycemic variability is not interchangeable with mean HbA1c change, and treatment satisfaction addresses a different question from laboratory-based glycemic control. The registry does not provide scale interpretation sufficient to translate every numerical direction into a clinical judgment.

These results can be viewed as contextual evidence about outcomes beyond the primary endpoint, but they do not replace or independently confirm the primary comparison. The comparisons are unadjusted and the registry lists no reported analyses for them. When many outcomes are examined, some may appear more unusual by chance, especially when no multiplicity strategy or hierarchy is reported. Their p-values and intervals should therefore be interpreted cautiously and not treated as a set of separate confirmatory findings.

Not all registered secondary outcomes have posted numerical results in the record. The absence of a posted result is not evidence that an outcome had no change or no difference. The registry does not report why some results are unavailable, whether they were analyzed, or how their reporting was selected. The overall secondary-outcome picture is consequently incomplete, and should be used to describe the available evidence rather than to make broad claims about all measured outcomes.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)
• Safety - Severe Hypoglycemia Incidence
• Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)
• Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)
• Change in Body Weight
• Safety - Diabetic Ketoacidosis Incidence

9. Statistical Interpretation

10. Statistical Methods Explained

Continuous outcomes are reported as means with standard deviations. A mean describes the average observed value in a group; a standard deviation describes how dispersed individual values are around that average. For the primary endpoint, the values are changes in HbA1c from baseline to 6 months. The mean is not the same as the change experienced by every participant, and the standard deviation is not a confidence interval for the group mean.

How should the mean difference be read?

The comparison is stated as the MDI group mean minus the pump group mean. Applying that sign convention to the posted primary means gives the posted difference of 0.7. Because the group means are negative changes, a positive difference in this direction corresponds to a larger average decrease in the pump group. The direction of a difference depends on the order of subtraction, so the comparison convention matters when reading its sign. The registry’s primary outcome description defines the endpoint but does not provide a detailed account of the statistical model used for the sponsor’s analysis.

What does a p-value describe?

The primary unadjusted p-value is <0.001. In general, a p-value is calculated under a specified null hypothesis and statistical model. It describes how unusual data at least as discrepant as those observed would be if that null hypothesis and model were correct. A smaller p-value can indicate greater incompatibility with the null under those assumptions, but it does not state the probability that the null is true. It also does not describe the size or importance of the effect, and it cannot correct for biases in design, measurement, missing data, or analysis.

The adjective “unadjusted” matters. It indicates that the posted p-value is not reported as adjusted for the examination of multiple outcomes or comparisons. No multiplicity adjustment is reported in the registry record. The reported p-value should not be silently treated as if it came from a prespecified family-wise error procedure or another correction.

What does a confidence interval add?

In general, a confidence interval gives a range of values compatible with the observed data and the method used to calculate it. Its endpoints reflect uncertainty in the estimate, rather than a range containing a specified proportion of individual participants’ results. A confidence interval for a mean difference is therefore not a prediction interval for what a new participant will experience. For the primary comparison, the posted interval is entirely positive under the MDI-minus-pump convention. That indicates that zero is outside the interval calculated for this comparison, but it does not settle the clinical interpretation of the estimate.

Why distinguish group variability from estimate precision?

The primary group standard deviations are 1.2 and 1.1. These summarize the spread of participant-level change scores within each arm. Precision of the between-group estimate depends on the variability and amount of information in both groups, together with the analysis method. A larger sample can generally reduce sampling uncertainty when other features are comparable, but it does not eliminate uncertainty or systematic bias. The registry does not report all analysis details needed to reproduce the sponsor’s estimate independently.

What can secondary comparisons establish?

The posted secondary comparisons use continuous-outcome summaries for the outcomes with available group means and standard deviations. Their recalculated estimates are simple, unadjusted comparisons from posted summary statistics. They are not a substitute for a sponsor-reported model, and they do not include adjustments for baseline values, covariates, clustering, or missingness. The registry record lists no reported analyses for these secondary outcomes. These comparisons can describe the numerical pattern in the posted summaries, but they should not be attributed to a fully specified inferential analysis that the registry does not report.

In general, multiple outcomes create a multiplicity issue: as more hypotheses are examined, the chance of at least one apparently unusual result can increase. A prespecified testing hierarchy, correction, or clear exploratory designation can help readers understand how to weigh findings. None is described in the registry record. The statistical methods used for any interim analysis, sample-size justification, or handling of protocol deviations are also not reported in the registry record, so no assumptions about them should be made.

Finally, general statistical interpretation must separate random error from other sources of uncertainty. Randomization supports a comparison of assigned groups, but does not guarantee identical observed characteristics or eliminate differential follow-up, measurement issues, or departures from assigned treatment. Open-label treatment may be especially relevant to subjective outcomes. The registry entries do not provide enough detail to assess these possibilities fully. The posted estimates are best read as summaries of the recorded trial results, with their stated precision and the reporting limitations described in the registry record.

11. Confidence Intervals and Precision

The primary mean difference is 0.7 for the MDI-minus-pump comparison. Its posted confidence interval lies above zero, and the unadjusted p-value is <0.001. Taken together, these features indicate that the posted primary estimate is distinguishable from zero under the reported comparison and calculation. The interval also shows that the exact size of the difference remains uncertain: it covers a range of positive values rather than identifying one fixed value as known without error.

A confidence interval is about uncertainty in an estimate, not the distribution of individual participant responses. The primary group standard deviations, 1.2 for pump treatment and 1.1 for MDI, describe within-group spread in change scores. They should not be read as uncertainty bounds on the difference. Nor does the confidence interval indicate whether a change is important to patients; that requires a clinical interpretation or threshold, which is not reported in the registry record.

The number of participants contributing to the primary summaries is 168 in the pump group and 163 in the MDI group. The registry record does not explain whether these counts include all randomized participants, how missing endpoint values were handled, or whether the analysis used an intention-to-treat population. Those details affect how precisely the estimate represents the randomized comparison and how readers should interpret the available-case summaries.

The secondary comparisons have their own confidence intervals and varying group counts. Their intervals reflect uncertainty for those specific outcomes and should not be used to infer precision for HbA1c. Unadjusted estimates and multiple outcomes add interpretive uncertainty beyond the width of any single interval. Precision is therefore only one part of the evidence: it describes sampling uncertainty under the calculation, not the full uncertainty from trial conduct, measurement, missingness, or selective reporting.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not the trial’s original design calculation. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each row considers detecting the stated fraction of the observed effect. The continuous-outcome figures are participants per arm; the general convention for time-to-event outcomes would be a total number of events, but the posted outcomes considered in these illustrations are continuous.

The 80% power column gives an estimated number of participants per arm for a design that would have an 80% chance of detecting the assumed effect, if that effect and the planning assumptions were correct. The 90% power column gives the corresponding number for a higher chance of detection. Power is a prospective design quantity under assumptions, not a measure of whether the observed trial result is reliable or important.

For each outcome, the rows consider the full observed effect and smaller fractions of that observed effect. The planning figures increase as the assumed effect gets smaller: a smaller difference is harder to distinguish from random variation, so more participants are generally needed. The figures are not the number enrolled in the trial and are not evidence that a particular sample size would guarantee a result. They also do not account for unreported features of the original trial design, such as any allowance for missing outcomes or the trial’s own prespecified assumptions.

This is not observed power. It is a planning illustration based on effect estimates from the posted results, which are themselves uncertain. Smaller observed estimates can produce especially large planning requirements, so the figures should be treated as sensitivity scenarios rather than as a recommendation or a reconstruction of the trial’s original sample-size justification. The registry record does not report that original justification.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.700; pooled standard deviation σ = 1.152.
2. n = 2 × (1.96 + 0.842)² × 1.152² / 0.700² = 42.5, rounded up to 43 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.7                      # observed difference in means
sigma <- 1.15184535436175                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1182493)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 43 (80% power), 57 (90% power)
 75% of observed effect: n per arm = 76 (80% power), 102 (90% power)
 50% of observed effect: n per arm = 171 (80% power), 228 (90% power)
power.t.test: 43.5 
Simulated power at n = 43 per arm: 0.794 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple secondary outcomes alongside the primary HbA1c comparison. It does not report a multiplicity adjustment, a hierarchy of hypotheses, or a distinction between confirmatory and exploratory secondary analyses. In general, testing multiple outcomes increases the opportunity for chance findings. If each result is considered on its own without accounting for the full set of tests, nominal p-values may overstate the strength of evidence across that set. The posted secondary p-values are unadjusted, so they should not be interpreted as controlling the overall chance of a false-positive conclusion.

The record identifies the primary endpoint and its timeframe, but a detailed statistical analysis plan is not reported in the registry record. The planned analysis model, covariate adjustment, procedures for interim analyses, and any rules for multiple testing are not reported. This limits the ability to judge whether every analysis was specified before the data were examined or to reconstruct the intended inferential framework.

Missing-data procedures and analysis populations are also not reported. The registry provides endpoint-specific participant counts, which differ across measures, but does not explain whether participants lacked measurements, were excluded for other reasons, or were analyzed under a particular population definition. It does not state whether missing outcomes were imputed, whether sensitivity analyses were conducted, or whether the main analysis followed intention-to-treat principles. These omissions matter because observed-case summaries may be affected if outcome availability is related to participant characteristics or response.

The registry record does not give a detailed account of protocol deviations, adherence, crossover, or changes in treatment after randomization. Those issues can affect the interpretation of a randomized assignment comparison, but their presence or absence cannot be inferred from the posted summaries. No conclusion about their impact is warranted without the relevant information.

These reporting gaps do not negate the reported results, but they constrain how completely the analysis can be evaluated. The primary result can be described using its posted estimate, interval, and unadjusted p-value. Greater confidence about the analysis strategy would require details on prespecification, multiplicity, missing data, and analysis populations that are not reported in the registry record.

15. 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: spinal stenosis l1-l2 (0.6%), hepatic abscess (0.6%), worsening hepatic abscess (0.6%), pancreatitis (0.6%), heart failure (0.6%).

The registry posts serious adverse event counts for 168 participants at risk in the pump group and 163 in the MDI group. Serious adverse events affected 13 participants in the pump group and 10 in the MDI group. Deaths are recorded as 0 in each group. These are counts, not a complete description of event timing, duration, severity by event, or causal relationship to treatment.

Other adverse events affected 108 participants in the pump group and 99 in the MDI group, using the same at-risk group sizes. The record also lists serious-event terms, including spinal stenosis L1-L2, hepatic abscess, worsening hepatic abscess, pancreatitis, heart failure, and abdominal pain, each shown with 0.6%. The registry excerpt does not give enough detail to assign each listed term to a specific treatment group or to assess its clinical context.

Adverse event counts should be interpreted as safety reporting, not as proof that an event was caused by the intervention. The registry does not report an analysis comparing groups, event exposure time, or detailed attribution and follow-up methods. No safety conclusion beyond the posted counts and listed terms can be drawn from these figures alone.

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

The primary result describes a difference in mean HbA1c change over the specified six-month period in this randomized comparison. The posted group means are negative, and the pump group’s mean change is more negative than the MDI group’s. With the comparison defined as MDI minus pump, the posted mean difference is 0.7. The confidence interval lies above zero, and the unadjusted p-value is <0.001. These values describe the recorded group comparison and its sampling uncertainty.

The result does not establish that every participant experienced a change matching the group average. The within-group standard deviations indicate variation in individual changes, and the registry does not provide distributions or subgroup results sufficient to characterize that variation further. The result also does not define whether the mean difference is clinically important. A clinical threshold or patient-centered interpretation of the HbA1c change is not reported in the registry record.

The comparison applies to the study context described: people with type 2 diabetes taking insulin and suboptimally controlled with MDI, randomized to pump treatment or MDI, with the primary endpoint assessed at 6 months. The result does not, on its own, establish what would occur in other populations, with different treatment approaches, or over longer follow-up.

Randomization is an important design feature for comparing assigned groups, but interpretation also depends on how participants were followed and analyzed. The registry does not report the analysis population, missing-data procedures, detailed allocation procedures, or adjustments. These omissions prevent a full assessment of how closely the posted summaries represent the original randomized groups and the intended analysis.

The secondary findings should not be treated as a unified measure of benefit or harm. They represent distinct outcomes, and some registered outcomes do not have posted numerical results. The unadjusted nature of the comparisons and the lack of a reported multiplicity plan further limit confirmatory interpretation. The findings support a statistical description of the posted results, not a recommendation about treatment choice.

17. Why This Trial Matters Statistically

This trial is statistically informative because it uses random allocation to compare two treatment strategies and specifies a direct, continuous primary endpoint: mean change in HbA1c from baseline to 6 months. The endpoint makes the direction of change interpretable, and the reported between-group estimate, confidence interval, and p-value allow readers to consider both the size and precision of the primary comparison rather than relying on group means alone.

The comparison also illustrates why estimates need their sign convention stated. The reported difference is MDI minus pump, whereas the group means are changes from baseline and both are negative. Reading the contrast in the stated order makes clear why the positive difference corresponds to the more negative mean change in the pump group. Without that convention, readers could misread the direction.

The record also illustrates the distinction between a primary finding and multiple secondary comparisons. Secondary outcomes can broaden understanding, but different measures answer different questions, and unadjusted results across multiple outcomes carry additional uncertainty. The incomplete posting of secondary results and missing analysis details show why registry summaries are not a substitute for a fully described statistical analysis plan and trial report.

Finally, planning illustrations based on observed effects can help readers see how required sample sizes depend on the effect assumed. Such figures are not the trial’s original design justification and do not turn the observed result into a forecast of replication. Together, the primary estimate, its precision, the secondary-outcome caveats, and the reporting gaps provide a useful example of how to read a clinical trial statistically without extending the evidence beyond what the registry records.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations are specific to interpreting this registry record. The trial is open-label, with no masking reported. That feature may affect outcomes that depend on participants’ perceptions or reporting, especially treatment satisfaction. It does not automatically invalidate a laboratory endpoint, but the lack of masking remains relevant to the overall assessment of how outcomes were measured and reported.

The posted primary summaries include 168 pump participants and 163 MDI participants, while secondary-outcome counts vary. The record does not explain the reasons for those differing counts or describe missing-data handling. As a result, the extent to which each outcome represents all randomized participants cannot be assessed from the registry record alone.

The registry identifies randomized allocation but does not report the allocation-generation or concealment methods. It also does not report the sponsor’s detailed statistical model, covariate adjustments, analysis population, or sensitivity analyses. Recalculated comparisons from summary statistics are unadjusted and should not be mistaken for a fully specified sponsor analysis.

Secondary outcomes are incompletely posted: six are listed as posted against seven outcome measures, while numerical results are available for fewer than all listed outcomes. No multiplicity procedure is reported. The missing results and lack of a testing hierarchy limit the strength of conclusions drawn from secondary comparisons. The record also does not report a clinical threshold for interpreting the primary mean difference or sufficient scale detail to interpret every secondary score.

Finally, follow-up for the primary endpoint is at 6 months. The registry does not establish whether the observed differences persist beyond that period. The posted information supports interpretation of the recorded short-term comparison, not assumptions about longer-term outcomes.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy — NCT01182493.
• Registry record last updated 2018-03-12; status last verified 2018-02.
• Results first posted 2016-03-15.
• 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.

22. Record Summary

NCT01182493 is a completed, randomized, open-label, parallel-group trial sponsored by Medtronic MiniMed, Inc. It enrolled 331 participants with type 2 diabetes and compared insulin pump treatment with multiple daily injections. The primary outcome was mean change in HbA1c from baseline to 6 months.

The posted mean changes were -1.1 for pump treatment and -0.4 for MDI. The MDI-minus-pump mean difference was 0.7, with an unadjusted p-value of <0.001 and a confidence interval above zero. Secondary outcomes cover glycemic variability, treatment satisfaction, body weight, and safety, but results are not posted for every listed outcome. The registry record does not report detailed analysis methods, missing-data procedures, analysis populations, or a multiplicity plan. Interpretation should therefore distinguish the primary posted comparison from the less complete, unadjusted secondary evidence and the safety counts.