Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes (NCT00401622), a randomized na study. The primary outcome is Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS..

2. Clinical Question

The clinical question is about the comparative change in a laboratory measure during use of the two monitoring approaches. It is not a comparison of whether participants monitored their glucose, but of the specified monitoring system against standard care with a traditional system. The registry describes the study as testing clinical benefits over 52 weeks of use. It does not report a broader primary question about complications, long-term outcomes, or overall quality of life.

The posted primary comparison estimates a mean difference of -0.17 for the OneTouch® Ultra®2 System relative to Standard Care. The registry’s sponsor-reported analysis gives a 95% confidence interval from -0.38 to 0.04 and p = 0.45. A separate unadjusted recalculation gives a similar rounded point estimate but a different p-value. These results should be read as estimates of the recorded group contrast, with uncertainty, rather than as proof that the groups are identical or that either approach has a particular clinical effect.

3. Trial Design

The registry describes a completed randomized, parallel-group study sponsored by LifeScan. The listed enrollment is 320. The study began on 2006-10-01, and primary completion is recorded as 2009-01-01. Its brief description concerns use of the OneTouch® Ultra®2 blood glucose monitoring system versus standard blood glucose monitoring during 52 weeks.

Participants were assigned to the OneTouch® Ultra®2 System or Standard Care. The control description specifies standard care with a traditional blood glucose monitoring system. Both interventions are classified as behavioral in the registry. Allocation is recorded as randomized, the model as parallel, and masking as none. Thus, the record indicates that participants were assigned to concurrent groups without masking; it does not give further details about how allocation was generated or concealed.

The primary endpoint is change in A1C from baseline to week 52. The primary outcome summaries list 125 participants for the OneTouch® Ultra®2 System group and 116 for Standard Care. These outcome-specific counts are not the same as the listed enrollment, and the record does not explain the difference. The secondary glycemic-excursion outcome has separate reported counts of 115 and 101. Serious and other adverse-event risk groups are each listed as 160 per arm. These counts refer to different registry outcome records and should not be added together or treated as interchangeable analysis populations.

The record labels the phase as NA. It does not report further detail on recruitment procedures, eligibility criteria, assignment concealment, participant adherence, or the handling of deviations from assigned treatment. Information about the trial’s original sample-size justification beyond the stated design objective is not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS., measured over From baseline to 52 wks.

The primary endpoint is the change in A1C from baseline to week 52, with the outcome expressed as a percentage. A1C is a blood measure used to assess longer-term glucose levels. In general, measuring its change over a defined follow-up period can describe whether the measure shifted during the study, while comparing changes between randomized groups helps distinguish the observed group contrast from change occurring in both groups.

The registry identifies the primary parameter as a least-squares mean and its dispersion as a standard error. In general, a least-squares mean is a model-based group estimate; its interpretation depends on the model used. The record reports that the sponsor’s primary analysis used ANCOVA and describes its parameter as a mean difference in final values. The endpoint title, by contrast, specifies change from baseline to week 52. The registry does not explain this difference in endpoint wording and analysis description, so the reported analysis should be understood using the wording attached to each result.

The posted group summaries for the primary outcome are -0.35 for the OneTouch® Ultra®2 System and -0.18 for Standard Care. The reported mean difference is -0.17, with a sponsor-reported 95% confidence interval from -0.38 to 0.04. The interval describes uncertainty around the estimated contrast; it includes values on either side of zero. The endpoint is useful for comparing the recorded change in A1C, but it does not by itself establish the clinical importance of the difference. A threshold for clinical importance is not reported in the registry record.

7. Results Posted in the Registry

• OneTouch® Ultra®2 System: mean -0.35 versus -0.18 on control; difference -0.17 (95% CI -0.38 to 0.04), standardized effect d = -0.21; z-test p = 0.107.

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 Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.

• 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:
  • OneTouch® Ultra®2 System: mean 102.70 versus 105.80 on control; difference -3.10 (95% CI -14.75 to 8.55), standardized effect d = -0.07; z-test p = 0.602.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between OneTouch® Ultra®2 System and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcome concerns change in daily glycemic excursions between the OneTouch® Ultra®2 and control blood glucose monitoring systems at 52 weeks. The endpoint is recorded in mg/dL. The registry reports group means of 102.7 and 105.8, and a recalculated mean difference of -3.1 with a confidence interval from -14.75 to 8.55. The sponsor’s reported analysis gives a mean difference of 7.56, with a 95% confidence interval from -7.24 to 22.36 and p = 0.31. These are distinct analyses and the record does not explain the difference in point estimates.

The broad pattern is that the secondary estimate is uncertain: its posted intervals include zero, and the sponsor-reported test does not indicate strong evidence against a zero-difference null. This pattern is not inconsistent with the uncertainty in the primary result, but the secondary outcome measures a different aspect of glucose variability and should not be treated as a direct confirmation of the primary A1C result. The record does not establish a formal relationship between the endpoints.

Unadjusted secondary findings generally carry less weight than a prespecified primary analysis because examining multiple outcomes can increase the chance of apparently notable findings arising by chance. In general, adjustment procedures or a clearly specified hierarchy can address multiplicity, but whether such procedures were planned or used is not reported in the registry record. The secondary result is therefore best read as supplementary evidence, with attention to its method, uncertainty, and the absence of reported multiplicity details, rather than as an independent confirmatory conclusion.

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

• Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.

9. Statistical Interpretation

10. Statistical Methods Explained

What does the reported mean difference represent?

A mean difference expresses the estimated separation between group means on the outcome’s original scale. For the primary result, the registry reports -0.17 for the OneTouch® Ultra®2 System relative to Standard Care. A negative estimate indicates that the value assigned to the intervention group is lower than the value assigned to the control group under the contrast’s stated ordering. Because the endpoint is a change measure, the direction should be interpreted alongside the endpoint definition and the registry’s analysis description, rather than treated as a stand-alone judgment of clinical value.

The group summaries list -0.35 for OneTouch® Ultra®2 and -0.18 for Standard Care. The registry gives the primary measure as a least-squares mean with standard error for dispersion. In general, a standard error describes the precision of an estimated mean; it is not the same as the spread of individual participant outcomes. The record does not provide enough detail to reconstruct the sponsor’s full model from the summary values.

What does ANCOVA contribute?

The sponsor reports an ANCOVA analysis. In general, analysis of covariance compares outcome values between groups while accounting for specified covariates in a statistical model. This can yield an adjusted estimate and uncertainty interval. Which covariates were included, how they were encoded, and how missing observations were handled are not reported in the registry record. Those details matter when interpreting or attempting to reproduce an adjusted result.

The registry describes the sponsor’s parameter as a mean difference in final values, even though the primary endpoint title refers to change from baseline to week 52. These phrases can refer to different analysis formulations. The record does not clarify whether the model used baseline values as covariates or how the endpoint wording maps onto the analysis parameter. The reported estimate should therefore be cited with its recorded method and label rather than attributing unreported model details.

How should the p-values be read?

The sponsor reports p = 0.45 for the primary ANCOVA result. A p-value measures how unusual data at least as incompatible with a specified null model would be, under the assumptions of the test. In general, it is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The registry’s unadjusted recalculation reports p = 0.107. That value comes from a different calculation based on posted summary statistics and should not be conflated with the sponsor’s result.

The secondary outcome has a sponsor-reported p = 0.31 and an unadjusted recalculated p-value of 0.602. These values also arise from distinct analyses. The registry does not report an adjustment for multiple comparisons; unadjusted secondary p-values should consequently be treated as exploratory rather than as stand-alone confirmatory evidence.

What is the role of the confidence interval?

A confidence interval gives a range of estimates reasonably compatible with the observed data under the method’s assumptions. In general, a 95% confidence procedure would cover the true parameter in 95% of repeated samples under those assumptions. It does not mean there is a 95% probability that this particular interval contains the true value. The sponsor’s primary interval is -0.38 to 0.04; the recalculated interval is -0.377 to 0.036. Both include zero. The reported interval is tied to the analysis that produced it, so the sponsor’s interval belongs with its ANCOVA result and the recalculated interval with the unadjusted calculation.

Why do the recalculated figures have a different basis?

The recalculation uses the posted means and standard errors to approximate an unadjusted comparison. The primary record notes that the pooled standard deviation is approximate. In general, reconstructing an analysis from group summaries cannot reproduce all features of a model-based analysis, including covariate adjustment or individual-level data patterns. The recalculated estimate and interval are useful for an independent summary-statistic perspective, but they are not a substitute for the sponsor’s analysis and do not demonstrate that the calculations use identical assumptions.

For the secondary glycemic-excursion outcome, the recalculated mean difference is -3.1 mg/dL, with a confidence interval from -14.75 to 8.55. The sponsor reports 7.56, with a 95% confidence interval from -7.24 to 22.36. Since the recalculation uses an unadjusted comparison and the sponsor reports a two-sided t-test, the estimates should be presented according to their recorded methods. The registry does not give further details to reconcile the differing point estimates.

These methods answer related but not identical questions. The sponsor’s reported model-based analysis is the principal account of the trial’s own analysis. Recalculation provides an additional, explicitly unadjusted reading of summary data. General statistical interpretation requires keeping the estimate, interval, test, endpoint definition, and analysis population together, rather than treating any single p-value as the full result.

11. Confidence Intervals and Precision

The primary sponsor-reported estimate is -0.17, with a 95% confidence interval from -0.38 to 0.04. The interval crosses zero and spans values below and above it. This means the data do not pin the group contrast to a single precise value; the estimate is compatible with more than one direction of difference under the analysis assumptions. The p-value of 0.45 likewise does not provide strong evidence against a zero-difference null under the sponsor’s test, but it does not establish that the groups are identical.

The unadjusted recalculation gives a 95% confidence interval from -0.377 to 0.036 around the -0.17 estimate. Its endpoints are close to the sponsor interval when rounded to two decimal places, but its p-value is 0.107 rather than 0.45. This illustrates why an estimate and confidence interval must be interpreted alongside the method used. The recalculated interval reflects the summary-statistic procedure, not the sponsor’s ANCOVA.

In general, a confidence interval describes statistical uncertainty, not the range in which every participant’s outcome lies. A narrower interval indicates greater precision for the group contrast, while a wider interval leaves more uncertainty about its size. Precision depends on factors such as variability, analyzed sample size, and analysis method; the record does not provide enough detail to attribute the observed interval width to any one factor.

The registry does not report a clinical-importance threshold for A1C change, so statistical uncertainty cannot be translated into a judgment about whether values within the interval would matter clinically. The interval is best read as a range of plausible estimates under the stated analysis, with zero among them, rather than as proof of no effect or proof of equivalence.

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 describe participants per arm, not total events. They are illustrations based on the observed effect, not the trial’s original sample-size calculation. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect as the effect to detect. The trial’s own original design assumptions beyond the recorded statement about its design objective are not reported in the registry record.

The 80% power column gives the participants per arm estimated for a design with an 80% chance of detecting the assumed effect under the listed planning assumptions, if that effect were the true effect and the assumptions held. The 90% power column uses a higher target chance of detection under those same assumptions. These are design-planning quantities, not guarantees about the outcome of a future study.

The rows describe planning for 100%, 75%, and 50% of the observed effect. For the primary comparison, the figures for 100% are 363 participants per arm for 80% power and 486 for 90% power; planning for 75% gives 646 and 864, and planning for 50% gives 1,452 and 1,943. The secondary outcome figures are larger: for 100%, 3,204 and 4,290; for 75%, 5,696 and 7,626; and for 50%, 12,816 and 17,157. Each pair corresponds to the 80% and 90% power targets, respectively.

Smaller assumed effects require more participants to detect under the same assumptions, which is why the figures increase as the planned fraction of the observed effect decreases. This is not observed power: it is a planning illustration, not a retrospective measure of how likely the completed trial was to detect its result.

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 = -0.170; pooled standard deviation σ = 0.817.
2. n = 2 × (1.96 + 0.842)² × 0.817² / -0.170² = 362.8, rounded up to 363 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 <- -0.17                      # observed difference in means
sigma <- 0.817310980284569                     # 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(401622)
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 = 363 (80% power), 486 (90% power)
 75% of observed effect: n per arm = 646 (80% power), 864 (90% power)
 50% of observed effect: n per arm = 1,452 (80% power), 1,943 (90% power)
power.t.test: 363.8 
Simulated power at n = 363 per arm: 0.802 (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. Analyses Reported by the Sponsor

The sponsor’s primary analysis is an ANCOVA result: a mean difference in final values of -0.17, with a 95% confidence interval from -0.38 to 0.04 and p = 0.45. This is the trial’s reported analysis and should be kept distinct from the recalculated unadjusted comparison. The recalculation uses posted summary statistics rather than the individual-level analysis and model used for the sponsor result.

The unadjusted recalculation gives a mean difference of -0.17, a confidence interval from -0.377 to 0.036, and p = 0.107. The point estimates are the same as reported to two decimal places, while the p-values differ. The registry does not state why they differ, so no specific cause can be assigned. In general, an adjusted model and an unadjusted summary-statistic calculation may use different information and assumptions; that general distinction does not establish which particular feature explains this pair of results.

The sponsor result should be cited as the study’s own analysis, with its method and interval. The recalculation can be useful as a separate check based on posted summaries, but it should not be presented as a correction to the sponsor’s analysis. The discrepancy flag is false. The registry does not provide further model details that would allow a full independent reproduction of the ANCOVA.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary A1C outcome and a secondary daily glycemic-excursion outcome. It does not report whether the trial prespecified a hierarchy among outcomes, adjusted significance thresholds for multiple testing, or used a multiplicity-control procedure. Without those details, the sponsor-reported secondary p-value should not be interpreted as though it were necessarily protected against the possibility of multiple comparisons. In general, multiplicity matters because repeated testing across outcomes can make chance findings more likely.

Information about missing outcome data is not reported in the registry record. The record does not state how many participants lacked week 52 measurements, whether missing values were imputed, or whether sensitivity analyses were conducted. The endpoint counts are 125 and 116 for the primary outcome and 115 and 101 for the secondary outcome, while the registry enrollment is 320. These are separate registry counts; no account of why they differ is reported, and they should not be used to infer the reasons for missingness or follow-up.

The analysis population is not described in enough detail to establish whether the sponsor used an intention-to-treat population, a per-protocol population, or another defined group. The record also does not report how treatment discontinuation, non-adherence, or changes in assigned care were handled in the analysis. Randomized allocation is recorded, but randomization alone does not identify the population included in each outcome analysis.

These omissions limit assessment of possible bias. In general, missingness can affect an estimate when the probability of having an observed outcome is related to the outcome itself or to group assignment. The registry does not provide information needed to assess that possibility in this study. Interpretation should therefore remain anchored to the posted analyzed outcomes and reported methods, while recognizing that the analysis population, missing-data approach, and multiplicity strategy are not reported in the registry record.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

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

Serious events with the highest arm-level rate: blocked arteries across groin (0.6%).

The serious adverse-event risk group is listed as 160 in each arm. The registry reports zero serious adverse events in the OneTouch® Ultra®2 System group and one in Standard Care. The other adverse-event category is listed as zero in both groups. These are registry event counts within the stated risk groups; they should not be interpreted as proof that no other harms occurred outside the recorded categories or observation period.

The registry lists BLOCKED ARTERIES ACROSS GROIN as a serious adverse-event term with 0.6%. It does not provide enough detail in this entry to assign that percentage to a specific arm or to characterize the event beyond the recorded term. Death counts are not reported in the registry record.

These figures are descriptive. With few recorded serious events, the counts alone do not provide a precise comparison of risk, and they do not establish that the groups had equal safety profiles. The registry does not report further information about event ascertainment, relatedness to the intervention, exposure time, or a formal safety comparison. The findings should be read as the adverse-event entries recorded, not as a complete estimate of all possible harms.

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

The posted data describe a randomized comparison of the OneTouch® Ultra®2 blood glucose monitoring system with standard care over 52 weeks. For the primary A1C outcome, the sponsor reports a mean difference of -0.17 and a 95% confidence interval from -0.38 to 0.04. The interval includes zero, leaving uncertainty about the direction and size of the group contrast. The sponsor’s p-value is 0.45. These figures do not establish a clear difference, but they also do not demonstrate that the approaches are equivalent.

The separate unadjusted recalculation gives a similar rounded point estimate but a different p-value. It is not the sponsor’s ANCOVA analysis and should be interpreted as a supplementary calculation from summary statistics. The registry does not explain the p-value difference or provide the model details needed to reproduce the sponsor analysis in full.

The secondary outcome also has an uncertain estimate, and the registry does not report whether multiplicity was addressed. The event counts are sparse, with one recorded serious adverse event in the Standard Care group and none in the OneTouch® Ultra®2 group; this does not establish comparative safety. Missing-data procedures and analysis-population definitions are not reported in the registry record.

In general, statistical evidence is only one part of interpretation. The registry does not provide a threshold for clinically important A1C change, detailed adherence information, or the full analysis plan. Consequently, the posted results support a careful description of the measured outcomes and their uncertainty, not a broad conclusion about clinical benefit, lack of benefit, equivalence, or safety. Conclusions should be limited to the recorded outcomes and follow-up in this trial.

18. Why This Trial Matters Statistically

This trial illustrates why an estimated treatment contrast should be read together with its uncertainty and analysis method. The primary sponsor estimate is straightforward to state, but its confidence interval includes zero, and the registry also contains an unadjusted recalculation with a different p-value. Keeping the sponsor’s ANCOVA result separate from the summary-statistic recalculation prevents unlike analyses from being treated as interchangeable.

The record also demonstrates the importance of precise endpoint language. The primary outcome title refers to change from baseline to week 52, while the sponsor analysis is described as a mean difference in final values. Those descriptions may correspond to different statistical formulations, and the registry does not explain their relationship. Reporting the exact endpoint and method helps readers avoid assuming details that are not documented.

Planning figures offer another useful statistical lesson. Sample-size illustrations based on observed effects rise sharply when the assumed effect is made smaller or the target power is increased. They are planning scenarios under stated assumptions, not evidence that the completed study had a particular observed power or that a future trial will necessarily reproduce the same effect.

Finally, the record makes visible the limits of registry reporting. It provides randomized allocation, outcome estimates, intervals, and adverse-event counts, but does not report key details on missing data, analysis populations, multiplicity, or the full statistical model. Those details are necessary for a complete appraisal of how robust the estimates are. The statistical value of the record lies in both what it reports and the boundaries it places on interpretation.

19. 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 trial-specific reporting limitations affect interpretation. The registry lists an enrollment of 320, while the primary and secondary outcome entries report different group counts. The reasons for those differences, the number of missing week 52 outcomes, and the handling of missing data are not reported in the registry record. Analysis-population definitions and sensitivity analyses are also not reported.

The primary endpoint is described as change from baseline, whereas the sponsor’s analysis parameter is described as a mean difference in final values. The registry does not explain how those descriptions relate, nor does it provide the ANCOVA covariates or other model specifications. This prevents full independent reconstruction of the sponsor analysis. The unadjusted recalculation is therefore a distinct summary-statistic analysis, not a replication of the sponsor’s model.

The record does not report a multiplicity strategy for the secondary outcome, a clinical-importance threshold for A1C, or detailed information about adherence and treatment discontinuation. Masking is recorded as none, but the registry does not describe outcome assessment procedures. Safety reporting gives event counts and one serious-event term but not event relatedness, exposure-adjusted rates, or death counts. These omissions limit conclusions about both efficacy-related outcomes and safety.

The registry records a completed randomized parallel-group study with 52 weeks of use, but the findings should not be generalized beyond the outcomes, population, and follow-up that are described. Broader claims about long-term effects or other clinical outcomes are not supported by the reported information.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes — NCT00401622.
• Registry record last updated 2019-05-15; status last verified 2019-05.
• Results first posted 2010-09-16.
• 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.

23. Record Summary

NCT00401622 is a completed randomized, parallel-group study sponsored by LifeScan, comparing the OneTouch® Ultra®2 System with Standard Care using a traditional blood glucose monitoring system. The registry lists 320 participants enrolled, no masking, and 52 weeks of use. The primary outcome is change in A1C from baseline to week 52.

The sponsor’s ANCOVA result is a mean difference of -0.17, with a 95% confidence interval from -0.38 to 0.04 and p = 0.45. An unadjusted recalculation gives -0.17, with a confidence interval from -0.377 to 0.036 and p = 0.107. The secondary glycemic-excursion result is also uncertain, and the record does not report multiplicity or missing-data procedures. Serious adverse-event counts are zero in the OneTouch® Ultra®2 group and one in Standard Care; death counts are not reported in the registry record.