Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose (NCT00741390), a randomized na study. The primary outcome is Blood Sample of Sufficient Volume to Yield a Valid Meter Reading.

2. Clinical Question

The clinical context in the registry record is the burden of obtaining a fingerstick sample during blood-glucose monitoring. The study therefore considered two related but distinct aspects of lancing: whether the sample was adequate for a meter reading and how the lancing experience was perceived. An adequate sample is a practical requirement for completing the measurement; pain and comfort describe the participant’s experience rather than the sample’s technical adequacy.

The main question is configuration-specific. The arms did not all receive the same set of devices, and the configurations were not assessed in identical numbers of participants. Accordingly, the primary question is not simply whether one device was better than another across one uniform group. The results would need to be interpreted in light of which devices were tested in each arm and the number assessed for each configuration. The registry record does not report the successful-reading counts or an estimate of a difference between configurations.

3. Trial Design

This was a completed, randomized, single-masked, parallel study with enrollment of 250 participants. The registry lists type 1 and type 2 diabetes mellitus as the conditions. The study began in 2008-08, and primary completion was recorded in 2008-09. The sponsor was Becton, Dickinson and Company. The phase was listed as NA.

Four arms assigned participants to different combinations of devices. Arm A tested BD/33G, OTM/33G and OTM/28G at Visit 1, then BD/33G and OTM/28G at Visit 2. Arm B tested BD/33G, OTM/33G and OTU/28G at Visit 1, then BD/33G and OTU/28G at Visit 2. Arm C tested BD/33G, OTM/33G and ACC/28G at Visit 1, then BD/33G and ACC/28G at Visit 2. Arm D tested BD/33G, OTM/33G and OTM/28G at Visit 1, then OTM/33G and OTM/28G at Visit 2.

Visit 1 assessed whether lancing produced enough blood for a valid meter reading. Visit 2 assessed perceived pain and overall comfort. For Visit 2 pain assessment, the registry describes using the lowest lancing-device setting that had produced a valid blood-glucose reading for that participant with the relevant device at Visit 1. The record also lists reported device preference within a lancing pair at Visit 2, and a pain difference analysis for Arm D.

The record identifies random allocation and single masking but does not report the randomization procedure, the party or parties masked, or how the sequence was generated or concealed. Details of the visit schedule beyond the stated visit labels, the interval between visits, and the conduct of the masking are not reported in the registry record. The design information therefore establishes the broad structure and device assignments, but not the operational details needed to reconstruct how the trial was run.

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: After enrollment, baseline characteristics such as demography, diabetes history, and current lancets were recorded for each subject. No additional baseline measures were taken. Thereafter, subjects were assigned to one of the 4 intervention arms. Subjects were able to complete the enrollment visit and Study Visit 1 activities on the first day.

Visit 1

Visit 2

Analysis population for the primary outcome, as defined in the registry: BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.

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 Blood Sample of Sufficient Volume to Yield a Valid Meter Reading, measured over Study Day 1 (Visit 1).

The primary endpoint was the number of participants in whom each device configuration produced a blood sample sufficient for a valid meter reading at Study Day 1, Visit 1. A successful lancing was defined as a technician using the lancing system to obtain a sample of sufficient volume for a valid reading. This is a binary outcome at the participant level for a given device assessment: the reading either met the study’s validity criterion or it did not.

This endpoint addresses a basic operational requirement of fingerstick glucose monitoring. A lancing procedure that does not yield enough blood cannot produce the intended meter reading, so sample adequacy is a direct measure of whether the device configuration completed that task. It differs from pain and comfort outcomes: those concern the subjective experience of the participant, while the primary endpoint concerns whether a technically usable sample was obtained.

The record states that the endpoint was assessed for several configurations and gives the numbers evaluated: BD/BD33g and Mini/BD33g were evaluated in 246 participants each, Mini/OT28g in 124, Ultra/OT28g in 63, and AC/AC28g in 60. The number with a valid reading in each group, and the corresponding proportions or uncertainty estimates, are not reported in the registry record. The record’s description of which participants were analyzed is incomplete, so the exact analysis-population rule cannot be fully reconstructed.

Because the measure is a count of participants with a successful reading, comparisons should be understood in relation to the participant count for each configuration. Unequal evaluation counts affect how much information each configuration contributes. No claim about which configuration had higher or lower adequacy can be drawn from the endpoint definition and denominators alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a binary participant-level measure: whether a device configuration yielded a blood sample sufficient for a valid meter reading. General statistical explanation: for a binary outcome, a basic summary is the number of participants meeting the definition alongside the number assessed. A proportion can communicate the frequency of success, while an interval estimate can communicate uncertainty around that proportion. The registry record gives evaluation counts but does not report the successful-reading counts, proportions, or confidence intervals.

What does a confidence interval communicate?

General statistical explanation: a confidence interval describes the uncertainty associated with an estimated quantity under a stated statistical method. A narrow interval indicates greater precision than a wide interval, all else equal. It does not guarantee that the estimate is unbiased, and it does not repair limitations in how participants were selected, how outcomes were measured, or how missing data were handled. No confidence intervals for the primary endpoint or other outcomes are reported in the registry record, so no precision assessment can be made for the trial’s outcome estimates.

Why does the study structure matter for comparisons?

Participants were randomized to arms, but each arm included assessments of more than one device configuration. Configurations were shared across some arms, and the number evaluated varied by configuration. The primary outcome description also refers to assessment of each device configuration within participants. General statistical explanation: observations from the same participant may be related, so treating them as independent can give an incorrect estimate of uncertainty. A suitable analysis may need to account for the within-participant structure as well as the randomized arm structure. The statistical model, comparison method, and treatment of repeated assessments are not reported in the registry record.

Randomization is intended to reduce systematic differences between assigned groups, on average, when comparing assigned interventions. It does not by itself specify the analysis. The record confirms randomized allocation, but does not report the sequence-generation method, allocation concealment, or a detailed analysis plan. It is therefore not possible to assess from the registry record whether the reported analyses followed an intention-to-treat approach, a per-protocol approach, or another defined population.

How should unequal evaluation counts be considered?

The record lists 246 participants evaluated for BD/BD33g, 246 for Mini/BD33g, 124 for Mini/OT28g, 63 for Ultra/OT28g and 60 for AC/AC28g. General statistical explanation: when outcome frequency and design are otherwise similar, estimates based on fewer observations tend to have greater sampling uncertainty. This is one reason to read an estimate together with its denominator and interval, rather than relying only on a point estimate. Here, the outcome counts and uncertainty intervals are not reported, so the effect of those differing denominators on the actual estimates cannot be assessed.

What can be concluded from the design description?

The primary outcome’s stated definition makes the success criterion operational: a technician had to obtain sufficient volume for a valid meter reading. The endpoint is not a measure of pain, preference, or general satisfaction. Those are separate outcomes assessed at Visit 2. For pain, the protocol description says the lowest setting that produced a valid reading at Visit 1 was used for the relevant device. General statistical explanation: when an outcome at a later visit depends on a result from an earlier visit, the later comparison can reflect both the device and the selection rule for the setting. Interpretation requires the analysis plan and outcome results, neither of which is fully reported in the registry record.

The trial lists 13 analyses and 4 outcome measures. These counts indicate that the record includes multiple analyses and outcomes, but do not reveal which analyses were confirmatory, which contrasts were planned, or how the outcomes were modeled. The statistical analysis plan, including test choice, model specification, covariate adjustment, and handling of multiple comparisons, is not reported in the registry record.

General statistical explanation: multiple testing arises when many hypotheses are assessed. If each is judged using a separate threshold without adjustment, the chance of at least one apparently notable result can increase. Methods to address multiplicity can include defining a primary contrast in advance, adjusting significance criteria, or presenting analyses as exploratory. The registry record does not report a multiplicity procedure, so the status and interpretation of the listed analyses cannot be determined from the analysis count alone.

The sample-size assumptions described for planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set as a stated fraction of an observed effect. These are planning assumptions, not reported details of the trial’s original design. The registry record does not report the trial’s own sample-size justification or a prospective power calculation. Planning illustrations should not be treated as observed power or as evidence that the study had a particular probability of detecting an effect.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 4 outcome measures and 13 analyses. The study also evaluated five device combinations, with different subsets assessed in the four arms and at the two visits. That creates multiple possible outcomes and contrasts, but the registry record does not identify a prespecified hierarchy of hypotheses or state which comparisons were primary, secondary, or exploratory beyond the named primary outcome. A multiplicity adjustment or other strategy for controlling the interpretation of multiple analyses is not reported in the registry record.

General statistical explanation: when several comparisons are examined, the opportunity to find an apparently unusual result by chance can increase. Knowing the planned comparisons and any adjustment method is important for judging whether a nominal statistical result should be treated as confirmatory. The analysis count alone does not show whether the comparisons were independent, whether they were selected in advance, or whether adjustment was used.

The primary outcome description says participants were analyzed for blood-volume adequacy if they completed depth-setting and volume testing for at least a stated part of the procedure, but the registry text is incomplete at that point. The full inclusion rule, handling of participants with incomplete assessments, and handling of invalid or missing readings are not reported in the registry record. The number enrolled is 250, while the device-specific evaluation counts differ; the record does not explain all reasons for those differences.

The analysis population for each secondary outcome, missing-data methods, and any imputation procedure are not reported in the registry record. Nor are withdrawals, exclusions after randomization, or the extent and pattern of missing outcomes described in the available record. Without these details, it is not possible to determine whether missingness could have affected the comparisons or whether the analyzed participants remained representative of those randomized.

11. 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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events among 62 participants at risk in Arm A, zero among 63 in Arm B, zero among 62 in Arm C, and zero among 63 in Arm D. These are observed counts for the reporting period described in the registry. They do not establish that the risk of serious events was absent, and the record does not provide a comparative statistical analysis of serious adverse events.

Other adverse events were reported for 5 participants in Arm A, 6 in Arm B, 11 in Arm C and 6 in Arm D. These are counts, not rates, and should be read alongside the number at risk in each arm. The registry record does not provide event descriptions for these other adverse events in the information available for this summary, nor does it state whether events were judged related to a study device or procedure. The counts alone cannot establish causation or a difference in risk between arms.

The record lists no serious adverse-event terms. Death counts are not reported in the registry record. Safety interpretation is therefore limited to the arm-level counts and should not be expanded into conclusions about overall safety or comparative safety.

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

The study was designed to evaluate whether several fingerstick lancing-device and lancet combinations could obtain enough blood for a valid meter reading, and to assess pain and comfort during use. The registry record defines the primary endpoint and describes how participants were assigned to device-testing arms. It also reports the numbers evaluated for each primary-outcome configuration and provides limited adverse-event counts.

Those design details explain what the study sought to measure, but they do not show the primary outcome results. The registry record does not report how many participants achieved a valid reading with each configuration, comparative estimates, or confidence intervals. As a result, it is not possible to state which configuration had more successful readings, how large any difference was, or how precisely a difference was estimated. The same limitation applies to pain, comfort and device preference: the outcomes are described, but their results are not reported in the registry record.

The findings, even if outcome values were available, would need to be interpreted in the context of the tested configurations, arm assignments, and differing evaluation counts. Some configurations were assessed in more than one arm, and the registry record does not report the statistical approach used to account for the study structure. It also does not report the full analysis populations, missing-data methods, or multiplicity approach.

General statistical explanation: a study outcome is evidence about the participants and conditions actually assessed, not automatically a guarantee of performance in every setting. The registry’s design and endpoint descriptions do not establish whether any device is preferable or appropriate for an individual. No treatment recommendation follows from the information reported. The record supports a description of the research question and available reporting, while the unreported outcome and analysis details prevent a quantitative conclusion about device differences.

13. Why This Trial Matters Statistically

This study is statistically interesting because it combines an objective task outcome with participant-reported experience. A valid meter reading is defined by whether the sample volume was sufficient for the technician to obtain a reading; pain and comfort capture different aspects of the lancing experience. Keeping these outcomes distinct matters because success on one does not, by definition, establish a result on another.

The design also uses several device combinations rather than a single uniform intervention and comparator. The arm assignments create overlapping assessments, while the numbers evaluated vary by configuration. Such a structure makes the analysis plan important: estimates and their uncertainty depend on how repeated assessments and arm assignment are handled. The registry record does not report that plan, so the design cannot be translated into a fully specified comparative analysis.

The record highlights another important reporting principle: denominators and outcome values serve different roles. The device-specific counts indicate how many participants were evaluated, but they do not disclose how many had a successful reading. Without numerators and uncertainty estimates, readers cannot judge either the observed frequency or its precision. Similarly, counts of other adverse events do not provide a complete comparison of safety.

Finally, the listed 13 analyses and 4 outcome measures make transparency about prespecification and multiplicity relevant. Statistical interpretation depends not only on the number of analyses but also on which comparisons were planned and how they were interpreted. Those details are not reported in the registry record. The trial therefore illustrates why a clear endpoint definition and design description are useful, while complete outcome reporting and analysis methods are necessary for judging comparative evidence.

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 main limitation for interpreting the study is that the registry record does not report the primary outcome counts or comparative estimates. It gives the definition of a successful lancing and the number evaluated for each configuration, but not the number who obtained a valid meter reading. Without those values, no comparison of blood-volume adequacy can be described.

Results for Visit 2 pain, overall comfort, and device preference are also not reported in the registry record. The pain procedure is described, including use of the lowest setting that yielded a valid reading at Visit 1, but the pain scores and their statistical summaries are absent. The registry record does not report confidence intervals, significance tests, or other measures of uncertainty for the listed outcomes.

The analysis-population description for the primary endpoint is incomplete. It refers to completion of depth-setting and volume testing but does not preserve the complete eligibility rule. Reasons for the different evaluation counts, exclusions, withdrawals, missing outcomes, and the handling of incomplete data are not reported in the registry record. The statistical method for within-participant assessments and the method for comparing configurations are likewise not reported.

The registry confirms randomized, single-masked, parallel allocation but does not state the randomization procedure, concealment method, identity of the masked party, or detailed conduct of masking. The analysis plan, sample-size justification for the trial, and multiplicity approach are not reported in the registry record. The sample-size assumptions described for planning illustrations should not be mistaken for the original trial’s design justification.

Safety reporting is limited to arm-level serious and other adverse-event counts. Event descriptions and death counts are not reported in the registry record. These reporting gaps restrict conclusions about both efficacy-related outcomes and safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose — NCT00741390.
• Registry record last updated 2010-03-10; status last verified 2010-03.
• Results first posted 2010-03-10.
• 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

The registry describes a completed, randomized, single-masked, parallel study enrolling 250 people with type 1 or type 2 diabetes mellitus. It evaluated five lancing-device and lancet combinations across four arms. The primary outcome was the number of participants obtaining a valid meter reading from a blood sample of sufficient volume at Visit 1. Visit 2 assessed pain, comfort and device preference.

The registry reports device-specific evaluation counts of 246 for BD/BD33g, 246 for Mini/BD33g, 124 for Mini/OT28g, 63 for Ultra/OT28g and 60 for AC/AC28g. It does not report the primary success counts or the Visit 2 outcome results in the record. Statistical analysis methods, missing-data handling, multiplicity procedures and the trial’s sample-size justification are not reported in the registry record.

No serious adverse events were reported in the four arms; other adverse-event counts were 5, 6, 11 and 6, respectively. Death counts are not reported in the registry record.