Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System (NCT03165110), a na na study. The primary outcome is Percent of Responses From Persons With Diabetes That 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success With Syncing the Reading on the Onyx Glucose Meter and App..

2. Clinical Question

The question is about reported experience with successful syncing, not a comparison of the system with another device or usual care. The record says staff obtained short questionnaire responses from people with diabetes. Response choices also included Disagree, Strongly Disagree, and No Opinion. Because the primary endpoint groups neutral responses with agreement, it does not represent positive agreement alone.

The record lists 47 participants as enrolled, while the stated primary-outcome population is 46 people. It does not explain the difference or state how many people completed the questionnaire. The primary result itself is not reported in the registry record, so the observed percentage and its precision cannot be described from this record.

3. Trial Design

This was a completed, single-group study of the Onyx blood glucose meter and app system. The registry lists Ascensia Diabetes Care as sponsor, describes the intervention as a device, and states that participants used the system at home. The study dates are 2017-03-17 to 2017-05-12 for start and primary completion, respectively. The registry status is COMPLETED.

The arm description identifies participants as people with type 1 or type 2 diabetes for at least 6 months who used insulin. The primary-outcome population is specified as 46 people with insulin-dependent diabetes. The enrollment field reports 47. The registry record does not explain how enrollment relates to the primary-outcome population or whether any participants did not contribute endpoint data.

Allocation is marked NA, the model is single group, and masking is listed as none. No randomized assignment or blinding is described. Accordingly, the study is a within-group evaluation of use and questionnaire feedback, not a randomized test against a control arm. The registry record does not report a comparator, a separate usual-care group, or a protocol-defined control condition.

The main study purpose is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter. The primary measure concerns questionnaire responses about syncing readings between the meter and app over 6 weeks. Secondary outcomes listed include changes in HbA1c%, fructosamine, body weight, BMI, and total daily insulin dose from study start to end. Results for these secondary measures are not reported in the registry record.

The registry record does not report the rationale for the enrollment target, eligibility criteria beyond the arm description, details of follow-up procedures, or a statistical analysis plan. The posted information supports describing the study structure and outcomes of interest, but not reconstructing design choices that are absent from the 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 46 people with insulin-dependent diabetes

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: 46 people with insulin-dependent diabetes

6. Primary Endpoint

The registry lists the primary outcome as Percent of Responses From Persons With Diabetes That 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success With Syncing the Reading on the Onyx Glucose Meter and App., measured over 6 weeks.

The primary endpoint is the percentage of responses from people with diabetes that were Strongly Agree, Agree, or Neither Agree nor Disagree to questionnaire statements about success syncing a blood glucose value from the meter to the app. The stated timeframe is 6 weeks. Staff obtained responses using short questionnaires, and the registry describes the target population as 46 people with insulin-dependent diabetes.

This endpoint is used to capture participants’ reported experience of a specific system function: whether meter readings sync with the app. It reflects user feedback rather than an objective measure of glucose control or a clinical outcome. The response set also allowed Disagree, Strongly Disagree, and No Opinion. Including the neutral category means that the endpoint’s stated grouping is broader than a measure of agreement alone; its percentage should not be interpreted as the percentage expressing positive endorsement.

The record does not report the observed percentage, the number of responses in each category, the number of completed questionnaires, or the calculation details for the endpoint. It also does not specify whether each person contributed one response or multiple responses to the statements. Consequently, the registry record does not provide enough information to assess the endpoint’s estimate or its precision. The endpoint definition is available, but its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For a binary or categorical outcome, a percentage describes how much of the stated response set falls into a defined category or group of categories. In this study, the primary endpoint groups three questionnaire responses: Strongly Agree, Agree, and Neither Agree nor Disagree. The endpoint is framed as a percentage, but its calculation depends on the number of qualifying responses and the denominator used. Those counts and the calculation details are not reported in the registry record, so the percentage cannot be reconstructed.

What does a confidence interval describe?

In general, a confidence interval communicates statistical uncertainty around an estimated quantity. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. The interval does not eliminate uncertainty or correct for limitations in study design, outcome measurement, or missing data. No confidence interval for the primary endpoint is reported in the registry record.

Why does the response denominator matter?

For questionnaire outcomes, the response-level denominator may differ from the number of participants if people can answer multiple statements or if some responses are missing. The record describes questionnaire statements and gives a primary population of 46 people, but it does not report the number of completed responses or whether responses were combined across statements. The appropriate denominator and handling of incomplete responses are therefore not reported in the registry record. This matters because a percentage is interpretable only in relation to the responses counted in its numerator and denominator.

What can a single-group design estimate?

In general, a single-group study can describe outcomes observed among its participants. It does not, by itself, estimate the difference between outcomes under the intervention and outcomes under a comparator. A comparison group can help distinguish the intervention’s association with an outcome from other explanations, such as changes over time or participants’ expectations. This registry record lists one group, no masking, and no comparator. Its primary question is accordingly about participants’ reported syncing experience, not a controlled estimate of comparative effect.

How should the planning illustration be understood?

The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Such a calculation is a hypothetical planning exercise, not the study’s own design rationale and not observed power. The registry record does not report the trial’s sample-size justification or enough primary outcome results to assess a specific planning scenario from the posted information.

Why can over-dispersion matter?

In general, over-dispersion occurs when the variation in observed data is greater than a statistical model expects. If it is ignored, standard errors may be too small and uncertainty may be understated. It can arise in some kinds of count or clustered data, depending on how observations are generated. The registry record does not report an over-dispersion assessment or a statistical model for the questionnaire endpoint. It is therefore not possible to say whether over-dispersion was relevant to the analysis or how it was handled.

What does recalculation mean?

When a result is labelled recalculated, it generally means an unadjusted estimate has been reconstructed from posted summary statistics. Such a calculation can provide a check or an illustrative alternative, but it does not replace the sponsor’s own analysis when the two differ. The registry record does not report a primary result or analysis entries for the endpoint, so there is no recalculated endpoint estimate to interpret. A planning sample size is also not observed power: it describes a hypothetical design under stated assumptions rather than the probability that this completed study detected an effect.

More generally, an analysis should match the outcome definition and the structure of the observations. For a questionnaire endpoint, that includes clarifying the response categories being grouped, the analysis population, the response denominator, and the treatment of missing or repeated answers. The registry record does not report these analysis details. Statistical methods cannot resolve those omissions without additional information.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Users of the Onyx Blood Glucose Meter/ App System ")
n      <- c(46)
events <- c(41)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Users of the Onyx Blood Glucose Meter/ App System   46  41  89.1  76.4  96.4  77.0  95.3  76.9  95.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 9 outcome measures and names several secondary outcomes, including changes in HbA1c%, fructosamine, body weight, BMI, and total daily insulin dose. It does not report the results for these measures or any analysis entries. The registry record does not report whether the primary endpoint was formally distinguished from other outcomes in a statistical testing plan or whether any adjustment for multiple comparisons was used.

In general, testing several outcomes can increase the chance that at least one result appears notable by chance. Multiplicity methods can address this issue, but their appropriateness depends on the planned questions and analysis. No multiplicity procedure is reported in the registry record, so it cannot be assumed that an adjustment was or was not used in analyses outside the posted record.

The record gives 47 as enrollment and describes the primary population as 46 people with insulin-dependent diabetes. It does not state how missing questionnaire responses, incomplete follow-up, or unavailable secondary outcome measurements were handled. The number of responses and the endpoint denominator are not reported in the registry record. It also does not define an intention-to-treat or other analysis population beyond the stated primary population.

These gaps affect interpretation: without the analysis population, response counts, missing-data approach, and multiplicity plan, readers cannot determine how the available observations were converted into results or how uncertainty across outcomes was handled. The posted record does not support assumptions about these methods.

12. 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

For the Users of the Onyx Blood Glucose Meter / App System at Home group, the registry records 46 people at risk for serious adverse events, zero with a serious adverse event, 46 at risk for other adverse events, two with other adverse events, and zero deaths. These are the counts listed in the registry record for this group.

The serious-event and other-event entries are separate categories in the record. The posted safety information does not name the other adverse-event terms, and the serious-event term list is empty. The record does not provide event descriptions, timing, severity details beyond the serious-event classification, or an assessment of whether events were related to the device or app. Those details are not reported in the registry record.

These counts do not constitute a comparison with another treatment or a background rate. The study has a single group and no comparator listed. The figures should be read as recorded safety counts in this group, not as proof that the system caused or prevented events, or as a comparative estimate of safety.

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

The record identifies a practical question: whether people with diabetes using the Onyx system at home reported that meter readings synced to the app. The primary endpoint groups agreement and neutral responses to questionnaire statements about syncing. That definition provides information about what the study intended to measure, but the registry record does not report the primary result itself.

Without the observed percentage, response counts, or a measure of uncertainty, the size and precision of any reported syncing experience cannot be assessed. Because the endpoint includes Neither Agree nor Disagree, it should not be described as a percentage of respondents who positively agreed. And because the questionnaire concerns syncing experience, it should not be treated as a measure of glucose control or another clinical outcome.

The single-group, unmasked design can support a descriptive account of feedback from the people who used the system. It cannot establish how responses would differ under a comparator, and it does not isolate the system’s contribution from other possible influences. The study record does not provide a comparative estimate.

The listed secondary outcomes concern changes in clinical or related measures, but their results are not reported in the registry record. The available safety counts describe events recorded in the study group; they do not supply a comparative assessment. Taken together, the posted information documents the study’s purpose, endpoint definition, design, and selected safety counts. It does not establish the magnitude of syncing success, changes in secondary outcomes, or comparative benefits or harms.

14. Why This Trial Matters Statistically

This trial is statistically useful to examine because it illustrates the distinction between a clearly named outcome and an interpretable result. The record defines a questionnaire-based endpoint about syncing meter readings to an app and specifies which response categories count. Yet it does not report the endpoint percentage, response counts, denominator details, or uncertainty. A definition alone is not enough to judge the size or precision of an outcome.

The grouping of neutral responses with agreement also matters. It changes the meaning of the percentage: it represents the share in a combined set of agreement and neutral categories, rather than positive agreement alone. Readers need to retain that definition when describing the endpoint and avoid giving it a more affirmative interpretation than its categories support.

The study structure is another important statistical feature. With one group, no masking, and no comparator, the central question is descriptive. The record can tell readers what experience the study intended to capture, but it cannot provide a controlled estimate of how the system compares with an alternative.

Finally, the record lists multiple secondary outcomes and provides limited safety counts, while leaving outcome results and analysis details unreported. This is a reminder that registered outcomes, posted estimates, analysis populations, and missing-data methods are distinct pieces of evidence. Without the results and methods, readers should not infer effects from the outcomes that were planned or listed.

15. 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 primary limitation for interpretation is that the registry record does not report the primary endpoint result. It also does not report response-category counts, the number of completed questionnaire responses, the endpoint denominator, or a confidence interval. Thus, neither the magnitude nor the precision of the primary measure is available from the posted record.

The endpoint combines Strongly Agree, Agree, and Neither Agree nor Disagree. This composite grouping includes neutral responses, so it does not isolate positive agreement. The record does not give response-level detail that would allow the categories to be considered separately.

The single-group design, absence of masking, and lack of a comparator limit the interpretation to description of the group’s experience. The record does not report how the 47 enrolled participants relate to the stated primary population of 46 people, or explain any difference. It also does not report whether all participants completed follow-up.

Although 9 outcome measures are listed, results for the secondary measures are not reported in the registry record. The record does not report the statistical analysis plan, missing-data handling, multiplicity approach, or analysis population definitions beyond the primary population description. Safety information lists counts but does not identify the other adverse-event terms or provide event details. These omissions prevent a more complete assessment of endpoint analysis, secondary outcomes, and safety context.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System — NCT03165110.
• Registry record last updated 2019-06-04; status last verified 2019-04.
• Results first posted 2019-06-04.
• 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.

19. Record Summary

The registry record describes a completed, single-group evaluation of the Onyx blood glucose meter and app system in people with diabetes who used insulin. Participants used the system at home; masking is listed as none, and no comparator is described. The primary endpoint concerns questionnaire responses over 6 weeks about syncing meter readings to the app, grouping Strongly Agree, Agree, and Neither Agree nor Disagree.

The registry reports 47 participants enrolled and identifies 46 people with insulin-dependent diabetes as the primary-outcome population. It lists 9 outcome measures, including secondary changes in HbA1c%, fructosamine, body weight, BMI, and total daily insulin dose. The primary and secondary outcome results are not reported in the registry record. Safety entries record zero serious adverse events among 46 at risk, two other adverse events among 46 at risk, and zero deaths. Analysis details, missing-data methods, and multiplicity handling are not reported in the registry record.