Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes (NCT05523362), a na na study. The primary outcome is Change in Average Glucose Levels as Measured by Continuous Glucose Monitor.

2. Clinical Question

The study objective was to evaluate the feasibility and clinical utility of continuous glucose monitoring for care of patients with type 2 diabetes receiving non-insulin therapies. The intervention is identified as a Dexcom continuous glucose monitor. The registry record names Dexcom G6 in the study title and describes use of the Dexcom G6 Pro during the blinded phase.

In that phase, participants wore the monitor in blinded mode for 10 days and could not access its readings. They performed standard care with twice-daily finger-stick glucose checks using a glucometer. The record also identifies a subsequent unblinded phase, but the full description of that phase is not available in the registry record. The study therefore addresses glucose measurement and device use within a single-group sequence, rather than estimating an effect against a concurrent randomized control group.

3. Trial Design

The registry lists this as a completed, single-group study with enrollment of 56. Allocation is recorded as NA, and masking is listed as none. The title and study objective concern the feasibility and clinical utility of Dexcom G6 continuous glucose monitoring among people with type 2 diabetes who were not using insulin therapy. The listed intervention is a Dexcom continuous glucose monitor.

The arm description is titled “Blinded followed by Unblinded.” It describes a blinded phase lasting 10 days, when participants wore the Dexcom G6 Pro without access to its data and performed twice-daily finger-stick glucose checks with a glucometer. The record says that this phase was followed by an unblinded phase, but the remaining details of the phase description are not reported in the registry record. The sequence should not be mistaken for a randomized comparison: the study is explicitly listed as single-group, with no like-for-like control comparison.

The primary outcome is average glucose measured by continuous glucose monitoring, with change assessed at 0, 30, 60 and 90 days. Secondary outcomes include changes in hemoglobin A1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, body mass index, systolic blood pressure and diastolic blood pressure. The record lists 15 outcome measures but no outcome analyses. It does not report a protocol-based sample-size justification, detailed statistical analysis plan, or analysis population definitions.

The study began on 2022-01-15, reached primary completion on 2023-11-30, and is listed as completed. These dates describe the registry timeline; they do not establish when each participant entered or completed each phase.

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: 2 people did not meet eligibility criteria. They were consented but did not participate in the study. A total of 56 participants signed consents and only 47 fully completed both phases of the study.

Phase 1- Blinded (10 Days)

Reasons for not completing this period:

Phase 2- Unblinded (3 Months)

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: 2 people did not meet eligibility criteria. They were consented but did not participate in the study. A total of 56 participants signed consents and only 47 fully completed both phases of the study.

6. Primary Endpoint

The registry lists the primary outcome as Change in Average Glucose Levels as Measured by Continuous Glucose Monitor, measured over 0, 30, 60, 90 days.

The primary endpoint is change in average glucose measured by continuous glucose monitor. It is defined as a mean, a continuous measure, with standard deviation identified as its dispersion measure. The stated assessment time points are 0, 30, 60 and 90 days, and the unit is mg/dl.

Average glucose condenses many monitor readings into a summary of glucose levels over a measurement period. Continuous monitoring can capture readings across time, whereas a finger-stick check gives a measurement at a particular moment. A mean can therefore describe the overall level of measured glucose during a period, while the standard deviation describes the spread of values around that mean. These are general interpretations of the statistical measures, not findings about this study.

Repeated measurements can describe how an endpoint changes across scheduled assessments, but interpreting such a pattern requires actual values and information about who contributed data at each time point. The registry record names the endpoint and assessment schedule but does not report the mean values, changes, standard deviations, confidence intervals, or statistical tests. It is therefore not possible to characterize the direction, size, or precision of any change in average glucose from the registry record.

The choice of an average also has limits as a summary: it does not by itself describe the full distribution of readings, the duration or timing of particular glucose patterns, or the experience of individual participants. Those aspects would require additional results and definitions, which are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies average glucose as a continuous measure summarized by its mean and standard deviation. A mean is a measure of the center of a set of observations; standard deviation describes how spread out observations are around that center. These are general statistical definitions. They do not substitute for the endpoint values, which are not reported in the registry record.

What repeated measurements can describe

The primary measure is scheduled at 0, 30, 60 and 90 days. Repeated measurements can describe the course of an outcome across assessment times. A statistical analysis might compare values between times, estimate a trajectory, or summarize change from an initial measurement. Which approach was used for this study is not reported in the registry record. Nor are the exact definitions of change, the number of readings used to form each average, or the observation windows reported.

Repeated observations from the same participant are generally related rather than independent. General methods for repeated data account for that dependence, because treating each observation as unrelated can misstate uncertainty. The registry record does not state whether a repeated-measures model, a simpler comparison, or another approach was used. It also does not report whether estimates were adjusted for any covariates.

What a confidence interval would add

In general, a confidence interval describes the uncertainty around an estimated quantity under a specified statistical method. Its width reflects precision: narrower intervals indicate more precise estimates under that method, while wider intervals indicate more uncertainty. The registry record does not report confidence intervals for average glucose or the listed secondary outcomes. Without estimates and intervals, neither the size of a change nor its precision can be assessed.

Distribution and variability

Means and standard deviations can be useful summaries, but they do not fully describe a distribution. If measurements are skewed or include unusually high or low observations, a mean and standard deviation may not show how readings are distributed. This is a general consideration, not a statement about the study data. Distributional plots or other summaries could add context, but the registry record does not report those data or the methods used to assess their distribution.

Single-group design and interpretation

The study is listed as single-group, with allocation NA, and the record warns that the arms are not a like-for-like control comparison. A within-group change over time can describe what was measured in participants, if such results are reported, but it does not by itself estimate a contrast against a concurrent control. General explanations for a before-and-after difference may include temporal changes or measurement conditions; the record does not establish whether any such factors affected this study.

Planning illustrations are not trial results

The planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. They are described as calculations based on the observed effect, with the effect to detect set as a stated fraction of that observed effect. These assumptions describe planning illustrations, not the trial’s own design or analysis plan. The record does not report a protocol-based sample-size justification, and the study itself is single-group rather than an equal-allocation two-arm comparison. Any illustrated sample sizes are planning quantities, not observed participant counts, evidence of statistical power for the completed study, or estimates of its outcome.

Why over-dispersion can matter

For count outcomes, over-dispersion means that variability exceeds what a chosen count model expects. In general, a model that fails to account for excess variability can produce uncertainty estimates that are too small. The primary outcome is continuous average glucose, not a count outcome, so this concept is not a description of the primary endpoint. The registry record does not report a count-outcome model or enough details to assess the use of such methods for other measures.

What is not specified

The registry record lists 15 outcome measures and zero analyses. It does not report the statistical tests or models, the handling of repeated observations, assumptions checks, covariate adjustment, missing-data methods, or an analysis population. It also does not report interim analyses or a detailed statistical analysis plan. These omissions prevent a reader from reconstructing the inferential methods or independently evaluating the precision of the endpoint results.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 15 outcome measures, including average glucose as the primary outcome and changes in several blood, body-size and blood-pressure measures as secondary outcomes. It reports zero analyses, so the posted record does not provide inferential results across these measures. A multiplicity strategy, such as a hierarchy of hypotheses or an adjustment for multiple testing, is not reported in the registry record.

In general, testing many outcomes can increase the chance of finding at least one apparently unusual result by chance. Whether and how to address that concern depends on the questions and analysis plan. No such plan is reported, so it is not possible to determine how the study treated multiple outcomes, repeated time points, or any subgroup analyses. The record also does not report whether the secondary outcomes were intended as exploratory or confirmatory.

Missing-data information is also not reported. The record does not state how many participants had outcome data at each scheduled time, why any measurements may have been unavailable, or whether a method was used to address missing observations. In repeated-measure studies, the available number of observations can vary over time; the enrollment count alone does not establish the analysis population at each assessment.

The record does not define an intention-to-treat, per-protocol, or other analysis population, and it does not describe exclusions or adherence criteria for outcome analyses. These details are needed to understand who contributed to an estimate and how missingness might affect its interpretation. Because no endpoint analyses or missing-data methods are reported, the results cannot be evaluated for multiplicity or sensitivity to incomplete observations.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry’s safety figures list separate groups labeled Blinded and Unblinded. For the blinded group, 56 participants are listed as at risk for serious adverse events and 56 as at risk for other adverse events; the recorded counts affected are 0 for each category, with 0 deaths. For the unblinded group, 47 are listed as at risk in each category; the recorded counts affected are 0 for serious adverse events and 0 for other adverse events, with 0 deaths.

These are registry counts, not estimates comparing randomized treatments. The study is listed as single-group, and the phases are sequential rather than a like-for-like control comparison. The denominators differ between the listed groups, and the record does not explain the participant flow between phases or provide exposure time. The counts therefore should not be read as a controlled comparison of risk.

The record lists no serious adverse event terms. The posted counts indicate that no participants are recorded as affected in the listed adverse-event categories, but they do not describe how events were collected, the observation duration for each participant, or whether other safety details were reported elsewhere. A zero recorded count is not, by itself, evidence that an event is impossible or that the intervention is free of risk.

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

This completed study is described as an evaluation of the feasibility and clinical utility of a continuous glucose monitor for people with type 2 diabetes who were not using insulin therapy. The registry identifies a single-group design, a blinded phase followed by an unblinded phase, and a primary outcome of average glucose measured by continuous glucose monitoring at 0, 30, 60 and 90 days. These registry entries describe the study question and structure, not the outcome of the study.

The registry record does not report numerical findings for average glucose or the secondary outcomes. It therefore does not establish whether average glucose changed, the magnitude or direction of any change, or the precision of an estimate. It also does not report analyses that would support an assessment of statistical uncertainty. The enrollment of 56 participants is not a substitute for outcome estimates or the number of participants with usable data at each time point.

Even if a within-group change were available, this design would not provide a randomized concurrent control comparison. A pattern over time could describe participants’ measurements, but would not by itself establish that the device caused that pattern. The registry specifically notes that the listed arms are not a like-for-like control comparison.

The posted safety counts record zero participants affected in the serious and other adverse-event categories in both listed groups, and zero deaths. Those counts should be interpreted in light of the denominators, the sequential design, and the absence of detailed information about exposure and event collection. They do not establish that no risk exists.

Accordingly, the registry record supports a description of the intended evaluation and the reported safety counts, but not a conclusion about clinical benefit, lack of benefit, or causal effects. The missing outcome estimates and analysis details are central to any statistical interpretation.

13. Why This Trial Matters Statistically

This study raises a useful statistical question about evaluating a monitoring device in routine care: which features of the data describe measurement feasibility, and which support inference about change in health measures? The registry defines average glucose measured by continuous monitoring as its primary outcome and names hemoglobin A1c and other clinical measures as secondary outcomes. The combination illustrates how a study may collect repeated device measurements alongside assessments from blood tests, height and weight, or blood pressure.

The design also highlights the distinction between sequential exposure phases and a controlled comparison. A blinded phase followed by an unblinded phase can structure an evaluation of device use, but it is not equivalent to random assignment to separate concurrent groups. Without a like-for-like control comparison, a change across time is descriptive unless additional design and analysis features support stronger causal interpretation. The registry explicitly cautions that the arms are not a like-for-like control comparison.

For biostatisticians and clinical researchers, the record also demonstrates why outcome labels and schedules are not enough to assess evidence. Interpretation depends on actual estimates, their uncertainty, the number of participants contributing data, missing-data handling, and the analysis plan. Those details are not reported for the outcomes in this registry record. The record lists 15 outcome measures but zero analyses, so the planned breadth of measurement cannot be translated into claims about observed effects.

The entry is therefore useful as a case in separating what a registry identifies—study objective, design, measures, timing and recorded safety counts—from what requires reported results and methods. It offers a concrete example of why completion status and enrollment do not alone convey the size or reliability of an outcome estimate.

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 primary limitation for statistical interpretation is that the registry record does not report numerical results for the primary endpoint or secondary outcomes. No average glucose estimates, changes, standard deviations, confidence intervals, or outcome tests are reported. The record lists 15 outcome measures but zero analyses, leaving no basis for judging the direction, magnitude, or precision of the measured outcomes.

The study is listed as single-group, with allocation NA, and the registry cautions that the arms are not a like-for-like control comparison. The sequential blinded and unblinded phases therefore cannot be treated as randomized concurrent groups. The record does not provide enough detail to characterize the unblinded phase fully; its description is incomplete in the registry record.

Although enrollment is listed as 56, the number with analyzable data at each of the primary assessment times is not reported. Participant flow, adherence, missing observations, and analysis populations are also not reported. The registry does not specify whether the primary endpoint used all monitor readings or how readings were summarized within each time point.

A detailed statistical analysis plan, sample-size justification, model specification, handling of repeated measures, covariate adjustment, multiplicity approach, and interim analyses are not reported in the registry record. The secondary outcome labels identify measures but do not provide their definitions, estimates, or analysis details. These gaps limit both independent reproduction and assessment of the robustness of any findings.

The safety record supplies counts and denominators but not exposure time or detailed event-collection procedures. The listed groups have different at-risk counts and are not a controlled comparison. Thus, the safety figures are descriptive registry entries rather than comparative estimates.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes — NCT05523362.
• Registry record last updated 2024-08-06; status last verified 2024-07.
• Results first posted 2024-08-06.
• 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

NCT05523362 is a completed, single-group study of the feasibility and clinical utility of Dexcom G6 continuous glucose monitoring for people with type 2 diabetes who were not using insulin therapy. The registry lists enrollment of 56, allocation as NA, masking as none, and a blinded phase followed by an unblinded phase.

The primary outcome is change in mean average glucose measured by continuous glucose monitor, in mg/dl, at 0, 30, 60 and 90 days. Secondary measures include hemoglobin A1c, cholesterol measures, triglycerides, body mass index, and systolic and diastolic blood pressure. The record lists 15 outcome measures and zero analyses; numerical outcome results are not reported in the registry record.

The safety entries record zero participants affected in the serious and other adverse-event categories for both listed groups, and zero deaths. The study began on 2022-01-15, reached primary completion on 2023-11-30, and is listed as completed.