This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Remote Glucose Monitoring System in Hospitalized Patients With Diabetic Ketoacidosis (DKA) (NCT05439928), a non-randomized na study. The primary outcome is Time to Resolution of Metabolic Acidosis.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05439928 |
| Phase | NA |
| Condition | Diabetic Ketoacidosis |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 163 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Columbia University |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized patients with diabetic ketoacidosis (DKA). The record describes the DEXCOM G6 group as including retrospective chart review and prospective patients; it does not give further eligibility details in the primary-outcome population field.
Intervention
Continuous glucose monitoring using the DEXCOM G6 in a step-down unit. The study description says the device provides glucose readings continuously in real time for nurses and providers.
Comparator
Hourly finger-stick point-of-care glucose monitoring in DKA patients triaged through the ICU. This is a historical control, not a concurrently randomized comparison group.
Primary question
How does time to resolution of metabolic acidosis compare between the DEXCOM G6 group and the historical-control group? Resolution is defined in the registry record using anion gap and bicarbonate thresholds.
The clinical question links a monitoring approach and care setting with a metabolic outcome. The study description frames remote monitoring as a way to investigate whether patients who need hourly glucose monitoring might be treated in a step-down unit when they do not need a higher level of care for another reason. That is a stated research aim, not a conclusion established by the registry record.
The comparison does not isolate the device from the care setting: the DEXCOM G6 group is described as receiving monitoring in a step-down unit, while the historical control received finger-stick monitoring through the ICU. Because allocation was non-randomized and the control is historical, differences in the groups or in the periods and settings of care could affect an outcome comparison. The record does not report an adjusted analysis that would address such differences.
3. Trial Design
The registry classifies this as a completed, non-randomized, parallel study with no masking. Enrollment is listed as 163. The record names Columbia University as sponsor and gives the study start as 2022-06-07 and primary completion as 2023-03-31. The phase is listed as NA.
The DEXCOM G6 group is described as patients with DKA monitored in a step-down unit, including both retrospective chart review and prospective patients. The comparator is described as a historical control: DKA patients receiving hourly finger-stick monitoring while triaged through the ICU. Thus, the groups differ not only in monitoring method but also in care setting and whether data were collected retrospectively or prospectively. The record does not report that participants were randomly assigned, and masking is listed as none.
The brief study description says hourly glucose monitoring traditionally requires ICU admission for finger-stick monitoring, and describes the study as investigating remote monitoring in the inpatient setting. It also states that the device is FDA approved for patients with diabetes and widely used for outpatient glucose monitoring. Those statements provide context for the research question; they do not establish the performance of inpatient monitoring in this study.
The listed secondary outcomes are length of ICU stay, length of hospital stay, and number of hypoglycemic events. The record lists 5 outcome measures, but reports 0 analyses. It does not report the participant flow, how the retrospective and prospective records were combined, the dates covered by the historical control, or details of an adjusted comparison. Those omissions limit assessment of how comparable the groups were and how the analysis handled differences in data collection.
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
| Stage | DEXCOM G6 CGM | Hourly Finger Stick Point of Care (Historical Control) |
|---|---|---|
| STARTED | 44 | 119 |
| COMPLETED | 44 | 119 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | DEXCOM G6 CGM | Hourly Finger Stick Point of Care (Historical Control) | Total |
|---|---|---|---|---|
| Participants analysed | 44 | 119 | 163 | |
| Age, Continuous | years | 53 (33 to 66.5) | 47.66 (33.23 to 62.85) | 49.26 (33.23 to 63.34) |
| Sex: Female, Male: Female | Participants | 19 | 56 | 75 |
| Sex: Female, Male: Male | Participants | 25 | 63 | 88 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 44 | 119 | 163 |
| Diabetes: Type 1 | Participants | 22 | 42 | 64 |
| Diabetes: Type 2 | Participants | 22 | 74 | 96 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Resolution of Metabolic Acidosis, measured over Up to 10 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | hours |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is time to resolution of metabolic acidosis, measured in hours, with a timeframe of up to 10 days. The registry defines resolution as anion gap (AG) <17 mEq/L and bicarbonate >19 mEq/L. It specifies that the endpoint is summarized by a median and inter-quartile range (IQR), but it does not report observed median or IQR values in the registry record.
As a general statistical concept, time to an event describes how long it takes for a defined event to occur. Here, the event is meeting the stated laboratory criteria for resolution. A median gives the middle of the observed time distribution, while the IQR describes the spread of its central half. These summaries can be useful when times are skewed or include unusually long observations, because a median is less affected by extreme values than a mean. The IQR conveys variability but is not a confidence interval and does not by itself quantify the precision of a group comparison.
The endpoint depends on the operational definition being applied consistently. The registry gives threshold criteria, but does not report further details such as how often laboratory values were assessed or how times were assigned when a qualifying measurement was not available. It also does not provide a comparison estimate or uncertainty interval. Consequently, the endpoint definition is clear at the threshold level, but the registry record does not permit assessment of the observed timing or precision of the comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the outcome and the comparison groups but does not report the primary endpoint results. No group medians, IQRs, between-group estimate, confidence interval, or p-value for time to resolution of metabolic acidosis is reported in the registry record. Therefore, the direction, size, and statistical precision of a primary-outcome difference cannot be described from this record. The outcome definition alone is not evidence that either monitoring approach led to faster or slower resolution.
The comparison also requires caution because it is non-randomized and uses a historical control. In general, random assignment helps balance measured and unmeasured characteristics between groups. A historical comparison does not have that protection: groups may differ in patient characteristics, clinical practice, care pathways, or data recording. These are general concerns for this design, not reported findings about this study. The registry record does not give an adjusted analysis or enough detail to determine whether such differences were measured or addressed.
The care settings are part of the contrast. The DEXCOM G6 group is described as monitored in a step-down unit, while the historical control received hourly finger-stick monitoring through the ICU. Accordingly, an observed difference, if reported elsewhere, would not automatically isolate the effect of the glucose-monitoring device from setting or other group differences. The record does not report a concurrent comparison that would separate those influences.
Safety entries list 0 serious adverse events among 44 at risk in the DEXCOM G6 group and 0 among 119 at risk in the historical-control group. Other adverse events are listed as 0 among 44 at risk in the DEXCOM G6 group and 3 among 119 at risk in the historical-control group; deaths are listed as 0 in each group. These entries should be read as registry counts, not as evidence that a monitoring approach is safer. The record does not identify the three other adverse events or provide an analysis of safety differences.
Overall, the registry supports a description of the intended comparison, endpoint definition, and recorded adverse-event counts. It does not provide the outcome data needed to judge the primary comparison or its uncertainty. The trial is marked completed, but completion status does not substitute for posted results.
9. Statistical Methods Explained
The study is classified as non-randomized, with no masking and a parallel model. In a parallel design, participants in different groups are followed under their assigned or observed group pathway rather than crossing between interventions. Here, however, the registry says allocation was non-randomized and describes one group as a historical control. The group labels therefore do not imply random allocation or exchangeability.
Why does non-randomization matter?
As a general statistical principle, randomization is intended to make treatment groups comparable, on average, with respect to factors that can influence outcomes. Without randomization, group membership can be related to patient characteristics, timing, clinical decisions, and the setting of care. Such differences may affect outcome estimates even if the monitoring approach itself has no effect. Statistical adjustment can address some measured differences, but cannot guarantee control of unmeasured or poorly measured factors. The registry record reports 0 analyses, so it does not describe an adjustment strategy or report an adjusted estimate.
The historical-control structure adds a time-related concern in general: care practices and documentation can change over time. The record does not state the time period for the historical control or describe whether clinical practices were stable. The DEXCOM G6 group includes both retrospective chart review and prospective patients, while the control is historical. Retrospective and prospective data collection can differ in completeness or measurement procedures; whether that happened in this study is not reported in the registry record.
How should the primary endpoint be summarized?
The endpoint is time to resolution of metabolic acidosis, with resolution defined by the stated anion-gap and bicarbonate thresholds. The registry specifies median and IQR summaries. In general, the median describes a distribution’s central location, and the IQR describes its central spread. Neither one alone supplies the uncertainty around a difference between groups. A confidence interval, when reported, expresses a range of estimates compatible with the data and a specified statistical procedure; it is not a guarantee that the true value lies within that range. No primary-outcome confidence interval is reported in the registry record.
Time-to-event methods can be useful when follow-up duration varies or when some participants have not experienced the event by the end of observation. Such participants may be censored rather than treated as if the event occurred at the end of follow-up. This is a general description of the method, not a claim about the analysis used in this study. The registry record does not report whether censoring occurred, whether a time-to-event model was used, or how observations without a recorded resolution time were handled.
What do the planning assumptions mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event tables, the illustration is described as giving the total number of events; other illustrations are described as participants per arm. The registry record does not report numerical planning requirements. These assumptions describe an illustration, not the study’s original design justification, and the registry does not state that they were used to plan this trial.
In general, a sample-size calculation estimates how much information a future study might need to detect a specified effect under stated assumptions. Its result depends on assumptions about the effect, variability, allocation, significance threshold, and analysis. A planning illustration is not observed power and does not establish whether the completed study was adequately powered. The original sample-size justification and statistical plan are not reported in the registry record.
What is not available for evaluating the analysis?
The registry lists 5 outcome measures and 0 analyses. The primary endpoint’s measurement timeframe is up to 10 days, but the record does not describe the analysis population, missing-data procedures, or handling of multiple outcomes. It does not report whether the primary endpoint analysis used a model, a direct comparison of medians, or another method. Without those details and the outcome estimates, readers cannot reproduce or assess the inferential analysis from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures, including time to resolution of metabolic acidosis as the primary outcome and length of ICU stay, length of hospital stay, and number of hypoglycemic events as secondary outcomes. It reports 0 analyses. No multiplicity procedure, such as an adjustment for testing multiple outcomes, is reported in the registry record.
As a general statistical principle, examining several outcomes can increase the chance that at least one result appears unusual by chance if each is tested separately. A prespecified outcome hierarchy or multiplicity adjustment can help clarify how evidence should be interpreted across several tests. The record does not state whether such a plan was established, so no claim can be made about how multiplicity was handled.
The primary-outcome population field is blank. The registry record does not report which participants were included in the primary analysis, how missing endpoint measurements were handled, whether data were excluded, or whether all enrolled participants contributed to each outcome. It also does not report imputation, sensitivity analyses, or reasons for missing data. These are important details because incomplete or selectively available data can affect both an estimate and its precision.
Likewise, the registry record does not describe interim analyses, stopping rules, a statistical analysis plan, or a sample-size justification. Their absence from the record should not be read as evidence that they did or did not exist; their status is not reported in the registry record. The completed status and enrollment entry do not resolve these analysis questions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| DEXCOM G6 CGM | 0 | 44 | 0.0% |
| Hourly Finger Stick Point of Care (Historical Control) | 0 | 119 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| DEXCOM G6 CGM | 0 of 44 |
| Hourly Finger Stick Point of Care (Historical Control) | 0 of 119 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| DEXCOM G6 CGM | 0 of 44 |
| Hourly Finger Stick Point of Care (Historical Control) | 3 of 119 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DEXCOM G6 CGM | Hourly Finger Stick Point of Care (Historical Control) |
|---|---|---|---|
| Hypoglycemic event defined as glucose level <70 mg/dL | Metabolism and nutrition disorders | 0 of 44 | 3 of 119 |
The registry lists 0 serious adverse events among 44 at risk in the DEXCOM G6 group and 0 among 119 at risk in the hourly finger-stick historical-control group. It lists 0 other adverse events among 44 at risk in the DEXCOM G6 group and 3 among 119 at risk in the historical-control group. Deaths are listed as 0 in both groups. No serious adverse-event terms are listed.
These are descriptive registry counts. They do not establish that the groups had equivalent safety, nor do they show that one monitoring approach caused or prevented an event. In general, a count of zero does not prove that an event cannot occur; interpretation depends on the amount of observation, event ascertainment, and the uncertainty around the estimate. The record does not report exposure duration, a comparative safety analysis, or details about the three other adverse events.
The at-risk entries should not be treated as a complete account of safety follow-up or as denominators for an independently calculated rate. No such rates or comparisons are reported in the registry record. The listed counts therefore provide a limited description of recorded events, not a definitive safety conclusion.
12. What the Result Does, and Does Not, Mean
This record describes an inpatient study of continuous glucose monitoring with the DEXCOM G6 in patients with DKA, compared with hourly finger-stick monitoring in a historical ICU control. Its primary endpoint is time to resolution of metabolic acidosis, defined using anion gap and bicarbonate thresholds. The record also identifies length of ICU stay, length of hospital stay, and number of hypoglycemic events as secondary outcomes.
What the record does not establish is the primary outcome result. It contains no reported group summaries or inferential comparison for time to resolution, and it reports 0 analyses. Thus, readers cannot use the registry record to determine whether the groups differed, how large a difference might have been, or how precisely any difference was estimated. A completed study status is not itself evidence for an outcome.
The study also cannot, from the registry description alone, separate the monitoring method from the care setting: the DEXCOM G6 group is described in a step-down unit, and the historical control received monitoring through the ICU. Because the design is non-randomized, any comparison would also require attention to differences between the groups and possible changes over time. The record does not report analyses that address these issues.
The adverse-event entries are limited counts and do not support a comparative safety conclusion. The registry record does not identify the other adverse events or provide uncertainty estimates for safety. Nor does it report enough detail to assess missing outcomes, the analysis population, or how multiple outcomes were handled.
In general, an informative treatment comparison needs an outcome estimate, an account of its uncertainty, and sufficient methods detail to judge bias and applicability. The registry record provides the research question and endpoint definition, but not the reported results and analysis detail needed for that assessment. The appropriate interpretation is therefore descriptive and limited to what the record states, without a claim that either approach produced a better clinical outcome.
13. Why This Trial Matters Statistically
The study addresses a practical statistical challenge: evaluating a monitoring approach that is connected to a different care setting. The stated research aim is to investigate whether continuous glucose monitoring could support care in a step-down unit for patients who do not need a higher level of care for another reason. The comparison with hourly finger-stick monitoring in an ICU historical control makes the distinction between a device effect and a care-setting effect especially important.
Statistically, a non-randomized historical comparison can be useful for describing experience and generating questions, but it is more vulnerable than a randomized comparison to group differences and changes over time. That does not make the observations irrelevant; it means that estimates require context and careful methods. An outcome difference would need to be interpreted in light of the groups’ comparability, data collection, and analysis. The registry record does not report enough analysis detail or outcome results to make that assessment.
The chosen primary endpoint is also consequential: it is a time-based measure tied to explicit laboratory thresholds. Clear definitions help readers understand what event is being counted, while reporting a distribution and uncertainty would help readers assess both the observed timing and the precision of a comparison. The registry specifies median and IQR summaries but does not report the observed summaries or a comparative estimate.
The record therefore matters as a description of the design and question, while also illustrating why registration alone is not a substitute for results reporting. Its endpoint definition and safety counts offer some information, but the absence of outcome analyses leaves the central comparative question unresolved in the registry record.
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 this trial record is that no primary endpoint results are reported. Although the endpoint is defined and a median with IQR is specified, observed values and a comparison estimate are absent. The record also reports 0 analyses, leaving the analysis method, uncertainty, and any adjustment unavailable.
The design is non-randomized and uses a historical control. The groups are described in different care settings, and the DEXCOM G6 group includes retrospective chart review as well as prospective patients. These features limit direct attribution of any possible outcome difference to the monitoring device alone. The registry record does not report the historical-control time period, detailed eligibility criteria, participant flow, or methods for establishing comparability.
Other important details are not reported in the registry record: the primary analysis population, missing-data handling, assessment frequency for the laboratory criteria, and methods for multiple outcomes. The record also does not provide numerical sample-size planning results, the original design justification, or a statistical analysis plan. It is therefore not possible to assess whether the stated endpoint analysis followed a prespecified plan or how sensitive it might be to missing information.
The adverse-event counts are limited and do not identify the other events or provide a comparative safety analysis. These limitations concern what can be concluded from the registry record; they do not establish that the study itself lacked additional information outside the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Remote Glucose Monitoring System in Hospitalized Patients With Diabetic Ketoacidosis (DKA) — NCT05439928.
- Registry record last updated 2025-05-14; status last verified 2025-04.
- Results first posted 2025-05-14.
- 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.
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18. Record Summary
The registry record describes a completed, non-randomized, parallel study with no masking, sponsored by Columbia University. Enrollment is listed as 163. The start date is 2022-06-07, and primary completion is 2023-03-31.
The comparison is between DEXCOM G6 continuous glucose monitoring in a step-down unit and hourly finger-stick monitoring in an ICU historical control. The primary outcome is time to resolution of metabolic acidosis, defined using anion gap <17 mEq/L and bicarbonate >19 mEq/L, with median and IQR specified for summary. The registry record does not report primary-outcome results and lists 0 analyses.
Secondary outcomes include length of ICU stay, length of hospital stay, and number of hypoglycemic events. Safety entries list no serious adverse events or deaths in either group and 3 other adverse events in the historical-control group. These entries are descriptive and do not establish comparative effectiveness or safety.