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 Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease (NCT03383627), a na na study. The primary outcome is Mean Glucose Concentration Measured by CGM.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03383627 |
| Phase | NA |
| Condition | Diabetes, Kidney Diseases |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Northwell Health |
| Results posted | Yes |
2. Clinical Question
Population
People with type 2 diabetes mellitus and late-stage chronic kidney disease. The registry title and summary describe this population, but the population field for the primary outcome is blank.
Intervention
Continuous glucose monitoring, using a Freestyle Libre Pro device. The description says research staff would place the device for 14-day monitoring and participants would return on Day 14 for removal and analysis.
Comparator
There is no separate comparator group in this single-group study. The record does not describe a randomized or like-for-like control comparison.
Primary question
What mean glucose concentration, in mg/dL, is measured by CGM over 14 days among the study population? The registry identifies this as the primary outcome but does not report its observed result or an analysis.
The clinical motivation in the registry summary concerns how well HbA1c and fructosamine characterize glucose exposure in later stages of chronic kidney disease. It notes limited data on the utility of these tests in this population and describes possible concerns about their accuracy. It presents CGM as a way to assess glucose exposure over time, including hyperglycemic and hypoglycemic excursions.
Those statements explain the rationale for measuring glucose with a device; they are not findings from this study. The record does not report a comparison between CGM and HbA1c or fructosamine, nor does it report an estimate of how closely any of these measures agree. The listed secondary outcomes concern mean serum fructosamine concentration and determination of serum fructosamine, but their results are not reported in the registry record.
3. Trial Design
The registry describes a completed, single-group study sponsored by Northwell Health. Its enrollment is listed as 80. Allocation and phase are recorded as NA, and masking is recorded as none. The study start date is 2017-11-30, and the primary completion date is 2018-08-21. The listed intervention is a continuous glucose monitoring device.
The arm description says that eligible participants would return to the research site on Day 1 for research staff to place the Freestyle Libre Pro device for 14-day monitoring. It says participants would be advised to return on Day 14 for device removal and analysis. The description ends with a reference to blood collection on Day 14 but does not provide the remainder of that procedure in the registry record.
A single-group design can describe measurements collected in the enrolled group, but it does not by itself estimate a between-group treatment contrast. There is no separate control arm, and the registry record does not describe random assignment. As a result, any observed glucose summary would be a description of the measured group rather than a randomized comparison with another group.
The record marks the study status as completed. Completion status does not establish that all enrolled participants contributed usable CGM data, that the primary outcome was analyzed, or that a particular result was obtained. The number analyzed and the handling of incomplete or unusable measurements are not reported in the registry record. Although the record lists seven outcome measures, it names only two secondary outcomes in the available outcome description. Details of the other measures are not reported in the registry record.
The record does not report a protocol-level sample-size justification or a statistical analysis plan. The sample-size illustrations associated with the posted results are explicitly planning illustrations based on an observed effect, not the study's own design rationale. They should not be read as evidence of a prospectively specified target or as observed power.
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 | Continuous Glucose Monitoring |
|---|---|
| STARTED | 80 |
| COMPLETED | 80 |
| NOT COMPLETED | 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 | Continuous Glucose Monitoring |
|---|---|---|
| Participants analysed | 80 | |
| Age, Continuous | years | 71.3 (SD 10.9) |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 61 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 77 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 11 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 10 |
| Race (NIH/OMB): White | Participants | 53 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 |
| Cause of Chronic Kidney Disease: Diabetes Mellitus Type 2 | Participants | 63 |
| Cause of Chronic Kidney Disease: Others | Participants | 17 |
| Medical History: Congestive Heart Failure | Participants | 20 |
| Medical History: Coronary Artery Disease | Participants | 26 |
| Medical History: Hypertension | Participants | 77 |
| Medical History: History of Stroke | Participants | 17 |
| Medical History: History of Maliganancy | Participants | 6 |
| eGFR: 0 to <=15 mL/min | Participants | 15 |
| eGFR: >15 to <=30 mL/min | Participants | 34 |
| eGFR: >30 to <=45 mL/min | Participants | 31 |
| BMI: <=25 | Participants | 14 |
| BMI: >25 to <=30 | Participants | 33 |
| BMI: >30 to >=35 | Participants | 21 |
| BMI: >35 | Participants | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Glucose Concentration Measured by CGM, measured over 14 Days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Inter-Quartile Range |
| Unit | mg/dL |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is mean glucose concentration measured by CGM, expressed in mg/dL, over a 14-day timeframe. The registry describes the measure as a mean calculated from measurements taken by the CGM device. It also specifies the inter-quartile range as the dispersion measure. The result itself, including the mean and its inter-quartile range, is not reported in the registry record.
In general, a mean provides a measure of the central level across the glucose readings included in an analysis. The inter-quartile range describes the spread of the middle portion of those readings and can help show how variable measurements are around the central level. These summaries answer different questions: the mean describes a typical level in an arithmetic sense, while the inter-quartile range describes dispersion. Neither alone describes the full pattern of glucose readings or the frequency and duration of particular excursions.
The registry summary explains why CGM may be useful for studying glucose exposure over time: it can capture measurements across the monitoring period, including hyperglycemic and hypoglycemic excursions. That is the study rationale, not a reported result. The registry does not provide a CGM data profile, a threshold-based analysis, or results for the excursions mentioned in the summary. It also does not report a direct comparison with HbA1c or fructosamine. Therefore, the specified endpoint identifies what the study intended to measure, but the record does not establish what value was observed or how it related to other measures.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clear measurement objective: summarize mean glucose concentration from CGM readings collected over 14 days in people with type 2 diabetes and late-stage chronic kidney disease. However, the record reports no analysis for this primary outcome. It therefore does not provide an observed mean, an inter-quartile range, a confidence interval, or a test of a statistical hypothesis. The numerical size and precision of the primary result cannot be assessed from the registry record.
The record lists enrollment as 80, but enrollment is not the same as the number with complete, analyzable CGM data. The number contributing to the primary analysis and the amount of missing or unusable data are not reported in the registry record. Without those details, the completeness and representativeness of the measured data cannot be evaluated.
The single-group structure also determines what the outcome could establish. A measured mean would describe the observed glucose readings in the analyzed group during the monitoring period. It would not, on its own, estimate a difference against an untreated group, another monitoring strategy, or a usual-care comparator. Nor would a group summary by itself establish whether HbA1c or fructosamine is accurate, because the registry does not report a comparison or agreement analysis for those measures.
The registry summary gives a rationale for studying CGM: it notes limited data on HbA1c and fructosamine in later-stage chronic kidney disease and describes potential limitations of those tests. These are background statements, not findings from the study. The listed secondary outcomes include mean serum fructosamine concentration and determination of serum fructosamine, but their values and any relationship with CGM are not reported in the registry record.
Any sample-size figures associated with this record are planning illustrations based on an observed effect under stated assumptions, not observed power and not evidence of the original design rationale. Because the record does not report an analyzed primary effect, those illustrations cannot substitute for an outcome estimate or its uncertainty. The appropriate interpretation is therefore limited: the registry specifies the intended CGM measure and study population, but does not report the result needed to judge its magnitude or precision.
9. Statistical Methods Explained
What does the primary measure summarize?
The outcome is a mean of CGM glucose measurements, with units of mg/dL, over a 14-day timeframe. In general, a mean is calculated by combining the values included in an analysis and expressing their central level. Its interpretation depends on which readings are included and how incomplete records are handled. The registry record does not report those data-processing details or the number of usable readings per participant.
The record specifies the inter-quartile range as the dispersion measure. In general, the inter-quartile range describes the span of the middle half of a distribution. It can communicate whether readings are clustered or spread out without requiring a normal, bell-shaped distribution. It does not describe every feature of the glucose profile, such as the timing or duration of excursions. No observed inter-quartile range is reported in the registry record.
Why does the study use CGM?
The registry summary explains that HbA1c and fructosamine are tests used to assess glucose levels over time, while noting limited information about their utility in later stages of chronic kidney disease and reasons to think they may be less accurate in this population. It describes CGM as a way to understand glucose exposure and hyperglycemic and hypoglycemic excursions. These statements are the study's rationale. They do not establish that CGM is more accurate or that either laboratory measure performed poorly in the enrolled group.
In general, repeated measurements can reveal variation over a monitoring period that a single summary from another test may not show. But to evaluate how measures relate, researchers need to report the relevant paired data and an appropriate comparison or agreement analysis. Such analyses are not reported in the registry record. The listed secondary outcomes concern serum fructosamine, but the record does not report their results or their relation to CGM.
What can a single-group analysis tell the reader?
The study is recorded as single-group, with no separate comparator arm. In general, a summary from one group can describe the measurements collected in that group. It cannot isolate a contrast between the intervention and a control condition when no control group is present. A single-group mean also cannot, by itself, establish that a measurement strategy caused a change or performed better than another approach.
Allocation is recorded as NA and masking as none. The record does not describe randomization or blinding. The absence of a comparator means that randomized between-group interpretation does not apply to the primary measure described in the registry. Whether other design features were used is not reported in the registry record.
How should uncertainty be understood?
In general, an estimate is more informative when accompanied by a measure of uncertainty. A confidence interval describes a range of values compatible with the data and analysis under the method's assumptions. Its width conveys precision: wider intervals indicate less precision, while narrower intervals indicate greater precision. The registry record reports no confidence interval for the primary outcome, so the precision of a primary estimate cannot be assessed.
A p-value, when reported, addresses compatibility of data with a specified statistical model and null hypothesis; it does not measure the size or clinical importance of an effect. No primary-outcome p-value or hypothesis test is reported in the registry record. The absence of a reported test should not be replaced by an inferred result.
What do the planning illustrations represent?
The listed assumptions describe planning illustrations computed from an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also state that the effect to detect is a specified fraction of the observed effect. These are assumptions for illustrative sample-size calculations, not evidence that the trial was originally designed as a two-arm study. The actual study is recorded as single-group.
In general, a planning calculation estimates the sample size associated with chosen assumptions about an effect, variability, significance level, and power. Such an estimate depends on those assumptions and is not a measure of the probability that a completed study has found a true effect. It is not observed power. The registry record does not report a protocol sample-size justification, and the illustrations cannot be treated as the original enrollment rationale.
The record lists no analyses. Accordingly, the primary outcome's observed mean, dispersion, and uncertainty are not available for interpretation. Statistical concepts can clarify what those results would mean if reported, but they cannot supply the missing outcome or analysis details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures and names two secondary outcomes: mean serum fructosamine concentration and determination of serum fructosamine. The primary outcome is mean glucose concentration measured by CGM. The record does not report analyses for these outcomes. Details of the other listed outcome measures are not reported in the registry record.
When a study examines multiple outcomes or performs multiple statistical tests, the chance of at least one apparently unusual result can increase. In general, a prespecified analysis plan can explain which outcomes are primary, how tests are prioritized, and whether any adjustment for multiple testing is intended. The registry record does not report a statistical analysis plan or a multiplicity strategy. Because no outcome analyses are reported, there is no basis for evaluating whether multiplicity adjustments were applied.
The record also does not describe how missing CGM readings, incomplete monitoring, or missing blood measurements were handled. The listed enrollment does not establish how many participants had complete data for each outcome. In general, missingness can affect both the precision and interpretation of results, particularly if the availability of measurements is related to participant characteristics or glucose patterns. The extent and handling of missing data are not reported in the registry record.
The primary outcome population field is blank. The record does not specify whether the analysis would include all enrolled participants, only those with usable CGM measurements, or another defined group. Analysis-population definitions and the number analyzed are not reported in the registry record, so the relationship between enrollment and any potential outcome estimate cannot be assessed.
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 |
|---|---|---|---|
| Continuous Glucose Monitoring | 0 | 80 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Continuous Glucose Monitoring | 0 of 80 |
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 |
|---|---|
| Continuous Glucose Monitoring | 0 of 80 |
The serious adverse event record lists the Continuous Glucose Monitoring group with 80 participants at risk for serious events and zero serious events. It also lists 80 participants at risk for other events and zero other events, and reports zero deaths. No serious adverse event terms are listed.
These are registry-recorded counts, not an estimate of comparative risk. With no separate control group, the figures do not provide a randomized safety contrast. The record does not report event definitions, surveillance procedures, duration of safety follow-up, or whether all participants completed follow-up. Those details are not reported in the registry record.
Zero recorded events should be read narrowly: the registry lists no events in these categories for the group. It does not establish that an event could not occur, nor does it quantify the precision of a safety estimate. The counts also do not describe symptoms or events that were not classified or reported in the record. The registry entry therefore gives a limited safety summary rather than a comprehensive assessment of device-related risk.
12. What the Result Does, and Does Not, Mean
The record documents a completed, single-group study of continuous glucose monitoring in people with type 2 diabetes and late-stage chronic kidney disease. It specifies mean CGM glucose concentration in mg/dL over 14 days as the primary outcome, with inter-quartile range as the dispersion measure. It also gives a rationale for examining glucose exposure in this population and lists serum fructosamine outcomes.
What the record does not provide is the primary result. No observed mean, inter-quartile range, confidence interval, or statistical analysis is reported. The listed enrollment of 80 does not show how many participants contributed usable measurements. The registry record therefore cannot establish the magnitude or precision of the glucose summary, the completeness of the data, or the result of the secondary outcomes.
The study's single-group design also limits interpretation. Even if a group mean were reported, it would describe the monitored group rather than a difference against a control group. The record does not provide a direct comparison of CGM with HbA1c or fructosamine, or an analysis establishing the accuracy of those measures in this population. Statements about possible limitations of HbA1c and fructosamine belong to the rationale in the registry summary, not to reported study findings.
The safety entries record zero serious events, zero other events, and zero deaths for the group. Those registry counts do not provide a comparative safety estimate or a detailed account of event monitoring. Taken together, the record describes the intended measurements and the study structure, but it does not report the outcome analyses needed to draw conclusions about the observed glucose profile or its relationship to other measures.
13. Why This Trial Matters Statistically
This study addresses a measurement question in a population for which the registry summary says data on HbA1c and fructosamine are limited: people with type 2 diabetes and later stages of chronic kidney disease. The stated rationale is that these measures may be less accurate in this setting and that CGM can capture glucose exposure over time, including excursions. Statistically, this makes the distinction between rationale and evidence especially important. A plausible reason to collect a measure is not itself evidence about its performance.
The primary outcome is a group-level summary of repeated CGM measurements over a defined 14-day period. Such a summary can be useful for describing central glucose levels, while the inter-quartile range conveys dispersion. Interpretation would also depend on the completeness and handling of measurements, which are not reported in the registry record. A mean alone would not fully describe the pattern of glucose excursions described in the study rationale.
The single-group design is also central to the statistical meaning. It can describe measurements in the monitored group, but it does not provide a direct randomized comparison with another group or test whether CGM differs from another assessment method. The registry record reports no analysis connecting CGM and fructosamine, and no primary result is available. As a result, the statistical importance of the record lies in identifying a relevant measurement question and an intended endpoint, while making clear that the posted record does not supply the evidence needed to answer it.
Planning illustrations based on an observed effect should be kept distinct from trial design and observed power. The registry explicitly describes them as illustrations, whereas the study itself is recorded as single-group. Treating those calculations as a design justification or as evidence of a study finding would confuse planning assumptions with reported results.
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 most important limitation for interpreting this record is that it does not report analyses. The primary endpoint is defined, but its observed mean and inter-quartile range are absent. No uncertainty interval or statistical test is reported. Thus, the magnitude and precision of the primary outcome cannot be assessed.
The single-group design does not provide a comparator for estimating a between-group contrast. It also does not, on its own, establish the performance of CGM relative to HbA1c or fructosamine. Although the summary gives a rationale involving those measures and the secondary outcomes include serum fructosamine, comparative results are not reported in the registry record.
Enrollment is listed as 80, but the record does not report the number analyzed, usable CGM data, or the completeness of monitoring. The handling of missing device readings and missing blood measurements is not reported. The primary outcome's population field is blank, and the analysis-population definition is not reported in the registry record.
The registry lists seven outcome measures but names only two secondary outcomes in the available description. It does not report a statistical analysis plan, a multiplicity strategy, or the protocol rationale for the enrollment target. The arm description also ends during its account of Day 14 blood collection, so the remaining procedural detail is not reported in the registry record.
Finally, the safety record lists zero events but does not provide detailed event definitions or follow-up procedures. These limitations reflect what is and is not documented in the registry entry; they do not establish that additional procedures or analyses were absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease — NCT03383627.
- Registry record last updated 2021-04-06; status last verified 2021-03.
- Results first posted 2020-04-07.
- 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
NCT03383627 is a completed, single-group study sponsored by Northwell Health. The registry lists enrollment as 80, allocation as NA, masking as none, and phase as NA. The study start date is 2017-11-30, and the primary completion date is 2018-08-21.
The study concerns people with type 2 diabetes and late-stage chronic kidney disease. Its intervention is continuous glucose monitoring using a Freestyle Libre Pro device. The primary outcome is mean glucose concentration measured by CGM in mg/dL over 14 days, with inter-quartile range specified as the dispersion measure.
The registry record does not report an analysis of the primary outcome. It lists two secondary outcomes concerning serum fructosamine and records zero serious events, zero other events, and zero deaths in the monitoring group. The number analyzed, missing-data procedures, and statistical analysis plan are not reported in the registry record.