Expanding Technology-Enabled Nurse Delivered Chronic Disease Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Expanding Technology-Enabled Nurse Delivered Chronic Disease Care (NCT05120544), a randomized na study. The primary outcome is Change in HbA1c.

2. Clinical Question

The central statistical question is whether the change in HbA1c differs between participants assigned to EXTEND Plus and those assigned to EXTEND over the scheduled follow-up. The record lists measurements at baseline and 3, 6, 9, 12, 18, and 24 months. It does not report the result at any of these time points, a single summary contrast across follow-up, or an estimate of the difference between arms. Accordingly, the research question can be described from the design and endpoint, but the primary comparison cannot be answered from the reported results.

3. Trial Design

NCT05120544 is a randomized, parallel-group trial sponsored by Duke University. Its title is “Expanding Technology-Enabled Nurse Delivered Chronic Disease Care.” The registry lists the study as completed, with an enrollment of 220. The recorded start date is 2022-04-21, and the primary completion date is 2025-08-13. The phase is listed as NA.

Participants were allocated to EXTEND Plus or EXTEND. The registry identifies the study as single masked, but does not report who was masked or how masking was maintained. It also does not report the allocation ratio, sequence-generation method, or allocation concealment procedures. Although randomized allocation is specified, those additional operational details are not reported in the registry record.

Both arms involved mobile monitoring devices. The arm descriptions identify a glucometer, blood pressure cuff, scale, and accelerometer, with device data transferred to Duke University Health System. The EXTEND description says participants could review data and trends in device apps. EXTEND Plus is described as nurse-delivered, with the device data used as part of that intervention. The available description does not establish all differences in contact, support, or intervention delivery between arms, so those details should not be inferred.

The primary outcome is change in HbA1c, assessed at baseline and 3, 6, 9, 12, 18, and 24 months. Secondary outcomes include blood pressure, weight, diabetes distress, diabetes self-management, perceived competence, medication non-adherence, and diabetes knowledge. The registry lists 9 outcome measures and 24 analyses. The particular analysis populations, handling of repeated measurements, and statistical model are not reported in the registry 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:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in HbA1c, measured over Baseline, 3, 6, 9, 12, 18 and 24 months.

The primary endpoint is change in HbA1c, expressed as percent change from baseline. HbA1c reflects glucose attached to hemoglobin, and the registry describes its measurement as a validated point-of-care or laboratory-based test. It is scheduled for assessment at baseline and 3, 6, 9, 12, 18, and 24 months.

In general, an endpoint is selected to represent an outcome relevant to the study question in a form that can be measured consistently. HbA1c is used in this trial to assess change in blood sugar over follow-up. A percent change from baseline expresses each participant’s follow-up measurement relative to their starting measurement, while the stated summary parameter is the mean. The registry lists standard deviation as the measure of dispersion.

The repeated schedule permits assessment at several stages of follow-up, but the record does not specify whether the primary inference is intended to use one time point, a combined trajectory, or another summary. It also does not report arm-specific means, changes, between-arm contrasts, confidence intervals, or p-values for HbA1c. The measurement schedule and endpoint definition therefore describe what was to be assessed, but not what the trial found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group design with EXTEND Plus and EXTEND as the study arms. Randomization is intended, in general, to make the assigned groups comparable at the point of allocation, including with respect to factors that may not have been measured. It does not guarantee that every characteristic will be identical between groups, particularly in a finite trial. The registry record does not describe the randomization sequence, allocation concealment, or any baseline comparison used in the analysis.

What does the mean endpoint represent?

The primary endpoint is a continuous measure: change in HbA1c, expressed as percent change from baseline. The listed summary parameter is the mean, and the listed measure of dispersion is the standard deviation. In general, a mean describes the central value of observations, while a standard deviation describes how spread out individual observations are around that mean. They answer different questions: a mean is a summary of the average outcome, while a standard deviation describes variation among participants.

The registry’s designation of a mean and standard deviation does not establish that a particular model was used to compare arms. It also does not specify whether the analysis compared mean changes at each follow-up time, modeled repeated measurements, or used another approach. Those methods, and any adjustment for baseline HbA1c or other covariates, are not reported in the registry record.

Why does repeated measurement matter?

The outcome is scheduled at baseline and several follow-up visits through 24 months. In general, measurements from the same participant are correlated: a person’s values over time are not independent observations. A statistical method for repeated measurements can account for this dependence and can use information across visits, depending on its specification. The record does not report whether such a method was used, how within-participant correlation was handled, or how the primary contrast across follow-up was defined.

Repeated follow-up also makes missing data consequential. Participants may not have measurements at every scheduled visit. In general, an analysis must specify how incomplete records are handled and the assumptions that support that handling. The registry record does not report the number of participants assessed at each visit, the amount or pattern of missing HbA1c data, or the method used to address missing observations. No assumption about complete follow-up or a particular imputation method can be made from the record.

How should uncertainty be read?

In general, a confidence interval gives a range of values compatible with the data and the statistical model at a stated confidence level. Its width conveys precision: narrower intervals indicate more precise estimates under the model, while wider intervals indicate greater uncertainty. A confidence interval for a between-arm difference would help readers assess both the range of plausible effects and whether the data are compatible with effects in different directions. The primary HbA1c estimates and confidence intervals are not reported in the registry record.

A p-value, in general, summarizes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions were true. It is not a measure of effect size, clinical importance, or the probability that the null hypothesis is true. No primary-outcome p-value is reported in the registry record, and a p-value alone would not replace an estimate with an uncertainty interval.

What does the design information establish?

The parallel design means the arms are concurrent groups rather than sequential treatment periods within each participant. The registry also records single masking, but does not identify who was masked. As the interventions involve devices and nurse-delivered support, the precise practical meaning of masking cannot be inferred from the label alone. Details about masking of participants, intervention staff, outcome assessors, or analysts are not reported in the registry record.

The record lists 9 outcome measures and 24 analyses. In general, evaluating multiple outcomes or time points creates a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. A prespecified hierarchy, adjustment procedure, or distinction between confirmatory and exploratory analyses can help readers understand that context. The registry record does not report such a plan, nor does it identify which of the 24 analyses correspond to confirmatory tests.

Planning sample sizes are conceptually different from observed trial outcomes. In general, planning calculations depend on assumptions about an effect, variability, allocation, significance threshold, and analysis method. An illustration based on an observed effect is not evidence of the trial’s original design rationale and is not observed power. The registry record does not report the trial’s own sample-size justification. No conclusion about the adequacy of the planned enrollment can be drawn from an unreported justification.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 9 outcome measures and 24 analyses, including a primary HbA1c outcome assessed at multiple scheduled times and several secondary outcomes. This raises questions about multiplicity and selective reporting, but the number of listed analyses alone does not tell readers which tests were prespecified, which were primary or exploratory, or whether any adjustment was used. A multiplicity procedure or testing hierarchy is not reported in the registry record.

Missing-data information is also limited. The record does not report how many participants contributed HbA1c measurements at each visit, reasons for missing measurements, or how incomplete follow-up was handled. It does not state whether analyses used all randomized participants, participants with available measurements, or another analysis population. The analysis population definitions are not reported in the registry record.

In general, missing-data methods depend on both the pattern of missingness and assumptions about why observations are absent. Different assumptions can affect estimates, especially when follow-up is incomplete. Sensitivity analyses can examine whether conclusions change under alternative assumptions, but their use is not reported in the registry record. Without those details, readers cannot assess the robustness of the primary analysis to incomplete outcome data.

The record’s enrollment and design information do not substitute for a statistical analysis plan. The primary model, handling of repeated measurements, analysis population, multiplicity strategy, missing-data approach, and sensitivity analyses are not reported in the registry record. These omissions limit assessment of how the listed outcomes and analyses were interpreted.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: stroke/stroke evaluation (7.3%), abdominal pain (3.6%), cancer-related admission (3.6%), diabetic ketoacidosis (2.7%), chest pain (2.7%).

The registry reports 31 serious adverse events in EXTEND Plus and 29 in EXTEND, with 110 participants at risk in each group. Other adverse events are reported as 26 in EXTEND Plus and 27 in EXTEND. Deaths are listed as 1 in EXTEND Plus and 2 in EXTEND. These are the recorded counts; the registry does not provide a statistical comparison of these safety figures.

The serious-event terms reported most often include stroke/stroke evaluation at 7.3%, abdominal pain at 3.6%, cancer-related admission at 3.6%, diabetic ketoacidosis at 2.7%, chest pain at 2.7%, and diabetic foot infection at 2.7%. The record does not clarify the denominators or whether a participant could contribute to more than one term. These percentages should therefore be read as reported, not converted into counts or interpreted as mutually exclusive categories.

In general, safety counts do not by themselves establish a difference in risk between arms. Interpretation also depends on how events were defined, the period of observation, exposure time, event recurrence, and attribution. Those details and causal assessments are not reported in the registry record. The counts should be treated as descriptive safety information, not as evidence that an intervention caused or prevented an event.

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

The registry record supports a description of the trial’s question and design: EXTEND Plus was compared with EXTEND in a randomized, parallel-group study enrolling 220 participants with type 2 diabetes and hypertension. The primary endpoint was change in HbA1c, with measurements scheduled from baseline through 24 months. The record also identifies secondary outcomes and provides safety counts.

It does not report primary HbA1c estimates or a between-arm comparison. As a result, the posted information does not establish the direction or size of any difference in the primary outcome, nor how precisely such a difference was estimated. No claim that either arm improved HbA1c more than the other can be supported from the reported primary-outcome information.

Likewise, the stated purpose of investigating self-management does not constitute a finding that self-management changed. The registry record does not provide results for the listed secondary outcomes, so their magnitude and uncertainty cannot be assessed. The fact that outcomes were named or measured does not show that a benefit, harm, or difference was observed.

The safety counts describe events recorded in each arm, but do not establish causality or a comparative safety effect. The record does not provide enough information about event definitions, exposure, recurrence, or statistical comparisons to draw those conclusions. In general, randomized assignment helps support comparisons when outcomes and analyses are reported, but design alone cannot replace outcome estimates.

Overall, the record documents a completed trial and its planned outcome framework, while leaving important result and analysis details unreported. Its contents support understanding what was studied and what safety counts were recorded; they do not support a conclusion about the primary treatment contrast or the effectiveness of either intervention.

13. Why This Trial Matters Statistically

This trial is statistically relevant because it evaluates a technology-enabled approach to chronic disease care using a randomized, parallel-group design. The comparison includes mobile monitoring in both arms, while EXTEND Plus is described as nurse-delivered. That makes clear definition of the intervention contrast important: readers need to know what differs between the arms before interpreting an estimated difference. The registry descriptions do not provide all details of that contrast.

The primary outcome is measured repeatedly over follow-up. Repeated outcomes can provide a richer picture than a single assessment, but they also require a clear estimand and analysis strategy. The registry identifies the scheduled HbA1c visits without reporting how the repeated observations were combined or compared. That gap illustrates why a list of outcome time points is not enough to interpret longitudinal evidence.

The trial also lists multiple secondary outcomes and analyses. In general, a transparent distinction between confirmatory and exploratory results helps readers judge multiplicity and avoid treating every nominal finding as equally conclusive. The registry record does not report how this issue was handled. Reporting estimates, uncertainty intervals, analysis populations, and missing-data methods would also help readers evaluate precision and robustness.

The record’s safety counts add descriptive context, but they require careful interpretation alongside event definitions and follow-up details. In this case, the counts are not accompanied by a reported comparative safety analysis. The broader statistical lesson is that design, outcome measurement, analysis, and reporting all contribute to what can be concluded. Here, key elements of the design are documented, but the primary results and several analysis details are not reported 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.

Important limitations of interpretation arise from what is not reported in the registry record. The primary outcome is defined and its assessment schedule is listed, but no HbA1c estimates, between-arm contrasts, confidence intervals, or p-values are reported. The effect’s direction, magnitude, and precision therefore cannot be evaluated.

The descriptions of the two arms are incomplete in the record. Both include four mobile devices and data transfer to Duke University Health System, and EXTEND Plus is identified as nurse-delivered. The record does not provide enough detail to characterize every difference in intervention delivery, intensity, or contact. Masking is recorded as single, but the masked parties and procedures are not stated.

Analysis details are not reported, including the model for repeated measurements, analysis populations, missing-data handling, and multiplicity approach. Participant characteristics and outcome completeness by visit are also not reported. Without these details, readers cannot assess baseline context, attrition, or the assumptions supporting the primary analysis.

The safety information is limited to reported counts and selected serious-event terms. Definitions, event attribution, recurrence, exposure time, and comparative testing are not reported in the registry record. These limitations mean that the safety figures should be read descriptively and that no causal or comparative safety conclusion can be drawn from them alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Expanding Technology-Enabled Nurse Delivered Chronic Disease Care — NCT05120544.
• Registry record last updated 2026-10-01; status last verified 2025-10.
• Results first posted 2026-10-01.
• 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

NCT05120544 is a completed, randomized, single-masked, parallel-group study sponsored by Duke University. It enrolled 220 participants and compared EXTEND Plus with EXTEND for people with type 2 diabetes and hypertension. The primary outcome was change in HbA1c, expressed as percent change from baseline and scheduled for assessment at baseline and 3, 6, 9, 12, 18, and 24 months.

The registry identifies 9 outcome measures and 24 analyses. It reports serious adverse event counts of 31 for EXTEND Plus and 29 for EXTEND, other adverse event counts of 26 and 27, and deaths of 1 and 2, respectively; each arm had 110 participants at risk. Primary HbA1c results, analysis methods, missing-data handling, and multiplicity procedures are not reported in the registry record. The design and safety information can be described, but the primary comparison cannot be quantitatively interpreted from the reported outcome information.