Evaluating Telementoring for CHW-centered Diabetes Initiatives: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluating Telementoring for CHW-centered Diabetes Initiatives (NCT04835493), a randomized na study. The primary outcome is HbA1c (%).

2. Clinical Question

3. Trial Design

This is a randomized, parallel-group trial with single masking, as recorded in the registry. The registry lists an enrollment of 320 and describes two groups: an intervention arm receiving the 12-month diabetes program and a usual-care arm. It does not say who was masked, how the randomization sequence was generated or concealed, or whether allocation was balanced within any subgroups; those details are not reported in the registry record.

The study is titled as an evaluation of telementoring for CHW-centered diabetes initiatives. The implementation approach is to mentor local clinics through telehealth as they initiate a program combining telehealth support, integrated CHWs, medication access, and diabetes education. The registry’s brief summary presents clinic mentoring as a strategy for initiating a multidimensional diabetes program in settings serving low-income and minority populations. The record does not provide clinic-level counts or explain whether clinics, individuals, or both were involved in the allocation process.

The primary outcome is HbA1c, with a baseline-to-12-month timeframe. The record lists additional outcomes spanning blood pressure, BMI, cholesterol, diabetes-care adherence measures, and CHW support on a program satisfaction questionnaire. The posted numeric secondary comparisons include continuous measures; the registry record does not report analyses for the listed adherence and satisfaction outcomes.

The trial is marked active, not recruiting. The registry lists a start date of 2022-09-01 and a primary completion date of 2025-04-30. These registry dates describe the study timeline, not the timing of every participant’s follow-up or the date of the posted outcome summaries. The registry does not report the trial’s original sample-size justification, its planned analysis populations, or whether interim analyses were planned.

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

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 HbA1c (%), measured over Baseline to 12-months.

The primary endpoint is HbA1c, reported as a percentage of glycated hemoglobin, over the baseline-to-12-month timeframe. HbA1c reflects glucose attached to hemoglobin and is used in diabetes research as a measure of longer-term glycemic status. In general, a continuous endpoint such as HbA1c allows investigators to compare average values or average changes between trial groups, while also describing how much participants’ values vary.

The registry describes the primary objective as comparing intervention versus control HbA1c levels. The posted summaries give a mean and standard deviation for each group: the intervention arm has a mean of -1.0 and standard deviation of 2.3, while usual care has a mean of 0.0 and standard deviation of 2.2. Because the stated timeframe is baseline to 12 months and the summaries include negative values, these are presented as changes over that interval. The unit is HbA1c percentage, so the estimated difference is expressed on that measurement scale.

HbA1c is relevant to the trial’s stated goal of evaluating a multidimensional diabetes program. It is one clinical measure, however, and does not by itself capture all aspects of diabetes care, clinic implementation, medication access, education, CHW support, or participant experience. The registry record does not report a fuller rationale for choosing this endpoint, a threshold for clinical importance, or whether the primary outcome was analyzed using an adjusted model.

7. Results Posted in the Registry

• Intervention: mean -1.00 versus 0.00 on control; difference -1.00 (95% CI -1.51 to -0.49), standardized effect d = -0.44; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Systolic Blood Pressure mmHg

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intervention: mean 2.50 versus 2.90 on control; difference -0.40 (95% CI -4.29 to 3.49), standardized effect d = -0.02; z-test p = 0.840.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Body Mass Index (BMI)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intervention: mean 0.00 versus -0.20 on control; difference 0.20 (95% CI -0.20 to 0.60), standardized effect d = 0.11; z-test p = 0.332.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Total Cholesterol

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intervention: mean -22.90 versus 12.40 on control; difference -35.30 (95% CI -46.21 to -24.39), standardized effect d = -0.74; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes cover several dimensions beyond HbA1c, including cardiovascular and body-size measures, cholesterol, diabetes-care processes, and patient-reported CHW support. Among the posted continuous comparisons, the direction and degree of statistical precision vary: some intervals include no mean difference, while another is separated from zero. This is a mixed pattern rather than a uniform shift across all the reported clinical measures.

The secondary findings can add context to the primary result, but they do not independently establish how or why the overall program might relate to HbA1c. The intervention combines multiple components, and the registry does not report analyses that isolate the contribution of telehealth support, CHW integration, medication access, or education. Nor does the registry provide results for all listed care-process and satisfaction outcomes. The available secondary comparisons therefore cannot describe the full range of program effects or implementation experience.

Secondary outcomes generally carry less confirmatory weight than a prespecified primary endpoint, especially when many measures are examined. In general, testing numerous outcomes without an adjustment or hierarchy increases the possibility that some results appear notable by chance. The registry record does not report a multiplicity strategy or a hierarchy for interpreting the secondary measures. Their unadjusted estimates and p-values should be treated as supportive or exploratory information, not as a collection of independent confirmations.

The reported secondary comparisons also have their own uncertainty. A result that does not exclude zero is not proof that the groups are identical; it indicates that the interval includes both no difference and values in either direction under the calculation used. Conversely, an interval that excludes zero does not resolve questions about multiplicity, practical importance, missing data, or the intended analysis population. The secondary outcomes are most informative when read alongside those limitations and the primary endpoint, rather than as standalone verdicts on the program.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Systolic Blood Pressure mmHg
• Body Mass Index (BMI)
• Total Cholesterol
• American Diabetes Association (ADA) Adherence Measures: Diabetes Foot Exam
• ADA Adherence Measures: Diabetes Eye Exam Screening
• ADA Adherence Measures: Urine Microalbumin Screening
• ADA Adherence Measures: Flu Vaccination
• Average Score for CHW Support on Program Satisfaction Questionnaire

9. Statistical Interpretation

10. Statistical Methods Explained

Several statistical ideas help interpret the posted comparisons. The registry describes a randomized, parallel-group design, but it does not report the detailed procedures used to generate or conceal the allocation sequence. Randomization is generally intended to make assigned groups comparable on average at the start of a trial. It does not guarantee that every measured or unmeasured characteristic will be balanced in a particular sample, and the registry record does not provide baseline characteristics with which to assess balance.

What a mean difference represents

For a continuous outcome, a mean difference compares the average outcome in one group with the average in another. For the primary endpoint, the posted estimate is -1.0 for intervention relative to usual care. The negative sign indicates that the intervention group’s reported average change is lower on the HbA1c scale. This is an unadjusted comparison calculated from the posted group summaries, not a description of every participant’s response. The standard deviations describe variation among observations within each group; they are not uncertainty intervals for the group means.

The reported comparison includes a 95% confidence interval and an unadjusted p-value. In general, a confidence interval is a range of values compatible with the data under the statistical method used, and its width conveys precision. A p-value describes how unusual data at least as incompatible with a null comparison would be under a specified model if the null were true. It is not the probability that the null hypothesis is true, and it does not measure the chance that the finding occurred by chance in an everyday sense. The registry record does not report the sponsor’s full model, assumptions, or inferential procedure for these outcomes, so the posted unadjusted summaries should not be mistaken for a complete prespecified analysis.

Unadjusted estimates and analysis choices

The mean differences and confidence intervals accompanying the posted group summaries are simple, unadjusted comparisons. In general, an adjusted analysis may account for baseline outcome values or other prespecified variables and can produce estimates that differ from an unadjusted comparison. Whether such a model was planned or used is not reported in the registry record. The record also does not state how repeated measurements, missing follow-up values, or clustering within clinics were handled. These are important design and analysis details in a clinic-based intervention, but their absence from the registry record does not establish that no such procedures were used.

The sample sizes associated with the primary summaries are 150 in intervention and 145 in usual care. The adverse-event summaries list 160 participants at risk in each arm, a different set of counts. The registry record does not explain the relationship between those counts, and they should not be treated as interchangeable denominators. Nor should enrollment of 320 be assumed to be the number contributing to each outcome summary.

Why variation matters

Standard deviations quantify the spread of individual measurements around their group mean. Greater spread makes a mean difference harder to estimate precisely when the number of participants is otherwise unchanged. For continuous outcomes, variation can also differ between groups. The posted primary standard deviations are similar in scale, but the registry does not report diagnostic checks or the exact method used to construct the confidence interval.

In general, over-dispersion matters most for outcomes analyzed as counts or rates: if the observed variation exceeds what a simple model assumes, standard errors can be too small and confidence intervals too narrow unless the model accounts for it. The posted primary and continuous secondary outcomes are reported as means and standard deviations, not as count outcomes. The registry record does not describe over-dispersion analyses, and no such analysis should be inferred.

Multiplicity and secondary comparisons

The registry lists a range of secondary outcomes in addition to the primary HbA1c endpoint. When many outcomes are examined, the chance of seeing one or more apparently notable results can increase, even if each comparison is considered separately. In general, multiplicity procedures can control error across a family of tests, while a prespecified hierarchy can identify which results are confirmatory and which are exploratory. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a rationale for the number of secondary measures. The secondary p-values should therefore be read as unadjusted, outcome-specific summaries rather than as evidence that accounts for all the comparisons.

The posted secondary summaries include systolic blood pressure, BMI, and total cholesterol. The registry also lists diabetes foot and eye examinations, urine microalbumin screening, flu vaccination, and CHW support on a satisfaction questionnaire. Analyses for those listed measures are not reported in the registry record. The absence of a posted analysis is not evidence that the measure was not collected or that it had a particular result.

What is not specified

The record does not report the original sample-size justification or the planned target effect for the trial. It does not give a detailed statistical analysis plan, define intention-to-treat or per-protocol populations, describe missing-data methods, or state whether interim analyses were planned. It also does not specify the masking target, details of implementation fidelity, or methods for accounting for clinic-level clustering. Such details are necessary to judge how the posted summaries relate to the intended confirmatory analysis. Without them, interpretation should stay close to the observed group summaries and their unadjusted uncertainty estimates.

11. Confidence Intervals and Precision

The primary HbA1c mean difference is -1.0, and its 95% confidence interval runs from -1.514 to -0.486. The interval is entirely below zero, indicating that the unadjusted summary-statistic estimate is separated from no mean difference under the calculation used. Its width also makes clear that the data are compatible with a range of effect magnitudes, not only the single point estimate. The interval concerns the group-average difference; it does not describe individual outcomes or guarantee that a future study would produce an estimate within those bounds.

For the posted secondary outcomes, interval location and width differ. The systolic blood pressure interval includes zero and spans estimates in both directions. The BMI interval also includes zero. The total cholesterol interval is below zero. Those patterns describe uncertainty in the individual unadjusted comparisons, not proof of no difference for outcomes whose intervals include zero or proof of a definitive effect for an outcome whose interval excludes zero. Precision and statistical compatibility should be considered alongside the estimates’ scale and the analysis context.

In general, confidence intervals depend on the data and the method used to calculate them. They can be affected by sample size, outcome variability, and modeling assumptions. The posted summaries provide group sizes and standard deviations for the continuous outcomes, but the registry record does not report a detailed sponsor analysis or explain the confidence-interval procedure. The posted intervals are therefore useful for describing the unadjusted comparisons, while not replacing the trial’s full analysis plan or report.

The registry does not state what difference would be clinically important for HbA1c, blood pressure, BMI, or cholesterol. A confidence interval can help assess the range of values compatible with the data, but it cannot by itself determine practical importance. Likewise, a narrow or wide interval does not establish whether a program is feasible or acceptable in clinic settings. Those questions require information beyond the statistical precision of these group comparisons.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size display is a planning illustration based on the posted observed effect, not the trial’s original design calculation. For these continuous outcomes, the figures are participants per arm, rather than total events. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; each planning row uses the stated fraction of the observed effect as the effect to detect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm under those assumptions for a design with an 80% chance of detecting the specified effect if that effect is the true one and the assumptions hold. The 90% power column gives the corresponding per-arm planning number for a design with a 90% chance. These are design calculations, not measures of the probability that the posted result is correct. This is not observed power.

The rows vary the effect used for planning. A row based on a smaller fraction of the observed effect asks what sample would be needed to detect a smaller difference. Smaller effects need more participants because they are harder to distinguish from random variation when outcome variability is similar. This is why the displayed participant requirements rise as the effect used for planning becomes smaller. The calculation is illustrative: it assumes the listed allocation, significance level, and normal approximation and does not account for any design features not stated in those assumptions.

The sample-size display should not be read as evidence that the trial was designed around the observed estimate, nor as a retrospective validation of the trial’s power. The registry lists enrollment of 320, while primary-outcome summaries include 150 intervention and 145 usual-care participants. The record does not explain how those enrollment and outcome-summary counts relate or whether the original planning target was met. Planning figures are most useful for understanding the scale of a future study under the stated assumptions, not for replacing a protocol-based sample-size rationale.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -1.000; pooled standard deviation σ = 2.251.
2. n = 2 × (1.96 + 0.842)² × 2.251² / -1.000² = 79.6, rounded up to 80 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1                      # observed difference in means
sigma <- 2.25140835710532                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4835493)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 80 (80% power), 107 (90% power)
 75% of observed effect: n per arm = 142 (80% power), 190 (90% power)
 50% of observed effect: n per arm = 319 (80% power), 427 (90% power)
power.t.test: 80.5 
Simulated power at n = 80 per arm: 0.795 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and a broad set of secondary outcomes. It does not report whether the statistical plan used a hierarchy, a family-wise error adjustment, or another approach to multiplicity. When many endpoints are tested, each additional comparison creates another opportunity for a result to appear statistically unusual by chance. In general, prespecifying which outcome is primary and how secondary tests will be interpreted helps distinguish confirmatory evidence from exploratory findings. Without a reported plan, the secondary p-values are best understood as unadjusted comparisons, not as a set of results with controlled overall error.

The registry record does not describe how missing outcome values were handled. It does not report the number of participants with missing HbA1c or secondary measurements, the reasons for missingness, or whether an imputation or other method was used. Missingness can affect interpretation if availability of an outcome is related to group assignment or to the outcome itself. The record also does not state whether all randomized participants were included in the primary analysis or whether another analysis population was used.

The record does not report an intention-to-treat definition, a per-protocol analysis, or a safety population definition. It also does not explain the difference between the primary-outcome group sizes and the adverse-event at-risk counts. Those counts should be interpreted as distinct posted summaries rather than assumed to refer to identical analysis sets. The original sample-size calculation, planned covariate adjustments, and interim analysis plans are not reported in the registry record.

There are further design details relevant to inference that are not reported, including how masking was implemented and whether the analysis accounted for participants being treated within clinics. The intervention is delivered through community clinics and involves clinic mentoring, but the registry does not give the number of clinics or state whether clinic-level clustering was included in the analysis. This information matters because outcomes from participants in the same clinic may be more alike than outcomes from participants in different clinics. These omissions do not show that an analysis was inadequate; they limit what can be verified from the registry record alone.

15. 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 adverse-event summaries list 160 participants at risk in each arm. In both the intervention and usual-care groups, the posted counts are zero for serious adverse events, zero for other adverse events, and zero deaths. These figures mean that no events in those categories are recorded in the posted summaries for the stated at-risk groups.

Zero reported events do not establish that the intervention is free of risk. They do not rule out events that were not captured, were not classified in the reported categories, or occurred outside the reporting period. The registry record does not provide adverse-event definitions, collection procedures, follow-up duration for these safety summaries, or an explanation of the at-risk counts in relation to the primary-outcome sample sizes. The record also does not list serious adverse-event terms.

Safety counts are descriptive and should be interpreted in light of the number of people observed and the duration and completeness of reporting. The registry’s zero counts are not a comparison of event rates adjusted for exposure time, and they do not establish equivalence between groups. They are a limited account of events recorded in the registry, not a complete safety assessment.

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

The posted primary comparison describes a lower mean HbA1c change in the intervention arm than in usual care over the baseline-to-12-month period. Its unadjusted confidence interval excludes zero. This is the statistical result represented by the posted group summaries; the registry record does not provide a sponsor-reported analysis or a complete statistical analysis plan against which to assess it.

The result does not by itself establish the practical importance of the observed difference. The registry does not report a threshold for a meaningful HbA1c difference, nor does a group-average estimate describe every participant’s experience. The endpoint captures one clinical measure, while the intervention encompasses clinic mentoring, CHW support, medication access, telehealth, and education. The result cannot identify which component, if any, accounts for the observed group pattern.

The randomized design is relevant to interpreting group comparisons, but key design and analysis details are not reported in the registry record. These include allocation procedures, the masking target, analysis populations, missing-data methods, and whether clinic-level clustering was addressed. The available summaries therefore should not be extended beyond the comparisons they describe. In particular, they do not establish effects for every secondary outcome or for participant subgroups.

Secondary results are varied, and the registry does not report analyses for every listed care-process and satisfaction measure. The multiplicity approach is also not reported, so unadjusted secondary findings carry less weight than a prespecified primary analysis. Safety summaries record no serious events, other events, or deaths in either group, but the record lacks details needed to interpret the completeness and duration of safety reporting.

The registry identifies the study as active, not recruiting, and gives a primary completion date of 2025-04-30. It does not state whether the posted outcome summaries are final or whether additional analyses will be reported. Readers should therefore distinguish the posted statistical summaries from broader conclusions about implementation, long-term outcomes, or the full clinical and safety profile of the program.

17. Why This Trial Matters Statistically

This trial is statistically interesting because it evaluates a multidimensional program intended to be initiated in community clinics, rather than a single isolated treatment component. Its randomized parallel-group design provides a framework for comparing the program with usual care, while its primary HbA1c outcome gives a continuous measure that can be summarized by group means and uncertainty intervals.

The posted primary estimate is accompanied by a confidence interval that excludes zero, making precision visible rather than reducing the comparison to a p-value alone. At the same time, the registry record illustrates why statistical evidence needs context: the original sample-size rationale, analysis plan, missing-data procedures, allocation details, and clinic-level analysis methods are not reported. Those omissions constrain how fully readers can assess the intended inferential framework.

The breadth of the secondary outcomes is another important feature. The registry includes clinical measures alongside diabetes-care adherence and CHW support satisfaction, which reflect different aspects of the intervention. Yet the posted numerical evidence is not equally complete across those domains, and no multiplicity strategy is reported. This makes it important to distinguish a primary finding from a collection of secondary comparisons and to avoid treating every endpoint as an independent confirmation.

The planning illustrations also show how sample-size requirements depend on the effect chosen for detection. They are useful for understanding the relationship between effect size and precision, but they do not disclose the trial’s original design assumptions or establish observed power. Overall, the registry supports a careful reading of the posted group summaries while leaving several protocol and analysis questions unresolved.

18. 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.

Several limitations specific to this registry record affect interpretation. First, detailed eligibility criteria and participant characteristics are not reported, so the population represented by the outcome summaries cannot be described beyond the registry’s framing of Latino(a)s in community clinics and type 2 diabetes. The record does not provide subgroup results or information about how representative participating clinics and participants are.

Second, the intervention is a package of telehealth support, integrated CHWs, medication access, and diabetes education, delivered in the context of telehealth mentoring for local clinics. The registry does not report implementation fidelity, uptake, the extent to which clinics delivered each component, or analyses separating the contribution of individual components. The comparator also includes usual clinical care and other clinic opportunities; the record does not establish how those services varied between clinics.

Third, the registry does not report the original sample-size justification, detailed statistical plan, analysis populations, or handling of missing outcomes. It does not state whether the analysis accounted for clinic-level clustering, despite the clinic-based setting. The number of clinics and the masking target are not reported. These are uncertainties about what can be evaluated from the registry record, rather than proof that the trial did not address them.

Finally, the secondary outcomes have no reported multiplicity strategy, and numeric analyses for several listed care-process and satisfaction measures are not reported in the registry record. The safety summaries show zero recorded events in both groups but lack details about definitions, ascertainment, and follow-up duration. The record does not clarify whether the posted outcome summaries are final. Together, these limitations favor a narrow interpretation of the available unadjusted estimates rather than broad conclusions about implementation, safety, or all dimensions of diabetes care.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Evaluating Telementoring for CHW-centered Diabetes Initiatives — NCT04835493.
• Registry record last updated 2026-10-14; status last verified 2026-08.
• Results first posted 2026-10-14.
• 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.

22. Record Summary

The registry describes a randomized, single-masked, parallel-group trial comparing a 12-month multidimensional diabetes program with usual care in community clinics. It lists type 2 diabetes as the condition and identifies HbA1c from baseline to 12 months as the primary outcome. The posted primary group summaries include 150 participants in the intervention arm and 145 in usual care, with an unadjusted mean difference of -1.0 and a 95% confidence interval from -1.514 to -0.486.

Posted secondary continuous comparisons cover systolic blood pressure, BMI, and total cholesterol. The registry also lists diabetes-care adherence and CHW support outcomes, but analyses for those measures are not reported in the registry record. Adverse-event summaries record zero serious events, zero other events, and zero deaths in both groups, with 160 participants at risk in each arm.

The registry marks the trial active, not recruiting, with a primary completion date of 2025-04-30. It does not report the original sample-size justification, a detailed statistical plan, missing-data methods, or multiplicity procedures. The posted comparisons are therefore best read as unadjusted summaries alongside the registry’s stated limitations.