Morbidity in Newly Diagnosed type2 Diabetes in Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Morbidity in Newly Diagnosed type2 Diabetes in Adults (NCT02002091), a registered phase not stated study. The primary outcome is Number and Prevalence of Patients With Diabetic Retinopathy.

2. Clinical Question

The study's stated main purpose was to assess the prevalence of chronic diabetic complications among newly diagnosed adults with type 2 diabetes in a suburban area of Algiers. Its secondary purpose was to study whether diabetic renal complications were a risk factor for atherothrombotic events. The listed follow-up outcomes include new cardiac events, stroke or transient ischemic attack, lower-limb atherothrombotic events, and cardiovascular deaths.

These questions describe different kinds of evidence. Retinopathy prevalence at recruitment is a cross-sectional description of the screened participants at that point in the study. The renal-complication question concerns events during follow-up and a comparison between groups defined by chronic kidney disease status. The registry record describes adjustment for age and major risk factors for that comparison, but does not report the analysis results or enough detail to establish how the adjustment was performed.

3. Trial Design

The registry record describes a prospective, observational cohort study sponsored by the University of Algiers. Its status is COMPLETED. The recorded study start is 2009-01 and the primary completion is 2013-12. Enrollment is listed as 327. The stated setting is a suburban area of Algiers, and the population is adults with newly diagnosed type 2 diabetes.

The primary outcome was assessed at recruitment. The registry describes screening for diabetic retinopathy by an ophthalmologist using conventional ophthalmoscopy, with retinal angiography performed if the ophthalmologist indicated it. The record says 309 participants underwent ophthalmoscopy and 18 did not. It does not report why some participants were not tested or whether the test was completed at a later time.

The study also describes one-year follow-up for cardiovascular events, comparing participants with and without chronic kidney disease after screening for complications. It states that treatment was non-specific and multi-interventional, but does not detail the treatment components. The comparison is not presented as a randomized allocation; allocation is not stated. Consequently, differences between the chronic kidney disease groups cannot automatically be attributed to kidney disease status or to any particular treatment.

The listed secondary outcomes include new cardiac events, new stroke or transient ischemic attack, lower-limb atherothrombotic accidents, and deaths from cardiovascular causes. The record lists 16 outcome measures and 12 analyses, but does not give a complete account of the analysis methods or results for those outcomes. A protocol, detailed eligibility criteria, recruitment procedures, follow-up completion figures, and reasons for withdrawal are not reported in the registry record. The stated design supports description of observed complications and follow-up events in the cohort; it does not, on its own, establish causal treatment effects.

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.

Screening

Reasons for not completing this period:

One Year Follow up

Analysis population for the primary outcome, as defined in the registry: From 327, 309 (113 men and 196 women) patients benefit from ophthalmoscopy with a trained ophthalmologist. 18 patients (9 men and 9 women) didn't perform the test. Each patient having a diabetic retinopathy was treated by the ophtalmologist who performed the examination

5. Baseline Characteristics

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

Population: We described gender, age, history of familial, major cardiovascular risk factors and mean anthropometric, blood pressure and biological measures

6. Primary Endpoint

The registry lists the primary outcome as Number and Prevalence of Patients With Diabetic Retinopathy, measured over At recruitment.

The primary endpoint is the number and prevalence of participants with diabetic retinopathy at recruitment. It is a binary clinical status summarized as a participant count: a participant either had retinopathy identified by the described screening process or did not. The endpoint description specifies conventional ophthalmoscopy by an ophthalmologist and retinal angiography when indicated by that ophthalmologist.

Prevalence is used to describe how common a condition is in a defined population at a particular point or period of assessment. In this study, the stated assessment time is recruitment, so the intended measure describes retinopathy among participants screened at entry. It is not an incidence measure of newly developing retinopathy over follow-up, and it does not compare assigned treatments.

The registry record reports that 309 participants underwent ophthalmoscopy and that 18 did not. It does not report the number diagnosed with retinopathy or the prevalence estimate. Therefore, the endpoint's result and its precision cannot be assessed from the registry record. It also does not specify how an indeterminate examination, an unavailable examination, or a participant without retinal angiography when it was not indicated was classified in the analysis. This distinction matters because the endpoint is based on the screening process, and the record does not provide enough detail to reconstruct the final analysis population or outcome definition beyond the stated procedures.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry entry gives some design and outcome details, but does not report a complete statistical analysis plan. The distinctions below explain how the stated outcome and comparison are generally interpreted; they do not identify methods that the investigators used unless the registry record says so.

What does a prevalence endpoint describe?

In general, prevalence is the share of a defined population found to have a condition at a specified assessment time. Here, the record names retinopathy at recruitment as the primary outcome and describes ophthalmologic screening. The endpoint is expressed as a count and prevalence of participants. The actual count and prevalence are not reported in the registry record, so neither the magnitude nor the uncertainty of the result can be reviewed.

A prevalence estimate depends on who was assessed and how the condition was identified. The registry record states that 309 participants had ophthalmoscopy and that 18 did not. It does not say whether the unexamined participants were excluded from the endpoint analysis, treated as having unknown status, or handled in another way. It also does not state whether ophthalmologists used a common grading system or how differences in examination findings were resolved. These details affect reproducibility and interpretation, but are not reported in the registry record.

How should counts and uncertainty be read?

In general, a count gives the number of participants meeting an outcome definition, while a prevalence estimate relates that count to a defined denominator. A confidence interval describes uncertainty around an estimate under the assumptions of its statistical method; it does not show that every value in the interval is equally likely or remove potential selection bias. No retinopathy count, prevalence estimate, or confidence interval is reported in the registry record. It is therefore not possible to assess whether the estimate is precise or to compare it statistically with another population.

For a binary outcome, the relevant information usually includes the number with the event, the number assessed, the denominator definition, and an uncertainty measure. The registry record does not provide all of these for the primary endpoint. The enrollment count alone is not a substitute for the endpoint denominator, because the record explicitly notes that some enrolled participants did not undergo the examination.

What does adjustment mean for the follow-up comparison?

The record describes comparing participants with and without chronic kidney disease on the occurrence of cardiovascular events and states that adjustment is done for age and major risk factors. In general, adjustment means comparing groups while accounting statistically for specified measured characteristics. It may reduce confounding from those characteristics if they are measured adequately and modeled appropriately. It does not make observational groups equivalent to randomized groups, and it cannot control unmeasured or poorly measured differences.

The exact adjusted model, included risk factors, effect measure, missing-data handling, and resulting estimates are not reported in the registry record. The listed secondary outcomes identify event types, including cardiac events, stroke or transient ischemic attack, lower-limb atherothrombotic accidents, and cardiovascular deaths. They do not supply the estimates needed to determine the size or precision of any association with chronic kidney disease.

What can the sample-size illustrations establish?

The planning illustrations described for the analysis use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For time-to-event outcomes, the illustration is based on the total number of events; for other outcomes, it is expressed as participants per arm. These are planning calculations, not observed power and not evidence that the study was designed with those assumptions.

In general, a planning sample size describes the size of a hypothetical study needed under specified assumptions. It does not show the probability that a completed study found a true effect, and it cannot replace an estimate with its confidence interval. The registry record does not report the study's own sample-size justification, and the numerical planning results are not needed to interpret the absent retinopathy estimate. A reader should distinguish any such illustration from the study's enrollment of 327 and from the number of participants who actually underwent the primary screening.

What is unknown about analysis choices?

The registry record lists 16 outcome measures and 12 analyses, but does not report the complete analysis plan, any interim-analysis procedures, or a method for adjusting for multiple outcome testing. It also does not say whether analyses followed a prespecified protocol. Those omissions limit assessment of how outcomes were selected, how many comparisons were conducted, and whether reported findings could be affected by analytical choices. No p-value or inferential result for the primary endpoint is reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Men Group", "Women Group")
n      <- c(113, 196)
events <- c(9, 18)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Men Group  113  9  8.0  3.7  14.6  4.2  14.4  4.3  14.5
ARM  Women Group  196  18  9.2  5.5  14.1  5.9  14.0  5.9  14.1

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 16 outcome measures and 12 analyses. It does not report how many analyses were planned for each outcome, which outcomes were designated as primary beyond the named retinopathy endpoint, or whether any method was used to account for multiple testing. When many outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase. As a general statistical point, prespecifying the main question and reporting all planned analyses helps readers distinguish confirmatory findings from exploratory ones. The record does not provide enough information to evaluate that distinction.

Missing outcome information is evident for the primary screening: 18 participants did not undergo ophthalmoscopy, while 309 did. Reasons for non-examination, the handling of these participants in the analysis, and any imputation procedure are not reported in the registry record. The record also does not provide follow-up completion counts for the cardiovascular outcomes, so the amount and pattern of missing follow-up data cannot be assessed.

The analysis population is not described in detail. The registry record does not state whether the primary endpoint used all examined participants, a different subset, or another rule. It also does not describe any population definition for the chronic kidney disease comparison or the listed follow-up outcomes. These omissions matter because denominators determine how counts are interpreted, and exclusions can affect which participants the results represent. No method for handling missing covariates in the stated age- and risk-factor-adjusted analysis is reported in the registry record.

12. 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 0.016% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: atherothrombotic event (2.8%).

The registry record lists serious-event counts separately for men's and women's groups. For men, it reports 109 at risk and 3 affected in the serious-event category, with 109 at risk and 18 affected in the other-event category; deaths are listed as 4. For women, it reports 191 at risk and 4 affected in the serious-event category, with 191 at risk and 29 affected in the other-event category; deaths are listed as 4. The record also identifies atherothrombotic event as the top serious term, at 2.8%.

These are registry-listed counts and a percentage, not a randomized treatment comparison. The record does not explain the definitions of the serious and other categories, whether the counts refer to participants or event episodes, or how the top-term percentage was calculated. It also does not provide the timing, severity grading criteria, or relationship assessment for the events. The listed deaths should not be assumed to be caused by a study treatment or to belong to a particular adverse-event category unless the record says so; it does not make that connection.

The sex-specific groups are not described as intervention and control arms. Accordingly, these figures should be read as descriptive safety information in the registry, not as evidence that a treatment caused or prevented events. The record's intervention description is non-specific and multi-interventional, and details of treatment exposure are not reported.

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

The registry record establishes that the study set out to describe diabetic complications in newly diagnosed adults with type 2 diabetes in a suburban area of Algiers. It identifies diabetic retinopathy prevalence at recruitment as the primary endpoint and describes ophthalmologic screening. It also lists cardiovascular events during follow-up as secondary outcomes and describes a comparison according to chronic kidney disease status.

What the record does not establish is the primary endpoint's numerical result. The retinopathy count and prevalence are not reported in the registry record, and no confidence interval or other measure of precision is given. The presence of an endpoint definition and a screening description cannot substitute for the result itself. The record also does not provide comparative estimates for the follow-up outcomes, so the magnitude, precision, and direction of any association with chronic kidney disease cannot be evaluated.

Even with results, an observational cohort comparison would require cautious interpretation. The chronic kidney disease groups were not described as randomized, and the registry record does not provide the full set of covariates, model details, or follow-up data. Adjustment for age and major risk factors is stated, but adjustment alone cannot establish causality or account for unmeasured differences. The study's non-specific multi-interventional treatment description does not allow treatment effects to be separated.

In general, statistical significance and clinical importance are different questions: a p-value concerns compatibility with a statistical null model, while an effect estimate and its uncertainty help characterize the magnitude and precision of an association. Neither a primary estimate nor inferential statistics are reported for retinopathy in the registry record. The reported safety counts should likewise be interpreted descriptively, because group definitions and event-category details are limited. Overall, the registry record is informative about the study's aims, population, and some procedures, but it does not provide the results required to judge the primary prevalence finding or the stated follow-up association.

14. Why This Trial Matters Statistically

This study is statistically interesting because it combines a prevalence question at recruitment with a follow-up question about cardiovascular events. Those questions use different denominators and answer different things. The primary endpoint concerns retinopathy identified through screening at entry, while the secondary outcomes concern new events during follow-up. A prevalence result should not be interpreted as an event rate over time, and a follow-up event count should not be treated as a baseline prevalence.

The record also illustrates why participation in measurement matters. Although enrollment is 327, ophthalmoscopy was performed for 309 participants and not performed for 18. The denominator for a prevalence estimate should be clear, and the missing examinations may affect interpretation if the unexamined participants differ from those assessed. The registry does not report the primary count or analysis denominator, so the reader cannot verify these elements from the outcome entry.

The comparison by chronic kidney disease status raises a separate issue: observational groups may differ in more than the characteristic used to define them. The registry states that age and major risk factors were considered for adjustment, but does not report the model or estimates. This makes the distinction between adjustment and randomization especially important. Statistical adjustment can address measured characteristics under model assumptions, but does not guarantee a causal interpretation.

Finally, the record lists multiple outcomes and analyses without reporting a full multiplicity plan or complete results. This makes transparent outcome reporting important for understanding which findings are central and how uncertainty should be judged. In this case, the endpoint descriptions and study aims are available, while the primary result and its precision are not. That gap demonstrates why a clear registry result should include the analyzed denominator, outcome count, estimate, and an uncertainty measure.

15. 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 central limitation for interpreting this record is that the primary retinopathy result is not reported. The registry gives the outcome definition and screening procedure, but not the number of participants found to have retinopathy, the prevalence, or a measure of uncertainty. This prevents assessment of the endpoint's magnitude and precision.

Outcome ascertainment was not complete for all enrolled participants: 309 underwent ophthalmoscopy and 18 did not. The reasons for not testing and the handling of these participants are not reported in the registry record. Without those details, the risk of bias related to incomplete screening cannot be assessed. The criteria for retinal angiography are described as dependent on the ophthalmologist's indication, but the record does not state how angiography results were incorporated into the endpoint classification.

The study is observational, and the chronic kidney disease comparison is not described as randomized. Although adjustment for age and major risk factors is stated, the specific factors, analysis model, and adjusted estimates are not reported. Residual confounding therefore remains a concern for interpreting any planned association, and the effect of treatment cannot be separated because treatment is described as non-specific and multi-interventional.

Further limitations include the absence of reported follow-up completion data, the lack of details on missing data and analysis populations, and limited information about multiplicity and the statistical plan. The record lists secondary outcomes and numbers of outcome measures and analyses, but does not provide their complete results. The available description also does not establish how broadly findings would apply beyond the stated population in a suburban area of Algiers. These are limitations of what can be assessed from the registry record; they do not establish that the study procedures themselves were inadequate.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Morbidity in Newly Diagnosed type2 Diabetes in Adults — NCT02002091.
• Registry record last updated 2024-06-21; status last verified 2024-06.
• Results first posted 2018-09-14.
• 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.

19. Record Summary

NCT02002091 is a completed prospective observational cohort study sponsored by the University of Algiers. It enrolled 327 adults with newly diagnosed type 2 diabetes in a suburban area of Algiers. The recorded study start is 2009-01, and primary completion is 2013-12.

The primary endpoint was the number and prevalence of participants with diabetic retinopathy at recruitment. The record describes screening by conventional ophthalmoscopy and retinal angiography when indicated. Ophthalmoscopy was performed for 309 participants: 113 men and 196 women; 18 did not undergo the test. The primary count and prevalence are not reported in the registry record.

The record also describes one-year follow-up comparing participants with and without chronic kidney disease for cardiovascular events, with stated adjustment for age and major risk factors. It lists secondary event outcomes and adverse-event counts, but does not provide full analysis details or comparative results. The registry record therefore clarifies the study's aims and some procedures, while leaving the primary prevalence estimate and its precision unavailable.