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 Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes (NCT01778751), a randomized early/phase 1 study. The primary outcome is Diabetes Control.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01778751 |
| Phase | EARLY/Phase 1 |
| Condition | Diabetes |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
The study asks whether a Home Telehealth-based behavioral education intervention for Veterans with persistent poorly controlled diabetes is associated with better diabetes control and related outcomes than educational materials and care managed by a primary provider. Its stated aims also include patient self-management and comorbid depressive symptoms. The registry record does not report results for these outcomes, so the clinical question cannot be answered from the posted outcome data.
Population
Veterans described as having persistent poorly controlled diabetes. The registry lists diabetes as the condition and records an enrollment of 50. Further eligibility details are not reported in the registry record.
Intervention
Home Telehealth with a behavioral education component. The intervention description says participants would enroll in the Home Telehealth program and receive standard telemonitoring equipment from nursing staff. The description ends before giving a complete account of the intervention.
Comparator
Diabetes educational materials and management per the participant’s primary provider. The registry lists this as the control arm.
Primary question
How does hemoglobin A1c, recorded as a percentage of glycosylated hemoglobin, change across baseline, 3 months, and 6 months? A numeric comparison between study arms is not reported in the registry record.
The study also lists diabetes self-care, self-reported medication adherence, and depressive symptoms as secondary outcomes. These outcomes help describe domains the investigators intended to assess, but the registry record does not provide their result estimates. The study’s intended question is therefore broader than the primary measure alone; the posted record does not establish whether any of these outcomes changed or differed between arms.
3. Trial Design
The registry identifies the study as randomized and lists a control arm and an intervention arm. It also records the study model as single group. Those descriptions do not align, and the registry record does not explain the discrepancy. The allocation field therefore indicates randomization, while the model field does not describe a parallel-arm model. Readers should keep this unresolved inconsistency in mind when interpreting the design.
The study is marked completed. Its recorded start is 2013-12 and its primary completion is 2014-12. The listed phase is EARLY PHASE1, and masking is listed as none. The sponsor is the VA Office of Research and Development. These registry fields describe the study record; they do not by themselves establish how study procedures were carried out.
The enrollment field records 50. The record lists two groups of Veterans, with educational materials and primary-provider management in the control description and Home Telehealth in the intervention description. The intervention description refers to standard telemonitoring equipment, including a Health Buddy 3 device for patients with landline phones and a Cardiocom Interactive Voice Response System, but the text ends before completing the description. Other details about the intervention’s content, schedule, or delivery are not reported in the registry record.
The primary outcome is hemoglobin A1c measured at baseline, 3 months, and 6 months. The record also lists three secondary outcomes and indicates four outcome measures and eight analyses. It does not state how those analyses were defined or whether the randomization was stratified, whether allocation was concealed, or how participants were followed. Those design details 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
| Stage | Control | Intervention |
|---|---|---|
| STARTED | 25 | 25 |
| COMPLETED | 23 | 23 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Control | Intervention |
|---|---|---|
| Lost to Follow-up | 1 | 0 |
| Withdrawal by Subject | 0 | 2 |
| Transfered care | 1 | 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 | Control | Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 25 | 50 | |
| Age, Continuous | years | 59.5 (SD 9.2) | 60.2 (SD 8.4) | 59.9 (SD 8.7) |
| Sex: Female, Male: Female | Participants | 0 | 2 | 2 |
| Sex: Female, Male: Male | Participants | 25 | 23 | 48 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 1 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 | 24 | 47 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 15 | 12 | 27 |
| Race (NIH/OMB): White | Participants | 8 | 13 | 21 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | participants | 25 | 25 | 50 |
6. Primary Endpoint
The registry lists the primary outcome as Diabetes Control, measured over Baseline, 3months, 6months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of glycosylated hemoglobin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is diabetes control measured by hemoglobin A1c, expressed as a percentage of glycosylated hemoglobin. The registry describes the measure as a mean with standard deviation and specifies measurements at baseline, 3 months, and 6 months. These repeated measurements are intended to characterize the outcome over time, but the record does not report the observed means, standard deviations, or a comparison between the arms.
In general, a continuous measure such as hemoglobin A1c can describe variation across participants as well as the average value in a group. The mean gives a measure of the group’s central level; the standard deviation describes how dispersed observations are around that mean. Neither measure alone shows how precisely an arm-to-arm difference is estimated. Confidence intervals and a clearly specified contrast would help convey that uncertainty, but endpoint estimates and intervals are not reported in the registry record.
Hemoglobin A1c is used in this study as a measure of diabetes control, as reflected in the registry’s primary outcome title and description. Repeated assessment can be useful for examining whether a measure changes over follow-up, but interpreting change requires knowing the values, the analysis population, and how incomplete measurements were handled. Those details are not available in the registry record. The endpoint definition is reported; its observed result is not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary endpoint and follow-up timepoints, but does not provide the hemoglobin A1c results. In particular, it does not report group means or standard deviations at baseline, 3 months, or 6 months, nor an estimated contrast between the intervention and control groups. There is therefore no posted primary-outcome estimate to interpret for direction, magnitude, or precision.
The study’s stated aims include diabetes control, self-management, and depressive symptoms. The record lists diabetes self-care, self-reported medication adherence, and depressive symptoms as secondary outcomes, but it does not provide their numerical findings. The existence of an outcome name is not evidence that the outcome improved, worsened, or differed between arms. Conclusions about those outcomes cannot be drawn from the registry information available.
In general, an estimated difference describes the observed contrast between groups, while a confidence interval indicates the uncertainty around that estimate under the analysis assumptions. A small or large point estimate cannot be interpreted in isolation: its precision, the outcome scale, the analysis plan, and the study context matter. No primary-outcome confidence interval or inferential test is reported in the registry record. A p-value, even if available, would not by itself convey the size or practical importance of an effect.
The record’s sample-size assumptions describe a planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. This is not an outcome result and does not establish that an effect was observed in a manner that can be evaluated from the registry. It also is not evidence of observed power. Numerical planning values are not included in the registry entries available for this interpretation.
The design fields need cautious reading: allocation is listed as randomized, but the model is listed as single group. The registry does not resolve that mismatch. In addition, without outcome estimates, analysis details, or information about missing measurements, the effectiveness of the intervention cannot be assessed statistically from this record. The appropriate interpretation is limited to the study’s stated aims, recorded design fields, endpoint definition, and adverse-event counts. The posted data do not support a conclusion about the effect of Home Telehealth on diabetes control or the secondary outcomes.
9. Statistical Methods Explained
The registry identifies hemoglobin A1c as a continuous primary outcome, summarized using a mean and standard deviation. It does not report the statistical method used to compare the groups or the measurements over time. The explanations below describe general statistical concepts relevant to this kind of outcome; they are not claims about the analysis actually used in this trial.
What does the mean describe?
For a continuous measure, the mean is the arithmetic average of the observed values in a group. It provides a compact description of the group’s central level, but it does not describe every participant’s value or how widely the values vary. A mean can be influenced by unusually high or low observations. Interpretation therefore benefits from considering the spread of the observations and the measurement scale, rather than treating the mean as a complete description of the group.
What does the standard deviation describe?
The standard deviation describes the spread of individual observations around the mean. A larger standard deviation indicates greater dispersion in the observed values; it is not the uncertainty of the mean itself. The uncertainty in an estimated mean or difference depends on additional information, including the amount of available data and the statistical model. The registry specifies standard deviation as the dispersion measure for the primary outcome but does not report the values.
Why do repeated measurements matter?
The primary measure is scheduled at baseline, 3 months, and 6 months. Repeated measurements can support questions about change over time, but the observations from the same participant are related rather than independent. General methods for repeated measures account for that within-participant relationship. A group comparison might focus on change from baseline, the difference between groups at a follow-up time, or a group-by-time pattern. These answer different questions and can produce different estimates. The registry record does not identify which contrast or repeated-measures method was used.
Baseline values can provide context for follow-up comparisons. A method that adjusts for baseline may differ from a comparison of raw follow-up values or a comparison of changes. The registry does not state whether baseline adjustment was used, how baseline imbalance was handled, or whether any covariates were included. It would be inappropriate to attribute any specific adjusted or unadjusted method to this study without that information.
How should precision be assessed?
A confidence interval is a general way to present the precision of an estimate. It gives a range of values compatible with the observed data under the model and assumptions used. A narrow interval indicates greater precision than a wide interval, while the interval’s position relative to a value representing no difference can help describe the statistical evidence for a contrast. A confidence interval does not remove uncertainty, and it does not by itself determine whether an effect is important in practice. No confidence intervals for the primary endpoint are reported in the registry record.
A p-value is a measure of how compatible the observed data are with a specified null model, under the assumptions of the statistical test. It is not the probability that the null hypothesis is true, and it does not measure the size of an effect. The planning assumptions name a two-sided significance level of 0.05, but that is part of a sample-size illustration. The record does not report the significance threshold used for the trial’s outcome analyses or provide a primary-outcome p-value.
What does over-dispersion mean in general?
Over-dispersion arises when observed variability is greater than a statistical model assumes. It is especially relevant for count outcomes, where a simple model may underestimate variability if observations are more heterogeneous than expected. The primary endpoint is continuous, and the registry does not identify an over-dispersion issue or a count model. The concept is relevant only as a general reminder that statistical models should reflect the variability and structure of the data; it is not a reported feature of this trial.
What can the planning assumptions tell readers?
The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are assumptions for an illustration, not a report of the analysis conducted or a measure of the study’s observed evidential strength. Planning sample sizes are not observed power. The registry does not report the trial’s own sample-size justification, the effect-size basis used in its original planning, or whether the illustration’s assumptions match the study’s actual design.
For a continuous endpoint, an illustration based on a normal approximation generally depends on assumptions about the variability and the contrast to be detected. If those assumptions do not match the study data or analysis, the illustration may not describe the study’s precision. The posted record does not provide enough endpoint data to assess those assumptions. No recalculated comparison is available, and the sponsor’s analysis cannot be assessed from the registry information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and eight analyses. It names diabetes control as the primary outcome and lists diabetes self-care, self-reported medication adherence, and depressive symptoms as secondary outcomes. The primary outcome itself is measured at baseline, 3 months, and 6 months. Multiple outcomes, timepoints, or analysis choices can create multiplicity: as the number of statistical questions increases, the chance of a nominally notable result arising by chance can also increase.
In general, a trial analysis plan may address multiplicity by defining a hierarchy of outcomes, selecting a primary timepoint or contrast, or adjusting significance criteria. The registry record does not report whether any such approach was used. It does not specify which of the eight analyses correspond to particular outcomes, timepoints, or contrasts, and it does not describe a multiplicity adjustment. The presence of multiple listed analyses alone does not establish that a correction was necessary or that one was applied.
Missing-data handling is also not reported in the registry record. It does not describe the amount or pattern of missing endpoint data, any imputation method, or sensitivity analyses. Nor does it define the analysis population, such as whether analyses included all randomized participants or only those with observed follow-up measurements. These details matter because incomplete follow-up can affect the estimate and its uncertainty, especially when missingness is related to outcome or treatment assignment.
Because the outcome estimates and analysis populations are not reported, the robustness of any treatment comparison cannot be assessed. The registry’s listed outcomes and analysis count describe the scope of the record, not the results or the adequacy of the analytic approach.
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 |
|---|---|---|---|
| Control | 4 | 25 | 16.0% |
| Intervention | 3 | 25 | 12.0% |
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 |
|---|---|
| Control | 12 of 25 |
| Intervention | 14 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Control | Intervention |
|---|---|---|---|
| Hospitalization | Cardiac disorders | 1 of 25 | 1 of 25 |
| Hospitalization | Respiratory, thoracic and mediastinal disorders | 1 of 25 | 1 of 25 |
| Hospitalization | General disorders | 0 of 25 | 1 of 25 |
| Hospitalization | Renal and urinary disorders | 0 of 25 | 1 of 25 |
| Outpatient Diagnosis | Respiratory, thoracic and mediastinal disorders | 1 of 25 | 0 of 25 |
| Hospitalization | Psychiatric disorders | 1 of 25 | 0 of 25 |
| Psychiatric Disorder | Psychiatric disorders | 1 of 25 | 0 of 25 |
| Hypoglycemia Requiring Asssistance | Investigations | 0 of 25 | 0 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Control | Intervention |
|---|---|---|---|
| Emergency Room Visit | General disorders | 6 of 25 | 7 of 25 |
| Emergency Room Visit | Infections and infestations | 1 of 25 | 3 of 25 |
| Emergency Room Visit | Musculoskeletal and connective tissue disorders | 3 of 25 | 1 of 25 |
| Emergency Room Visit | Renal and urinary disorders | 1 of 25 | 2 of 25 |
| Planned Surgery and Proceedures | Surgical and medical procedures | 1 of 25 | 2 of 25 |
| # Pts with >5 BG Values <70 mg/dL from 1st encounter to end of study | Investigations | 0 of 25 | 3 of 25 |
| Emergency Room Visit | Respiratory, thoracic and mediastinal disorders | 1 of 25 | 1 of 25 |
| Emergency Room Visit | Vascular disorders | 1 of 25 | 1 of 25 |
| Biopsy | Endocrine disorders | 0 of 25 | 1 of 25 |
| Biopsy | Skin and subcutaneous tissue disorders | 1 of 25 | 0 of 25 |
Serious events with the highest arm-level rate: hospitalization (4.0%), outpatient diagnosis (4.0%), psychiatric disorder (4.0%), hypoglycemia requiring asssistance (0.0%).
The adverse-event fields list a serious-event affected count of 4 in the control group and 3 in the intervention group, with 25 at risk in each group. For other events, the affected counts are 12 in the control group and 14 in the intervention group, again with 25 at risk in each group. These are descriptive registry counts. They do not establish that the intervention caused or prevented an event, and they should not be read as a comparative safety analysis without definitions, follow-up details, and an analysis method.
The record also lists serious-event terms with percentages: Hospitalization, 4.0%; Outpatient Diagnosis, 4.0%; Psychiatric Disorder, 4.0%; and Hypoglycemia Requiring Asssistance, 0.0%. The registry information does not connect these listed percentages to a specific study arm in the adverse-event details, so they should not be interpreted as arm-specific rates. Death counts are not reported in the registry record.
In general, adverse-event counts depend on how events were defined, collected, and attributed, as well as the period during which participants were monitored. The record does not provide enough detail to determine whether counts refer to events or people, whether events could be counted more than once, or whether follow-up was comparable. The reported figures are therefore best read as registry descriptions, not as proof of a safety difference.
12. What the Result Does, and Does Not, Mean
The record documents a study intended to evaluate Home Telehealth with behavioral education for Veterans with persistent poorly controlled diabetes. It identifies diabetes control measured by hemoglobin A1c as the primary outcome and gives measurement timepoints of baseline, 3 months, and 6 months. It also names patient self-management, medication adherence, and depressive symptoms among the outcomes of interest. These details explain the study’s aims and the types of outcomes selected.
They do not show what happened to participants’ hemoglobin A1c or secondary outcomes. The registry record contains no numerical outcome estimates, no arm-to-arm effect estimate, and no confidence interval or inferential test for the primary endpoint. Consequently, it cannot establish the size, direction, or precision of an outcome difference. It cannot support a conclusion that the intervention did or did not change diabetes control, self-management, medication adherence, or depressive symptoms.
The adverse-event figures are counts and listed terms, not a complete comparative safety assessment. Their interpretation is limited by the absence of event definitions, attribution details, and outcome analysis. Likewise, the planning assumptions are not trial results and are not evidence of observed power.
In general, a clinical trial’s findings need to be read alongside its design, outcome estimates, uncertainty, missing-data handling, and analysis population. Here, the record labels allocation as randomized but also describes the model as single group, without resolving the inconsistency. The status and outcome definitions do not compensate for missing results or missing methodological details. The most supportable reading is that the registry records the study’s intent and selected measures, while its posted information does not permit an assessment of treatment effect.
13. Why This Trial Matters Statistically
This study is statistically notable because its stated primary measure is continuous and repeated over follow-up. That structure makes the choice of estimand and analysis important: a comparison at a follow-up time, a comparison of changes from baseline, and a model of the full time pattern do not represent the same question. The registry identifies measurement times but does not say which contrast was used. Without the outcome estimates and analysis method, readers cannot assess either the result or how directly it answers the intended question.
The record also illustrates why consistent design descriptions matter. Randomized allocation and a single-group model are both recorded, but the relationship between those fields is not explained. Clear reporting of the analysis population, treatment assignment, outcome availability, and group comparisons is necessary for readers to understand the evidence generated by a trial.
Multiplicity is another statistical consideration because several outcomes and analyses are listed. A prespecified outcome hierarchy and clearly reported contrasts help distinguish primary evidence from exploratory findings. Those analysis details are not reported in the registry record. Similarly, reporting estimates with uncertainty would allow readers to judge precision rather than relying on a claim of statistical significance alone.
The registry’s sample-size assumptions are described as a planning illustration, not a record of observed power or a substitute for an outcome analysis. This distinction matters because planning calculations address hypothetical design conditions, whereas trial interpretation depends on the observed estimates and their uncertainty. The posted record does not supply those primary results. Thus, the statistical importance of the study lies in the questions and design features it records, alongside the need for transparent results and analysis reporting to answer those questions.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this specific trial is that the registry record does not report primary or secondary outcome estimates. It therefore does not permit assessment of the observed hemoglobin A1c values, changes over follow-up, between-group contrasts, or precision. The primary endpoint is described, but its numerical results are unavailable.
The design description is internally inconsistent: allocation is recorded as randomized, while the study model is recorded as single group. The registry does not explain how these fields fit together. The intervention description also ends before providing a complete account of the telemonitoring equipment and intervention procedures. Details on the duration, intensity, fidelity, and actual delivery of the behavioral education component are not reported in the registry record.
Additional interpretive details are absent, including the trial’s own sample-size justification, statistical analysis plan, analysis population, handling of missing measurements, and approach to multiple outcomes and timepoints. There is no reported account of baseline characteristics or follow-up completeness. Without these details, it is not possible to assess comparability, attrition, or the sensitivity of an estimate to analytic choices.
The safety information is limited to registry counts and listed terms. Event definitions, collection procedures, attribution, and arm-specific context for the listed percentages are not reported. These limitations do not show that the study was poorly conducted; they describe what cannot be evaluated from the registry record. Interpretation should remain confined to the design fields, outcome definitions, and adverse-event information that are actually recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes — NCT01778751.
- Registry record last updated 2016-01-25; status last verified 2015-12.
- Results first posted 2016-01-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record concerns Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes, sponsored by the VA Office of Research and Development. It is marked completed, with a recorded start of 2013-12 and primary completion of 2014-12. The record lists randomized allocation, no masking, EARLY PHASE1, enrollment of 50, and a single-group model; the relationship between randomized allocation and the single-group model is not explained.
The primary outcome is diabetes control measured by mean hemoglobin A1c, with standard deviation as the dispersion measure and assessments at baseline, 3 months, and 6 months. Diabetes self-care, self-reported medication adherence, and depressive symptoms are listed as secondary outcomes. Numerical results for these outcomes are not reported in the registry record. Adverse-event fields contain group counts and serious-event terms, but do not provide a complete comparative safety analysis. The record describes planning assumptions but not the trial’s own sample-size justification or outcome-analysis methods.