Managing Diabetes to Gain Opportunities for a More Active Life: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Managing Diabetes to Gain Opportunities for a More Active Life (NCT03692208), a randomized na study. The primary outcome is Documentation of Diabetes Goal.

2. Clinical Question

The clinical question is about whether a goal is recorded, rather than whether a particular goal is achieved or whether a clinical marker changes. The endpoint description gives an A1C target as an example of a personalized goal and defines the measure as yes or no. Thus, the outcome concerns a step in care planning that can be identified in the electronic health record.

The delayed-intervention arrangement means that the comparison is intended to distinguish the period when one group is offered the intervention from the period when the other group is receiving usual care. The registry record does not report results that would establish the size or precision of any difference in goal documentation. It also does not report a single comparison across the two named time points. The question can therefore be described from the registered outcome and design, but the available record does not support a conclusion about the observed effect.

3. Trial Design

NCT03692208 is recorded as a completed randomized, parallel-group trial sponsored by the University of Chicago. The registry lists an enrollment of 110 and records the phase as NA. The start date is 2018-10-29, and the primary completion date is 2020-08-12. Masking is listed as none.

The intervention is classified as behavioral and is named My Diabetes Goal Survey and Optional Care Management. The intervention-arm description says participants receive a MyChart email asking them to complete an initial questionnaire. Questionnaire completion is described as required before risk-factor tracking begins and before the portal is opened for requests. The registry record does not report further detail about the care-management procedures or the content and frequency of subsequent contacts.

The delayed-intervention/control group is described as receiving usual care for the first 6 months and then receiving the survey and intervention. This design allows the registry’s stated baseline and 6-month outcome time points to be considered in the context of a delayed offer. However, details of the timing of assessments, the exact analysis population at each assessment, and how participants were handled if they did not complete the questionnaire are not reported in the registry record.

The primary outcome population description refers to a total sample of 100 participants, while the trial enrollment is listed as 110. The registry record does not explain the relationship between those figures. It lists 4 outcome measures and 1 analysis, but the primary outcome is not reduced to a single comparison in the posted analysis. The record does not report a fuller statistical analysis plan or explain the planned handling of the repeated time points.

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.

Before assignment: 110 Participants were randomized to either intervention or delayed intervention, but only 75 participants completed the initial survey immediately after randomization that was a required element to participate in the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: We reviewed the electronic health records to assess how many participants of the total sample of 100 participants had a documented goal in the EHR at baseline and at months.

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: Does not include 7 participants in the intervention arm and 3 from the delayed intervention arm who withdrew from the study prior to receiving the intervention.

6. Primary Endpoint

The registry lists the primary outcome as Documentation of Diabetes Goal, measured over Baseline, 6 months.

The primary endpoint is documentation of a personalized goal for diabetes care in the electronic health record. It is defined as a yes-or-no measure, with an A1C target given as an example of such a goal. The registry names baseline and 6 months as the assessment time points.

This endpoint can be used to assess whether goal-setting is being recorded as part of care. In general, a process measure can help describe whether a care activity occurred, without directly measuring a patient’s health status or whether a goal was reached. Documentation can also be examined through an electronic health record, which is the source named in the registry record for this outcome.

The endpoint does not itself measure A1C, achievement of a personalized target, or a change in diabetes symptoms. The registry lists personalized A1C goals and patient ability to reach personalized goals among the secondary outcomes, but results for those outcomes are not reported in the registry record. The primary outcome description refers to the number of participants with a documented goal, but no counts by group or time point are reported. Consequently, the endpoint’s definition is clear enough to identify the type of event being counted, but its observed frequency and any between-group contrast cannot be evaluated from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is being counted?

In general, a binary outcome records whether each participant has an event or characteristic, such as whether a goal is documented. Each participant’s outcome is classified into one of two states, and group results can be described using counts and proportions. The registered primary outcome is defined in this way: documentation of a personalized diabetes-care goal, yes or no. The registry record does not provide the counts needed to describe the observed outcome in either group.

For a binary endpoint measured at more than one time point, several statistical questions are possible. One can describe the proportion with a documented goal at each assessment, compare groups at a particular assessment, or estimate how the outcome changes over time. These are not interchangeable questions. A comparison of groups at 6 months, for example, is different from comparing the change from baseline, and repeated observations from the same participant are related rather than independent. The registry names baseline and 6 months but does not report which contrast or model was used.

What would an effect estimate and interval tell readers?

In general, an effect estimate gives a numerical description of a contrast between groups. Depending on the analysis, it might be expressed as a difference in proportions, a ratio, or another measure. A confidence interval accompanies an estimate to show the range of values reasonably compatible with the data and the specified statistical procedure. A narrower interval indicates greater precision than a wider interval, though precision alone does not determine whether a result is important in practice.

No effect estimate or confidence interval for the primary endpoint is reported in the registry record. It is therefore not possible to describe the direction, size, or precision of an observed contrast. No new effect measure can be reconstructed from the registry information because the group-by-time outcome counts are absent. A p-value is also not reported. In general, a p-value addresses how compatible data are with a specified null model; it does not measure the size of an effect, establish causation by itself, or show the probability that a result is true.

Why does the repeated assessment matter?

In general, analyses of repeated binary outcomes should account for the fact that measurements from one participant are connected. Treating those observations as if they came from unrelated participants can misrepresent uncertainty. A suitable analysis also needs a clearly defined comparison, such as a group contrast at a selected time point or a group difference in change. The record names multiple time points and notes that the primary outcome was not reduced to one comparison. The statistical model and target contrast are not reported in the registry record, so no particular approach can be attributed to this trial.

In general, a randomized allocation supports comparisons between assigned groups, but analysis details still matter. The analysis population, adherence to assigned treatment, missing outcome handling, and timing of assessments can affect what an estimate represents. Those details are not reported in the registry record. The registry’s parallel-group and unmasked design labels describe the broad structure, not the full analytic procedure.

What do the planning assumptions mean?

The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, these are assumptions used to explore how many participants per arm might be needed for a future study to detect a specified effect under a chosen power target. Such planning values depend on the assumed effect and other design inputs.

The observed effect and the numerical planning results are not reported in the registry record. The illustration therefore cannot be independently interpreted from the posted information. It is not a statement of the trial’s original design rationale, and it is not observed power. The registry record does not report the original sample-size justification. General sample-size calculations describe planning scenarios; they do not establish whether the current study’s estimate is precise or whether an effect was observed.

How should an unadjusted recalculation be understood?

In general, recalculation from posted summary statistics can be useful for checking a simple unadjusted comparison, but it is not a substitute for the sponsor’s own analysis. It may not reproduce an analysis that accounts for repeated measurements, covariates, missingness, or other features of the design. No recalculated result is reported for the primary outcome in the registry record, and there is no posted group summary from which to make one. The record does not report a sponsor estimate for comparison or indicate a discrepancy between a sponsor analysis and a recalculation.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, including the primary documentation outcome and secondary outcomes concerning personalized A1C goals and ability to reach personalized goals. It does not report a multiplicity strategy, such as whether any adjustment was planned for assessing several outcomes or comparisons. In general, testing multiple hypotheses can increase the chance of at least one nominally unusual result when all null hypotheses are true. Whether adjustment is needed depends on the analysis goals and the claims being made; no trial-specific approach is reported.

The primary endpoint has baseline and 6-month time points, and the record indicates that it was not reduced to one comparison because of its several categories or time points. The registry does not state which time point, contrast, or repeated-measures method was intended to serve as the primary inferential test. It also does not report whether secondary outcomes were confirmatory or exploratory.

Missing-data methods and the number of participants with available outcome data are not reported in the registry record. The primary outcome population description refers to a total sample of 100 participants, while enrollment is listed as 110; the record does not explain the relationship. It does not state how missing electronic health record documentation was distinguished from a documented absence of a goal, or how incomplete questionnaires and other missing observations were handled. The analysis population, including any rules based on assignment or participation, is not reported in the registry record. These omissions limit interpretation of both the outcome denominator and the potential for missingness to affect the comparison.

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

The result that can be interpreted from the registry record is the definition of the primary outcome: whether a personalized diabetes-care goal was documented in the electronic health record at baseline and at 6 months. The record also describes a randomized parallel-group design in which the comparison group initially receives usual care and later receives the intervention. These features clarify what the trial set out to examine, not what it found.

No primary-outcome counts, group comparison, effect estimate, confidence interval, or p-value are reported in the registry record. The available information therefore cannot show whether documentation differed, how large a difference might have been, or how precisely it was estimated. The completed status does not fill this gap. Nor do the listed secondary outcomes establish whether participants reached personalized goals or whether A1C changed.

In general, documentation of a care goal is a process outcome. A record that a goal was documented does not, by itself, show that the goal was achieved, that care quality improved, or that a patient’s health changed. Conversely, an absence of documentation does not necessarily establish that a discussion did not occur; that depends on how the outcome was assessed, and the registry does not report further validation details.

The trial design can support a comparison of assigned groups when outcomes and analysis are reported, but randomization alone does not supply the missing estimates. Without the outcome data and analysis details, no conclusion about the intervention’s effects follows from the registry information. The endpoint should be understood as an assessment of goal documentation, not as a direct measure of clinical benefit or harm.

12. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a care process and a clinical outcome. The primary endpoint asks whether a personalized goal appears in the electronic health record. That is a measurable implementation-related event, but it is not the same as achieving the goal or improving a health marker. Keeping those constructs separate prevents a process measure from being interpreted as a patient outcome.

The trial also illustrates why a time-point definition is part of the statistical question. Baseline and 6-month assessments can support different comparisons, and repeated observations from the same participant require appropriate handling in analysis. The registry record identifies both times but does not report a single primary contrast or the method used to account for repeated observations. That limits the statistical interpretation even though the broad randomized, parallel-group design is recorded.

Finally, transparency about outcome counts, denominators, missing data, and estimates is essential for readers to judge precision and generalizability. Here, enrollment is listed as 110, while the primary outcome description refers to a total sample of 100, without an explanation. The record does not report group-specific primary-outcome counts or an effect estimate. These gaps make the study question identifiable, but prevent assessment of the magnitude and uncertainty of the result from the registry record alone.

13. 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 registry record does not report primary-outcome results, including participant counts by group and time point, an effect estimate, a confidence interval, or a p-value. This is the central limitation for statistical interpretation: the direction, magnitude, and precision of the outcome comparison cannot be assessed.

The primary outcome population description refers to a total sample of 100 participants, whereas the trial enrollment is listed as 110. The record does not explain whether this reflects eligibility, availability of electronic health records, missing outcome data, or another distinction. It also does not report the number analyzed at either assessment or the analysis population. These details are necessary to understand the denominators behind a binary outcome.

The registry identifies baseline and 6 months as outcome time points and notes that the outcome was not reduced to one comparison. It does not describe the intended primary contrast, the statistical model, or how repeated observations were handled. Missing-data procedures, multiplicity handling, and a trial-specific sample-size justification are not reported in the registry record.

The intervention description gives some information about the questionnaire and portal-based process, but further details of care management and intervention delivery are not reported. Masking is listed as none. The record does not provide information about adherence, contamination, or other implementation factors that could help explain the relationship between assignment and documented goals. These are limitations of the information available in the registry record, not evidence that any particular issue occurred.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Managing Diabetes to Gain Opportunities for a More Active Life — NCT03692208.
• Registry record last updated 2023-02-21; status last verified 2023-01.
• Results first posted 2023-02-21.
• 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.

17. Record Summary

NCT03692208 is a completed, randomized, unmasked, parallel-group behavioral trial sponsored by the University of Chicago. It lists enrollment as 110 and concerns type 2 diabetes mellitus. The recorded start date is 2018-10-29, and the primary completion date is 2020-08-12.

The intervention is My Diabetes Goal Survey and Optional Care Management. The delayed-intervention/control group is described as receiving usual care for the first 6 months, followed by the survey and intervention. The primary outcome is documentation of a personalized diabetes-care goal in the electronic health record, defined as yes or no and named for baseline and 6 months.

The registry record lists 4 outcome measures and 1 analysis. It does not report a primary-outcome comparison or its uncertainty. The primary outcome population description refers to a total sample of 100 participants, and the record does not explain how that relates to the listed enrollment. Statistical analysis details, missing-data procedures, and a trial-specific sample-size justification are not reported in the registry record.