Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress (NCT05941000), a randomized na study. The primary outcome is Mean Within-Subject Difference in Glucose Time in Range.

2. Clinical Question

3. Trial Design

The registry describes a randomized, unmasked crossover study of continuous glucose monitoring paired with remotely delivered behavior-change techniques. It is marked completed. The listed enrollment is 3. The brief summary describes a 10-week study with a two-week baseline/run-in period followed by an eight-week intervention period.

During the run-in, usual blood glucose and physical activity were to be monitored. During the intervention period, participants were to receive the physical-activity and mood interventions in alternating order. The registry describes four two-week intervention blocks and two possible orders, with randomization determining the order. All participants were reported to have received both interventions. This within-person arrangement allows each participant’s observations under one intervention to be considered alongside observations under the other, but it does not remove uncertainty created by a small sample or by changes over time.

The planned assessments included continuous glucose monitoring and repeated self-report measures. The summary says mood and health-related behavior measures and a hemoglobin A1C test were to be completed every two weeks. The primary outcome timeframe specifies continuous measurement across the study, with baseline/run-in and intervention periods summarized separately. The record lists four secondary outcomes: steps per day, diabetes self-management behaviors, depressive symptom severity, and health-related problem-solving.

The registry lists a start date of 2024-09-10 and a primary completion date of 2025-02-28. It does not report the rationale for the reported enrollment, whether the study had interim analyses, or how the completion status relates to the planned enrollment described in the brief summary.

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

Analysis population for the primary outcome, as defined in the registry: Primary and secondary outcomes were analyzed using the full sample of 3 participants. All participants received both interventions in this cross-over design study. Randomization indicated the order in which participants received the interventions (ABBA or BAAB with Intervention A = CGM + BCTs for physical activity and Intervention B = CGM+BCTs for mood). Outcomes are reported for all 3 participants by intervention.

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 Mean Within-Subject Difference in Glucose Time in Range, measured over Measured continuously during the 10-week study. Averages are computed for baseline/run-in (2 weeks) and intervention (8 weeks; grouped in 4 blocks of 2 weeks) periods. Data are aggregated, averaging 2 blocks for physical activity and 2 blocks for mood..

The primary endpoint is the mean within-subject difference in glucose time in range, expressed as percent time in range. Continuous glucose monitoring measured the percentage of time glucose was between 70-180 mg/dL. The registry describes summarizing this measure during the two-week baseline/run-in period and during the intervention blocks, then aggregating the intervention blocks for physical activity and mood separately.

Time in range is a continuous measure: it can take a range of values rather than placing each participant into a simple category. The registry states that higher values reflect better blood glucose management. Comparing a participant’s measurements across periods can describe how the measure varied alongside each intervention condition. A within-subject summary also retains information about the direction and size of changes for each participant, rather than relying only on group averages.

In general, continuous monitoring can capture values across the measurement period rather than at a single assessment. However, an average alone does not show how consistently participants changed, how much their individual responses differed, or how precise the estimated mean is. The posted results do not include confidence intervals or participant-level results. The registry describes paired samples t-tests for comparing aggregated intervention values with baseline/run-in, separately for each intervention, but no p-values or inferential analysis results are listed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean summarize?

The primary outcome is continuous, and the registry reports it as a mean. In general, a mean is the arithmetic average of the observed values in a group or period. It gives a compact description of the center of those values, but it can conceal differences among participants. The registry also reports standard deviations. In general, a standard deviation describes the spread of observations around their mean; it is not itself a confidence interval and does not show the precision of the estimated mean.

The posted time-in-range summaries are 7.5 with standard deviation 8.85 for the physical-activity condition and 5.83 with standard deviation 7.18 for the mood condition. Each summary lists 3 participants. The endpoint is described as a mean within-subject difference, but the record does not provide the underlying participant-level changes or a confidence interval. Readers should therefore treat these as descriptive estimates whose precision is not quantified in the posted results.

What is a within-subject comparison?

In general, a within-subject design compares measurements from the same person across conditions or time periods. Each participant can serve as their own reference, which can reduce the influence of stable differences between people. Here, the registry says all participants received both intervention conditions and that randomization determined order. The primary outcome description specifies comparing the aggregated intervention value with baseline/run-in, separately for each intervention.

A within-subject analysis depends on having interpretable paired measurements. It also requires care when observations are collected over time: the period, order, and sequence may matter. The registry describes alternating intervention blocks, but the posted results do not include block-level or sequence-specific estimates. They also do not report how any period or order effects were evaluated.

What would a paired t-test address?

The registry’s outcome description names paired samples t-tests for comparing aggregated post-intervention values with baseline/run-in. In general, a paired t-test evaluates whether the mean of paired differences is distinguishable from zero under the test’s assumptions. It uses the paired differences, rather than treating measurements from the same participant as independent observations. The registry does not post a test statistic, p-value, confidence interval, or analysis result for this endpoint. It also does not report diagnostic checks or details about how assumptions were assessed. No conclusion about statistical significance can be drawn from the listed means and standard deviations alone.

Why does small-sample variation matter?

In general, estimates based on few participants are sensitive to individual observations. A standard deviation describes observed dispersion, while a confidence interval would communicate uncertainty in the estimated mean under a specified method. These are different quantities. The posted results include standard deviations but not confidence intervals. With such limited reported enrollment, the summaries should be interpreted as preliminary descriptions, not as precise estimates of a broader population effect.

In general, over-dispersion means that observed variation is greater than a statistical model expects. It can make standard errors or confidence intervals from an unsuitable model misleading. The registry does not report an over-dispersion assessment or a model-based analysis for this continuous endpoint. This is a general consideration, not a reported finding from this trial.

What do planning illustrations mean?

Planning sample-size illustrations use assumptions about an effect and a statistical procedure to show how many participants per arm might be needed for a chosen power target. In general, they are prospective planning aids, not evidence that a completed study had a particular probability of detecting an effect. The posted sample-size section is described as an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It is not the trial’s own design justification and is not observed power. The specific planning values are not reported in the registry record addressed by these registry entries, so no sample-size recommendation can be stated.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("CGM Paired With Behavior Change Technique Interven", "CGM Paired With Behavior Change Technique Interven")
n   <- c(3, 3)
m   <- c(7.5, 5.83)
sp  <- c(8.85, 7.18)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  CGM Paired With Behavior Change Technique Interven  3  7.500  8.850  -14.485  29.485
CARM  CGM Paired With Behavior Change Technique Interven  3  5.830  7.180  -12.006  23.666

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four secondary outcomes and reports six outcome measures overall. The primary outcome description calls for separate analyses for the physical-activity and mood interventions. The registry does not report a multiplicity adjustment, a hierarchy of outcomes, or a plan for interpreting multiple tests. In general, testing several outcomes or contrasts can increase the chance of at least one apparently notable result arising by chance. Whether and how to adjust depends on the study’s aims and prespecified analysis plan; that plan is not reported in the registry record.

Missing-data procedures are not reported in the registry record. The posted primary summaries do not describe the number of measurements available at each period, reasons for missing observations, or any imputation or other handling strategy. This matters because a within-subject comparison may require measurements from the same participant across periods. The registry’s analyzed population statement says outcomes used the full sample of 3 participants, but it does not provide a separate account of completeness for each outcome or assessment period.

The analysis population is described as the full sample of 3 participants, and all participants received both interventions. The registry lists 3 participants for each intervention summary. Because this is a crossover design, those group labels should not be interpreted as evidence of separate sets of participants. The record does not report a per-protocol analysis, exclusions from analysis, or a sensitivity analysis addressing missing data.

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% reporting threshold.

The registry reports 0 serious adverse events in the physical-activity intervention group, with 3 participants at risk, and 0 in the mood intervention group, also with 3 participants at risk. It reports 0 other adverse events in each group and 0 deaths in each group. No serious adverse event terms are listed.

These figures describe what was recorded in the registry for the stated groups. A zero count means no events of that type were reported in those group summaries; it does not establish that an event is impossible or that risk is absent. The small reported sample limits how much can be learned about uncommon events. Because the study is a crossover and all participants received both conditions, the group labels should not be read as independent parallel cohorts or added to infer a number of distinct participants.

The registry does not provide further detail about event definitions, collection procedures, severity grading beyond the serious/other categories, or time at risk. The adverse-event counts therefore support only a narrow description of the posted record, not a broad safety comparison between the interventions.

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

The posted results show descriptive mean within-subject differences in glucose time in range for the two intervention labels: 7.5 for the physical-activity condition and 5.83 for the mood condition. The corresponding standard deviations are 8.85 and 7.18. These summaries give a sense of the reported averages and variability in the analyzed sample, but the record does not provide confidence intervals, p-values, or an inferential comparison.

The results do not establish that one intervention condition produced a larger change than the other. The registry describes paired comparisons against baseline/run-in, not a reported head-to-head test of the two conditions. The posted summaries also do not show participant-level changes, sequence-specific effects, or how time and intervention order were handled analytically. Those omissions prevent a more detailed assessment of how the crossover results relate to each intervention.

The findings also do not establish what would occur in a larger or different population. The registry reports an analyzed sample of 3 participants, while its brief summary describes a planned group of participants. The record does not explain this difference. The outcome summaries therefore require particular caution about precision and generalizability.

In general, a completed study can contribute useful descriptive information even when it does not provide a precise comparative estimate. Here, the record documents the study structure and posts summary values, but it does not report the inferential results needed to quantify uncertainty about the intervention-related changes. These findings should not be treated as proof for or against either intervention.

14. Why This Trial Matters Statistically

This trial is statistically notable for using a randomized crossover design to study two behavior-change conditions paired with continuous glucose monitoring. In general, crossover designs can make within-person comparisons possible because participants experience multiple conditions. That can be useful when outcomes vary substantially between people. It also makes order and time important: an intervention received earlier may be experienced under different circumstances than one received later.

The registry describes alternating two-week blocks and randomized order, while the primary outcome summary aggregates blocks by intervention. This highlights a practical statistical issue: aggregation can simplify interpretation, but it may hide variation across periods or differences in sequence. The posted record does not provide block-specific results or a reported analysis of order and period effects, so these features cannot be evaluated from the available summaries.

The study also illustrates why descriptive results and inferential results should be distinguished. The record provides means and standard deviations for the primary outcome but no confidence intervals, test statistics, or p-values. A small sample can support a description of the observed data, but it gives limited information about the precision or generalizability of an estimated effect. Statistical interpretation depends not only on the point estimates, but also on uncertainty and the analysis used to obtain them.

Finally, the difference between the registry’s reported enrollment and the larger group described in its brief summary makes transparent accounting important. The record does not explain that discrepancy. Clear reporting of analyzed populations, missing observations, crossover sequences, and analysis results would help readers understand how a personalized-trial design performed and what it can inform in future research.

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 principal limitation for interpreting the posted primary result is the small analyzed sample: the registry says outcomes were analyzed using the full sample of 3 participants. Estimates from a small sample may be unstable, and the posted standard deviations indicate observed variation. Confidence intervals and participant-level results are not reported, so precision and response patterns cannot be examined.

The registry’s brief summary describes a planned group of participants, whereas the enrollment and analysis population fields report 3. The reason for this difference is not reported in the registry record. The record also does not explain whether the posted outcome summaries represent all planned assessments or how missing measurements were handled.

The crossover structure creates further interpretive questions. The registry describes randomized intervention order and alternating blocks, but it does not post block-level results, sequence-specific summaries, or an analysis of order, period, or carryover effects. The primary endpoint description names paired tests against baseline/run-in, but test results and details about assumption assessment are absent.

Multiplicity handling, an analysis plan, and a sample-size justification are not reported in the registry record. The primary results also lack confidence intervals and p-values. These reporting limits mean the posted values are descriptive rather than a fully quantified comparative result. The registry does not provide enough information to assess how sensitive findings might be to alternative analysis choices.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes Distress — NCT05941000.
• Registry record last updated 2026-09-22; status last verified 2026-08.
• Results first posted 2026-09-22.
• 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

The registry identifies a completed randomized, unmasked crossover study of continuous glucose monitoring paired with remotely delivered behavior-change techniques for physical activity or mood among adults with type 2 diabetes and diabetes distress. The listed enrollment is 3. The brief summary describes a 10-week study, including a two-week baseline/run-in and an eight-week intervention period.

The primary endpoint was mean within-subject difference in glucose time in range, measured as percent time in the 70-180 mg/dL range. The posted summaries are 7.5 with standard deviation 8.85 for the physical-activity intervention and 5.83 with standard deviation 7.18 for the mood intervention; each lists 3 participants. No inferential comparison, confidence interval, or p-value is reported. The registry also reports 0 serious adverse events, 0 other adverse events, and 0 deaths in each intervention group.

The record does not explain the difference between its listed enrollment and the larger group described in the brief summary. Missing-data methods, multiplicity handling, and details of the statistical analysis beyond the stated paired-test approach are not reported.