Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1 (NCT04203173), a randomized na study. The primary outcome is Glycemic Control (HbA1c).

2. Clinical Question

The trial asks whether adding structured financial incentives to nurse education and home telemonitoring changes glycemic control compared with nurse education and home telemonitoring alone. It also asks whether any effect persists after incentives are withdrawn and whether effects differ across racial and ethnic groups. The registry record describes those as study questions; it does not establish that every question has a posted analysis.

The primary comparison is a difference between group means, not a count of participants who crossed a clinical threshold. The posted results show mean HbA1c of 8.39 percent in the FINANCE-DM group and 8.61 percent in the TIDES group at 12 months. The reported mean difference is 0.22 percent, with the comparison expressed as TIDES minus FINANCE-DM. This is a description of the posted group averages; it does not by itself answer every question in the trial’s stated objectives.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial, with 450 participants enrolled and a completed status. The sponsor is the State University of New York at Buffalo. The registry lists the study start as 2019-12-01 and primary completion as 2025-06-30. These are registry entries, not evidence about when each participant entered or completed follow-up.

In a parallel-group design, participants are assigned to one of the study groups and each group receives its assigned intervention during the study. Random allocation is intended, in general, to make the groups comparable at the point of assignment. The registry does not report the allocation ratio, the method used to generate or conceal assignments, or further details about what was masked. Those details are not reported in the registry record.

The two assigned conditions share nurse education and home telemonitoring. The intended contrast is the addition of structured financial incentives in FINANCE-DM. The active comparator description says glucose and blood-pressure readings were reviewed by a nurse educator and used to tailor and reinforce behavior change. This shared care is relevant when interpreting the comparison: it is not a contrast between the full intervention and no education or monitoring.

The primary outcome is mean HbA1c at 12 months. The posted secondary outcome is HbA1c at 18 months, which relates to the stated question of whether effects persist after incentives are withdrawn. The registry summary describes that later assessment as 6 months after withdrawal, or 18 months after randomization. Results at two times can describe the pattern across follow-up, but they do not establish a participant-level trajectory unless the analyses account for repeated measurements. The statistical approach to repeated measures is not reported in the registry record.

The registry also raises a question about differences across racial and ethnic groups. Subgroup results or an analysis addressing that question are not reported in the registry record. Similarly, details of the trial’s original sample-size justification and statistical analysis plan are not reported in the registry record, so the posted planning illustrations should not be mistaken for the trial’s design calculations.

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: Overall number of participants analyzed at 12months differs from participant flow chart, which represents analysis at 18months.

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 Glycemic Control (HbA1c), measured over HbA1c at 12 months follow-up.

The primary endpoint is mean percent HbA1c measured at 12 months of follow-up. HbA1c is a continuous measure, and the registry says blood specimens were obtained by trained phlebotomists or a nurse. The posted summary reports the mean and standard deviation for each group, along with a between-group mean difference and its uncertainty.

As a general statistical matter, a continuous endpoint retains information across the range of observed values rather than reducing participants to categories. Comparing means can therefore summarize a difference in the average measurement between randomized groups. The standard deviation describes the spread of individual measurements within a group; it is not the uncertainty around the group mean or the treatment contrast.

HbA1c is used as the trial’s measure of glycemic control. That role is defined by the registry; the posted endpoint alone does not establish the clinical importance of a particular difference, nor does it show how individual participants changed. The registry does not report a threshold-based responder endpoint or a minimally important difference for interpreting the mean contrast.

The analysis population deserves attention. The registry notes that the overall number analyzed at 12 months differs from the participant flow chart, which represents analysis at 18 months. The primary summary lists 197 participants in FINANCE-DM and 190 in TIDES. The registry does not explain the analysis-population discrepancy or how missing endpoint measurements were handled. Thus, the mean comparison can be described from the posted results, but the basis for inclusion in each analysis is not fully clear from the registry record.

7. Results Posted in the Registry

• TIDES Intervention: mean 8.61 versus 8.39 on control; difference 0.22 (95% CI -0.10 to 0.54), standardized effect d = 0.14; z-test p = 0.182.

8. Secondary Efficacy Endpoints

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

Glycemic Control (HbA1c)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • TIDES Intervention: mean 8.72 versus 8.39 on control; difference 0.33 (95% CI -0.03 to 0.69), standardized effect d = 0.19; z-test p = 0.074.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TIDES Intervention and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcome is mean HbA1c at 18 months. It is the same type of measurement as the primary endpoint, assessed later, and it relates to the study’s stated interest in whether effects persist after financial incentives are withdrawn. The results show a pattern in the same direction as the primary comparison, with TIDES having the higher posted mean. The secondary comparison remains uncertain, as its confidence interval crosses zero.

This broad pattern is useful as a description of the registry results, but it does not establish persistence or change over time. The participants included in the 18-month summary differ in number from those in the 12-month analysis, and the registry does not report an analysis directly comparing treatment effects across time. A formal claim about persistence would ordinarily require a defined analysis that accounts for the relationship between measurements over time and the uncertainty in the change; such an analysis is not reported in the registry record.

The secondary result should be read alongside, not as a substitute for, the primary result. The direction at the later visit does not resolve the uncertainty in the primary comparison, and one follow-up estimate cannot answer the registry’s broader question about effects across racial and ethnic groups. No subgroup results are reported in the registry record.

Unadjusted secondary results generally carry less weight when multiple outcomes or time points are examined. As a general statistical issue, looking across several comparisons increases the opportunity for a result to appear notable by chance. The registry does not report whether a multiplicity strategy was prespecified or applied. The later result is therefore best treated as supportive descriptive information, not as an independent confirmation or a definitive test of sustained effect.

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

• Glycemic Control (HbA1c)

9. Statistical Interpretation

10. Statistical Methods Explained

The registry presents continuous HbA1c outcomes as group means and standard deviations, followed by a mean difference, confidence interval, and unadjusted p-value. These are useful summaries, but the record does not provide a full statistical analysis plan. In particular, details such as covariate adjustment, the exact model, treatment of repeated measurements, and missing-data procedures are not reported in the registry record.

What does the mean difference represent?

The posted contrast is TIDES minus FINANCE-DM. At 12 months, the group means are 8.61 and 8.39 percent, respectively, and the posted mean difference is 0.22 percent. At 18 months, the corresponding means are 8.72 and 8.39 percent, and the posted contrast is 0.33 percent. A positive estimate therefore indicates a higher group mean in TIDES for these comparisons. This direction describes the arithmetic contrast; interpretation of the endpoint’s clinical importance is a separate question.

Because HbA1c is treated as a continuous outcome, the summary focuses on average values rather than the number of participants meeting a binary definition. The standard deviations at 12 months are 1.67 for FINANCE-DM and 1.57 for TIDES. At 18 months, they are 1.75 and 1.77. Standard deviations describe variability among participant measurements. They do not indicate how precisely the difference in means has been estimated; that uncertainty is represented by the confidence interval.

How should the confidence interval be read?

In general, a confidence interval describes the range of estimates reasonably compatible with the data and the method used to construct the interval. It conveys uncertainty more directly than a point estimate alone. Here, the posted intervals for both follow-up comparisons cross zero. Zero corresponds to no difference between the group means. Because the interval includes zero, these results do not rule out no difference under the stated comparison and analysis.

A confidence interval is not a guarantee that the true effect lies inside its limits, and it does not tell us the probability that the treatment effect equals a particular value. Its interpretation depends on the analysis assumptions. The registry does not report enough methodological detail to evaluate all of those assumptions or determine whether the posted intervals are adjusted for any covariates. The registry labels the associated p-values as unadjusted.

What does the p-value add?

A p-value summarizes how incompatible the observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, the probability that chance alone caused the result, or a measure of clinical importance. The posted unadjusted p-values are 0.182 at 12 months and 0.074 at 18 months. Read alongside the confidence intervals, they indicate that the posted comparisons do not sharply distinguish the estimated differences from zero.

“Unadjusted” matters because the registry also posts more than one outcome-time summary. If several comparisons are examined, the chance of at least one apparently unusual result can increase. Whether the investigators used a prespecified hierarchy, multiplicity correction, or another approach is not reported in the registry record. The posted p-values should therefore be treated as individual, unadjusted summaries rather than as a complete multiplicity-controlled analysis.

What is and is not recalculated?

The results displayed in the tables and plots are generated from the posted summary statistics, and the registry comparison is not flagged as discrepant. Any simple unadjusted recalculation based on group summaries is not a replacement for the sponsor’s analysis or for an analysis that accounts for the trial design in greater detail. No adjusted estimate, model-based subgroup result, or repeated-measures analysis is reported in the registry record. The methods used by the investigators beyond the summaries shown are not reported in the registry record.

The two follow-up analyses have different participant counts. The 12-month summary lists 197 participants in FINANCE-DM and 190 in TIDES; the 18-month summary lists 186 and 178. The registry does not explain why these analysis counts differ or indicate whether all randomized participants were included in the main analyses. It also does not describe imputation or other missing-data methods. General statistical practice recognizes that missing measurements can affect group comparisons if the reasons for missingness differ across groups or relate to the outcome; whether that occurred cannot be determined from the registry record.

What assumptions apply to the planning illustration?

The sample-size illustration is based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It examines the stated fractions of the observed effect. These are assumptions for the posted illustration, not evidence of the trial’s original design assumptions. The registry’s own sample-size justification is not reported in the registry record. The illustration is useful for seeing how a target effect and desired power relate to sample size under those assumptions, but it does not establish what was planned before enrollment.

In general, equal allocation means the illustration assumes the same number of participants in each arm. The normal approximation is a calculation method for estimating sample requirements. Whether that approximation matches the investigators’ original planning process is not reported in the registry record. These distinctions matter because sample-size calculations depend on the target effect, variability, significance level, allocation, and analysis method; changing assumptions can change the resulting planning figures.

11. Confidence Intervals and Precision

The confidence intervals are central to interpreting the mean differences. At both 12 and 18 months, the posted interval crosses zero. This means the data are consistent with no difference as well as with positive and negative values within the interval. The point estimates favor lower mean HbA1c in FINANCE-DM relative to TIDES under the posted subtraction direction, but the uncertainty is wide enough that the observed direction should not be treated as conclusive.

The unadjusted p-values, 0.182 at 12 months and 0.074 at 18 months, are consistent with that uncertainty. They do not establish that a difference exists, and they do not prove that no meaningful difference exists. A confidence interval is more informative than a binary label because it shows the range of contrasts compatible with the data and method. The exact interval limits are displayed in the posted results; the key interpretive point is that both include zero.

Precision depends in part on the amount of outcome information and its variability. The primary analysis includes 197 participants in FINANCE-DM and 190 in TIDES, while the 18-month analysis includes 186 and 178. The standard deviations indicate substantial variation in individual HbA1c measurements relative to the mean contrasts. The posted results therefore warrant attention to uncertainty rather than treating the point estimate as an exact effect.

The registry does not report whether confidence intervals were adjusted for covariates, multiplicity, or the repeated assessment. It also notes a discrepancy between the 12-month analysis count and the flow chart representing 18 months, without explaining it. These gaps limit assessment of precision beyond the reported intervals. A narrow interval would not in itself resolve questions about bias or analysis choices; here, interpretation should remain tied to the stated summary and its limitations.

12. Planning a Similar Trial: Sample Size

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

The sample-size table and curve are planning illustrations based on the observed effect, not a record of the trial’s original design calculation. The posted assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The table considers planning for 100%, 75%, and 50% of the observed effect. Because the outcome is continuous, the figures refer to participants per arm, not total events.

The 80% power column gives the estimated number of participants per arm under which the calculation would have an 80% chance of detecting the stated effect, if the assumptions hold and the effect is real at that size. The 90% column gives the corresponding planning target for a 90% chance. In general, greater planned power requires more participants when the other assumptions are held fixed. A smaller target difference is harder to distinguish from variation, so the table requires more participants per arm when planning for a smaller fraction of the observed effect.

For the 12-month comparison, The table shows 853 participants per arm for 80% power and 1,142 for 90% when planning for 100% of the observed effect. For 75%, the corresponding figures are 1,517 and 2,030; for 50%, they are 3,412 and 4,568. These values illustrate how the required sample increases as the target effect becomes smaller. They do not describe the number enrolled or analyzed in this trial.

The separate 18-month illustration has its own observed effect and planning figures, shown alongside the results. The registry’s original design assumptions, including its intended detectable effect and sample-size justification, are not reported in the registry record. These calculations are a planning illustration and are not observed power: they do not tell us the probability that this completed trial detected an effect or the probability that a null result is correct.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = 0.220; pooled standard deviation σ = 1.622.
2. n = 2 × (1.96 + 0.842)² × 1.622² / 0.220² = 852.9, rounded up to 853 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.219999999999999                      # observed difference in means
sigma <- 1.62167982491781                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

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

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4203173)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 853 (80% power), 1,142 (90% power)
 75% of observed effect: n per arm = 1,517 (80% power), 2,030 (90% power)
 50% of observed effect: n per arm = 3,412 (80% power), 4,568 (90% power)
power.t.test: 853.9 
Simulated power at n = 853 per arm: 0.802 (20000 replicates)

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

14. Multiplicity, Missing Data and Analysis Populations

The registry posts a primary HbA1c outcome at 12 months and a secondary HbA1c outcome at 18 months. It also describes questions about sustainability after incentives are withdrawn and differences across racial and ethnic groups. The record lists two outcome measures but no reported analyses in its analysis listing. At the same time, numerical outcome comparisons are posted. This means the registry contains summary results, but does not provide a complete account of the analyses behind them.

Multiplicity refers, in general, to the interpretive issue created by testing or estimating several outcomes, time points, subgroups, or contrasts. When many comparisons are considered, an apparently notable result can occur by chance more often than in a single prespecified test. The registry does not report a multiplicity adjustment, a hierarchy among the endpoints, or which analyses were designated in advance. The unadjusted p-values should therefore not be interpreted as if the registry established control of error across all questions or comparisons.

The registry’s stated racial and ethnic subgroup question has no posted analysis. It is not possible to infer subgroup consistency from the overall means. Subgroup analyses can also be less precise than overall comparisons, and their interpretation depends on whether an interaction or other suitable comparison was planned. The relevant analysis plan and results are not reported in the registry record.

Missing-data methods are also not reported in the registry record. The number analyzed at 12 months is noted to differ from the participant flow chart, which represents analysis at 18 months. Posted analysis counts are 197 and 190 at 12 months, and 186 and 178 at 18 months, for FINANCE-DM and TIDES respectively. Those counts do not by themselves explain why measurements are absent or whether participants were excluded from an analysis. No imputation method, missingness assumption, or sensitivity analysis is described.

The registry does not report the primary analysis population definition, whether the comparisons follow intention-to-treat principles, or how protocol deviations were handled. Those omissions matter because the analysis population and missing-data approach can affect the interpretation of randomized comparisons. The posted results can be described as presented, but the registry record does not support a detailed assessment of multiplicity control, missingness, or the full analysis strategy.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists serious adverse events for 224 participants at risk in FINANCE-DM and 226 at risk in TIDES. It reports zero serious adverse events in each group and zero deaths in each group. The other adverse-event counts listed are also zero for both groups. No serious adverse-event terms are listed.

These entries describe what appears in the registry safety summary; they do not establish that no adverse events occurred outside the categories or reporting period covered by that summary. The record does not provide event definitions, collection procedures, follow-up completeness, or a detailed narrative explaining the zero counts. It also does not report comparative safety analyses. The figures should therefore be read as registry-reported counts, not as proof that either intervention is free of risk.

The number at risk for these safety summaries differs from the number in the primary HbA1c analysis. These are separate denominators for different summaries, and the registry does not explain the relationship between them. The safety figures should not be used to infer the completeness of the outcome analyses or to calculate a comparative risk beyond the counts shown.

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

The posted results describe mean HbA1c in two randomized groups, one receiving financial incentives in addition to nurse education and home telemonitoring, and the other receiving nurse education and home telemonitoring alone. At both follow-up times, the TIDES mean is higher than the FINANCE-DM mean. The corresponding confidence intervals cross zero, so the data do not provide a precise separation of the group averages.

This does not mean the groups are proven identical. A nonzero difference remains compatible with the data, as does no difference. Nor does the point estimate alone establish that any difference is clinically important. The registry does not give a minimally important difference or a threshold for interpreting the mean contrast. The results are about group averages and do not show how much an individual participant’s HbA1c changed.

The comparison is specifically between two active approaches. Since both groups receive nurse education and home telemonitoring, the posted contrast concerns adding structured financial incentives to those shared components. It cannot isolate the effect of nurse education, telemonitoring, or any individual component on its own. The registry also does not report results addressing whether intervention effects differ across racial and ethnic groups.

The 18-month outcome relates to the question of sustainability after incentives are withdrawn, but a later group comparison alone does not demonstrate that an effect was maintained or changed. The registry does not report a formal analysis of the difference between time points, and the analysis counts vary. The overall pattern is descriptive and should be interpreted with those qualifications.

These results are not medical advice and do not determine what a person should do. They are registry summaries from one trial, with uncertainty and gaps in reporting about analysis populations, missing data, and statistical methods. The strongest supported interpretation is limited to the posted group means, mean differences, and their uncertainty at the stated follow-up times.

17. Why This Trial Matters Statistically

Statistically, this trial is useful because the intervention contrast is defined against an active comparator rather than against no contact or no monitoring. Both groups include nurse education and home telemonitoring, while structured financial incentives are included in FINANCE-DM. That design makes the posted mean comparison relevant to the incremental contrast described by the trial, while also limiting conclusions about the shared components.

The outcome is continuous HbA1c, summarized at two follow-up times. This allows the registry to show the group averages and their variation, rather than only reporting a binary outcome. The confidence intervals and p-values also illustrate why an estimated direction is not the same as a precise conclusion: both comparisons have intervals that cross zero, and both remain uncertain.

The later assessment connects to the stated interest in whether effects persist after incentives are withdrawn. However, a later endpoint needs careful interpretation, especially when analysis counts differ and no repeated-measures or change analysis is posted. This trial therefore illustrates the distinction between observing a pattern at two times and formally establishing a time-related treatment effect.

The planning illustrations further show how sample-size requirements depend on the target effect and desired power. Their assumptions are stated, but they are not the trial’s original design justification. Keeping planning calculations separate from observed results is important: a post hoc illustration cannot retrospectively explain the study’s design or turn an uncertain result into a definitive conclusion.

Finally, the registry’s stated subgroup question and the lack of posted subgroup analysis highlight the difference between a research objective and an answer supported by reported results. A statistically informative record needs not only outcome values, but also clear analysis populations, missing-data methods, multiplicity handling, and results for the questions being asked.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this registry record constrain interpretation. First, the record notes that the number analyzed for the 12-month outcome differs from the participant flow chart, which represents analysis at 18 months. It does not explain the discrepancy. The primary analysis counts and the later counts are therefore not enough to reconstruct participant flow or determine why some measurements are not represented.

Second, the registry does not report how missing HbA1c measurements were handled, how the analysis population was defined, or whether the comparisons followed intention-to-treat principles. Without those details, the possibility that analysis choices affect the estimates cannot be evaluated from the posted record.

Third, the registry does not report the statistical model, covariate adjustment, repeated-measures approach, multiplicity plan, or original sample-size justification. It posts unadjusted comparisons, but does not describe whether additional prespecified analyses were conducted. The stated question about racial and ethnic differences is not accompanied by subgroup results.

Fourth, the primary endpoint is a group mean at 12 months, while sustainability is considered through a later outcome at 18 months. The record does not report an analysis directly testing change in the treatment contrast over time. Different participant counts at the two time points also mean that the results should not be interpreted as a simple within-person trajectory.

Finally, the registry safety summary lists zero serious adverse events and zero deaths, but does not include detailed event definitions or a narrative about ascertainment. The reported counts can be described, but they do not resolve all questions about safety reporting. These limitations concern what can be learned from the posted registry information; they are not evidence that the trial necessarily failed to conduct analyses that are not shown.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1 — NCT04203173.
• Registry record last updated 2026-07-24; status last verified 2026-07.
• Results first posted 2026-07-24.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

The registry describes FINANCE-DM as a completed, randomized, double-masked, parallel-group study with 450 participants enrolled. It compares financial incentives added to nurse education and home telemonitoring with an active comparator consisting of nurse education and home telemonitoring. The primary endpoint is mean HbA1c at 12 months; a secondary HbA1c outcome is posted at 18 months.

At both time points, the posted mean is higher in TIDES than in FINANCE-DM, but the confidence intervals cross zero and the comparisons remain uncertain. The registry also reports zero serious adverse events and zero deaths in both groups. Analysis-population details, missing-data methods, multiplicity handling, subgroup results, and the trial’s original sample-size justification are not reported in the registry record.