Diabetes mellitus is characterized by uncontrolled hyperglycemia affects millions people worldwide, especially in lower-middle-income countries (LMICs) and contributes to micro- and macrovascular complications (1, 2). It has been observed that type 2 diabetes mellitus (T2DM) has increased globally, regardless of income or geographic location, over the past 30 years (3). According to the World Health Organization (WHO), diabetes accounts for 1.5 million annual deaths across countries (1). Recent studies from all over the world estimated that 10.5% of people had diabetes mellitus, with forecasts of 12.2% by the year 2045 (2–5). According to a 2021 study by the International Diabetes Federation (IDF), 537 million people internationally had diabetes, a number expected to increase to 643 million by 2030 and 783 million by 2045 (6). These data highlight the economic burden of diabetes treatment and the challenges of affordability for patients (6). The economic impact of diabetes in North India is staggering, with annual treatment costs exceeding ₹50,000–₹1,00,000 per patient (7). Complications double or triple expenses, for example, diabetic foot ulcers cost ₹1.5–3 lakhs per hospitalization (8). Although Ayushman Bharat-PMJAY covers hospitalization costs, outpatient care (medicines, tests, and doctor consultations) remains largely out-of-pocket (OOP). A recent study found that in Uttar Pradesh, 70% of diabetes care expenses are OOP, pushing 5-7% of households into poverty annually (9).

In low- and middle-income countries, the healthcare system faces significant obstacles in diabetes management, with fragmented care delivery, urban-rural disparities, and inadequate insurance coverage. These systemic gaps lead to delayed diagnoses, higher complication rates, and increased healthcare expenditures among low-income households. The present work aimed to assess the impact of education and empowerment on reducing direct and indirect costs of T2DM management.

Table 1 presents comprehensive baseline data showing well balanced groups: mean age ~49 years, 58% male, 47% low SES (<₹10,000/month), 56% rural residents, and only 14% insured. No significant between-group differences (all p>0.05) confirm comparability. A total of 320 adults with type 2 diabetes mellitus were enrolled at baseline, and all participants completed the 24-month follow-up assessments, resulting in a complete dataset across all study time points. The intervention group demonstrated a significant decline in direct costs compared with the control group over the 24-month follow-up period (p < 0.001), while Cohen’s d quantified the standardized between-group effect size. Larger negative d values at later time points indicate a substantial cost advantage associated with the intervention. Each time point shows a significant decrease in direct costs, indicating sustained economic benefits following education and empowerment interventions among patients with T2DM (Table 2; Figure 1).

Descriptive inspection revealed marked declines in mean patient-level costs over time. The LMM demonstrated strong, statistically significant reductions relative to baseline: estimated baseline mean was ₹5,160.15 (95% CI ₹4,983.51–₹5,336.79). Estimated mean differences versus baseline were −₹1,476.70 at 6 months (95% CI −₹1,583.66 to −₹1,369.74; p < 0.001), −₹2,209.49 at 12 months (95% CI −₹2,316.45 to −₹2,102.53; p < 0.001), −₹2,671.00 at 18 months (95% CI −₹2,777.96 to −₹2,564.04; p < 0.001), and −₹3,117.05 at 24 months (95% CI −₹3,224.01 to −₹3,010.09; p < 0.001). These results indicate a substantial and progressive reduction in expenditure across the two-year follow-up.

In our study, the cost-trajectory clustering approach revealed three major clusters within the study population. Cluster 0 comprised 95 patients with moderate baseline costs and a steady reduction. Cluster 1 included 115 T2DM patients who presented with a gradual, stable decline in direct costs, while Cluster 2 included 109 T2DM patients who showed a sharp, high-magnitude cost reduction (Figure 2). In multivariable regression analysis, a higher baseline cost (β = 0.582, p < 0.001) and higher baseline HbA1c (β = −611.53 per % HbA1c, p < 0.001) independently predicted greater cost reduction over 24 months. Baseline HbA1c was also significantly associated with cost reduction (β = −611.53 per % HbA1c; bootstrap 95% CI −811.17 to −403.31; p < 0.001), suggesting greater clinical burden at entry predicted larger subsequent cost declines. Age, travel, and parking costs were not significant predictors in the study population. Bootstrap confidence intervals further confirmed the robustness of these associations. Age and ancillary costs (travel and parking) were not significant predictors. These findings were consistent with estimates derived from mixed effects modeling. Table 3 and Figure 3 show a substantial decrease in ancillary (indirect) cost in the study population (p<0.001).

The results of the present study showed progressively increasing statistical significance, thereby confirming sustained effects beyond six months in T2DM patients who received education and empowerment (Table 4). Furthermore, the subgroup comparison of odds ratios for glycaemic control showed statistically significant improvement after education and empowerment in T2DM patients (Table 5; Figure 4). Table 6 presents standardized effect sizes derived from mean cost differences using Cohen’s conventional thresholds, and large effects were observed after one year of the intervention (Figure 5). A mixed-effects model was fitted for participants’ group, time point, and their interaction, and which identified a negative interaction coefficient indicating a steeper decline in cost over time in the education-and-empowerment group compared to the control group (Table 7). The complete mixed-effects model demonstrated substantial patient-level heterogeneity, with random intercepts explaining 37% of total variance (ICC = 0.37) and random slopes indicating moderate patient-specific trajectory variation (ρ=0.42). Model fit was excellent (AIC = 24,932.4). The significant group-by-24-month interaction (-420.1, 95% CI -781 to -59, p=0.022) confirms the intervention group’s steeper cost trajectory compared to controls, robust despite individual variability in baseline costs and temporal patterns. Difference-in-Differences sensitivity analysis: Aggregated pre- and post-intervention Difference-in-Differences analysis supported the primary findings of the LMM, demonstrating a significantly greater reduction in annualized costs in the intervention group compared with controls (−2,095.04 vs. −695.02, respectively). The estimated DiD effect was −1,400.02 (p = 0.018), indicating a 2.6-fold greater reduction in cost in the intervention arm. Table 8 presents the linear mixed-effects model for changes in the direct cost pattern, showing a statistically significant reduction in direct costs for patients with T2DM after receiving education and empowerment. We assessed the regression coefficients using bootstrap confidence intervals (Table 9) and found a significant association between baseline cost and HbA1c, thereby highlighting the robustness of these predictors.

This two-year, prospective, longitudinal, controlled, interventional study (quasi-experimental) demonstrated a robust and significant decline in diabetes-related expenditure, including both direct and indirect costs, following the implementation of education and empowerment approaches. Direct costs decreased by 60% compared to the baseline, while indirect costs declined substantially. The findings of our study align with the observations of previously published studies by Grover et al. (2022) and Kumar et al. (2023), which reported similar economic benefits following educational interventions for chronic disease management (11, 12). The results are consistent with previous findings, in which structured diabetes self-management education and empowerment (DSMEE) have been shown to reduce healthcare expenditure significantly. Previously published meta-analyses showed that DSMEE improved glycaemic control while reducing healthcare expenditure (13–17). Chrvala et al. (2016) and Powers et al. (2020) also demonstrated the beneficial role of education in sustained glycaemic control; Pal et al. (2013) also reported similar findings in the Indian context (17).

Regression analysis in our study further demonstrated that baseline cost and HbA1c were major predictors of cost change, concluding that patients with poor glycaemic control and higher medical-related expenditure derived the greatest economic benefits. Furthermore, Gilmer et al. (2005), Zhang et al. (2010), and Li et al. (2013) demonstrated that a 1% reduction in HbA1c is associated with a 13% reduction in expenditure for care for patients with T2DM (18–20). Similar observations were made by Stratton et al. (2000) and Nichols et al. (2007) (21, 22).

Our study demonstrates sustained reductions in diabetes-related costs over time, as evidenced by odds ratios rising from 2.31 at six months to 9.75 at 24 months. Such behavioural changes among patients changes the empowerment interventions, often need time to translate into tangible cost outcomes, which is corroborated by a previously published study of Duncan et al. (2011) and Steinsbekk et al. (2012) who reported that long-term interventions have a significant effect on glycaemic control and healthcare costs (23, 24). Subgroup analysis of the study group showed a substantial reduction in costs among patients with both poor and good baseline glycaemic control; these findings are supported by previous studies by Khunti et al. (2018) and Sturt et al. (2015) (25, 26).

Ancillary costs, including travel and parking, also showed a non-significant decrease in T2DM patients, likely due to a lower frequency of hospital visits driven by better glycaemic control and fewer diabetes-related complications. Grover et al. (2019) and Joshi & Anjana (2021) reported that educational and digital interventions significantly reduced the travel-related burden in Indian patients (11, 27–29). Education and empowerment contribute to substantial reductions in direct and indirect costs and to improved patient-oriented outcomes, thereby reducing the overall healthcare burden on patients. From a health systems perspective, the observed cost reductions suggest that structured education and empowerment interventions could complement existing public-sector initiatives such as the NP-NCD. Integration of such interventions within primary and secondary care settings may enhance cost efficiency while supporting long-term glycaemic control, particularly in resource-constrained environments. Further long-term follow-up studies are needed to assess the scalability of such interventions at the national level through comprehensive evaluation (30–40).

This study demonstrated sustained reductions in direct and indirect costs through education and empowerment interventions. Over time, higher odds ratios indicated a positive impact of the intervention on glycaemic control and cost reduction. Although the findings support the cost-effectiveness of structured self-management interventions, their overall impact will depend on their integration into existing healthcare frameworks. Integrating self-management interventions into existing tertiary and primary healthcare frameworks of tertiary and primary healthcare could improve cost-effectiveness, efficiency, and empowerment in different communities.