Type 2 Diabetes Mellitus (T2DM) is one of the Non-Communicable Chronic Diseases (NCCD) largely influenced by genetics, lifestyle, diet, habits, and environmental factors (Boutayeb, 2010; Budreviciuteet al., 2020; Dermanet al., 2008; India – International Diabetes Federation, n.d.; Ranieriet al., 2022). T2DM is characterized by impaired insulin secretion and insulin resistance affecting 90% of individuals worldwide, particularly in low- to middle-income countries, posing an increased mortality rate and reduced quality of life for the patients. The ICMR-INDIAB study reports that about 62.4 million people have diabetes, while 77.2 million are prediabetic in India (Anjanaet al., 2011; Lambrinouet al., 2019). Whereas the global prevalence of diabetes stands at 9.3%, impacting 473 million people, it is predicted to increase to 10.2% i.e.,700 million individuals, by 2045, primarily in high-income countries and urban settings compared to rural (Saeediet al., 2019). Developing countries like India and Nepal face an increased risk of diabetes due to sedentary lifestyles and dietary habits, such as high-carbohydrate consumption, obesity, and insulin resistance for which preventive measures such as lifestyle and dietary changes to lower glycaemic index by including high-protein diets and physical activity play a crucial role (Fitipaldiet al., 2018; Shrestha and Ghimire, 2012; Stephenson et al., 2014).

Numerous clinical trials have demonstrated that targeted weight reduction, increased physical activity, and the adoption of diets low in saturated fat, fibre and protein rich diets are effective as primary treatments or adjuvants with pharmacological therapy to prevent the progression of the T2DM (Diabetes Prevention Program (DPP) – NIDDK, n.d.; Espinosa-Salas and Gonzalez-Arias, 2023; Haaseet al., 2021; Hill-Briggset al., 2020; Mohamed, 2014; Uusitupa et al., 2019). The expenditure for managing diabetes is estimated at $414 billion (Yang et al., 2018). By 2030, the global prevalence of diabetes may rise to 10%, leading to economic costs between $2.12 trillion and $2.48 trillion (Bommer et al., 2018). In India, the annual economic cost for managing diabetes is approximately INR Rs. 10,969.6 ($132.83), where the majority of the expense is related to drug prescriptions, increased with hospitalization and mortality worsens the condition socioeconomically (Fanoet al., 2013; Let al., 2024; Shah et al., 2013). Cost-effectiveness analysis conducted by the Diabetes Prevention Program found that interventions applied in clinical practices, particularly lifestyle interventions, were effective across all age groups (Hermanet al., 2005). These interventions significantly improve glycaemic control and reduce glycosylated haemoglobin (HbA_1c) levels, contributing to better health and improved economic outcomes through cost-effective treatments (García-Molinaet al., 2020). Thus, this study aimed to assess the health and economic outcomes associated with diabetes in consideration of the lifestyle of the T2DM patients.

This was a cross-sectional study conducted in tertiary care hospital and research centre in rural settings for a period of 6 months (February 2024 to July 2024). The hospital settings provide multi-speciality facilities for various health issues and diabetic related issues as well and the hospital is accessible to more than three cities. The study was conducted in accordance with the Ethical guidelines for biomedical research on human participants and Declaration of Helsinki; after obtaining approval from the Institution Ethics Committee (IEC/AH&RC/AC/10/2024) and we reported this article as per the STROBE Checklist (Elm et al., 2007). And after explanation of specific of the study informed consent was obtained from the study participants as provided in supplementary file S3 and S4.

The T2DM patients aged 18 or above, increased HbA_1c ≥ 6.5%, RBS ≥ 200mg/dl, FBS ≥ 120 mg/dl and PPBS ≥ 140 mg/dL were considered for this study. After the explanation of all the specific methods, those who were willing to give written consent were included in the study.

Participants less than age 18, T1 DM patients, gestational diabetes patients and those who were not willing to give informed consent were excluded from the study. And patients had right to withdraw from study at any point of the study without any explanation.

Random sampling technique was used to calculate the sample size in this study. We estimated a minimum sample size of 196 participants with a margin of error of 5%, population proportion of 50%, precision of 0.05, at 95% of confidence interval with a prevalence of 8.3% in India according to Indian diabetic federation (India – International Diabetes Federation, n.d.). Sample size was calculated by using random sampling method, the desired sample size was calculated by using the formula for infinite sample size (n₀) and was found to be 384. The actual sample size was calculated by using finite sample size (n) formula and was found to be 196.

Formula used to calculate infinite sample size (n₀) was:

Where:

• Z = 1.96 (Z score for a 95% confidence interval)
• P = 50% (population proportion)
• E = 5% (margin of error)

And the finite sample size (n) was Calculated by using following formula,

Where:

• n₀ = 384 (desired sample size for an infinite population)
• N = 400 (assumed population size)

Thus, the final sample size for the study was found to be 196 participants.

Patients demographics details and clinical data such as patient history, age, diabetic status, presence of comorbidities and laboratory reports were obtained from the patients, using a pre-designed data collection form (Supplementary file S1). The pilot study of 30 participants with questionaries resulted 0.870 Cronbach value and reliability analysis interpreting good internal consistency of the questionnaire.

The questionnaire was composed of three parts, Diabetic status of the patient (Part 1) to determine the patient diabetic status and control over the diabetes and was made to scales with score such as 1-10 Indicates Under control, 11-20 Indicates Average control, 21-30 Indicates Poor control. Lifestyle, diet and habits related (Part 2) data of the patient, the pattern of diet, lifestyle and habit among diabetes patients was assessed in this section mainly to know the attitude, perception and knowledge of the diabetic patients where, 1-10 is Modified control on diabetes, 11-20 is Average control on diabetes and 21-30 is Non modified control on diabetes. And Pharmacoeconomic (Part 3) related information of the patient which includes, the economic burden which includes the scales with scores as 1-10 as Acceptable economic status, 11-20 is Average economic status and 21-30 as provided in supplementary file S2.

All the collected data were entered into Microsoft Excel sheets, thoroughly verified, and analysed Statistical Package for the Social Sciences (SPSS) free version 25.0 developed by IBM (Armonk, 2017). The categorical and continuous data were presented as frequency with percentages and mean with standard deviation respectively. Chi square and Cor-relation statistical methods were used to check the association between the variables of Parts of the questionnaire i.e., Diabetic status (Part1) and lifestyle, diet and habits parameters (Part 2) with pharmacoeconomic status (Part 3). Linear regression was analysed for the demographics with direct and indirect cost of cost of illness of diabetes.

The indirect cost was calculated based on the human capital approach and India’s national floor level minimum wage is INR 5,340 monthly, the Minimum Wages Act provided specific powers to the Central and State Government in 2023 in India (Official Website of Labour Department, Government of Puducherry, India, n.d.).

A total of 196 patients with T2DM were included of which 121 (61.7%) were male and 75 (38.2%) were female; most of the patients 90(45.9%) belongs to 41-60 years of age group, and also, median age of 86 (43.88%) belongs to 61-80 years of age group. It was observed that more than half, 127 (64.8%) of the patients were not had any habits and 97 (49.49%) were unemployed. The median income per month in Indian rupees were found to be 21000-30000 (17.35%), most of the patients were farmers 48 (24.5%) by occupation.

Also, 70 (35.5%) had T2DM only and more than 60% were had T2DM with comorbidities such as hypertension 67 (34.18%), hypothyroidism 13 (6.63%), chronic obstructive lung disease 7 (3.57%) and others. And most of the patients were on medication metformin 100 (39.84%) described in Table 1.

The association between the total score obtained from the Diabetic status part and the lifestyle part of the questionnaire of the individual patient compared by using Chi square and correlation statistical methos resulted with p value of <0.05, CI of 95% (p value <0.001, 95% CI) and p value of <0.001, under 99% of confidence interval. Similarly, the association between the total score of the patient’s diabetic status and pharmacoeconomic parts of the questionnaire were resulted with p value of <0.05, CI of 95% (p value <0.003, 95% CI) and p value of <0.001, under 99% of confidence interval as provided in Table 2.

The mean of the total direct cost found to be $ 29.04. While the mean of total indirect cost found to be $56.67. The mean of total cost (direct cost + indirect cost) was observed to be 85.71 USD (29.04+56.67), which is Rs. 7,197 Indian rupees as described in Table 3.

Various demographic factors assessed for linear regression with direct and indirect cost and the significant association observed for Inj. glargine and indirect cost with a p value of <0.05, 95% of confidence interval. While, duration of hospital stays, glaucoma, chronic liver disease and Injection Mixtard were resulted in significant p value of <0.05, 95% of confidence interval with direct cost as provided in Table 4.

T2DM is still a global concern affecting nearly 90% of individuals worldwide particularly in low to middle income countries resulting in increased mortality and cost associated for the long-term treatment of the same (Anjanaet al., 2011; Bommeret al., 2018; Fanoet al., 2013; India – International Diabetes Federation, n.d.; Let al., 2024; Shah et al., 2013). Thus, the findings of this study emphasize the critical role of lifestyle, diet, and habits in the effective management of diabetes, these factors not only improve the quality of life of diabetic patients but also reduce the associated economic burden. It was observed that major proportion of included participants were aged between 41 and 60 years. A similar study by Khowaja LA et al., found mean age of population to be (38%) 51 and 60 years (Khowajaet al., 2007). However, remaining were 35.9% and 26.1% of 41 to 50 and 20 to 40. Also, in our study 61.7% were males and 38.2% were females respectively. Where the study from Pakistan by Butt M D et al., found the female population with more proportion 52.2% than male 47.5% (Buttet al., 2022).

The increasing global economic burden of diabetes, especially in countries like India, the United States, and China, address the lifestyle factors effective in management of type 2 diabetes relies heavily on lifestyle modifications targeting obesity and physical inactivity mitigates the diabetes risk and overall burden of the disease (Alfaifi, 2023; Campbellet al., 2011; Cobdenet al., 2007; Foreyt and Poston, 1999; Galavizet al., 2018; Ratner, 1997; Sagarraet al., 2014). In terms of economic outcomes, this study found the total cost for diabetic patients, including direct and indirect expenses, was approximately ₹7,197 (85.71 USD). Which exceeds the Indian National minimum wage of ₹5,340 per month. This financial burden suggests that many diabetic patients may struggle to afford necessary treatments, posing a challenge for government and healthcare policymakers. Similar study by M. Laxy et al. found that the Lifestyle Change Intervention significantly reduced type 2 diabetes risk and proved more cost-effective than routine care, with an Incremental Cost-Effectiveness Ratio (ICER) of US$34,000 per Quality-Adjusted Life Year (QALY) (Laxyet al., 2020).

Other studies support the idea that lifestyle changes that can significantly increase the economic burden of diabetes. Similar studies carried out by L. A. Khowaja et al. found that medication constituted the largest cost component (46%), followed by laboratory costs (32%), with direct costs averaging Rs. 1,930 per visit. Also, the study by Raghuram N. et al. reported that the mean monthly health cost stood at 1,098.25 INR, representing approximately 17% of household expenses, with variations observed between gender and urban and rural environments (Nagarathnaet al., 2020).

The smaller population was a limitation of study, and further studies with a larger population shall be planned to strengthen our findings. This study was conducted among the rural population and hence future comparative studies are needed to understand the effect of lifestyle status, economic status and health status in diabetic patients to provide a support for diabetic patients in managing their disease and economic status as well.

The findings of the study highlight the significant role of lifestyle factors diet, physical activity and habits in managing diabetes, which not only improves health outcomes but also reduces the economic burden associated with the disease. In developing countries like India many patients struggle to afford costly antidiabetic medications and longer hospital stays. Thus, promoting of accessible healthcare and preventive measures by government health programmes and policy makers is essential to reducing the economic impact of diabetes. Further adequately powered prospective studies are needed to strengthen these findings.

We acknowledge Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri Hospital and Adichunchanagiri University, BG Nagara for providing all the infrastructure to conduct this study. Also, we thank the patient participated in the study for their support.