Diabetes Distress and its Associated factors among Patients Attending a Tertiary Care Center in Eastern India

Abstract

Introduction:

Diabetes distress (DD), a negative emotional state, significantly impacts glycemic control and self-management of diabetes. The prevalence of DD is estimated to be high and needs a better understanding of the modifiable factors. However, scanty data are available.

Research Design and Methods:

We have recruited type 2 diabetes mellitus (DM) patients aged 18–65 years attending Endocrinology OPD of a tertiary health care center (THC) from June 2022 to September 2023. Participants with comorbid psychiatric illnesses or use of psychiatric medications were excluded. DD was determined by a language-validated diabetes-specific distress-17 (DDS-17) scale, and depressive symptoms were screened by patient health care questionnaire-9 (PHQ-9). Screening was done for various microvascular complications, and associated clinical and laboratory data were recorded. Univariate and multivariate logistic regressions were performed to identify the association of various factors with overall diabetes distress and its subdomains.

Results:

A total of 443 participants were recruited. The overall prevalence of DD was 39.3%. In the multivariate logistic regression, duration >5 years, diabetic nephropathy, and depressive symptoms (>10 score as per PHQ-9) were found to be associated factors of DD.

Conclusions:

The prevalence of DD is high in tertiary care settings. Younger age, higher HbA1C, disease duration of more than 5 years, and depressive symptoms are significant associated factors. Regular screening and measures to combat diabetes distress are required, particularly in the young-onset diabetes group.

INTRODUCTION

Diabetes, a chronic metabolic disease, is characterized by the development of several micro- and macrovascular complications if the glycemia is not adequately controlled. Diabetes distress (DD) is a negative psychological or emotional state originating from the stressor of living with diabetes and significantly impacts the self-management ability.[1] DD is associated with higher HbA1C and is a risk factor for suboptimal glycemia in longitudinal follow-up.[2,3,4] Various validated questionnaires as problem areas in diabetes (PAID) and diabetes distress scale-17 (DDS-17) are commonly used in clinical studies.[1] DD is found in approximately 36% of patients with diabetes mellitus (DM) and is correlated with female sex and the presence of depressive symptoms according to a meta-analysis.[5] DD can be graded as no distress, moderate distress, and severe distress as per the DDS-17 scale.[6] The latter two groups are considered to be clinically meaningful distress. DD significantly affects diabetes self-management in the Indian population[7] and thus should be assessed in the clinical setting. The prevalence of DD in India is estimated to be very high, to the tune of 40–50%, and more so in the community setting.[7,8]

There have been several risk factors identified for DD in earlier studies, but very few studies have explicitly looked into the influence of various complications on DD in South Asian population and lower- and middle-income country groups (LMIC). The primary objective was to estimate the prevalence of diabetes distress, and the secondary objective was to determine if diabetes distress was associated with prevalent complications related to diabetes.

RESEARCH DESIGN AND METHODS

The study was conducted in the outpatient department of Endocrinology and Metabolism of the All India Institute of Medical Sciences (AIIMS), Kalyani, a tertiary care center in Eastern India, from June 2022 to September 2023. This was an analytical cross sectional study by design. The study was performed as per the declaration of Helsinki after getting the necessary ethical approval from the institute’s ethical committee (ref no: IEC/AIIMS/KALYANI/Meeting/2022/67). Written informed consent was obtained from all the study participants before recruitment.

All consecutive patients of both genders aged 18 years and above with a known history of T2DM for at least 1 year duration and on oral medications or insulin were included. Patients with known present/past psychiatric illness and/or currently on medications, any underlying endocrinological disorder or medications or pancreatitis which can lead to secondary diabetes mellitus, history of cerebrovascular disease (CVA) within the past 5 years, previous history of hematological disorder and currently on blood transfusion, pregnant and lactating women, cancer and/or a history of radiation or chemotherapy, CKD (eGFR <15 ml/m²/min), and heart failure or chronic airway diseases were excluded.

Considering a prevalence of of diabetes distress as 24.8% in previous studies[9] conducted in this region and a confidence interval of 95% and a precision of 0.05, a sample size of 300 was needed. However, for more power, we intended to recruit 400 patients. This was decided based on feasibility issues and other previous studies performed in the South Asian region.[10]

Height, weight, body mass index (BMI), and blood pressure were collected. The BMI subclassification was done according to the WHO guidelines for the Asian population.[11] Past history of atherosclerotic cardiovascular disease (ASCVD), foot ulcer and amputation, and peripheral arterial diseases were collected. Baseline data regarding glycemic control and other comorbidities like hypertension, dyslipidemia, and hypothyroidism were collected.

Further, neuropathy was screened by the Michigan Neuropathy Screening Instrument (MNSI), including the questionnaire and physical examination.[12] For retinopathy, a dilated fundus examination was performed and classified as per Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria. For nephropathy screening, the estimated glomerular filtration rate (GFR) was calculated from the CKD-EPI equation based on serum creatinine. Furthermore, urinary spot albumin and creatinine ratio were noted for albuminuria.

For the determination of diabetes distress, BDDS-17, a Bengali version of DDS-17, which has already been validated in a similar setting and language, was used.[13] A total of subscale scores of more than two were considered clinically significant.[6] Screening questionnaire of the PHQ-9 was also administered to assess depression. A score of more than ten on the PHQ-9 scale was considered clinically significant.[14]

The outcome variable in the study was prevalence of diabetes distress. Various factors as age, gender, biochemical parameters, adherence to medications, glycemic state, and presence of complications were assessed in this study.

Statistical analysis

The normality of the data was assessed through the Kolmogorov–Smirnov test. Data were expressed as mean/SD and median with IQR when non-normally distributed. Tests of hypothesis like independent t-test, Mann–Whitney test, or ANOVA were used. Pearson’s correlation coefficient or Spearman’s rho was used to find correlations between variables as per their distribution. Logistic regression analysis was performed to analyze the association of various factors with DD. Factors significant in bivariate logistic regression (P < 0.25) were analyzed in multivariate logistic regression by backward elimination method. Goodness of fit was assessed using Hosmer–Lemeshow test. A P < 0.05 in the multivariate regression model was taken as significant. All the statistical tests were performed by the STATA software version 22.

RESULTS

Among the participants, 254 (57.3%) were males and the mean age was 49.3 ± 9.65 years. About 48.1% of them were found to be overweight. The mean duration of diabetes in the study sample was 9.5 years. Early onset of the disease (defined as diagnosis below 40 years of age) was seen in 32.7% (n = 145). Only 14.2% of participants (n = 63) had HbA1c levels below the recommended value of 6.5. Fasting blood glucose levels below the recommended levels of 130mg/dl were seen in 46% (n = 204), and post-prandial blood glucose levels below 180 mg/dl were seen in 33.2% (n = 147) [Table 1].

Table 1.

Baseline characteristics of the study participants (n=443)

Variable		Results
Age (in years) [Mean (±SD)]		49.3 (9.65)
Gender	Male	54.3% (n=254)
	Female	45.7 % (n=189)
BMI	Underweight	2.7% (n=12)
	Normal	27.8% (n=123)
	Overweight	48.1% (n=213)
	Obese	21.4% (n=95)
Duration of diabetes (in years) [Mean (±SD)]		9.53 (6.52)
Age at diabetes diagnosis (in years) [Mean (±SD)]		39.9 (9.3)
Glycemic parameters [Mean (±SD)]	FBS (mg/dl)	145.9 (49.4)
	PPBS (mg/dl)	226.7 (82.0)
	HbA1C (%)	8.4 (2.0)
[Mean (±SD)]	Cholesterol	168. 7 (42.6)
	Triglycerides	165.1 (91.2)
	LDL	93.9 (36.2)
	HDL	44.6 (10.6)

Participants were mainly on oral antidiabetic medications only (84%, n = 372). About 68.2% of participants (n = 305) who missed at least three or more doses of medications in the preceding month of the interview were labeled as nonadherent, as per the World Health Organization criteria.[15] A remarkable percentage of participants had a deranged lipid profile, that i.e., 80.1% (n = 355). Furthermore, 69.3% of participants had hypertension. Hypoglycemia incidence during the past 6 months was noted in 9% of the participants (n = 40).

A detailed ophthalmological evaluation, that is, ultrawide field fundus photograph and dilated fundus examination, was done in 345 participants. In this evaluation, 22% had retinopathy of different grades (n = 98). Further, nephropathy was detected in 42.4% of patients (n = 188) based on albumin excretion. On symptomatic and monofilament examination, the clinical neuropathy screen was positive in 29.3% of patients (n = 130). However, assessing the two components of the MNSI tool, 45 (10.2%) participants were found to have diabetic neuropathy [Table 2].

Table 2.

Distribution of participants by complications assessment

Variable	Criteria	n (%)
Creatinine	<1.3	425 (95.9)
	≥1.3	18 (4.1)
Urine albumin-to-creatinine ratio	<30	255 (57.6)
	30-300	168 (37.9)
	>300	20 (4.5)
Atherosclerotic Cardiovascular disease	Yes	25 (5.6)
Foot ulcer	Yes	7 (1.6)
Diabetic Retinopathy	Yes	98 (22.1)
Diabetic Nephropathy	Yes	192 (43.3)
Diabetic Neuropathy	Yes	45 (10.2)
Hypoglycemia	Yes	40 (9.0)

The overall prevalence of DD was 39.3% (95% CI: 35-44). Emotional burden was the highest in the subdomain, including 49.9% of participants (95% CI: 45.2–54.6). The prevalence of regimen-related, interpersonal, and physician-related distress was 27.3%, 42.9%, and 14.5%, respectively [Table 3].

Table 3.

Distribution of diabetes distress among participants by domains

Domain	Mean (±SD)	Prevalence (95% CI)
Emotional Burden	2.4 (1.43)	49.9 (45.2 – 54.6)
Physician-related	1.34 (0.78)	14.5 (11.2 – 17.8)
Regimen-related	1.96 (1.0)	42.9 (38.3 – 47.5)
Interpersonal	1.75 (1.2)	27.3 (23.1 – 31.5)
Composite DDS Score	1.92 (0.80)	39.3% (35.0 – 44.0)

The prevalence of depression was 24.6% (95% CI: 20.6-28.6), and the majority were in the moderate category (18.3%).

A logistic regression analysis was performed to identify associated factors related to DD. It was observed that a duration of more than 5 years, nephropathy, and moderate to severe depression (>10 score as per PHQ-9 scale) were significantly associated on multivariate logistic regression [Table 4].

Table 4.

Association of selected variables with diabetes distress in study participants (n=443)

Variable		Diabetes distress present n (%)	Diabetes distress absent n (%)	Crude OR (95% CI)*	Adjusted OR (95% CI)*
Age				0.97 (0.9 – 1.0)	-
Gender	Male	82 (32.3)	172 (67.7)	1	1
	Female	92 (48.7)	97 (51.3)	1.98 (1.4 – 2.9)	1.46 (0.9 – 2.3)
Adherence	Yes	117 (38.4)	188 (61.6)	1	-
	No	57 (52.8)	51 (47.2)	1.1(0.8 – 1.7)
BMI	Underweight	6 (50.0)	6 (50.0)	1	-
	Normal	50 (40.7)	73 (59.3)	0.68 (0.2 – 2.3)
	Overweight	79 (37.1)	134 (62.9)	0.59 (0.2 – 1.9)
	Obese	39 (41.1)	56 (58.9)	0.70 (0.2 – 2.3)
Status of diabetes	Controlled	14 (22.2)	49 (77.8)	1	1
	Uncontrolled	160 (42.1)	220 (57.9)	2.5 (1.4 – 4.8)	1.8 (0.9 – 3.7)
Lipid profile	Controlled	37 (42.0)	51 (58.0)	1	-
	Uncontrolled	137 (38.6)	218 (61.4)	0.87 (0.5 – 1.4)
Late onset diabetes	No	71 (49.0)	74 (51.0)	1	1
	Yes	103 (34.6)	195 (65.4)	0.55 (0.4 – 0.8)	0.80 (0.4 – 1.6)
Age at diagnosis				0.96 (0.9 – 1.0)	0.99 (0.9 – 1.1)
Duration in years	<5years	49 (33.3)	98 (66.7)	1	1
	≥5 years	125 (42.2)	171 (57.8)	1.46 (0.9 – 2.2)	1.93 (1.0 – 3.7)
Diabetic Retinopathy	No	133 (38.6)	212 (61.4)	1	-
	Yes	41 (41.8)	57 (58.2)	1.15 (0.7 – 1.8)
Diabetic neuropathy	No	146 (36.7)	252 (63.3)	1	1
	Yes	28 (62.2)	17 (37.8)	2.84 (1.5 – 5.4)	1.97(0.9 – 4.2)
Diabetic nephropathy	No	85 (33.9)	166 (66.1)	1	1
	Yes	89 (46.4)	103 (53.6)	1.69 (1.2 – 2.5)	1.85 (1.2 – 2.9)
Hypertension	No	98 (41.9)	136 (58.1)	1	1
	Yes	76 (36.5)	132 (63.5)	0.8 (0.5 – 1.2)	0.72 (0.5 – 1.2)
Medications	Oral	139 (37.4)	233 (62.6)	1	1
	Injectable (Insulin)	35 (49.3)	36 (50.7)	1.63 (0.9 – 2.7)	1.01 (0.5 – 1.9)
Depression	No	96 (28.7)	238 (71.3)	1	1
	Yes	78 (71.6)	31 (28.4)	6.24 (3.9 – 10.1)	6.21 (3.7 – 10.5)

*Wald Chi-square test was used to assess significance in bivariate analysis. **Percentages in parentheses are row-wise

On multivariate logistic regression, female gender (aOR: 1.89, P < 0.001, 95% CI: 1.23–2.89), diabetic neuropathy (aOR: 2.50, P = 0.02, 95% CI: 1.14–5.48), and depression (aOR: 3.57, P < 0.001, 95% CI: 2.13–5.97) were found to be significantly associated with the emotional burden. Presence of nephropathy (aOR: 1.68, P = 0.02, 95% CI: 1.09–2.60) and presence of depression (aOR: 4.27, P < 0.001, 95% CI: 2.58–7.10) were found to be significantly associated with regimen related burden [Supplementary Tables 1 and 2].

DISCUSSION

Diabetes distress, a negative emotional state, is known to be associated with poor glycemic control[16] and low health literacy, contributing to adverse health outcomes.[17] Understanding this phenomenon and identifying its associated factors can help improve patient support and clinical outcomes.

This study found a high prevalence of DD in a tertiary care center (40%). Longer diabetes duration, presence of nephropathy, high PHQ-9 scores, younger age, and high HbA1C were associated with high DD. Presence of diabetic neuropathy and nephropathy were significantly associated with emotional burden and regimen-related burden, respectively.

Our finding is similar to a recent study from southern India.[18] However, our finding of higher DD is different from a previous study done in eastern India,[9] possibly reflecting the use of a language-validated DDS-17 scoring and inclusion of young onset diabetics. Our finding of the prevalence of DD is also aligned with an earlier meta-analysis, that is, 36%.[5]

In general, female patients and the presence of depressive symptoms are associated with higher DD.[5,19] However, in our study, only the presence of high depressive symptoms influenced DD. Diabetes patients with increased levels of depressive symptoms as per various screening tools (like PHQ-9) may not reflect clinically meaningful depression.[20] Nonetheless, it is certain that presence of high depressive symptoms affects all domains of the diabetes specific distress.[21] Diabetes distress may be conceptualized as adjustment disorder as per our current psychiatric nosology. Understanding this distinction is further required as for syndromal depression management, antidepressant is the mainstay, whereas for the diabetes distress management, a collaborative care model needs to be developed.[22]

An interesting finding of our study is that lower age was significantly associated with overall distress. Diabetes prevalence in relatively young people is increasing, and they are more vulnerable to diabetes-specific distress.[19,23,24] However, we also note that the sole contribution of early onset of diabetes (less than 40 years of age) to the overall distress score was insignificant in our study. Recent research by Barker et al.[25] confirmed that younger age was associated with higher depressive symptoms and diabetes-specific distress.

An essential objective of our study was to evaluate the relationship of prevalent micro- and macrovascular complications with ongoing diabetes distress. After adjusting for various confounders and using various regression models, presence of nephropathy is associated with increased overall diabetes distress. The presence of complications is associated with the development of diabetes distress according to a study.[26] Though the presence of neuropathy has been associated with emotional distress in type 1 diabetes,[27] these findings in type 2 diabetes mellitus might have further clinical importance since it will be interesting to note if alleviation of neuropathic symptoms can decrease the emotional burden. Earlier in a multiethnic cohort, Ismail and colleagues[28] did not find any association between microvascular complications and diabetes distress in newly diagnosed diabetes over 2 years, but they found increased odds for the development of macrovascular complications with depressive symptoms. In our study, the mean duration of diabetes was 9.53 years, which may account for the difference. The finding of nephropathy related to higher regimen-related distress is interesting as a recent Japanese study showed that males with higher diabetes distress at baseline are at risk of progression of diabetic nephropathy.[29]

The primary strength of the study is that it comprehensively evaluated the relationship of various diabetic micro- and macrovascular complications with the prevalent diabetes distress in a real-world setting. The study used a validated DDS-17 score. Moreover, early-onset diabetes cases are represented well in the study, and since the mean onset of diabetes was approximately 40 years, this study contributes to the diabetes distress research in early-onset diabetes as well.

Despite its clinical relevance, diabetes distress is often not routinely assessed in standard diabetes care. Emerging evidence suggests that persistent distress is significantly associated with poor glycemic control and may lead to long-term deterioration in patients’ quality of life. Routine screening using tools like the Diabetes Distress Scale in clinical and community settings can be introduced under National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD). Patient-centered education, psychological counseling (e.g. Cognitive Behavioural Therapy, motivational interviewing), and peer support can reduce emotional burden. Involving families and empowering community health workers like ASHAs can enhance the psychological support of patients. Integrated care models incorporating mental health services within routine NCD clinics can be a crucial intervention. Strengthening the mental health-NCD care interface will improve both emotional wellbeing and diabetes outcomes. Digital tools like telemedicine and mHealth apps can be used to facilitate ongoing monitoring and counseling. Therefore, integrating the assessment and management of diabetes distress into existing NCD care frameworks—particularly under the NP-NCD—can play a pivotal role in improving both psychological and metabolic outcomes. Prioritizing mental health support within diabetes care is essential to achieving holistic, patient-centered management and advancing long-term public health goals in India.

CONCLUSION

In conclusion, the prevalence of diabetes distress is high in tertiary care setting. Younger age, higher HbA1C, a disease duration of more than 5 years, and high depressive symptoms are related to increased diabetes distress. The presence of peripheral neuropathy and nephropathy is related to high emotional and regimen-related burden, respectively. Regular screening and measures to impact diabetes distress are required, particularly in the young-onset diabetes group.

Data availability statement

Data of the study will be made available upon reasonable request.

Ethics approval

The study was performed as per the declaration of Helsinki after getting the necessary ethical approval from the institute’s ethical committee (ref no: IEC/AIIMS/KALYANI/Meeting/2022/67). Written informed consent was obtained from all the study participants before recruitment.

Contributors

AR initiated the study concept and design. AR, TS and SP further developed the design and recruited participants. Data analysis was carried out by AR, TS and SP. AR wrote the first draft of the manuscript, and all authors edited, reviewed, and approved the final version of the manuscript. AR and SP are the guarantors of this work, had full access to all the data in the study and takes responsibility for the accuracy of the data analysis.

Conflicts of interest

There are no conflicts of interest.

SUPPLEMENTARY FILE_DDS STUDY

A. Operational definitions:

Nephropathy: Nephropathy was defined as persistent eGFR <60 mL/min/1.73 m² with albuminuria (ACR ≥30 mg/g), due to Diabetes mellitus[1]. According to KDIGO guidelines there are 3 categories of albuminuria mentioned below:

A1- mildly increased (U-ACR <30 mg/g)

A2- moderately increased (U-ACR 30-300 mg/g)

A3- severely increased (U-ACR >300 mg/g)

The eGFR was calculated from serum creatinine measurements, with renal impairment defined as an eGFR of less than 60 ml per minute per 1.73 m²[2].

Retinopathy: Retinopathy was diagnosed and graded according to the Early Treatment Diabetic Retinopathy Study scale (ETDRS) or if clinically significant macular edema was present in either eye by fundus photography. And if required dilated fundus examination was performed

Neuropathy: Michigan neuropathy screening instrument is a screening tool for assessing the development of Diabetic neuropathy in patients suffering from long diabetes mellitus. Michigan Neuropathy Screening Instrument (MNSI), which included a 15-item interviewer-administered symptom questionnaire and a bilateral lower-extremity clinical examination assessing ankle reflexes and vibration sensation at the great toes. Scores on the MNSI range from 0 to 8, with higher scores indicating more severe symptoms of neuropathy. Diabetic peripheral neuropathy was defined as an MNSI score of 7 or higher or an examination score of 2.5 or higher, as previously described.[3]

Atherosclerotic cardiovascular disease: The following were noted: Coronary heart disease (CHD) clinically manifested by myocardial infarction, angina pectoris, stroke and transient ischemic attack. Peripheral artery disease features like intermittent claudication, aortic atherosclerosis and thoracic or abdominal aortic aneurysm. The assessment of any patients suffering from ASCVD or any events of cardiovascular accident or stroke was thoroughly detailed in our patient information sheet with past records and active ongoing disease, if any, was noted.

B. Study tools and methodology:

DDS-17:

The Diabetes distress 17 scale was developed for determination of diabetes distress in patients suffering from diabetes mellitus. This scale contains 17 potential problem areas that people with diabetes experience

The DDS-17 has 17 items to score. The scoring is from 1 to 6. The scoring will be done by the patient in a validated translated version of the DDS used in this study named as BDDS-17. The score has four separate domains including:

• 1) Emotional burden (average of 5 items 2,4,7,11,14 divided by 5);

• 2) Physician related distress (average of 4 items 1,5,11,15 divided by 4);

• 3) regimen distress (average of 5 items, 6.8,3,12,16 divided by 5);

• 4) interpersonal distress (average of 3 items 9,13,17 divided by 3).

Average score of less than 2 reflects no or little distress, average score between 2.0-2.9 reflects moderate distress, average score more than 3 reflects severe distress. A total of subscale scores more than 2 (moderate distress) is considered clinically significant.[4]

PHQ-9: Patient Depression Questionnaire. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression[5]. It is a self-administered questionnaire, and it has 9 questions, the patient was asked to fill up the questionnaire after their consultation in the OPD of AIIMS Kalyani with the DDS-17 questionnaire in the same day itself

The interpretation of the score is mentioned below:

1-4: Minimal depression

5-9: Mild Depression

10-14: Moderate Depression

15-19: Moderately Severe

20-27: Severe Depression

Biochemical methods:

The biochemical parameters which were evaluated in this study for the determining the complications of diabetes involves blood samples and urine samples which was measured in aseptic conditions and abiding proper standard operating protocol of the Department of Biochemistry, All India Institute of medical sciences. The parameters includes- the fasting blood glucose, post prandial blood glucose , HbA1C, serum creatinine urinary spot albumin creatinine ratio (U-ACR), fasting lipid profile. The HbA1c was measured by HPLC method by Arkray instrument, Japan. And the fasting blood glucose, post prandial blood glucose , serum creatinine , U-ACR, fasting lipid profile was measured by Vitros 4600 instrument following the Reflectance photometry principle (ortho-clinical diagnosis). All these tests were being done in the laboratory of Department of biochemistry in all india institute of medical sciences , Kalyani following proper protocols.

Association of various factors with subdomains of diabetes distress scale

1. On multivariate logistic regression, female gender, presence of diabetic neuropathy and presence of depression as per PHQ-9 questionnaire were found to be significantly associated with emotional burden. (Table – 1)

2. On multivariate logistic regression, presence of diabetic nephropathy, and presence of depression as per PHQ-9 questionnaire were found to be significantly associated with regimen related burden. (Table – 2)

Supplementary Table 1.

Association of select variables with emotional burden of diabetes distress score

Variable		Unadjusted OR P, 95% CI	Adjusted OR P, 95% CI
Age		0.96 0.00, 0.94 – 0.98	0.99 0.70, 0.95 – 1.03
Gender	Male	1	1
	Female	2.43 0.00, 1.66 – 3.59	1.89 <0.001, 1.23 – 2.89
Adherence	Yes	1	-
	No	1.0 0.98, 0.67 – 1.50
BMI	Underweight	1	-
	Normal	1.20 0.77, 0.37 – 3.92
	Overweight	0.84 0.76, 0.26 – 2.68
	Obese	1.16 0.81, 0.35 – 3.85
Status of diabetes	Controlled	1	1
	Uncontrolled	2.05 0.01, 1.18 – 3.57	1.52 0.17, 0.83 – 2.79
Lipid profile	Controlled	1	-
	Uncontrolled	0.79 0.33, 0.50 – 1.27
Late onset diabetes	No	1	1
	Yes	0.64 0.03, 0.43 – 0.96	1.39 0.31, 0.74 – 2.62
Age at diagnosis		0.96 0.00, 0.94 – 0.98	0.96 0.07, 0.92 – 1.00
Duration in years	<5years	1	-
	≥5 years	1.19 0.38, 0.80 – 1.77
Diabetic Retinopathy	No	1	-
	Yes	1.24 0.35, 0.79 – 1.95
Diabetic neuropathy	No	1	1
	Yes	3.07 0.001, 1.54 – 6.12	2.50 0.02, 1.14 – 5.48
Diabetic nephropathy	No	1	1
	Yes	1.26 0.23, 0.86 – 1.83	1.28 0.25, 0.84 – 1.95
Hypertension	No	1	1
	Yes	0.76 0.15, 0.52 – 1.11	0.75 0.19, 0.48 – 1.16
Medications	Oral	1	1
	Injectable (Insulin)	1.56 0.09, 0.93 – 2.61	1.00 0.99, 0.54 – 1.86
Depression	No	1	1
	Yes	4.26 0.00, 2.62 – 6.93	3.57 <0.001, 2.13 – 5.97

Supplementary Table 2.

Association of select variables with regimen related burden of diabetes distress score

Variable		Unadjusted OR P, 95% CI	Adjusted OR P, 95% CI
Age		0.97 0.00, 0.95 – 0.99	1.00 0.84, 0.97 – 1.04
Gender	Male	1	1
	Female	1.69 0.00, 1.15 – 2.48	1.37 0.16, 0.88 – 2.13
Adherence	Yes	1	1
	No	1.66 0.01, 1.10 – 2.48	1.53 0.06, 0.98 – 2.4
BMI	Underweight	1	-
	Normal	0.43 0.17, 0.13 – 1.42
	Overweight	0.51 0.27, 0.16 – 1.67
	Obese	0.73 0.61, 0.22 – 2.46
Status of diabetes	Controlled	1	1
	Uncontrolled	1.60 0.1, 0.91 – 2.81	1.24 0.48, 0.67 – 2.32
Lipid profile	Controlled	1	-
	Uncontrolled	0.70 0.13, 0.44 – 1.16	0.61 0.07, 0.36 – 1.03
Late onset diabetes	No	1	1
	Yes	0.64 0.03, 0.43 – 0.96	0.86 0.65, 0.45 – 1.64
Age at diagnosis		0.96 0.00, 0.94 – 0.98	0.98 0.33, 0.93 – 1.02
Duration in years	<5years	1	-
	≥5 years	1.09 0.68, 0.73 – 1.62
Diabetic Retinopathy	No	1	1
	Yes	1.37 0.17, 0.87 – 2.15	1.40 0.21, 0.83 – 2.35
Diabetic neuropathy	No	1	1
	Yes	2.40 0.00, 1.27 – 4.53	2.00 0.07, 0.95 – 4.21
Diabetic nephropathy	No	1	1
	Yes	1.49 0.04, 1.02 – 2.18	1.68 0.02, 1.09 – 2.60
Hypertension	No	1	1
	Yes	0.61 0.01, 0.41 – 0.88	0.54 <0.001, 0.34 – 0.85
Medications	Oral	1	1
	Injectable (Insulin)	1.19 0.50, 0.71 – 1.98	0.78 0.43, 0.42 – 1.46
Depression	No	1	1
	Yes	4.44 0.00, 2.79 – 7.09	4.27 <0.001, 2.58 – 7.10

Funding Statement

Nil.