Diabetes, a serious long-term condition, is considered one of the great global health challenges of the twenty-first century. An estimated 463 million people had diabetes in 2019, and this is expected to reach 578 million by 2030 and 700 million by 2045. The countries with the highest number of adults with diabetes include China, India, and the USA. Those living with diabetes are predisposed to complications such as retinopathy, neuropathy, cardiovascular disease, and diabetic foot disease. Moreover, psychological complications such as anxiety and depression are also common and impact psychosocial life and everyday functioning, contributing to poor quality of life [QoL]. The American Diabetes Association has classified diabetes into the following categories: 1. type 1 diabetes (T1D) “due to autoimmune beta cell destruction leading to absolute insulin deficiency” 2. type 2 diabetes (T2D) “due to progressive loss of beta-cell insulin secretion frequently on the background of insulin resistance” 3. Gestational diabetes mellitus (GDM) as “diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation” and 4. specific types of diabetes due to other causes (example- monogenic diabetes syndromes0). It is important to understand the impact of each of these types of diabetes on QoL in order to achieve the best outcomes for all patients.
Quality of life (QoL)/Health-Related Quality of Life (HRQoL) and diabetes
The World Health Organisation (WHO) has defined QoL as “an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” QoL is considered an important health outcome, with good quality of life representing the ultimate therapeutic goal in chronic conditions. The term was first used in medical literature in the 1960s and since then has gained considerable popularity in research and clinical practice. QoL includes four main components namely physical, psychological, social relationship, and environment.
The term, “Health-Related Quality of Life (HRQoL)” is an inclusive term and is defined as the “physical, psychological and social domains of health, seen as distinct areas that are influenced by a person's experiences, beliefs, expectations, and perceptions.” In the current literature, QoL and HRQoL are used interchangeably although each has its own meaning. In some definitions, HRQoL reflects health status, whereas in others it goes beyond health and encompasses concepts more consistent with QoL such as the environment. QoL is a broader concept and covers all aspects of life, including education and social environment which reach beyond health. HRQoL, on the other hand, is used to measure self-perceived health or disease status and to understand the distinction between aspects of life related to health.
QoL is decreased in patients with diabetes and becomes even worse when complications develop, or comorbidities exist. Diabetes can negatively affect physical well-being in four major ways: 1) by leading to the development of long-term complications, 2) by being associated with short-term complications, 3) through the demands imposed by various treatment regimens, and 4) by affecting psychological functioning via its impact on mood. For instance, persistent fatigue and tiredness can occur due to elevated blood glucose levels. Conversely, hypoglycemia (low glucose levels) symptoms can also be exhausting and discouraging. Thus, both hypo- and hyperglycemia may affect the patient's overall sense of well-being. Lastly, social wellbeing is also compromised as diabetes can affect the patient's social relationships.
The significant determinants shown to affect QoL among patients with diabetes include the type of diabetes, its duration, glycemic control, gender, complications, treatment regimen, and psychosocial factors.
Tools used to measure QoL/HRQoL in patients with diabetes
Both generic and diabetes-specific instruments are widely used to measure the various domains of QoL. Overall, health and comorbidities are measured by generic tools, whereas diabetes-specific tools address diabetes-related aspects and the burden and impact of diabetes on an individual's lifestyle. The most popular instrument used to measure general QoL is the WHO Quality of Life (WHOQoL) questionnaire. Among the diabetes-specific tools, the Diabetes Quality of Life (DQOL) and Audit of Diabetes-Dependent Quality of Life (ADDQoL) are the most popular. In a recent scoping review, theme analysis of 30 diabetes-specific tools to measure QoL was undertaken and determined that tools often measured the impact of societal attitudes, public policies, and context on QoL in addition to mental, physical, and social health components.
Quality of life and diabetes in India
India is currently second in the world in diabetes prevalence, with an estimated 77 million people affected in 2019, and this number is expected to reach 101 million by 2030. The Indian Council of Medical Research (ICMR) - India DIABetes (ICMR-INDIAB) study has reported diabetes prevalence in 15 of the 31 states/union territories of India completed and published to date. The average prevalence was 7.3%; however, large differences in prevalence are observed between the states, indicating epidemiological transition.
The earliest studies on diabetes QoL in India were conducted among T1D patients in 2007 and among T2D patients in 2009. Since then, QoL assessment publications have increased however they are largely reported from tertiary care hospital settings and characterized by small sample sizes. Hence, the results of the studies cannot be generalized to the larger Indian population. In addition to the existing drawbacks as stated above, more QoL assessment tools are being developed, increasing the complexity of generalizing from multiple QoL tools. A recent article reported a scarcity of QoL studies among diabetic patients in India as a major limitation of the current literature.
Hence, better recognition of the importance of the QoL construct in managing chronic conditions is important and a review of QoL studies, timely. Therefore, this scoping review aims to explore the current state of knowledge on QoL in people with diabetes in India. This paper also attempts to study the various factors associated with QoL in those with diabetes in India.
This scoping review was based on the five stages outlined in the Arksey and O’Malley Framework and guidelines from the Joanna Briggs Institute. The Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR) were used. Registration on the International Prospective Register of Systematic Reviews (PROSPERO) was not possible as scoping reviews had not been accepted at the time of the review.
Stage 1: Identifying the research questions
- What are the various measurement tools used to measure QoL/HRQoL status among patients with diabetes in India?
- What are the various factors reported to be associated with quality of life and diabetes in India?
Stage 2: Identifying the relevant studies
The scoping review included all original studies published in English on QoL assessment and diabetes in India. The review included all types of diabetes including T1D, T2D, gestational diabetes, and other forms of diabetes. Grey literature including conference proceedings, dissertation, and thesis reports was included. The inclusion criteria contained “observational studies” and were not restricted to any type of diabetes and included adults and children. The exclusion criteria included “intervention studies” and “nondiabetic patients.” The keywords searched consisted of “Diabetes” AND “Quality of life OR health related quality of life” AND “India.” The search terms were intentionally kept broad and sensitive enough to include all relevant studies in the review. The search strategy used in PubMed is found in Table 1.
The databases used for the review included PubMed, Scopus, and Medline and were searched between April and July 2020. The results were then imported to Covidence systematic review software, (Veritas Health Innovation, Melbourne, Australia; available at www.covidence.org), a web-based platform, which helps to streamline the collection of articles. The references of identified publications were screened for any additional relevant papers.
Stage 3: Study selection
Two independent investigators were involved in the study selection process. AR ran the searches in the individual databases and screened the titles in Covidence. The full-text review was conducted independently by AR and PR and, in case of disagreement, a third reviewer (VM) was consulted as a subject expert.
Stage 4: Charting the data
A template for data extraction is presented in Table 2.
Stage 5: Collating, summarizing, and reporting the results
A PRISMA diagram showing the screening results is shown in Figure 1.
Overall, 497 studies were imported for screening, of which 43 duplicate references were removed. A title/abstract screening of the remaining 454 articles was done, and 398 studies considered were removed due to nonrelevance of the subject to the objective of the review. After a full-text review of 56 articles, 15 studies were excluded due to having the wrong outcomes/settings and finally, 41 studies were included in the scoping review. A summary of the reviewed articles is in Appendix 1.
Of the 41 selected studies, one study was conducted in a community setting, one study was conducted at primary health care center setting, and another at secondary care facility, with the 38 remaining studies conducted in tertiary health care facilities. The public health care system in India is a three-tier structure comprising primary, secondary, and tertiary levels. Primary health care centers are involved in providing primary care, whereas district hospitals and sub-divisional hospitals provide secondary care. Tertiary health care is delivered by medical college hospitals. The identified studies largely come from the southern part of India (19 studies) with thirteen studies reported from the state of Karnataka.
Most of the QoL assessment studies (39 studies) among diabetes patients in India have been published within the last decade. Overall, there were 31 studies that included T2D patients, four studies on T1D patients, one study on GDM, whereas five studies did not report their diabetes classification. The reviewed studies tended to have small sample sizes with sample size justification provided in only nine studies. While four studies mentioned the use of convenience sampling, 28 studies did not mention their sample design.
Five case-control studies where diabetes respondents were compared with nondiabetes patients were identified, whereas the remainder of studies were cross-sectional.
Quality of life and type of diabetes
There were 29 studies with QoL assessment in T2D cohorts. Four studies reported QoL assessment among T1D patients. A single study reported QoL assessment among mothers with gestational diabetes mellitus. Seven studies have conducted QoL assessment among both T1D and T2D patients with diabetes.
Only a few studies reported the mean QoL scores among T2D patients, and the scores varied drastically among different QoL assessment tools as seen in Appendix 1. The minimum score of 38.40 was reported from using the SF-36 tool, and the maximum score of 86.83 was reported by QOLID. Four studies reported scores that varied between 54.8 and 57.8.
Among the T1D patients, the mean DAWN QoL scores reported were 35 and 29.3 which indicated a moderate QoL. The higher DAWN scoring indicates a greater impact on QoL.
Quality of life and gender
Of the reviewed studies, only 14 reported gender and QoL. Poorer QoL in women than men were reported in nine studies on T2D and in one study on T1D. It is of interest that three studies had reported better QoL among female respondents with diabetes when compared to their male counterparts.
Poor sleep quality was frequently reported among females as compared to men with T2D, which had detrimental effects on the HRQoL assessment.
Quality of life and duration of diabetes
Of the 41 reviewed studies, seven studies reported a longer duration of diabetes to be associated with poorer QoL among T2D patients. However, this factor was not reported in the T1D studies.
Quality of life and glycemic control
Not surprisingly, poor glycemic control was associated with impaired QoL in three studies among T2D patients. Similarly, poor glycemic control was associated with poor QoL among T1D children in one article.
Quality of life and diabetes-related complications
Of the 41 reviewed articles, four studies reported QoL assessment and diabetes-related complications. A cross-sectional study on QoL assessment among 382 T1D and T2D patients with different microvascular and macrovascular complications reported that diabetic complications were associated with reduced QoL. Neuropathy and nephropathy were associated with lower QoL as compared with other diabetic complications.
A case-control study (100 cases and 100 controls) among T2D patients from Delhi reported lower mean values of WHO-QoL for all the domains in patients with complications of diabetes (more specific for nephropathy and neuropathy) as compared with patients without diabetes complications.
Among the microvascular complications of diabetes, diabetic retinopathy (DR) and QoL assessment were reported in three studies. One study reported lower QoL among patients with diabetes with diabetic retinopathy (DR) as compared to those without. The study participants included T1D and T2D patients. The lowest QOL scores were obtained from subjects with proliferative diabetic retinopathy (PDR). The second was a cross-sectional study that reported poor QoL with proliferative diabetic retinopathy (PDR) as compared with nonproliferative DR (NPDR) in 250 T2D patients. The third, a prospective, observational study among 189 T2D patients reported a significant reduction in HRQoL with the severity of retinopathy.
Quality of life and treatment regimen
Better QoL was observed among patients receiving a single- or two-drug regimen as compared with patients receiving a combination regimen of oral hypoglycemic agents (metformin, glipizide, voglibose, repaglinide, sitagliptin, and vildaglitpin) and insulin in one study with T2D patients. Treatment satisfaction of patients receiving metformin alone or in combination with glipizide was better than that of the patients receiving oral hypoglycemic agents and/or insulin.
Quality of life and psychosocial factors
A study from Jaipur (n = 50) reported that more than half of patients with T2D noted impaired QoL. In another cross-sectional study, among 300 T2D participants from Delhi, poor sleep quality was reported and associated with poor QoL.
A case-control study showed that depression was significantly more prevalent among people with T2D than controls and was associated with poorer QoL.
A study among T2D patients with and without depression reported that in the presence of depression, QOL deteriorated.
Quality of life and comorbidities/metabolic syndrome
Of the 41 reviewed studies, only two assessed QoL among T2D patients with comorbidities or metabolic syndrome. A stroke had a high negative impact on the physical HRQoL. The presence of comorbidities affected the physical component summary (PCS) and the mental component summary (MCS) of the Short Form Health Survey-12. Subjects with visual impairment and stroke had significantly reduced quality of life. Among T2D diabetes patients with metabolic syndrome, a greater significant decline is observed in PCS and MCS as compared to those without metabolic syndrome.
Commonly used QoL measurement tools in Indian studies
The QoL assessment among T2D patients in India has been conducted using both generic and diabetes-specific instruments [Table 3]. Among the generic tools, the WHOQoL-BREF tool was employed in eleven studies and the SF-36 V2 questionnaire in nine studies. The diabetic-specific QOLID questionnaire tool was used in eight studies. Table 3 describes the commonly used QoL assessment tools used in India identified in the review.
The WHOQOL-BREF (10 studies) and SF 36 (eight studies) are the most commonly used generic instruments among T2D subjects in India. One study used both generic and diabetes-specific tools for QoL assessment and found that both instruments are equally effective and reliable in the evaluation of QoL among diabetes patients.
In recent years, the QOLID questionnaire has been increasingly used among Indian researchers. QOLID is specifically designed for an Indian population and has high internal consistency of 0.894 (identified using Cronbach's alpha) and discriminant validity which makes it popular among Indian researchers. Cronbach's alpha is provided as a measure of the internal consistency and expressed as a number between 0 and 1.
For QoL assessment among T1D patients, four different questionnaires were used [Table 3] including Diabetes Control and Complications Trial (DCCT) (modified for the Indian context), DAWN Youth QoL, Diabetes specific quality of life score (DSQoL). In a recent study, the QOLID questionnaire mainly designed for the Indian diabetic adult population was translated into Hindi and modified with minor changes for T1D children.
The present review is the first to our knowledge to collate articles related to QoL assessment in people living with diabetes in India. The review demonstrates that most evidence on QoL in India is available in individuals with T2D patients. The QoL assessment among T1D Indian children is scarce and needs to be investigated in future studies. In addition, there is little to no evidence of QoL in the Indian population for gestational diabetes mellitus (GDM) and monogenic forms of diabetes. As five million women have GDM in India and new cases of monogenic diabetes are continually being reported due to advances in the field of molecular genetics, QoL assessment needs to be urgently addressed in these subtypes of diabetes in order to be able to offer more support to these groups.
The largest number of studies (19 studies) were reported from southern states of India, many from teaching tertiary hospitals/institutions, especially from Karnataka as compared to other regions (North, East, West) of the country. One of the possible reasons could be that Karnataka has the largest number of teaching medical institutions in India. Notably, only a single study was reported from community settings. In the future, QoL assessment needs to be undertaken in large community settings with a proper sample size selection to understand the QoL status at the population level, which is currently missing. The presently available studies have small sample sizes, come from hospital settings, and have a short duration which makes it difficult to generalize the findings for a larger population.
During this review, it was observed that QoL is largely reported as being better among men as compared with women with diabetes, a consistent finding with studies conducted across the world. A study was done in a secondary care setting highlighted the need to improve the QoL among women with diabetes. Rubin et al. in their review paper stated that men with diabetes have an advantage over women in HRQoL and recommended control for gender in future studies, which would be relevant to the Indian settings as well.
Though many studies in recent years have used QOLID as a measurement tool, generic questionnaires such as WHOQOL-BREF and SF-36 V2 continue to be used in India. The WHOQOL-100 was initially developed with international consensus but more recently a short form WHOQOL-BREF, with validity and reliability similar to the longer measure, has become available. Many prefer to use the WHOQOL-BREF questionnaire as it is associated with a low time burden. Though not diabetes-specific, it is largely applicable to people with diabetes and has been validated in Indian languages including Hindi.
The SF-36 V2 questionnaire contains two components (Physical Component Summary and Mental Component Summary) and includes eight domains. The questionnaire is available in Indian languages – Hindi and Kannada. The Cronbach's alpha score for Hindi version is 0.70. Though this tool is popular among Indian researchers, the reviewed studies have not stated the reasons behind selecting the tool.
QOLID is a reliable and valid questionnaire developed for Indian patients with diabetes. It contains eight domains with 34 questions and takes 7 min to complete. The QOLID questionnaire is also now modified to measure QoL among Indian children. The questionnaire has high internal consistency, discriminant validity, and has an overall Cronbach's alpha value of 0.894. However, the tool is designed for middle- and higher-income groups, and the authors suggest that the tool should be redeveloped for wider socio-economic groups and for community settings. In the future, this questionnaire should be modified and validated for the Indian population across various socio-economic status levels. Socioeconomic status is defined as “a measure of an individual or family's economic and social position in relation to others, based on various variables for that like income, education, occupation, etc.”
Table 4 illustrates the various domains of the commonly used questionnaire for QoL assessment.
Newer questionnaires have also been developed to measure QoL, including MDQoL-17 which was developed and validated in 2010 and is available in local languages. Another QoL assessment questionnaire was developed only for diabetic foot ulcer patients. Though it is encouraging to have newer tools for QoL assessment available, these should be properly validated before entering common use. For example, one review paper identified Short Form -12 and Appraisal of Diabetes Scale as ideal and feasible tools for QoL assessment in busy clinical settings.
The following section recommends several factors to be considered for the selection of QoL assessment tools in future research.
Guidelines to select the right tool for QoL assessment
With new tools being developed for Indian settings, care should be taken to select the right tool for assessment. One of the best ways to avoid the unnecessary development of new instruments is to select an existing and validated measure. It is important to understand the various domains, the questionnaire will measure. It is also important to analyze the previous validation of the questionnaire and report psychometric properties. Cronbach's alpha is the most widely used objective measure of internal reliability and the acceptable value ranges from 0.70 to 0.95. The WHOQOL-BREF, Appraisal of Diabetes Scale and QOLID have Cronbach's values of 0.78, 0.80, and 0.89, respectively, showing that they are all reliable tools.
It is also important to understand the purpose of the specific tool. Was it developed for clinical, research, or community settings? Is it patient-centered, treatment-centered, or diet-centered? The questionnaire should be made culturally appropriate to include patients’ needs and perspectives. It is crucial to consider the length of the questionnaire in order to avoid “questionnaire fatigue.” It has been suggested to keep shorter questionnaires for clinical screening and longer measures for researchers to gain further insights into the assessment of QoL.
In addition, a few questions can be considered while selecting an ideal QoL measure as suggested by Speight et al. They include the hypothesis and objective of the study, examination of the instrument and with each item and its response options, in case of generic measures are any relevant issues missed, response acceptance by the respondents, previous validation of the questionnaire in the given population/country/language, and analysis of data. If the clinician and researchers are not confident in such analysis, they can collaborate in a multidisciplinary team with a social scientist experienced in the development, use, and interpretation of measures in diabetes.
Limitations of the study
This study has some limitations. The quality of the reported studies is largely poor, with low homogeneity, and hence it was not possible to combine them into a meta-anlysis. Except for a few studies, most lacked a robust study methodology, many have not followed a scientific approach to sampling, relying on convenience sampling. Similarly, very few studies have mentioned the rationale as to why a particular QoL assessment questionnaire was preferred. In addition, several studies have not reported a thorough data analysis and interpretation.
Therefore, it is recommended that future research on QoL assessment in India should aim for better-designed studies with greater scientific rigor. Such studies would help in a better understanding of QoL and diabetes in India.
With the increased prevalence of diabetes in India and around the world, it is becoming even more important to assess the QoL as an outcome measure in long-term illness and management. The review is the first of its kind from India to review the various QoL assessment tools used. The current review showcased that poorer QoL was observed in people with diabetes as compared to those without diabetes. However, the reviewed studies were largely focused on T2D patients, with significant methodological issues, and small samples limiting their validity and generalizability. There is an urgent need to conduct extensive and high-quality QoL assessment studies with sample sizes representative of various groups and types of diabetes in India to address this gap in the evidence.
National recommendations are available in India for psychosocial management of diabetes, which provide practical guidelines to achieve qualitative improvement in diabetes management. Similarly, a consensus statement has been issued to address the psychosocial challenges and management for South Asian women with diabetes. However, as highlighted in this review, extensive research in this area is still required. Following this, further research on these guidelines should be updated to improve the psychosocial aspects of patients with diabetes in India.
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Conflicts of interest
There are no conflicts of interest.
Footnotes: Sample size-n; QoL- Quality of Life; S. D- Standard Deviation; QOLID- Quality of Life Instrument for Indian Diabetic Patients; DR- Diabetic Retinopathy;
aWHOQOL-BREF- is a 26-item brief questionnaire over four major domains namely physical, psychological, social relationships, and environment. The responses of the WHOQOL-BREF are scored in a Likert scale fashion from 1 to 5. The total raw scores for these five dimensions will be transformed into 0 and 100 and then the analysis of the transformed score to be done with low score indicating poor QoL.
bHealth-related quality of life-EQ-5D or European Quality of Life- 5 Dimensions questionnaire consists of two parts- the first part is a health status categorized into five dimensions- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which scores from 0 (no problem) to 1 (extreme problems). The response to the first part is converted into an EQ-5D profile or EQ-5D index which ranges from -0.111 to 1, where 1 represents preferred health. The second part is a visual analog scale (VAS) to determine the overall health status and contains 20 cm scale to measure the patient's perception of quality of life on the day of the interview. The scale ranges from 0 to 100, 0 represents worst health, while 100 represents the best health.
cQOLID- developed in India consists of 34 items with eight domains on general health, role limitations due to physical health, symptom frequency, physical endurance, treatment satisfaction, financial worries, diet advice satisfaction, and mental health. The items were scored from 1 to 5, the maximum possible score is 169 and the minimum 34. The quality of life is classified into good (125-169), moderate (79-124), and poor (34-78).
dDown Quality of Life for young- is a 22-item validated questionnaire in six domains namely impact of symptoms related to diabetes, the impact of the treatment, impact on activities, parents’ issues, worry about the future, and perception of one's own health. Administered to subjects 10-18 years which each question having five possible responses ranging from ‘0’ (never) to ‘4’ (all the time) and the responses are added to get the total score for the subscale. Higher scores indicate a greater adverse impact on QoL
eSF-12 Short Form Health Survey 12 (SF-12) is a shorter version of the 36-item SF-36.
fSF-36 V2- It consists of 36 items covering eight domains: physical functioning (PF), role limitations caused by physical health problems (RP), bodily pain (BP), perception of general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional health problems (RE) and mental health (MH). The eight domains may be further grouped into two summary measures of the physical component summary (PCS) and the mental component summary (MCS). These aggregated scores are converted into norm-based scores (mean, 50; SD, 10), and higher scores indicate a more favorable physical functioning and psychological well-being.
gADDQoL-ADDQoL questionnaire is a third-generation individualized QoL instrument and contains 19 item domains. It evaluates the general QoL as well as the diabetes-dependent QoL. ADDQoL starts with two overview items assessing the patient's present global QoL (range + 3–−3) and the impact of diabetes on the QoL (range − 3–+3). For both items, lower scores indicate a poorer QoL. In the subsequent items, the respondent rates the impact of diabetes (range − 3 to + 3) and the importance of QoL (range 3–0) on 19 item domains.
hNational Eye Institute 25- Item Visual Function Questionnaire (NEI-VFQ-25)- The NEI-VFQ-25 consists of questions related to general health and vision, difficulties with activities and response to vision problems. To calculate an overall composite score for the VFQ-25, simply average the vision-targeted subscale scores, excluding the general health rating question. By averaging the sub-scale scores rather than the individual items, we have given equal weight to each sub-scale, whereas averaging the items would give more weight to scales with more items.
iModified Diabetes Quality of Life (MDQoL)-17- It consists of 17 questions that comprise seven domains, which include physical functioning, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All the contents are scored so that a high score depicts a more favorable health state. The possible scores are 0-100, 0 being the minimum and 100 being the maximum score. Scores represent the percentage of the total possible score achieved.
jAppraisal of Diabetes Scale (ADS)- is a seven-item diabetes-specific scale that attempts to assess patients’ feelings and attitudes about diabetes. It consists of items covering distress caused by diabetes, control over diabetes (two items), uncertainty due to diabetes, anticipated future deterioration, coping, and effect of diabetes on life goals. Each question in this scale uses Likert scale with five possible answers (1 - not at all, 2 - slight, 3 - moderate, 4 - very, and 5 - extremely). The total score can range from 0 (best level of health) to 35 (worst level of health). Thus, a lower score on the ADS scale suggests better QOL.
kQuality of Life Enjoyment and Satisfaction Questionnaire (Q-LES) SF- The raw scores on QLESQ-SF were converted to percentage maximum scores (QLESPER).
lDCCT- Diabetes Control and Complications Trial (DCCT) questionnaire, after deleting questions found irrelevant in Indian context and those pertaining only to type 1 diabetic subjects were used.