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Objective To investigate the incidence of genital infection due to the use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in patients with type 2 diabetes mellitus (T2DM) concomitant coronary artery diseases (CAD). Methods A single-center, physician-initiated study was conducted at a tertiary-care center in India. The study enrolled patients with T2DM who were taking SGLT-2 inhibitors for at least two months and divided them into two groups: patients with concomitant CAD as the case group and without CAD as the control group. Demographic data and medical history of patients were documented using a standard questionnaire. Itching and swelling were the signs used for the diagnosis of genital infection. Results A total of 270 consecutive patients with T2DM were enrolled and divided into two groups: 48 patients with CAD as the case group and 222 patients without CAD as the control group. The mean age of patients with CAD was 63.27±7.53 years and without CAD was 58.32±14.89 years. The mean HbA1C levels were 8.40±1.71% in the case group and 8.60±7.20% in the control group. A total of 14.6% of patients with CAD and 12.6% of patients without CAD were found to have genital infections (p=0.712). SGLT-2 inhibitors were stopped in only six patients who had genital infections and all the patients were managed using anti-fungal cream and via maintenance of proper hygiene. The overall incidence of genital infection was about 12.96%, of which only 2.7% required discontinuation of this crucial therapy. Conclusion In conclusion, the incidence of genital infection with the use of SGLT-2 inhibitors is similar among patients with T2DM with concomitant CAD and without CAD. The measures to prevent genital infection should be strongly emphasized. However, larger, well-designed studies are required to validate the current findings.

Background We assessed the humoral immune response of both ChAdOx1-nCOV (CovishieldTM) and BBV-152 (CovaxinTM) vaccines in Indian health care workers (HCW). Methods A Pan-India, Cross-sectional, Coronavirus Vaccine-induced Antibody Titre (COVAT) study was conducted that measured SARS-CoV-2 anti-spike binding antibody quantitatively, 21 days or more after the first and second dose of two vaccines in both severe acute respiratory syndrome (SARS-CoV-2) naive and recovered HCW. Primary aim was to analyze antibody response (seropositivity rate, Geometric Mean Titre [GMT] and 95% Confidence Interval [CI]) following each dose of both vaccines and its correlation to age, sex, blood group, body mass index (BMI) and comorbidities. Here we report the results of anti-spike antibody response after first and two completed doses. Results Among the 515 HCW (305 Male, 210 Female) who took two doses of both vaccines, 95.0% showed seropositivity to anti-spike antibody. However, both seropositivity rate and GMT (95% CI) of anti-spike antibody was significantly higher in Covishield vs. Covaxin recipients (98.1 vs. 80.0%; 129.3 vs. 48.3 AU/mL; both p 60-years, males, people with any comorbidities, and history of hypertension (HTN) had a significantly less anti-spike antibody GMT compared to age ≤ 60 years, females, no comorbidities and no HTN respectively, after the completion of two doses of either vaccine. Gender, presence of comorbidities, and vaccine type were independent predictors of antibody seropositivity rate and anti-spike antibody titre levels in multiple logistic and log transformed linear regression analysis. Both vaccine recipients had similar solicited mild to moderate adverse events and none had severe or unsolicited side effects. Conclusions Both vaccines elicited good immune response after two doses, although seropositivity rates and GMT of anti-spike antibody titre was significantly higher in Covishield compared to Covaxin recipients.

Background: The available evidence was systematically reviewed to evaluate the effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors (SGLT2i) on cardiovascular (CV) and renal outcomes in people with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors (MRF), with or without heart failure (HF), and per estimated glomerular filtration rate (eGFR) rate at baseline. Methods: We comprehensively searched three electronic databases to retrieve publications up to 30th November 2019, which were screened for inclusion. The data extracted for the outcomes according to baseline ASCVD, HF, and eGFR levels were meta-analyzed using fixed effects model. Results: Of the 735 screened citations, 15 primary and secondary publications from five CV or renal outcome trials were included. SGLT2is reduced the risk of CV death or hospitalization for HF (HHF), HHF alone, and composite renal-specific outcome, irrespective of ASCVD and HF at baseline. The three-point major adverse cardiovascular events (3P-MACE) risk was reduced by 14% (p

Background: Globally, 425 million individuals were living with diabetes in 2017, and the numbers are expected to rise to 693 million by 2045. India, with more than 72 million people with type 2 diabetes mellitus (T2DM) in 2017, was reported to have the second largest population of individuals living with T2DM (https://www.diabetesatlas.org/upload/resources/previous/files/8/IDF_DA_8e-EN-final.pdf). The traditional Indian diet is heavily dependent on carbohydrates, and this acts as an obstacle for diabetes control. Carbohydrate restriction is associated with improvements in glycemic control and a reduction in the risk of the worsening of the disease and its complications. Objective: We investigate the real-world effectiveness of personalized carbohydrate reduction by using seed-based flour (sunflower seeds, pumpkin seeds, watermelon seeds, soya, and flaxseeds) with high-carbohydrate grain-based flour in the food along with remote health coach support for patients on the high glycated hemoglobin (HbA1c) levels and weight loss of patients. Materials and Methods: This study is a nonrandomized outpatient intervention focusing on adults with T2DM. With their consent, patients were enrolled from four clinics across Gujarat, Ahmedabad. The key inclusion criteria focused on patients with Hba1c between 7 and 10 with a body mass index more than 25 kg/m2 from 21 to 60 years of age. The key exclusion criteria were patients with advanced renal, cardiac, or liver dysfunction, pregnancy or planned pregnancy, historical ketoacidosis problems, and patients on SGLT2 inhibitors or pre-mix insulin. The intervention was personalized carbohydrate restriction. Patients were advised to avoid high-carbohydrate food categories such as grains, sugars, and high-carbohydrate fruits. They were advised to take seeds and nuts-based flour, nonstarchy vegetables, sprouts, and berries family fruits. Patients were also provided with recipes and options for all meals of the day. No restriction was made on the intake on nonstarchy vegetables. Patients were also provided with Diahappy Health’s Health coach to constantly provide remote support to resolve queries and doubts through phones. Duration of Study: For each participant, the study was carried out for 12 weeks at a stretch. Benefits: The study demonstrates an average 2.34% drop in HbA1c levels in participants who completed the program. There was also an average weight drop of 9 kg achieved in the participants.

Although insulin delivery devices are widely used by the patients, there is a paucity of published guidelines to help professionals manage their patients in insulin therapies. To provide simple and easily implementable guidelines to health care physicians on the choice of insulin delivery devices in routine clinical practice, experts in diabetes gathered together and discussed the recommendations at the National insulin Summit 2018. An ideal insulin delivery device should accurately deliver the prescribed dose of insulin and be easy to use. Recommendations are: (1) insulin should be initiated by using an insulin device if the patient seems to discontinue insulin therapy. (2) Pen devices offer accurate dosing than a syringe and vial and are associated with cost savings in the long term. (3) Switching over from syringes and vial to disposable pen devices improves adherence. (4) FlexPen

Diabetes Mellitus is the silent killer of the 21st century affecting 425 million people all over the world. The situation is worse in south east Asia particularly India where the prevalence is increasing at a rapid pace. The overall prevalence of diabetes in all 15 states of India was 7.3%. Coronary artery disease (CAD) contributes the highest in morbidity, mortality and financial burden of diabetes. Observational studies and RCTs report the prevalence of silent myocardial ischaemia in asymptomatic DM as 22%. There are many ways to estimate cardiovascular risk in asymptomatic diabetes people like clinical risk score, various biomarkers and other modalities like exercise stress test, echocardiography, Ankle Brachial Index (ABI), Carotid Intima Media Thickness (CIMT), Coronary Artery Calcium Score (CAC), CT angiography, Cardiac MRI, Nuclear Imaging etc. In this article we tried to review various modalities and their usefulness in screening asymptomatic ASCVD. Out of all available modalities CAC score is found to be very cost effectiveness and sensitive way to predict ASCVD. Still CAC is an underutilized modality to screen asymptomatic ASCVD in diabetes people.

Aim/HypothesisFive subgroups were described in European diabetes patients using a data driven machine learning approach on commonly measured variables. We aimed to test the applicability of this phenotyping in Indian young-onset type 2 diabetes patients.MethodsWe applied the European derived centroids to the Indian type 2 diabetes patients diagnosed before 45 years of age from the WellGen (n = 1612) cohort. We also applied de novo k-means clustering to the WellGen cohort to validate the subgroups. We then compared clinical and metabolic-endocrine characteristics and the complication rates between the subgroups. We also compared characteristics of the WellGen subgroups with those of two young European cohorts ANDIS (n= 962) and DIREVA (n=420). Subgroups were also assessed in two other Indian cohorts, Ahmedabad (n = 187) and PHENOEINDY-2 (n = 205).ResultsBoth Indian and European young type 2 diabetes patients were predominantly classified into severely insulin-deficient (SIDD) and mild obesity-related (MOD) subgroups, while the severely insulin-resistant (SIRD) and mild age-related (MARD) subgroups were rare. In WellGen, SIDD (53%) was more common than MOD (38%), contrary to figures in Europeans (Swedish: 26% vs 68%, Finnish: 24% vs 71% respectively). A higher proportion of SIDD compared to MOD was also seen in Ahmedabad (57% vs 33%) and in PHENOEINDY-2 (67% vs 23%). Both in Indians and Europeans, the SIDD subgroup was characterized by insulin deficiency and hyperglycemia, MOD by obesity, SIRD by severe insulin resistance and MARD by mild metabolic-endocrine disturbances. In WellGen, nephropathy and retinopathy were more prevalent in SIDD compared to MOD while the latter had higher prevalence of neuropathy.Conclusions /InterpretationOur data identified insulin deficiency as the major driver of type 2 diabetes in young Indians, unlike in young European patients in whom obesity and insulin resistance predominate. Our results provide useful clues to pathophysiological mechanisms and susceptibility to complications in young Indian type 2 diabetes, and suggest a need to review management strategies.

BackgroundTwo vaccines are currently being administered in India to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed the humoral immune response after the first dose of two vaccines ChAdOx1-nCOV (Covishield™) and BBV-152 (Covaxin™) in Indian health care workers (HCW).MethodsThis ongoing, Pan-India, Cross-sectional, Coronavirus Vaccine-induced Antibody Titre (COVAT) study is being conducted amongst HCW, with or without past history of SARS-CoV-2 infection. SARS-CoV-2 anti-spike binding antibody is being assessed quantitatively at four timepoints between 21 days or more after the first dose to 6 months after the second dose. Primary aim is to analyze antibody response following each dose of both vaccines and its correlation to age, sex, body mass index (BMI) and comorbidities. Here we report the preliminary results of anti-spike antibody response after the first dose.ResultsAmongst the 552 HCW (325 Male, 227 Female), 456 and 96 received first dose of Covishield and Covaxin respectively. Overall, 79.3% showed seropositivity after the first dose. Responder rate and median (IQR) rise in anti-spike antibody was significantly higher in Covishield vs. Covaxin recipient (86.8 vs. 43.8%; 61.5 vs. 6 AU/ml; both pConclusionsWhile both vaccines elicited immune response, seropositivity rates to anti-spike antibody were significantly higher in Covishield recipient compared to Covaxin after the first dose. Ongoing COVAT study will further enlighten the immune response between two vaccines after the second dose.HighlightsThis study evaluated the humoral antibody response of two SARS-CoV-2 vaccines Covishield™ and Covaxin™ in Indian health-care workers.Both vaccines showed seropositivity to anti-spike antibody, 21 days or more after the first dose.Responder rates were higher in Covishield recipient compared to Covaxin in propensity-matched cohorts.Past SARS-CoV-2 infection, presence of comorbidities and vaccine type received were independent predictors of antibody response after the first dose.

Objective: To assess the real-world management practices of subjects with type 2 diabetes mellitus (T2DM) and type 1 diabetes mellitus (T1DM) in India. Methods: This cross-sectional study was conducted between 7 March 2016 and 15 May 2016 in India as part of the seventh wave (2016) of the International Diabetes Management Practices Study (IDMPS). Adult subjects with T1DM or T2DM visiting physicians during a 2-week recruitment period were included. Results: A total of 55 physicians included 539 subjects who met eligibility criteria. Of 495 subjects with T2DM, 303 were treated with oral glucose lowering drugs (OGLDs) only, 158 were treated with OGLD + insulin, and 27 received insulin only. Among 44 subjects with T1DM receiving insulin, 13 (29.5%) were also treated with OGLD therapy. The most commonly used insulin regimens were basal alone (69/184; 37.5%) and premixed alone (63/184; 34.2%) in subjects with T2DM, and basal + prandial insulin (24/44; 54.5%) in subjects with T1DM. Proportions of subjects achieving glycemic targets were low [glycated haemoglobin (HbA1c) Conclusion: Timely insulinization, education and empowerment of people with diabetes may help improve glycemic control in India.

The family is the basic social unit and should be taken as the basic unit of engagement and intervention in diabetes care as well. Family members not only contribute to diabetes care and support but are also prone to all effects arising from this. Shared genetic and environmental factors lead to a higher prevalence of diabetes in family members, and open a window of opportunity for diabetes prevention as well. The Ahmedabad Declaration of 2018, titled “The Family and Diabetes” has been released during the Annual Conference of the Research Society for Study of Diabetes India (RSSDI). It supports the theme of World Diabetes Day 2018–2019 and lends its voice towards strengthening the family in our quest for optimal diabetes control.

Background and aims Mucormycosis is an invasive fungal infection and carries a significant morbidity and mortality. A number of cases of mucormycosis have been reported in association with COVID-19. In this study, a consortium of clinicians from various parts of India studied clinical profile of COVID-19 associated mucormycosis (CAM) and this analysis is presented here. Methods Investigators from multiple sites in India were involved in this study. Clinical details included the treatment and severity of COVID-19, associated morbidities, as well as the diagnosis, treatment and prognosis of mucormycosis. These data were collected using google spreadsheet at one centre. Descriptive analysis was done. Results There were 115 patients with CAM. Importantly, all patients had received corticosteroids. Diabetes was present in 85.2% of patients and 13.9% of patients had newly detected diabetes. The most common site of involvement was rhino-orbital. Mortality occurred in 25 (21.7%) patients. On logistic regression analysis, CT scan-based score for severity of lung involvement was associated with mortality. Conclusion Universal administration of corticosteroids in our patients is notable. A large majority of patients had diabetes, while mortality was seen in ∼1/5th of patients, lower as compared to recently published data.

In 2015, India had an estimated 69.2 million people with diabetes and a national prevalence of 8.7%. Evidence is mounting for the benefits of telemedicine in diabetes care, but remains limited on mobile-health (m-Health) interventions.This study assessed the impact of an m-Health diabetes platform on clinical outcomes, patient-reported outcomes, patient and provider satisfaction, and app usage.This open-label, two-arm parallel study enrolled 91 people at 3 sites in India, aged 18-65, with type 2 diabetes, and an A1c between 7.5% and 12.5% (58-113 mmol/mol). Participants were randomly assigned 1:1 to m-Health or usual care and observed for 6 months. All received free visits, laboratory tests, transportation fees, and strips and lancets. Intervention participants received the m-Health app and a mobile phone data stipend.A1c change was previously reported as statistically significant. Significantly more participants in intervention than control had improved medication adherence (39.0% vs. 12.8%; p = 0.03) and increased frequency of blood glucose (BG) self-testing (39.0% vs. 10.3%; p = 0.01) at 6 months from baseline. No other outcomes were significantly different. Among m-Health users, 75% of participants actively used the app at week 24. Participants entered 29,668 medications and 2,575 BG readings, sent 497 messages, and received 890 messages. Most participants (80%) were satisfied with all aspects of the app and all seven providers rated the software very acceptable.Participants assigned to m-Health had increased medication adherence and frequency of BG testing compared with usual care participants.This tool could be an effective way to expand access to quality chronic disease care and improve outcomes.

This study evaluated the adherence and swallowing experience with novel oval-shaped, compact-sized metformin (500 mg/1000 mg)-glimepiride (1mg/2mg) combination, sustained-release tablet (Gluformin G1/Gluformin G2 SR; GM-new-SR) in Indian patients with T2DM, previously treated with conventional metformin-glimepiride combination tablet.Patients' adherence, swallowing experience, and satisfaction were assessed at baseline and month-3 by Adherence to Refills and Medication Scale (ARMS12; adherent: ARMS12 score=12; nonadherent: ARMS12 score12) and questionnaire based 5-point Likert scale, respectively. Safety was also assessed.Of 1550 patients enrolled, 1547 (99.8%) completed the study. After 3 months of switching to GM-new-SR tablets, adherence rate increased from 4.38% to 91.1%, with concurrent reduction in mean ARMS-12 score by 6.3±4.36 (p0.0001). Compared to baseline, all glycemic indices, HbA1c, PPG, and FPG, significantly improved (p0.0001) in the overall population. Reduction in HbA1c levels was significant only in patients who were adherent to therapy as opposed to nonadherent patients (7.8±1.74 to 7.1±0.85, p0.0001 vs. 7.7±1.39 to 6.7±0.77, p=0.4276). Most patients attributed ease of swallowing of GM-new-SR tablets to its modified shape (95.5%) and size (94.9%). Most patients (90.4%) were satisfied with the new tablet formulation. Size of the tablet was the most common reason for patients' nonadherence with conventional tablets, which was reported to be less frequent with GM-new-SR tablets (2.5% vs 53.4%).Treatment with GM-new-SR tablets significantly increased adherence and was associated with improvement in glycemic indices, which could be attributed to the compact shape and size of the new tablet formulation.

Background and Aim: The cost of diabetes complication management is always much higher than the cost of diabetes treatment, even with novel and expensive molecules available. Thus, it is better to halt complications in the initial phase of the disease, rather than just treating hyperglycemia. Sodium-glucose co-transporter-2 inhibitor (SGLT-2i) is marking a new era in the management of type 2 diabetes mellitus (T2DM), showing significant benefits for mortality, hospitalization due to heart failure, and renal complications. The usage of SGLT2 inhibitors in clinical practice is still low. The aim of our study to know the prevalence and reasons for not prescribing SGLT-2i among Indian diabetologists. Materials and Methods: A cross-sectional survey was conducted in 10 states of India from 15 March to 31 July 2019. The primary question was asked to a doctor for the next 20 new patients at the clinic, “Was the patient initiated with SGLT-2i treatment?” If it was “Yes” the patient was excluded and if the marked option was “No” then the reason was selected for not prescribing the drug. Results: Out of 1132 patients, 687 (60.69%) patients were not prescribed SGLT2 inhibitors. Among them, the main reason for not prescribing SGLT-2i was cost (41.45%), followed by catabolic state (19.62%). Conclusion: It was found that cost is the major reason for not prescribing SGLT2 inhibitors. In spite of promising glycemic and extra glycemic benefits, it is the need of an hour to increase awareness and abetting physicians to prescribe SGLT-2 inhibitors in all appropriate patients at early stage of the disease to prevent the complications and its higher expenditure at the later stage of the disease.

As the epidemic of type 2 diabetes continues to grow, newer pathophysiologic mechanisms of diabetes are being unraveled in quick succession. From a simplistic model of insulin deficiency and insulin resistance, researchers have moved to a multipronged explanation of the disease. In addition to the ominous octet, eight other players, such as catecholamines, vitamin D deficiency, renin–angiotensin system, testosterone deficiency, melatonin, renal gluconeogenesis, intestinal sodium-glucose cotransporter 1, and gut microbiota, seem to participate in the etiopathogenesis of glucose intolerance and type 2 diabetes. Collectively, these 16 players comprise a cluster of interrelated etiologies implicated in the pathogenesis of diabetes, prompting the authors to address them as the “sweetening sixteen.” While exploring these factors, the authors wish to emphasize that diabetes treatment should focus on the reversal of these proposed pathogenetic defects and not simply reduction of hemoglobin A1C.

Aim: To evaluate and monitor quality of diabetes care in a single risk score format BLUE INDEX (BI). Design and Method: We assessed overall health of patients with T2DM based on 10 parameters - 3 goals (A1c, BP, lipids), 4 self-care parameters (diet, exercise, follow-up, habits), and 3 health parameters (general health, infection, hypoglycemia). We categorized each parameter into six grades and formulated BI with minimum score 0 and maximum 50. BI > 45 = excellent and > 40 is considered as favorable. BI < 35 = undesirable. We calculated BI for 100 patients with T2DM > 1 year and repeated it at 2nd visit (3 months) and 3rd visit (6 months). Patients were educated for importance of each parameter and their overall health score was discussed. At the end of 3rd visit improvement in each parameter was studied. Result: 100 patients with T2DM > 1 year were studied and divided into 3 groups as per BI. Group A= BI < 35, Group B = BI 35-45 and Group C = BI > 45. At baseline there were 76, 17 and 7 patients in Group A, B and C respectively with mean BI =26 ±2. After 3 month - 33, 44 and 23 patients in Group A, B and C respectively with mean BI = 37±3 and after 6 months there were 21, 41 and 38 patients in Group A, B and C respectively with mean BI = 42±2. There was 61% improvement in BI over the 6 months. Conclusion: The BI provides comprehensive, pragmatic and patient centered mean of assessing care in persons with diabetes. The main role is in clinical triage, helping identify high risk persons who need intensive clinical intervention. Disclosure D. Panchal: None. S. Phatak: None. P. Zinzuwadia: None. B.D. Saboo: None. D. Hasnani: None. S. Kalra: None. A.K. Das: None. S. Dwivedi: None.

Aims/Introduction Biosimilar insulin can reduce treatment costs, although the extent of its use is largely unknown. We examined biosimilar insulin use and its associations with the quality of glycemic control using the Joint Asia Diabetes Evaluation register. Materials and Methods We carried out a cross‐sectional analysis in 81,531 patients with type 1 and type 2 diabetes enrolled into the Joint Asia Diabetes Evaluation Program from 2007 to 2014. All insulin related terms are extracted from the Joint Asia Diabetes Evaluation portal, and compared clinical profiles between biosimilar and originator insulin users. Multivariate analysis was performed to assess the association of biosimilar insulin compared with originator insulin with dosage, glycated hemoglobin and hypoglycemia events. Results Amongst 81,531 patients, 20.5% (n = 16,738) were insulin‐treated. In four countries with high use of biosimilar insulin, 4.7% (n = 719) of insulin users (n = 10,197) were treated with biosimilar insulin (India n = 507, 70.3%; the Philippines n = 90, 12.5%; China n = 62, 8.6%; Vietnam n = 60, 8.3%). Biosimilar insulin users were younger and had higher body mass index, glycated hemoglobin, insulin dosage and more frequent hypoglycemia than originator insulin users. These associations were non‐significant after adjustment for confounders. Only age, college education, diabetes education, lipid control, physical activity and history of cardiovascular complications were independently associated with these quality measures. Conclusions Biosimilar insulin use is not uncommon in Asia. Data exclusion due to incomplete capturing of brand names suggests possibly higher use. The multiple determinants of the quality of glycemic control call for establishment of prospective cohorts and diabetes registers to monitor the safety and efficacy of different brands of biosimilar insulin and their impacts on clinical outcomes.

Diabetes prevalence in India was 8.7% in 2015 and is rising because of rapid urbanization, increasing life expectancy, and a diet rich in sugar and fat (1). However, less than 20% of people living with diabetes in India achieved target A1C levels in 2011 (2). India’s growing prosperity fuels this epidemic and, through increased mobile phone access, also offers pathways to improve care. A recent review of reviews confirmed the overall benefits of telemedicine in diabetes management (3), but little research has been conducted in developing countries. A total of 91 people aged 18–65 years with type 2 diabetes, an A1C between 7.5 and 12.5% (58 and 113 mmol/mol), and an Android smartphone were recruited at three sites in Ahmedabad, Chennai, and Mumbai (March–May 2015), randomized 1:1 to the Gather mobile health (mHealth) intervention or usual care, and observed for 6 months. All received free visits, laboratory tests, and test strips and lancets. Intervention participants received the mHealth app and a mobile phone plan stipend. Data were collected through physical measurements, laboratory tests, …