Dapagliflozin Improves Body Fat Patterning, and Hepatic and Pancreatic Fat in Patients With Type 2 Diabetes in North India.

CONTEXT: Excess hepatic and pancreatic fat may contribute to hyperglycemia. OBJECTIVE: The objective of this study was to examine the effect of dapagliflozin (an SGLT2 inhibitor) on anthropometric profile, liver, and pancreatic fat in patients with type 2 diabetes mellitus (T2DM). METHODS: This is an observational interventional paired study design without a control group. Patients (n = 30) were given dapagliflozin 10 mg/day (on top of stable dose of metformin and/or sulfonylureas) for 120 days. Changes in anthropometry (circumferences and skinfold thickness), surrogate markers of insulin resistance, body composition, liver, and pancreatic fat (as measured by magnetic resonance imaging (MRI)-derived proton density fat fraction [FF]) were evaluated. RESULTS: After 120 days of treatment with dapagliflozin, a statistically significant reduction in weight, body mass index (BMI), body fat, circumferences, and all skinfold thickness was seen. A statistically significant reduction in blood glucose, glycated hemoglobin A1c, hepatic transaminases, fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and postprandial C-peptide was noted, while HOMA-ß, postprandial insulin sensitivity, and fasting adiponectin were statistically significantly increased. There was no change in lean body mass. Compared to baseline there was a statistically significant decrease in mean liver FF (from 15.2% to 10.1%, P < .0001) and mean pancreatic FF (from 7.5% to 5.99%, P < .0083). Reduction in liver fat was statistically significant after adjustment for change in body weight. CONCLUSION: Dapagliflozin, after 120 days of use, reduced pancreatic and liver fat and increased insulin sensitivity in Asian Indian patients with T2DM.

Efficacy of Digitally Supported and Real-Time Self-Monitoring of Blood Glucose-Driven Counseling in Patients with Type 2 Diabetes Mellitus: A Real-World, Retrospective Study in North India.

PURPOSE: Poor glycemic control is prevalent in patients with type 2 diabetes mellitus (T2DM) in India. This study aims to understand the effectiveness of a smartphone-connected glucometer, real-time feedback, and contextualized counseling on glycemic control and hypoglycemic episodes in T2DM patients. METHODS: This retrospective, multicenter study reviewed the medical records of T2DM patients belonging to several cities of north India, who were digitally engaged with a smartphone-connected glucometer and who had received at least one counseling session between September 2019 and July 2020. Intervention included self-monitoring of blood glucose (SMBG) using a smartphone-connected glucometer enabled with real-time transmission of information to certified diabetes educators (CDE) and their corresponding counseling based on SMBG findings. RESULTS: Of 7111 adult T2DM patients included in this study, majority (75%) of the patients received a single session of counseling, and the remaining patients received 2 (16.7%), 3 (5%), 4 (2%), or ≥5 (1.3%) sessions. The mean age of the patients was 51.6 years, and the majority (77.9%) were males. Digital monitoring of BG and counseling with CDE significantly reduced the mean fasting (by 9.6%), pre-prandial (by 9.9%), and post-prandial (by 9.2%) BG values in 53%, 52%, and 54% of patients, respectively. The majority (81.4%) of patients showed no hypoglycemic episode (≤70 mg/dL) post-counseling. The hypoglycemia episodes observed with FBG, pre-prandial, and post-prandial BG values were reduced significantly by 58.5%, 48.1%, and 61.8%, respectively, post-counseling. CONCLUSION: Digitally supported and real-time SMBG-driven counselling was effective in glycemic control and reduction of hypoglycemic episodes in T2DM patients in India. Moreover, reduction in hypoglycemia may be due to back end real-time support of CDE intervention.

COVID-19 associated mucormycosis: A Descriptive Multisite Study from India.

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.

High prevalence of post COVID-19 fatigue in patients with type 2 diabetes: A case-control study.

BACKGROUND: Post COVID-19 syndrome (PCS) has emerged as a major roadblock in the recovery of patients infected with SARS-CoV-2. Amongst many symptoms like myalgia, headache, cough, breathlessness; fatigue is is most prevalent and makes the patient severely debilitated. Research on PCS, in particular fatigue, in patients with diabetes has not been done. METHODOLOGY: In this prospective study, we included patients with type 2 diabetes (T2D) who had COVID-19 (mild to moderate severity), and matched T2D patients who did not suffer from COVID-19. Demography, anthropometry, glycemic measures, treatment, and details of COVID-19 were recorded. Symptoms were scored using Chalder Fatigue Scale (reported as fatigue score, FS) and handgrip strength (in kg) was recorded by Jamar Hydraulic Hand Dynamometer. RESULTS: A total of 108 patients were included (cases, 52, controls, 56). Both groups were matched for age, duration of diabetes, BMI, TSH, serum albumin and vitamin D levels. T2D patients who had COVID-19 showed significantly more fatigue when compared with patients who did not have COVID-19 but both groups had comparable handgrip strength. Furthermore, patients with T2D with previous COVID-19 infection and who had FS > 4 have had significant higher inflammation markers during acute illness, and post COVID-19, had increased post prandial blood glucose levels, lost more weight, had reduced physical activity and showed significantly lower handgrip strength as compared to those with FS < 4. CONCLUSION: Patients with T2D who had COVID-19 infection as compared to those without had significantly more fatigue after the acute illness, and those with higher FS had reduced handgrip strength indicating sarcopenia, even after careful matching for common contributory factors to fatigue at baseline. Rehabilitation of those with FS>4 after acute infection would require careful attention to nutrition, glycemic control and graduated physical activity protocol.

Management of diabetes mellitus through teleconsultation during COVID-19 and similar scenarios - Guidelines from Indian Council of Medical Research (ICMR) expert group.

INTRODUCTION: Emergence of COVID-19 pandemic has led to increased use of telemedicine in health care delivery. Telemedicine facilitates long-term clinical care for monitoring and prevention of complications of diabetes mellitus. GUIDELINES: Precise indications for teleconsultation, clinical care services which can be provided, and good clinical practices to be followed during teleconsultation are explained. Guidance on risk assessment and health education for diabetes risk factors, counselling for blood glucose monitoring, treatment compliance, and prevention of complications are described. CONCLUSION: The guidelines will help physicians in adopting teleconsultation for management of diabetes mellitus, facilitate access to diabetes care and improve health outcomes.

Breakthrough COVID19 infections after vaccinations in healthcare and other workers in a chronic care medical facility in New Delhi, India.

BACKGROUND AND AIMS: Vaccinations for COVID19 are now open to all adults in India. However, spread of COVID19 infection continues unabated. We aimed to ascertain number of breakthrough COVID19 infections after vaccinations in a chronic care, diabetes-centric healthcare facility. METHODS: We reviewed rigorously maintained data of vaccinations, health status, symptoms of COVID19 & RT-PCR testing of all staff (doctors, nurses, paramedical workers, and other staff) in our health care facility from January 16, 2021 till date. RESULTS: Out of 123 employees, 113 were vaccinated (Covaxin, 28, Covishield, 85). Second dose was completed in 107 (94.7%) and first dose in 6 persons (5.3%). Symptomatic COVD19 infections occurred in 19 persons (16.9%) post any dose of vaccine. Symptomatic breakthrough infections > 14 days after second dose occurred in 15 persons (13.3%). Except one (required hospitalization), all 14 had mild COVID19 disease. CONCLUSIONS: We report mild symptomatic breakthrough infections as seen in our health care facility. Research in breakthrough infections in India should be extended to other institutions and community to obtain larger data.

Heterogeneity in presentation of hyperglycaemia during COVID-19 pandemic: A proposed classification.

Diabetes and hyperglycemia occurring during COVID-19 era have implications for COVID-19 related morbidity/mortality. In this brief review, we have attempted to categorise and classify such heterogenous hyperglycemic states. During COVID-19 pandemic broadly two types of hyperglycemia were seen: one in patients without COVID-19 infection and second in patients with COVID-19 infection. Patients not inflicted with COVID-19 infection and diagnosed with either type 2 diabetes mellitus (T2DM) or type 1 diabetes mellitus (T1DM) show more severe hyperglycemia and more ketoacidosis, respectively. In former, it could be attributed to weight gain, decreased exercise, stress and in both type of diabetes, due to delayed diagnosis during lockdown and pandemic. In patients with COVID-19 and associated pneumonia, altered glucose metabolism leading to hyperglycemia could be due to corticosteroids, cytokine storm, damage to pancreatic beta cells, or combination of these factors. Some of these patients present with diabetic ketoacidosis, hyperglycemic hyperosmolar state or both. We have provided a framework for categorisation of hyperglycemic states, which could be consolidated/revised in future based on new research data.

Glycemic parameters in patients with new-onset diabetes during COVID-19 pandemic are more severe than in patients with new-onset diabetes before the pandemic: NOD COVID India Study.

BACKGROUND AND AIMS: It is not known if new onset diabetes during Coronavirus-19 disease (COVID-19; NOD COVID) is phenotypically or biochemically different than new onset diabetes before COVID-19 (NOD). METHODS: All adults diagnosed with new onset diabetes from during the time of COVID-19 were compared with new onset diabetes prior to COVID-19 from two tertiary care hospitals in Chennai and Delhi. RTPCR test for SARS-CoV-2 virus was done as appropriate, and COVID-19 antibody test was done in all other NOD COVID patients. RESULT: A total of 555 patients with new onset diabetes were included in the study (282 NOD and 273 NOD COVID patients). Patients with NOD COVID had higher fasting and post prandial blood glucose and glycated hemoglobin levels vs. NOD patients. Both the groups had high average body mass index; ∼28 kg/m2. Interestingly, fasting C-peptide levels were significantly higher in the NOD COVID group vs. NOD group. There was no difference in C-peptide levels or glycemic parameters between the COVID-19 antibody positive and negative NOD COVID cases. CONCLUSION: Individuals who were diagnosed with diabetes during COVID-19 epidemic (NOD COVID) do not significantly differ from those diagnosed before COVID-19 in symptomatology, phenotype, and C-peptide levels but they had more severe glycemia.

About 1/3rd of north Indian patients less than 50 years of age with type 2 diabetes have high pulse wave velocity indicating high risk of atherosclerosis.

BACKGROUND AND AIMS: Asian Indian patients with type 2 diabetes mellitus (T2DM) have a high cardiovascular risk even at young age. There is a need to assess this increased risk and identify atherosclerosis early so that appropriate measures for risk reduction can be taken. We aimed to study carotid-femoral pulse wave velocity (Cf-PWV), a non-invasive indicator of atherosclerosis, in patients with diabetes below 50 years of age and its correlation with markers of obesity and other cardiovascular risk factors. METHODS: Patients (n, 299) with T2DM below 50 years of age underwent measurement of Cf-PWV by applanation tonometry. Anthropometric parameters, blood pressure, liver span, glycosylated hemoglobin, serum lipid profile, urinary microalbumin, ankle brachial index and carotid intima media thickness were measured. RESULTS: Data show that 32.4% of patients had high Cf-PWV, with mean values higher in males than females. On stepwise multiple linear regression analysis, the significant independent determinants of PWV were age, systolic blood pressure, waist circumference, microalbumin and liver span. CONCLUSION: About one third patients with T2DM less than 50 years of age, in north India have increased arterial stiffness which correlates with blood pressure, abdominal obesity, liver size and microalbumin, indicating increased risk for coronary artery disease.

Increase in the risk of type 2 diabetes during lockdown for the COVID19 pandemic in India: A cohort analysis.

Lockdown due to the Coronavirus disease 2019 (COVID 19) pandemic may cause weight gain and enhance the risk of type 2 diabetes mellitus (T2DM). We aimed to determine this risk in apparently non-diabetic individuals. MATERIAL METHODS: Baseline demographic and clinical data from 100 apparently non-diabetic household members (related or unrelated) of patients with type 2 diabetes mellitus were collected until 49 days of lockdown and analyzed using the XL-STAT statistical software. A two-pronged analytical strategy was employed. First, the metabolic risk profile related to age, sex, weight, family history, and exercise pattern was analyzed. This was followed by an assessment of the risk of developing type 2 diabetes using an established risk assessment engine. RESULTS: There was a trend towards weight gain seen in 40% of the cohort, with 16% of the population experiencing a 2.1-5 kg weight increment. When all the risk parameters were analyzed together using the ADA risk engine, there was an increase in the ADA diabetes risk score in 7% of the population, with 6.66% in the high-risk group. There was a further increase in weight among 3% of the population who were already obese at baseline. CONCLUSION: We show an increased risk of T2MD consequent to weight gain during 49 days of lockdown in India.

Effects of nationwide lockdown during COVID-19 epidemic on lifestyle and other medical issues of patients with type 2 diabetes in north India.

BACKGROUND AND AIMS: During the current pandemic of COVID-19, India is under lockdown which could cause disruption in diet and lifestyle in patients with type 2 diabetes (T2DM). We aimed to study lifestyle changes and other common issues related to treatment in our previously seen and treated patients with T2DM. METHODS: Patients (n, 150) who were regularly following up before lockdown were interviewed telephonically (after 45 days of start of lockdown) regarding lifestyle changes, stress and other diabetes-related questions. RESULT: Carbohydrate consumption and frequency of snacking increased in 21% and 23% patients, respectively. Interestingly, 27% patients reported an increase in consumption of fruits. Exercise duration was reduced in 42% and weight gain occurred in 19% patients. Frequency of doing self-monitoring of blood glucose (SMBG) was decreased in 23% patients. 'Mental stress' of any kind was reported in 87% patients. Availability of medicines and insulin was uninterrupted in 91% patients. Knowledge about telemedicine was present in 69% and majority (92%) of these patients preferred video consultation. CONCLUSION: During 45 days of lockdown increase in carbohydrate intake, decrease in exercise, decreased SMBG and widespread mental stress in patients with T2DM was recorded, factors which may destabilize or exacerbate hyperglycemia and hypertension. Some positive changes (e.g. increased intake of fruits) were also observed.

Marked erythrocytosis during treatment with sodium glucose cotransporter-2 inhibitors-report of two cases.

SGLT-2 inhibitors are known to increase hematocrit. We present two cases with marked asymptomatic erythrocytosis developing after taking SGLT-2 inhibitors. No other predisposing or causative factor was found and SGLT-2 inhibitor drug was the most likely cause in both cases. Both patients underwent phlebotomy and haematocrit came down after withdrawing the offending drug.

Telemedicine for diabetes care in India during COVID19 pandemic and national lockdown period: Guidelines for physicians.

BACKGROUND AND AIMS: In view of restrictions on mobility of patients because of COVID-19 pandemic, face-to-face consultations are difficult. We sought to study the feasibility of telemedicine in this scenario. METHODS: PubMed and Google Scholar search engines were searched using the key terms 'telemedicine', 'diabetes', 'COVID-19 up to 31st March 2020. In addition, existing guidelines including those by Ministry of Health and Family Welfare (MOHFW), Government of India, were accessed. RESULTS: We discuss evidence and general guidelines regarding role of telemedicine in patients with diabetes along with its utility and limitations. CONCLUSIONS: Telemedicine is a useful tool for managing patients of diabetes during this lockdown period. However, there is limited data and further research is required.

Diabetes in COVID-19: Prevalence, pathophysiology, prognosis and practical considerations.

BACKGROUND AND AIMS: High prevalence of diabetes makes it an important comorbidity in patients with COVID-19. We sought to review and analyze the data regarding the association between diabetes and COVID-19, pathophysiology of the disease in diabetes and management of patients with diabetes who develop COVID-19 infection. METHODS: PubMed database and Google Scholar were searched using the key terms 'COVID-19', 'SARS-CoV-2', 'diabetes', 'antidiabetic therapy' up to April 2, 2020. Full texts of the retrieved articles were accessed. RESULTS: There is evidence of increased incidence and severity of COVID-19 in patients with diabetes. COVID-19 could have effect on the pathophysiology of diabetes. Blood glucose control is important not only for patients who are infected with COVID-19, but also for those without the disease. Innovations like telemedicine are useful to treat patients with diabetes in today's times.

Dipeptidyl peptidase 4 inhibitors linked bullous pemphigoid in patients with type 2 diabetes mellitus: A series of 13 cases.

BACKGROUND: Dipeptidyl peptidase 4 (DPP4) inhibitors have increasingly been linked to bullous pemphigoid, but there is paucity of data from India where about 1.85 million patients have been estimated to use these drugs. METHODS: In 30,000 patients with T2DM seen by us in two tertiary care centres since 2015, we detected 13 cases of bullous pemphigoid linked to DPP4 inhibitors. We used WHO-UMC (World Health Organisation-Uppsala Monitoring Centre) causality assessment system for assessment. RESULTS: Lesions of bullous pemphigoid appeared at varied intervals (within 1 weeks-2 years) after start of DPP4 inhibitors. Implicated drugs were Linagliptin (n, 8), Vildagliptin (n, 4) and Sitagliptin (n, 1). Mostly, lesions were seen after 60 years age, and over trunk and extremities. Skin biopsy was compatible with bullous pemphigoid in two patients. Lesions regressed within a month of stopping DPP4 inhibitors in 9 patients while delayed regression up to 6 months in 4 patients. Overall, skin lesions remitted in all patients and did not recur. CONCLUSION: Any new bullous lesion appearing while patient is on DPP4 inhibitors should be considered as bullous pemphigoid and should necessitate prompt withdrawal of the drug.