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OBJECTIVE The aim of this cross-sectional study was to comprehensively assess bone health in women with prior gestational diabetes mellitus, including bone microarchitecture (TBS), bone mineral density (BMD, DXA) and bone turnover (osteocalcin). DESIGN, PATIENTS AND MEASUREMENTS Study participants underwent a detailed anthropometric, biochemical and hormone assessment, including insulin and osteocalcin measurement. BMD was measured at lumbar spine, femur neck and total hip using DXA and TBS derived from lumbar spine DXA images using TBS iNsight software. RESULTS A total of 240 women (mean age: 33.3 ± 5.0 years; median postpartum duration: 34 [interquartile range 13.0-54.5] months were evaluated. At the current visit, 115 (47.9%) and 36 (15%) women had prediabetes and diabetes, respectively. Women with dysglycemia (diabetes/prediabetes) had a higher BMD at all three sites, compared to those with normoglycemia; however, the difference was not statistically significant. Women with dysglycemia had a significantly lower TBS (1.32 ± 0.09 vs. 1.35 ± 0.09; p = .038). In the fully adjusted model, the odds ratio for association between diabetes and low TBS was 2.92 (95% confidence interval: 1.20, 7.08; p = .018). Women with dysglycemia had significantly lower serum osteocalcin levels (18.6 ± 8.5 ng/ml vs. 21.5 ± 9.7 ng/ml; p = .018). HOMA-IR (r = -.285, p

Introduction We aimed to evaluate whether SARS-CoV-2 infection is associated with beta cell dysfunction and progression of glycemic and cardiometabolic variables in an established cohort. Methods Study participants (n = 352, 46.9% men) underwent a detailed evaluation at two time points: (a) pre-COVID (2016–19) and (b) peri-COVID (2020–21). At the second visit, SARS-CoV-2 infection was determined on the basis of a quantitative S1/S2 IgG antibody test (DiaSorin Liaison) and/or a documented history of infection. Results A total of 159 (45.2%) participants were seropositive for SARS-CoV-2, of whom 122 (76.7%) had mild/asymptomatic infection. Progression in body mass index (BMI) category [34 (21.4%) vs. 22 (11.4%), p = 0.011] was seen in a significantly higher proportion of the participants in the infected group compared to the non-infected group. Progression in glycemic and insulin indices [homeostasis model assessment of insulin resistance (HOMA-IR), Matsuda index, and oral disposition index (oDI)] categories was also evident in a larger proportion of participants in the infected group; however, the difference was not statistically significant. On logistic regression analysis, the association between SARS-CoV-2 infection and BMI category progression was statistically significant [fully adjusted OR 2.14 (95% CI, 1.18–3.90; p = 0.013)]. Conclusion In this longitudinal study, predominant mild/asymptomatic SARS-CoV-2 infection was associated with increase in BMI, but not with worsening of beta cell function and insulin resistance, nor glycemic progression.

Glycemic control has remained an enigma despite a large number of anti-diabetic drugs being available. Clinical practice and guidelines have focussed largely on optimal and rational use of anti-diabetes drugs to achieve care goals. This study aims to delineate factors impacting glycemic control from real-world data. Retrospective, cross-sectional data comprising 15,689 prescriptions from 4647 people living with diabetes and attending an endocrine clinic over a 5-year period was extracted from EMR (electronic medical records) of the clinic. Data pertaining to drugs prescribed, glycemic control attained and patient behavioral factors like diet, drug and exercise adherence was analysed to delineate the contribution of patient or care team-dependent factors towards glycemic control. Factors related to patient behavior affected glycemic control linearly with statistically lower HbA1c in people with better adherence to diet, medications and exercise. People who did any self-monitoring of blood glucose at home had significantly better glycemic control. On the other hand, a number of medications were negatively associated with glycemic control. Hypoglycemia had no impact on glycemic control. A number of visits to treating physician were positively associated with glycemic control but impact plateaued after 6 visits. Patient behavior and activation-related factors are predominant drivers of glycemic control.

Aims/Introduction This study aims to evaluate the prevalence of and factors associated with non‐alcoholic fatty liver disease (NAFLD) in Indian women with prior gestational diabetes mellitus (GDM) diagnosed using International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. Materials and Methods This cross‐sectional study (2018–2019) enrolled women with and without prior GDM. Study participants underwent detailed assessments, including relevant medical, obstetric and demographic details; 75‐g oral glucose tolerance test with glucose and insulin estimation at 0, 30 and 120 min; and other relevant biochemical and anthropometric measurements. NAFLD status was defined by ultrasonography. Results We evaluated a total of 309 women (201 and 108 with and without prior GDM, respectively) at a mean age of 31.9 ± 5.0 years and median of 16 months (interquartile range 9–38 months) following the index delivery. The prevalence of NAFLD was significantly higher in women with prior GDM (62.7% vs 50.0%, P = 0.038; grade 2 and 3 disease, 13.9% vs 6.5%). On logistic regression analysis (fully adjusted model), the odds of NAFLD were 2.11‐fold higher in women with prior GDM (95% confidence interval 1.16–3.85, P = 0.014). Overweight/obesity, metabolic syndrome, prediabetes and homeostasis model of assessment of insulin resistance (a measure of insulin resistance) were positively associated with NAFLD, whereas the Matsuda index (a measure of insulin sensitivity) showed a negative association with NAFLD. Conclusions The prevalence of NAFLD is high in women with prior GDM. Such women also have a high burden of cardiometabolic risk factors. Future studies should evaluate the intermediate and long‐term hepatic and cardiovascular risk, and the impact of lifestyle interventions in reducing morbidity in such women., This study evaluated the prevalence and risk factors of non‐alcoholic fatty liver disease in Indian women with prior gestational diabetes mellitus diagnosed using International Association of Diabetes and Pregnancy Study Groups criteria. Ultrasonography of abdomen was used to define non‐alcoholic fatty liver disease status. Prevalence of non‐alcoholic fatty liver disease was significantly higher in women with prior gestational diabetes mellitus (62.7% vs 50.0%, P = 0.038; grade 2 and 3 disease, 13.9% vs 6.5%).

Introduction Our aim is to propose an evidence-based strategy for screening postpartum dysglycemia. Methods This study included adult non-pregnant women who were diagnosed with gestational diabetes (GDM) using International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria during their index pregnancy (2012–2019). Eligible participants underwent a concurrent oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) test. A detailed questionnaire documenting relevant personal and medical history was filled, and the relevant anthropometric parameters were recorded. Results We evaluated data from 377 women at a mean (± SD) age of 32.1 ± 4.6 years and at a median duration of 15 (10–33) months following childbirth. Diabetes was diagnosed in 42 (11.1%) women. Use of a combination cutoff [fasting plasma glucose (FPG) ≥ 6.1 mmol/L or glycated hemoglobin (HbA1c) ≥ 6.0% (42 mmol/mol)] avoided OGTT in 80.9% of the study cohort, without missing the diagnosis of diabetes in any study subject. The diagnosis was missed in 2.4% of women with diabetes (and 0.3% of whole cohort) using only the FPG criterion (≥ 5.6 mmol/L) or HbA1c criterion [HbA1c ≥ 5.7% (39 mmol/mol)] alone. These tests avoided the need for an OGTT in 75.3% and 65.5% of women, respectively. Conclusions The proposed strategies are likely to be both patient- and physician-friendly and have the potential to address several barriers for postpartum screening among women with prior GDM.

Background and aims Diabetes and coronavirus disease 2019 (COVID-19) share a bidirectional relationship. Hyperglycemia occurring in the setting of either previously diagnosed or undiagnosed diabetes is known to be associated with poor outcomes. Here, we aim to provide a simple and practical guidance on the diagnosis and management of hyperglycemia in admitted patients with COVID-19. Methods The guidance is formulated based on experience of authors and relevant literature on the subject searched using Pubmed. Results Every patient admitted to a COVID care facility should be investigated for hyperglycemia using a combination of tests including capillary blood glucose, fasting plasma glucose and HbA1c. Oral glucose lowering drugs can be considered in patients with mild COVID illness who have mild hyperglycemia [pre-meal blood glucose of

Background and Aim The coronavirus disease 2019 (COVID-19) outbreak has rapidly crossed international boundaries and placed increasing demands on healthcare facilities worldwide. Patients with diabetes and uncontrolled blood glucose levels are at increased risk for poor clinical outcomes and in-hospital mortality related to COVID-19. Therefore, achieving good glycaemic control is of paramount importance among hospitalised patients with COVID-19. Basal-bolus insulin therapy is a safe and effective intervention for the management of hyperglycaemia in hospitalised patients. The aim of this article is to provide a practical guidance for the use of the basal-bolus insulin regimen in hospitalised patients with COVID-19 and diabetes mellitus. Methods This guidance document was formulated based on the review of available literature and the combined personal experiences of the authors. We provide a comprehensive review on the use of the basal-bolus insulin regimen, including its principles, rationale, indications, prerequisites, initiation, and dose titration, and also suggest targets for blood glucose control and different levels of capillary blood glucose monitoring. Various case scenarios are used to illustrate how optimal glucose control can be achieved, such as through adjustments in doses of prandial and basal insulin, the use of correctional insulin dosing and changes in the timing and content of major and minor meals. Conclusion The practical guidance for the use of the basal-bolus insulin regimen in hospitalised patients with COVID-19 and diabetes mellitus presented here can be used for patients admitted to hospital for indications other than COVID-19 and for those in ambulatory care. Electronic supplementary material The online version of this article (10.1007/s13300-020-00873-3) contains supplementary material, which is available to authorized users.

Background: There is no published literature on the profile of patients with tall stature (TS) from India. This study aimed to evaluate the etiological and clinical profile of patients with TS referred to our hospital. Materials and Methods: We performed a retrospective review of records of patients referred to us for evaluation of TS (January 2007 to March 2020). Relevant clinical, anthropometric, biochemical, and radiological data at presentation were recorded, and the final diagnosis reviewed. Results: The study included 16 subjects (6 boys, 10 girls) with a mean age at presentation of 13.2 ± 3.6 years. Most subjects were pubertal (n = 10) and belonged to the overweight or obese category (n = 10). The mean height and height standard deviation score (SDS) were 172.3 ± 20.3 cm and 3.6 ± 1.5, respectively, while mean mid-parental height (MPH) and MPH SDS were 168.8 ± 8.8 cm and 1.2 ± 0.9, respectively. The etiological diagnoses were familial TS (n = 9), acrogigantism (n = 3), obesity-related TS (n = 2), constitutional advancement of growth (n = 1), and Marfan syndrome (n = 1). The mean height SDS in subjects with acrogigantism was 6.4 ± 1.2 compared to 3.0 ± 0.6 in those with other etiologies of TS. Only one girl with familial TS and significantly increased predicted adult height (+4.56 SDS) opted for sex steroid therapy. Conclusion: Familial TS is the most common diagnosis among patients referred for evaluation to our hospital. One should consider the possibility of acrogigantism in patients with growth acceleration, extreme TS, and markedly increased gap between height SDS and MPH SDS. Most patients with familial TS require reassurance and sex steroid therapy should be reserved for highly selected cases.

IntroductionGestational diabetes mellitus (GDM), once considered a transient condition during pregnancy, is now a firmly established risk factor for type 2 diabetes mellitus (T2DM). Women whose blood glucose levels do not return to normal soon after giving birth are particularly at high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions are recommended for women with GDM to prevent or delay the subsequent development of T2DM. Recent systematic reviews and meta-analyses have suggested postpartum lifestyle interventions may be beneficial in reducing the risk of developing diabetes in women with GDM, however, included studies were generally small, many had a high risk of bias and subsequent data have become available with new trials likely to complete in the next couple of years. In addition, to the best of our knowledge, formal systematic review and meta-analysis of other approaches to preventing diabetes in this population (e.g. pharmacotherapy) has not been attempted. Therefore, an updated systematic review is needed and will be formulated as a living systematic review to ensure the inclusion of emerging studies.Methods and analysisA living systematic review and a prospective meta-analysis to examine the effectiveness of postpartum interventions in reducing the risk of developing T2DM in women with recent GDM.Ethics and disseminationEthics committee approval is not required. The data included will be from published studies, and a continued living systematic review and prospective meta-analysis will occur once a year for the next five years. Results of the review will be disseminated at relevant meetings.PROSPERO registration numberCRD42021279891Strengths and limitations of this studyA living systematic review will allow continuous surveillance of emerging literature on different lifestyle interventions in women with a history of GDM and allow identification of effective strategies for diabetes prevention.We estimate considerable heterogeneity of interventions which may limit our ability to make clear conclusions.

With millions of people getting affected with COVID-19 pandemic caused by a novel severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), people living with post COVID-19 Symptoms (PCS) are expected to rise in the future· The present study aimed at assessing PCS comprehensively and its associated factors among COVID-19 recovered adult population in north India.MethodsIn a tertiary health centre at Delhi, an online based cross-sectional study was conducted using a semi-structured questionnaire, developed by employing a nominal group technique, in aged 18 years and above who were SARS-CoV-2 positive during the month of January to April 2021. Socio-demographic, various potential risk factors, including pre-existing morbidities, vaccination status, and severity of acute COVID-19 illness, information on acute illness for management and a spectrum of PCS were collected between June 16 to July 28, 2021. Each participant was contacted telephonically before sending the survey link. PCS were presented as relative frequency; chi-square test, odds ratio, including adjusted, were calculated to rule out association between PCS and potential predictors.ResultsA total of 773 of 1801 COVID recovered participants responded to the link reaching a participation rate of 42·9%, with a median age of 34 years (IQR 27 to 44). Male respondents were 56·4%. Around 33·2% of them had PCS at four or more weeks, affecting almost all body organ systems. The most prevalent PCS were fatigue (79·3%), pain in the joins (33·4%), muscle (29·9%), hair loss (28·0%), headache (27·2%), breathlessness (25·3%), sleep disturbance (25·3%) and cough (24·9%). The prevalence of PCS was reduced to 12·8% at 12 weeks after positive test. Factor such as female gender, older age, oxygen supplementation during the acute illness, working in healthcare care facilities, the severity of acute illness, and pre-existing co-morbid were risk factors for PCS. Further, vaccination (second dose) reduced the odds of developing PCS by 45% compared to unvaccinated participants (aOR 0·65; 95%CI 0·45-0·96). Finally, 8·3% of participants rated their overall health status was either poor or very poor following COVID-19 illness.ConclusionsThe PCS involves almost all organ systems, regardless of the severity of acute COVID-19 illness. Two doses of vaccine help to reduce development of PCS.Research in ContextEvidence before this studyAlthough the evidence is mounting in prolonged COVID-19 symptoms among COVID-19 survivors, to date, the full range of such post-COVID-19 symptoms (PCS) is not yet fully understood. There is a lack of studies that assessed PCS comprehensively among persons who have recovered from the COVID-19illness. For example, limited data are available on psychosocial, behavioral, and oral manifestations related to PCS. Further, there is a paucity of studies that included a wide range of determinants of PCS and the association of vaccination with the development of PCS across the world. Our study is the first such study conducted among COVID-19 recovered persons who with a majority of them employed in a tertiary health care institute of north India.Added value of this studyOur study, for the first time, investigated a wide range of post-COVID-19 manifestations among COVID-19 recovered persons in organ-specific and psychosocial behavioral aspects, making this the largest categorization of PCS currently (in total 16). The study included telephonic calls to each eligible candidate which helped in ensuring the COVID-19 status at the time of the study. Since the participants either were employees in the hospital or their dependents that enhance the accuracy of reporting PCS. The most prevalent symptom was unspecific PCS (85.6%), e.g., fatigue, followed by musculoskeletal manifestations (49·8%), Ear, Nose and Throat symptoms (47·5%), neurological (47·0%), cardio-respiratory (42·4%, gastrointestinal (36·2%), ocular symptoms (31·9%), dermatological symptoms (31·5%), and cardio-vascular (24·5%) symptoms, and mental health symptoms (23·7%). The rest of the organ specific symptoms were observed in less than 20% of the respondents. Older age, female gender, pre-existing co-morbid, oxygen supplementation during acute illness, the severity of illness, working in health care institutions were associated with PCS. Vaccination after the second dose was protective against PCS compared to non-vaccinated participants. Further, our study also reported a rating of the overall health status among COVID survivors, whereby around 8.3% of them reported being a poor or very poor health.Implications of all the available evidencePCS affects a multi-organ organ system, irrespective of the severity of acute-phase COVID-19 illness and hospitalization. Such persistent COVID-19 symptoms, compounded by its heterogeneity among COVID survivors can pose a substantial burden to the affected individuals and their families and additional challenges for healthcare delivery and public health service. The current study shows that one in three individuals experience persistent COVID-19 symptoms. Since the COVID pandemic is still ongoing across the world, therefore, the number of people experiencing PCS is likely to be increased substantially further. An integrated PCS care strategy, but not limited to organ-specific healthcare disciplines, others such as psychosocial support, including counseling and education, rehabilitation, community-based rehabilitation programs will be required for management. Prioritization of PCS care to elder and co-morbid patients should be recommended. Expediting the vaccination drive will be helpful to reduce the development of persistent COVID-19 symptoms. Research, collaborative and multidisciplinary, is required to understand the underlying pathophysiology mechanism for PCS.

Various studies have shown a positive co-relation between Vitamin D deficiency and severity of Allergic Rhinitis (AR) based on subjective symptoms. AR is also associated with serum eosinophilia and raised levels of various interleukins (IL)—particularly IL-4, IL-5 and IL-13. To compare serum Vitamin D levels, IL-4, IL-5, and IL-13 levels, and eosinophilia in AR patients with healthy controls and co-relate disease severity using Sino-nasal Outcome Test-22 (SNOT-22) score in patients with Vitamin D deficiency. 30 patients and 30 healthy controls were recruited. 10 ml blood sample was drawn from each patient and healthy control. It was then processed to evaluate absolute eosinophil count, serum levels of Vitamin D, and IL-4, IL-5, and IL-13. 93.33% of patients with AR and 70% of healthy controls had decreased Vitamin D levels (below 25 ng/ml). The mean Vitamin D levels was 10.50 ± 2.34 ng/ml and 17.54 ± 2.84 ng/ml in the patient and control group, respectively (p = 0.001). But there was no significant co-relation between SNOT-22 score and Vitamin D level, and between interleukin levels in patient and control group. Vitamin D deficiency is associated with Allergic Rhinitis and therefore, checking Vitamin D levels in patients with AR can be considered as routine practice in outpatient clinics. However, co-relation between severity of Allergic Rhinitis and Vitamin D levels and the proven therapeutic role of Vitamin D in Allergic Rhinitis is still debatable and thus, requires large sample size randomised controlled trials.

The aim of this study was to investigate the concordance of dysglycaemia (prediabetes or diabetes) and cardiometabolic traits between women with a history of gestational diabetes mellitus (GDM) and their spouses. Using hospital medical records, women with GDM (diagnosed between 2012 and 2016) and their spouses were invited to participate in the study and to attend a scheduled hospital visit in a fasting state. Sociodemographic, anthropometric and medical data were collected, and a 75 g OGTT with serum insulin estimation, HbA1c measurement and fasting lipid profile were performed at the visit. Prediabetes and diabetes were defined using ADA criteria and the metabolic syndrome was defined using IDF criteria. A total of 214 couples participated in the study. Women were tested at a mean ± SD age of 32.4 ± 4.6 years and median (quartile [q]25–q75) of 19.5 (11–44) months following the index delivery, while men were tested at a mean ± SD age of 36.4 ± 5.4 years. A total of 72 (33.6%) couples showed concordance for dysglycaemia, while 99 (46.3%) and 51 (23.8%) couples were concordant for overweight/obesity and the metabolic syndrome, respectively. A total of 146 (68.2%) couples showed concordance for any of the above three factors. The presence of dysglycaemia in one partner was associated with an increased risk of dysglycaemia in the other partner (OR 1.80 [95% CI 1.04, 3.11]). Similarly, being overweight/obese (OR 2.19 [95% CI 1.22, 3.93]) and presence of the metabolic syndrome (OR 2.01 [95% CI 1.16, 3.50]) in one partner was associated with an increased risk of these conditions in the other partner. Both women and men were more likely to have dysglycaemia if they had a partner with dysglycaemia. Women with a partner with dysglycaemia had a significantly higher BMI, waist circumference and diastolic BP, and a significantly higher probability of low HDL-cholesterol (

Dynamic tests are often considered as the backbone of endocrinology. These tests involve the use of an exogenous agent to manipulate the body's hormonal milieu for the diagnosis and characterization of an endocrine disorder. They are especially helpful in the evaluation of certain endocrine conditions, such as disorders of growth and pubertal maturation and disorders of sex development. A great deal of heterogeneity exists across clinicians with regard to the usage, methodology, and interpretation of these tests. This review outlines various dynamic tests used to evaluate adrenal and gonadal function in pediatric and adult endocrinology, along with their clinical application and interpretation.

Aims To confirm non-inferiority of insulin degludec/insulin aspart (IDegAsp) once-daily (OD) versus insulin glargine (IGlar) U100 OD + insulin aspart (IAsp) OD for HbA1c after 26 weeks, and compare efficacy and safety between groups at W26 + W38. Methods A 38-week, randomised, open-label, treat-to-target (HbA1c Results For W0–W26, mean percentage-change (standard deviation) HbA1c was: IDegAsp, −1.1 (0.9); IGlar U100 + IAsp, −1.1 (0.8); estimated treatment difference: 0.07% (95% confidence interval [CI]: −0.06; 0.21) confirmed non-inferiority. At W26 and W38, target HbA1c achievement, and mean fasting and postprandial glucose were similar across groups. At W38, more subjects achieved target HbA1c without hypoglycaemia with IDegAsp (22.5%) than with IGlar U100 + IAsp (21.1%), with significantly fewer nocturnal episodes (W0–W38, estimated rate ratio: 0.61 [95% CI: 0.40; 0.93]). Safety profiles were similar across treatment groups throughout. Conclusions IDegAsp OD/BID are effective treatment intensification options versus multiple injection basal–bolus therapies, achieving similar glycaemic control, with significantly less nocturnal hypoglycaemia.

Drug therapy in diabetes care along the duration of diabetes has been documented scarcely in literature, especially from Indian subcontinent. An audit of an endocrine practice from New Delhi was conducted to understand the current diabetes practice and its direct cost to the patient. Aims: The aim of this study was to analyze the current trend in the use of antidiabetes as well as other drugs for comorbidities along the duration of diabetes. The study also aimed to analyze the direct drug cost to patients. Settings and Design: Retrospective cross-sectional study. Subjects and Methods: Data captured in clinic electronic medical records of an endocrine practice was analyzed. Statistical Analysis Used: Data was analyzed descriptively using machine learning codes on python platform. Results: Records of 489 people who attended the clinic during the 6-month period were retrieved. Data of 403 people with diabetes were analyzed after exclusion of incomplete data. Use of antidiabetic drug increased from 1.44 (0.78) [mean (standard deviation)] in people with a duration of diabetes

Background: Women with recent gestational diabetes mellitus (GDM) have increased risk of developing type 2 diabetes mellitus (T2DM). We aimed to determine whether a resource- and culturally-appropriate lifestyle intervention could prevent glycaemic deterioration in South Asia. Methods: This was an open-label parallel-group randomised trial. Women with GDM from 19 urban hospitals in India, Sri Lanka and Bangladesh underwent an oral glucose tolerance test (OGTT) 3-18 months post-partum. Those without T2DM were randomised to a 12-month lifestyle intervention focused on diet and physical activity or usual care. The primary outcome was the proportion with worsening category of glycaemia based on OGTT using American Diabetes Association criteria: 1) normal glucose tolerance to pre-diabetes (impaired fasting glucose and/or impaired glucose tolerance) or T2DM; or 2) pre-diabetes to T2DM. Secondary outcomes included new-onset T2DM, and change in body weight. Findings: 1823 women underwent OGTT at a median of 6·9 months post-partum. After excluding 162 (8·9%) with T2DM, 1612 (37·5% with pre-diabetes and 62·5% with normoglycaemia) were randomised between November 2017 and January 2020. Baseline mean age was 30·9 years (SD 4·9), mean BMI was 26·6 kg/m 2 (SD 4·7). Among participants randomised to the intervention, 79·7% were exposed to all programme content although pandemic lockdowns impacted the delivery model. After 14·5 months median follow-up, 1308 (81·2%) participants had primary outcome data. The intervention, compared to usual care, did not reduce worsening glycaemic status (25·5% vs. 27·1%; hazard ratio, 0·92 [95% CI: 0·76‒1·12]) or any secondary outcome. There was no evidence of heterogeneity of intervention effect by baseline characteristics. Interpretation: A large proportion of South Asian women in urban centres develop dysglycaemia soon after a GDM-affected pregnancy. A low-intensity lifestyle intervention, substantially modified due to the COVID-19 pandemic, did not prevent subsequent deterioration in glycaemic status. Alternate or additional approaches are needed, especially among high-risk individuals. Trial Registration: Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov (NCT03305939). Funding: Global Alliance for Chronic Disease grants from the Indian Council of Medical Research (NO.58/1/1/GACD/NCD-II) and Australian National Health and Medical Research Council (1093171). Additional funding was received from USV Pharmaceuticals Ltd. and Lupin Pharmaceuticals Ltd. for sub-studies (data not reported here). Declaration of Interest: None to declare. Ethical Approval: The study protocol was approved by Human Research Ethics Committees of the All India Institute of Medical Sciences (India), icddr,b (Bangladesh), Faculty of Medicine, University of Kelaniya (Sri Lanka) and the University of Sydney (Australia)

Aim: To refine and contextually adapt a postpartum lifestyle intervention for prevention of type 2 diabetes mellitus (T2DM) in women with prior gestational diabetes mellitus (GDM) in Bangladesh, India, and Sri Lanka.Materials and Methods: In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with women with current diagnosis of GDM, and health care professionals involved in their management, to understand relevant local contextual factors for intervention optimization and implementation. This paper describes facilitators and barriers as well as feedback from participants on how to improve the proposed intervention. These factors were grouped and interpreted along the axes of the three main determinants of behavior–capability, opportunity, and motivation. IDIs and FGDs were digitally recorded, transcribed, and translated. Data-driven inductive thematic analysis was undertaken to identify and analyze patterns and themes.Results: Two interrelated themes emerged from the IDIs and FGDs: (i) The lifestyle intervention was acceptable and considered to have the potential to improve the existing model of care for women with GDM; and (ii) Certain barriers such as reduced priority of self-care, and adverse societal influences postpartum need to be addressed for the improvement of GDM care. Based on the feedback, the intervention was optimized by including messages for family members in the content of the intervention, providing options for both text and voice messages as reminders, and finalizing the format of the intervention session delivery.Conclusion: This study highlights the importance of contextual factors in influencing postpartum care and support for women diagnosed with GDM in three South Asian countries. It indicates that although provision of postpartum care is complex, a group lifestyle intervention program is highly acceptable to women with GDM, as well as to health care professionals, at urban hospitals.

Background and aims Blood glucose measurement is central to the diagnosis and management of patients with diabetes. Considering that a clinician relies heavily on blood (or rarely other body fluid) glucose values for decision making, an understanding of the basic aspects of glucose measurement in body fluids is necessary. Methods A literature search was conducted in PubMed for articles in English on measurement of glucose in body fluids. Results Glucose can be measured in several body fluids, namely blood, interstitial fluid, urine, cerebrospinal fluid, pleural fluid and ascitic fluid in appropriate clinical settings. For blood glucose measurement, the present-day enzymatic methods have replaced the older reducing and condensation methods on account of their better accuracy. It is important to consider preanalytical factors such as sample collection, storage and transport when analyzing a laboratory blood glucose report. The measurement of glucose in interstitial fluid using continuous glucose monitoring system (CGMS) enables better understanding of glucose trends and fluctuations. The CGMS data should be reported using standard metrics which include parameters such as mean 24-h glucose, glycemic variability and time-in, below and above range. The measurement of glucose in urine sample is rarely ever used these days and should be reserved for exceptional circumstances. Conclusion This review provides a detailed account of various aspects of glucose measurement including their evolution, pitfalls, and their utility in current clinical practice.

Background and aims The coronavirus disease 2019 (COVID-19) pandemic has immensely strained healthcare systems worldwide. Diabetes has emerged as a major comorbidity in a large proportion of patients infected with COVID-19 and is associated with poor health outcomes. We aim to provide a practical guidance on screening of hyperglycemia in persons without known diabetes in low resource settings. Methods We reviewed the available guidelines on this subject and proposed an algorithm based on simple measures of blood glucose (BG) which can be implemented by healthcare workers with lesser expertise in low resource settings. Results We propose that every hospitalized patient with COVID-19 infection undergo a paired capillary BG assessment (pre-meal and 2-h post-meal). Patients with pre-meal BG, Highlights • In-patient hyperglycemia is associated with poor clinical outcomes, especially in patients with undiagnosed diabetes. • We propose an algorithm for screening of in-patient hyperglycemia in low resource settings. • This algorithm should be researched further in low resource and other settings.

Background There is little data on the prevalence and effects of eating disorders in patients with T2DM. Aims To evaluate the presence of eating disorders (ED) and their association with glycemic control and metabolic parameters in adult patients with type 2 diabetes mellitus (T2DM). Methods A cross-sectional study was conducted in the endocrinology outpatient unit of our tertiary care centre between January 2017 to December 2018. Eating Attitudes Test (EAT-26) and Binge Eating Scale (BES) questionnaires were used to screen for ED in adults with T2DM (group 1) and controls without T2DM (group 2). Cut off scores ≥18 on BES was considered as a positive screen for Binge eating disorder in participants with and without T2DM. A score of ≥30 on EAT-26 was defined as abnormal for participants with T2DM and ≥20 for those without T2DM. Formal psychiatric assessment was done to diagnose ED in those who screened positive on the basis of scores on BES or EAT-26 or both. Demographic, anthropometric and relevant medical details like duration of treatment, glycemic control, complications were recorded. Results A total of 512 individuals (256 in each group) participated in this study. Out of these, 10.9% of individuals with T2DM and 14.1% of those without T2DM screened positive for ED, with no significant difference in the two groups. After a detailed psychiatric assessment, two patients (0.8%) in each group were confirmed to have ED. Participants with T2DM who were on thiazolidinediones had higher odds (2.2) of screening positive for an ED.(p = 0.03). Conclusions Our study reveals that eating disorders are not very common in our clinical population of T2DM, and the prevalence is comparable to BMI matched individuals without T2DM. The prevalence rates of eating disorders are lower (in both controls and patients with T2DM) than those reported from developed western countries.

Background: This study was designed to evaluate the effectiveness of a yoga-based exercise program (YBEP) in improving glycemic control in people with type 2 diabetes mellitus. Materials and Methods: Patients on stable oral glucose-lowering agents for at least 3 months and HbA1c 7.5%–10% were randomized in 1:1 ratio. The primary outcome measure was the difference of change in mean HbA1c between groups. Results: The participants (n = 81) had mean (±standard deviation) age of 50.6 (±8.5) years and HbA1c of 8.5 ± 0.7% (68.97 ± 7.42 mmol/mol). The follow-up data were available in 96% (78/81) of participants. Of 40 participants, 25 (62.5%) attended ≥75% (≥10 out of 13) of the sessions in YBEP. On the intention to treat analysis, a favorable reduction (0.21% 95% confidence interval [−0.34, 0.75], P = 0.454) in HbA1c was seen in YBEP group as compared to usual care. The reduction in HbA1c by ≥0.5% was observed in 44.7% of participants in YBEP as compared to 37.5% in usual care arm, respectively. Those who attended ≥75% of the sessions had better HbA1c reduction of 0.3% in comparison to 0.1% reduction seen in those who attended 0.5% in 44.7% in the yoga group, suggests, that it can be prescribed as an exercise to individuals who are unable to walk either due to limited joint mobility, adverse weather conditions, lack of space for walking, cultural or religious prohibitions for women for outdoor physical activity, and so on. CTRI registration no: CTRI/2017/05/008564.

Objectives To evaluate if the parental origin of X-chromosome has an impact on the phenotype and biochemical profile in Turner syndrome (TS). Result of the previous studies have been equivocal and could be attributable to the multicentric study design with different experts examining heterogeneous TS population of various ethnic background. Methods A cross-sectional single center study from Northern India. Fifty nine diagnosed subjects of TS and their parents participated in the study. Parental origin of intact X-chromosome was determined using 12 highly polymorphic short tandem repeats (STR) on X-chromosome. For the evaluation of parent-of-origin effects, typical phenotypic traits including congenital malformations, anthropometry, body composition by dual energy X-ray absorptiometry (DXA) and biochemical profile were compared. Clinical stigmata of TS in all subjects were examined by a single expert. Results The intact X-chromosome was of maternal origin (Xm) in 49.1% subjects while 50.9% had paternal origin (Xp). Skeletal anomalies were more common in Xm group, out of which prevalence of short neck and short fourth metatarsal reached statistical significance (p=0.04 and 0.01 respectively). A strong correlation was observed between subject’s baseline height standard deviation score (Ht SDS) and paternal height (r=0.593, pp group. This effect was not seen in Xm subjects whose baseline Ht SDS showed no significant correlation with maternal height, paternal height or MPH. No differences were detected between the groups with regard to biochemical profile or body composition. Conclusions We speculate that the differences in skeletal anomalies and height correlations between Xm and Xp groups could be due to the modifying effect of epigenetic signature on short stature homeobox (SHOX) gene of Xm. SHOX gene is not modified on Xp thereby explaining the paucity of skeletal changes and height correlations in Xp subjects.

AIM To evaluate the burden and association of cardiometabolic risk factors in the spouses of women with and without hyperglycaemia in pregnancy. METHODS Women with (n = 204) and without (n = 197) hyperglycaemia in pregnancy, along with their spouses, participated in this cross-sectional study. The hyperglycaemia in pregnancy group included women with gestational diabetes and diabetes in pregnancy. A detailed questionnaire was completed for all participants (men and women), documenting relevant personal and medical history, along with biochemical investigations (men). RESULTS A total of 401 couples were evaluated at the time point during the pregnancy of 24.7 ± 5.2 gestational weeks (mean ± sd). Dysglycaemia (prediabetes or diabetes), overweight/obesity (BMI ≥25 kg/m2 ) and metabolic syndrome were detected in 120 (58.9%), 123 (60.3%) and 98 spouses (48.3%) of women with hyperglycaemia in pregnancy, respectively. In the fully adjusted model, an increased risk of dysglycaemia [odds ratio 1.43 (95% CI 0.95-2.17); P = 0.088], overweight/obesity [odds ratio 1.49 (95% CI 0.98-2.27); P = 0.064] and metabolic syndrome [odds ratio 2.00 (95% CI 1.30-3.07); P = 0.001] was seen in the spouses of women with hyperglycaemia in pregnancy. The prevalence of these metabolic conditions was higher in spouses of women with diabetes in pregnancy compared to spouses of women with gestational diabetes mellitus. CONCLUSIONS A high burden of cardiometabolic risk factors was observed in the spouses of women with hyperglycaemia in pregnancy. The opportunity provided by pregnancy could be used by the healthcare system not only to improve the health of the woman and her offspring, but also her spouse.

Background Hypothyroidism is frequently found to be associated with morbid obesity. Effect of bariatric surgery on type 2 diabetes, hypertension, and sleep apnea has been studied extensively but there is a dearth of literature on its impact on thyroid function. We had published our experience of laparoscopic sleeve gastrectomy and its effect on hypothyroidism in morbidly obese patients previously. In this study, we have tried to evaluate the impact of bariatric surgery on the whole cohort of hypothyroid patients and compare the effect of various bariatric procedures on thyroid hormone replacement dose. Objective To assess outcome of bariatric surgery on the hypothyroid patients and to compare the outcomes of laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, and one-anastomosis gastric bypass in terms of reduction of thyroid hormone replacement dosage. Setting Tertiary care University Hospital, India; Government Practice. Methods This is a retrospective analysis of a database of all bariatric procedures done in a single unit at a tertiary care teaching hospital in India. Morbidly obese patients with hypothyroidism on thyroxine replacement were identified and their preoperative and postoperative thyroid hormone replacement dosage (THR) and thyroid stimulating hormone levels were compared. Results Of 883 patients undergoing bariatric surgery, 180 patients were hypothyroid (on thyroxine replacement). Ninety-three patients were included in the final analysis. The mean age of the study population was 42.2 ± 10.4 years and the mean preoperative body mass index was 47.8 ± 8.3 kg/m2. Mean follow-up duration was 29.8 ± 19.6 months. The excess weight loss was 58.9%. Fifty-two (55.8%) patients had a decrease in the in THR dosage, 37 (39.8%) had no change in THR dosage, and 4 patients required an increase in THR dosage. Decrease of THR dose was observed in 61.7% patients in laparoscopic sleeve gastrectomy in comparison to 45.4% in bypass group. Conclusion Bariatric surgery might cause reduction of thyroid replacement dosage in hypothyroid, morbidly obese patients.

Introduction This study was designed to investigate the effectiveness of a video-based lifestyle education program (VBLEP) in improving glycemic control in people with type 2 diabetes mellitus compared with usual care. Methods Patients on stable oral glucose-lowering agents for at least 3 months and HbA1c 7.5–10% were randomized in a 1:1 ratio. Primary outcome measure was the difference in change in mean HbA1c between groups. Results The participants (n = 81) had mean (± SD) age of 50.1 (± 9.4) years and HbA1c of 8.5 ± 0.7% (68.87 ± 7.56 mmol/mol). The follow-up data were available in 96% (78/81) of participants. Of 40 participants, 36 (90%) attended ≥ 75% (≥ 3 out of 4) of the sessions in the VBLEP. In the intention-to-treat analysis, a significant reduction [0.6% 95% CI (0.1, 1.1), p = 0.013] in HbA1c was seen in the VBLEP group compared with usual care. A ≥ 1% reduction in HbA1c was observed in 39.5% of participants in the VBLEP compared with 15% in the usual care arm. However, a ≥ 0.5% reduction in HbA1c was observed in 65.8% of participants in the VBLEP compared with 37.5% in the usual care arm (p = 0.012). There was a significant change in weight and body mass index in the VBLEP group compared with usual care. The participants who were employed, had a family history of diabetes, had no diabetes-related complications, and were in the VBLEP group had higher odds of having a favorable HbA1c reduction (≥ 0.5%, combined analysis both groups) from baseline. Conclusion The VBLEP demonstrated a significant and clinically relevant HbA1c reduction compared with usual care. A simple VBLEP, when delivered in an interactive manner, can aid in improving glycemic outcomes in the Indian population. Trial Registration CTRI/2017/05/008564.

Multiple endocrine neoplasia type 1 (MEN1) syndrome is characterized by combined occurrence of tumors of endocrine glands including the parathyroid, the pancreatic islet cells, and the anterior pituitary gland. Parathyroid involvement is the most common manifestation and usually the first clinical involvement in MEN1 syndrome, followed by gastroentero-pancreatic neuroendocrine tumors (NETs). Here we present a case where the patient initially presented with metastatic gastric NET and a single parathyroid adenoma was detected incidentally on (68)Ga-DOTANOC PET/CT done as part of post (177)Lu-DOTATATE therapy (PRRT) follow-up. Further (18)F-fluorocholine PET/CT showed four adenomas for which the patient subsequently underwent subtotal parathyroidectomy.

Introduction To study the utility of glycated hemoglobin (HbA1c) in the diagnosis of diabetes in patients with cirrhosis as compared to the gold standard oral glucose tolerance test (OGTT) and to see the effect of anemia and severity of cirrhosis on its performance. Methods Individuals (n = 100) with an established diagnosis of liver cirrhosis were recruited. The OGTT was performed as described by the World Health Organization (WHO). The severity of cirrhosis was calculated using the Child–Turcotte–Pugh (CTP) score. The severity of anemia was defined according to WHO criteria. The utility of HbA1c was compared against the OGTT results. Test sensitivity and specificity were used to describe the diagnostic accuracy of HbA1c. Results A total of 100 subjects aged 46.9 ± 9.1 years (mean ± standard deviation) participated in the study, of whom 65% were recruited from out patient department of our hospital. The overall sensitivity and specificity of a HbA1c level of ≥ 6.5% for the diagnosis of diabetes in patients with cirrhosis was 77.1% (95% CI 59.9, 89.6) and 90.8% (95% CI 81.0, 96.5), respectively. The positive and negative predictive values were 81.8% (95% CI 67.3, 90.8) and 88.1% (95% CI 80.0, 93.2), respectively. The area under the curve was 0.85 (95% CI 0.75–0.94). The sensitivity of HbA1c for diagnosing diabetes in outpatients was 87.0% (95% CI 66.4, 97.2) and was better than that for diagnosing diabetes in hospitalized patients (58.3%; 95% CI 27.7, 84.8). The sensitivity of HbA1c for diagnosing diabetes was poor in patients with moderate to severe anemia. The difference in sensitivity and specificity was not statistically different for CTP classes A, B and C. The prevalence of diabetes as defined by American Diabetes Association OGTT criteria was 35% (95% CI 25.7–45.2%). Conclusions Taking OGTT as the gold standard, the sensitivity of HbA1c for diagnosing diabetes is good when used in outpatients with cirrhosis. However, the sensitivity of HbA1c decreases when it is used for hospitalized patients, suggesting that it is not a good test for diagnosis of diabetes in such cases. It also performs poorly if the patient has moderate to severe anemia.

Background We aim to provide a practical guidance on the use of intravenous insulin infusion for managing inpatient hyperglycemia. Methods and results This document was formulated based on the review of available literature and personal experience of authors. We have used various case scenarios to illustrate variables which should be taken into account when deciding adjustments in infusion rate, including but not restricted to ambient blood glucose level and magnitude of blood glucose change in the previous hour. Conclusion The guidance can be generalized to any situation where dedicated protocols are lacking, trained manpower is not available and resource constraints are present.

Key Messages: Octreotide can be used as an adjunctive therapy to increase phosphorus levels in patients with tumor-induced osteomalacia. Malignant phosphaturic mesenchymal tumor (PMT) may benefit from treatment with peptide receptor radionucleotide therapy. Context: The success of treatment modalities for malignant PMT is limited. Octreotide has been used to treat hypophosphatemia in patients with tumor-induced osteomalacia with equivocal results. To our knowledge, there are no reports of octreotide or peptide receptor radionuclide therapy use for malignant PMT. Case Description: We report a 40-year-old man having hypophosphatemia, phosphaturia (tubular maximum of phosphorus corrected for glomerular filtration rate of, Octreotide was used in osteomalacia caused by a malignant phosphaturic tumor, with moderate results; peptide receptor radionuclide therapy with 177Lutetium then produced a moderate response lasting 6 months.

Background: Residents' perception on quality of endocrinology training in India is not known. This study aimed to evaluate the perceptions about endocrinology residency programs in India among current trainees as compared to practicing endocrinologists. Methods: Trainees attending a preconference workshop at the annual conference of Endocrine Society of India (ESI) were given a questionnaire designed to evaluate their perceptions on their training. These evaluated the reasons for choosing endocrinology, their experiences during residency, and career plans. Practicing endocrinologists attending ESICON with at least 5-year experience were evaluated as controls. Results: Questionnaires from 63 endocrine trainees and 78 practicing endocrinologists were analyzed. Endocrinology is perceived to be the super-specialty with the best quality of life (QOL) but fair with regard to financial remuneration. Among current trainees, 61.89%, 31.74%, and 34.91% are satisfied with training in clinical endocrinology, laboratory endocrinology, and clinical/translational research, respectively. The corresponding figures for practicing endocrinologists are 71.78%, 25.63%, and 30.75%, respectively. Exposure to national endocrinology conferences during their endocrinology residency was adequate. However, exposure to international endocrinology conferences, research publications, project writing, and grant application are limited. Laboratory endocrinology is rated as the most neglected aspect during endocrine residency. Most of the trainees want to establish their own clinical practice in the long run. Very few trainees (17.46%) wish to join the medical education services. Conclusion: There is a good perception of QOL in endocrinology in spite of average financial remuneration. There is dissatisfaction with the quality of training in laboratory endocrinology and clinical research. Very few endocrine trainees consider academics as a long-term career option in India.

Familial hypercholesterolemia (FH) is an autosomal dominant disorder due to mutation of apolipoprotein-B receptor gene causing severe dyslipidemia. Lifestyle modification and medical treatment attenuate the disease progression, but as these fail to control the blood cholesterol levels, low-density lipoprotein (LDL) apheresis comes forth as a treatment option. To the best of our knowledge, the following is the very first case of pediatric FH being treated by LDL-apheresis to be reported from India. A severely malnourished female child presented with yellowish skin lesions over different parts of the body, viz., bilateral Achilles tendon, both knees, elbows, both pinnae, and outer canthus of both eyes. She had a strong family history of borderline hypercholesterolemia and was diagnosed as a case of FH. She was maintained on diet modification. LDL-apheresis was planned as the cholesterol levels were not controlled with the diet modificationt. However, unavailability of an appropriate kit in India for LDL-apheresis led to the use of the modified PL1 kit meant for therapeutic plasma exchange procedures. We conducted two sessions of LDL-apheresis. After the first session, the LDL-cholesterol (LDL-C) level fell by 75.9% and the total cholesterol fell by 73.5%. A second procedure led to a decline in total cholesterol level by 18.6% and LDL-C by 19.46%. Subsequently, she was advised diet modification and statin therapy with regular follow-up after every 6 months. Thus, the cascade filtration technique is a safe and effective treatment option for removing the undesired lipoproteins.

Background: Anxiety has been shown to be associated with poor outcomes in people with diabetes. However, there has been limited data, especially from India, which has specifically examined whether diabetes mellitus is associated with an increased likelihood of comorbid anxiety. Aim: The aim was to estimate the prevalence of anxiety in patients with diabetes and to determine the association of anxiety with age, sex, and other related parameters. Setting: Endocrine clinic, tertiary care hospital. Design: Cross-sectional. Materials and Methods: The study was cross-sectional carried out in endocrinology clinic of tertiary care hospital in North India. Cases were patients with type 2 diabetes mellitus above 30 years of age. Anxiety was assessed using the generalized anxiety disorders 7-item (GADs-7) scale. The relationship with a sociodemographic profile, duration of diabetes, hypertension, and microvascular complications was also analyzed. Results: Seventy-three subjects (42.5% females) with mean age 50.8 ± 9.2 years were evaluated. The prevalence of anxiety was 34%. Severe anxiety (GAD-7 score ≥15) was present in three (4%) subjects, moderate anxiety (GAD-7 score ≥10) was present in six (8%) subjects, and mild anxiety was present in 16 (22%) of subjects. Anxiety increased with fasting plasma glucose, hypertension, was more in women, but the differences were not statistically significant. Conclusions: Our study demonstrates a higher prevalence of anxiety in patients with type 2 diabetes. No factor was significantly associated with anxiety. Therefore, anxiety should be assessed in each and every patient, irrespective of other factors.

AimTo evaluate the feasibility and potential effectiveness of a lifestyle intervention (diet and physical activity) among women with history of gestational diabetes mellitus (GDM), delivered by trained facilitators.MethodsFifty-six normoglycaemic or prediabetic women with prior GDM were recruited at mean of 17 months postpartum. Socio-demographic, medical and anthropometric data were collected. Six sessions on lifestyle modification were delivered in groups (total four groups, with 12–15 women in each group). Pre and post intervention (6 months) weight, body mass index (BMI), waist circumference, 75 g oral glucose tolerance test, blood pressure (BP) and lipid parameters were compared.ResultsThe intervention was feasible, with 80% of women attending four or more sessions. Post-intervention analyses showed a significant mean reduction of 1.8 kg in weight, 0.6 kg/m2 in BMI and 2 cm in waist circumference. There was also a significant drop of 0.3 mmol/L in fasting plasma glucose, 0.9 mmol/L in 2 h post glucose load value of plasma glucose, 3.6 mmHg in systolic BP, and 0.15 mmol/L in triglyceride levels. Changes in total cholesterol, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol and diastolic BP were non-significant.ConclusionsThis study showed feasibility of the lifestyle intervention delivered in group sessions to women with prior gestational diabetes.

IntroductionThe development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective.Methods and analysisThe Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie’s Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive sampling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders.Ethics and disseminationEthics approval has been obtained from the respective human research ethics committees of the All India Institute of Medical Sciences, New Delhi, India; University of Sydney, New South Wales, Australia; and site-specific approval at each local site in the three countries: India, Bangladesh and Sri Lanka. This includes approvals from the Institutional Ethics Committee at King Edwards Memorial Hospital, Maharaja Agrasen Hospital, Centre for Disease Control New Delhi, Goa Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Diabetes Research Foundation, Christian Medical College Vellore, Fernandez Hospital Foundation, Castle Street Hospital for Women, University of Kelaniya, Topiwala National Medical College and BYL Nair Charitable Hospital, Birdem General Hospital and the International Centre for Diarrhoeal Disease Research. Findings will be documented in academic publications, presentations at scientific meetings and stakeholder workshops.Trial registration numbersClinical Trials Registry of India (CTRI/2017/06/008744); Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov Registry (NCT03305939); Pre-results.

Aim We studied women between 8 and 20 weeks of gestation with the aim of evaluating and comparing those having normoglycemia and GDM according to WHO 2013 criteria. Methods In this cross-sectional study (2017–2019), eligible pregnant women underwent a 75-g OGTT, followed by placement of a CGMS. Results Women (n = 96, 58 with normoglycemia and 38 with GDM) were enrolled at 14.0 ± 3.2 weeks of gestation. Mean preprandial, 1-h and 2-h postprandial and peak glucose values were significantly higher in women with GDM. Peak glucose value was achieved 60.0 ± 12.3 and 64.3 ± 11.6 min after meal in the normoglycemia and GDM group, respectively. 24-h mean glucose (5.8 ± 0.6 vs. 5.3 ± 0.4 mmol/L), mean daytime glucose (6.0 ± 0.6 vs. 5.5 ± 0.4 mmol/L) and mean nocturnal glucose (5.4 ± 0.7 vs. 5.0 0 ± 0.5 mmol/L) were significantly higher in women with GDM. Total time spent in range was significantly lower in the GDM group compared to the normoglycemia group (92.1 vs. 98.2%). Conclusions This study highlights differences in glycemic patterns between women with normoglycemia and GDM in the context of a South Asian population where burden of GDM is high but good quality data in early pregnancy are limited.

© 2016 Diabetes UK Aim: To investigate the distribution of and risk factors for dysglycaemia (Type 2 diabetes and prediabetes) in women with previous gestational diabetes mellitus in India. Methods: All women (n = 989) from two obstetric units in New Delhi and Hyderabad with a history of gestational diabetes were invited to participate, of whom 366 (37%) agreed. Sociodemographic, medical and anthropometric data were collected and 75-g oral glucose tolerance test were carried out. Results: Within 5 years (median 14 months) of the pregnancy in which they were diagnosed with gestational diabetes, 263 (72%) women were dysglycaemic, including 119 (32%) and 144 (40%) with Type 2 diabetes and prediabetes, respectively. A higher BMI [odds ratio 1.16 per 1-kg/m2 greater BMI (95% CI 1.10, 1.28)], presence of acanthosis nigricans [odds ratio 3.10, 95% CI (1.64, 5.87)], postpartum screening interval [odds ratio 1.02 per 1 month greater screening interval 95% CI (1.01, 1.04)] and age [odds ratio 1.10 per 1-year older age 95% CI (1.04, 1.16)] had a higher likelihood of having dysglycaemia. The American Diabetes Association-recommended threshold HbA1c value of ≥ 48 mmol/mol (6.5%) had a sensitivity and specificity of 81.4 and 90.7%, respectively, for determining the presence of Type 2 diabetes postpartum. Conclusion: The high post-pregnancy conversion rates of gestational diabetes to diabetes reported in the present study reinforce the need for mandatory postpartum screening and identification of strategies for preventing progression to Type 2 diabetes. Use of the American Diabetes Association-recommended HbA1c threshold for diabetes may lead to significant under-diagnosis.

This communication explores the concept of flexibility, a propos insulin preparations and insulin regimes used in the management of type 2 diabetes. The flexibility of an insulin regime or preparation is defined as their ability to be injected at variable times, with variable injection-meal time gaps, in a dose frequency and quantum determined by shared decision making, with a minimal requirement of glucose monitoring and health professional consultation, with no compromise on safety, efficiency and tolerability. The relative flexibility of various basal, prandial and dual action insulins, as well as intensive regimes, is compared. The biopsychosocial model of health is used to assess the utility of different insulins while encouraging a philosophy of flexible insulin usage.

Facilities for measuring methotrexate (MTX) levels are not available everywhere, potentially limiting administration of high-dose methotrexate (HDMTX). We hypothesized that serum creatinine alteration after HDMTX administration predicts MTX clearance. Overall, 122 cycles in 50 patients of non-Hodgkin lymphoma or acute lymphoblastic leukemia aged ≤18 years receiving HDMTX were enrolled prospectively. Plasma MTX levels were measured at 12, 24, 36, 48, 60, and 72 hours; serum creatinine was measured at baseline, 24, 48, and 72 hours. Correlation of plasma MTX levels with creatinine levels and changes in creatinine from baseline (Δ creatinine) were evaluated. Plasma MTX levels at 72 hours showed positive correlation with serum creatinine at 48 hours (P = .011) and 72 hours (P = .013) as also Δ creatinine at 48 hours (P = .042) and 72 hours (P = .045). However, cut-off value of either creatinine or Δ creatinine could not be established to reliably predict delayed MTX clearance. Greater than 50% Δ creatinine at 48 and 72 hours significantly predicted grade 3/4 leucopenia (P = .036 and P = .001, respectively) and thrombocytopenia (P = .012 and P = .009, respectively) but not mucositis (P = .827 and P = .910, respectively). Delayed MTX elimination did not predict any grade 3/4 toxicity. In spite of demonstration of significant correlation between serum creatinine and Δ creatinine with plasma MTX levels at 72 hours, cut-off value of either variable to predict MTX delay could not be established. Thus, either of these cannot be used as a surrogate for plasma MTX estimation. Interestingly, Δ creatinine effectively predicted hematological toxicities, which were not predicted by delayed MTX clearance.

‘B eta-cell failure’ is a frequently used term to describe the structural and functional inability of the cells to fulfil their metabolic responsibility. This editorial reviews the anatomy and physiology of the beta cell, and describes factors which regulate this. The authors focus on semantics, comparing the phrases ‘beta-cell failure’, ‘functional mass’, and ‘beta-cell insufficiency’. They suggest the use of ‘beta-cell insufficiency’, with descriptors such as ‘partial’ and ‘complete’, or ‘reversible’ and ‘irreversible’, to convey betacell dysfunction in type 2 diabetes. A three-phase taxonomic structure: beta-cell sufficiency, partial/reversible beta-cell insufficiency and complete/irreversible beta-cell insufficiency, is proposed as a tool to understand pathophysiology and facilitate therapeutic decision-making.

Aim This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. Methods Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 ± 3 months postpartum and those without Type 2 diabetes, a total sample size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional individual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes; or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. Discussion The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry No: SLCTR/2017/001; and ClinicalTrials.gov Identifier No: NCT03305939).

Background Incidence of imatinib-induced toxicity and its influence on clinical outcomes in Indian patients with CML is not well-studied. We investigated the influence of imatinib-induced toxicity on therapeutic outcomes in newly diagnosed patients with CML. We also studied the effect of drug levels on imatinib-induced hematological toxicity. Methods Two hundred and fifty newly diagnosed patients with chronic-phase CML, started on imatinib therapy, were enrolled and followed-up for 24 months. Toxicity due to imatinib were assessed and graded as per CTCAE. Cytogenetic and molecular responses were assessed by conventional bone-marrow cytogenetics and qRTPCR using international scale, respectively, based on which patients were categorized as imatinib responders and non-responders. Imatinib trough levels were measured using LC-MS/MS. Multivariate analysis was done to find the influence of various covariates on imatinib response. Results A total of 719 adverse reactions due to imatinib occurred among 250 enrolled patients. Hematological toxicity was the most common imatinib-induced toxicity and its incidence was significantly higher in non-responders than responders (65% vs. 35%; P Conclusions Imatinib induced hematological toxicities significantly influence cytogenetic and molecular response in patients with CML. Active monitoring and prompt management of imatinib induced adverse events is indispensable to achieve optimal therapeutic outcomes. Clinical trial identification Not Applicable. Editorial acknowledgement Not Applicable. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Diabetes mellitus is associated with a variety of musculoskeletal (MSK) manifestations affecting the hand, which can significantly affect a patient’s quality of life. While a great deal of attention is paid to the chronic microvascular complications of diabetes, the MSK complications are often ignored in clinical practice. It is important to diagnose them as their presence has been found to correlate with chronic microvascular complications of diabetes especially retinopathy. We describe a case of a young male with long-standing type 1 diabetes mellitus and chronic microvascular complications, who presented to us with several manifestations of diabetic hand syndrome.

Coformulations are a novel pharmaceutical development in diabetology. They are composed of two medicinal products, both of which maintain their distinct pharmacokinetic and pharmacodynamic properties. Currently available coformulations include combinations of basal and rapid-acting insulin, and basal and glucagon-like peptide 1 receptor agonists (GLP1RA). This review describes three coformulations which are in advanced stages of development, or are approved in certain markets. We discuss the basic and clinical pharmacology of these drugs, while describing clinical usage of the commercially available insulin degludec aspart (IDegAsp). Electronic supplementary material The online version of this article (doi:10.1007/s13300-015-0106-2) contains supplementary material, which is available to authorized users.

The sodium-glucose cotransporter 2 (SGLT-2) inhibitors are a novel class of glucose-lowering drugs which act by inhibiting the reabsorption of filtered glucose from the kidneys. Their effect on insulin and glucagon levels has recently been studied but is not fully explained. This communication proposes various hypotheses: A direct effect of SGLT-2 inhibition on the alpha cell receptors, a paracrine or intra-islet mediated effect on alpha cell sensitivity to glucose, and a calorie restriction mimetic action, to explain the impact of these drugs on the insulin glucagon ratio.