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Insulin Glargine in Type 1 Diabetes Mellitus: A Review of Clinical Trials and Real-world Evidence Across Two Decades.
Saboo, B, Chandalia, H, Ghosh, S, Kesavadev, J, Kochar, IPS, Prasannakumar, KM, Sarda, A, Bantwal, G, Mehrotra, RN, Rai, M
Current diabetes reviews. 2024;(1):e100323214554
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Abstract
BACKGROUND Over the past two decades, insulin glargine 100 U/mL (Gla-100) has emerged as the "standard of care" basal insulin for the management of type 1 diabetes mellitus (T1DM). Both formulations, insulin glargine 100 U/mL (Gla-100) and glargine 300 U/mL (Gla- 300) have been extensively studied against various comparator basal insulins across various clinical and real-world studies. In this comprehensive article, we reviewed the evidence on both insulin glargine formulations in T1DM across clinical trials and real-world studies. METHODS Evidence in T1DM for Gla-100 and Gla-300 since their approvals in 2000 and 2015, respectively, were reviewed. RESULTS Gla-100 when compared to the second-generation basal insulins, Gla-300 and IDeg-100, demonstrated a comparable risk of overall hypoglycemia, but the risk of nocturnal hypoglycemia was higher with Gla-100. Additional benefits of Gla-300 over Gla-100 include a prolonged (>24- hours) duration of action, a more stable glucose-lowering profile, improved treatment satisfaction, and greater flexibility in the dose administration timing. CONCLUSION Both glargine formulations are largely comparable to other basal insulins in terms of glucose-lowering properties in T1DM. Further, risk of hypoglycemia is lower with Gla-100 than Neutral Protamine Hagedorn but comparable to insulin detemir.
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Expert Consensus Recommendations on Time in Range for Monitoring Glucose Levels in People with Diabetes: An Indian Perspective.
Mohan, V, Joshi, S, Mithal, A, Kesavadev, J, Unnikrishnan, AG, Saboo, B, Kumar, P, Chawla, M, Bhograj, A, Kovil, R
Diabetes therapy : research, treatment and education of diabetes and related disorders. 2023;(2):237-249
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Keeping up with the global scenario, diabetes prevalence is on rise in India. Inadequate glycemic control is a major cause of diabetes-related morbidity and mortality. The conventional standards of care (SOC) in diabetes, including self-monitoring of blood glucose and measurement of glycated hemoglobin, have supported achievement of glycemic control, yet there are a few limitations. With the use of current technologies and metrics, such as continuous glucose monitoring (CGM) and standardized CGM data reporting, the continuous real-time glucose levels can be measured, and importantly, the percentage of time above, below, and within the target glucose range can be calculated, which facilitates patient-centric care, a current goal in diabetes management. International consensus recommendations endorse the incorporation of CGM and CGM data reporting in SOC for diabetes management. The guidelines provide time in range (TIR) thresholds for different patient populations and different types of diabetes. However, extrapolation of these global guidelines does not aptly cover the Indian population, which has diverse diet, culture, and religious practices. In this context, a consensus meeting was held in India in 2021 with experts in the field of diabetes care. The purpose of the meeting was to develop consensus recommendations for TIR thresholds for different patient profiles in India. Those expert recommendations, together with an evidence-based review, are reported here. The aim of this agreement is to aid clinicians across India to routinely use CGM and CGM data reports for optimizing individualized diabetes care, by implementing clinical targets for TIR.
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Type 2 Diabetes in Women: Differences and Difficulties.
Kesavadev, J, Abraham, G, Chandni, R, Chawla, P, Nambiar, A, Deshpande, N, Joshi, S, Jothydev, S, Krishnan, G, Das, AK
Current diabetes reviews. 2022;(8):e081221198651
Abstract
BACKGROUND Lifestyle modification, along with medication, has improved the quality of life of patients with type 2 diabetes (T2D), but the treatment of diabetes in women still lacks a gender-centric approach. METHODS Expert opinions to improve diabetes management in women were collated from the open discussion forum organized by the sixth Jothydev's Professional Education Forum Diabetes Convention, which included global diabetes care experts and the general public. The review is also based on the studies published in electronic databases such as PubMed and Google Scholar that discussed the problems and challenges faced by the Indian diabetes care sector in treating women with diabetes. RESULTS The complex interplay of biological, socioeconomic, psychosocial, and physiological factors in women with type 2 diabetes has not been well addressed to date. Biological factors such as neurohumoral pathways, sex hormones, genetic predisposition as well as gender-based environmental and behavioural differences must be considered for modern personalized diabetes treatment. Most importantly, pregnant women with diabetes deserve special attention. This vulnerable phase has a marked impact on the future health of both the mother and the offspring. CONCLUSION The review provides an overview of the challenges and issues that exist in the clinical management of diabetes and its complications among women in India. Women-centric clinical approaches should be encouraged for the effective management of diabetes in Indian women.
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Role and importance of high fiber in diabetes management in India.
Saboo, B, Misra, A, Kalra, S, Mohan, V, Aravind, SR, Joshi, S, Chowdhury, S, Sahay, R, Kesavadev, J, John, M, et al
Diabetes & metabolic syndrome. 2022;(5):102480
Abstract
BACKGROUND & AIMS India is facing a triple burden of pre-diabetes, diabetes, and obesity. Unhealthy eating habits and physical inactivity have been linked to the onset and progression of type 2 diabetes mellitus (T2DM). Despite dietary recommendations, individuals consume inadequate amounts or unsuitable type of dietary fiber (DF) which needs correction. An Expert group attempted to review and report on the role and importance of high DF in the management of T2DM and offer practical guidance on high fiber use in daily diet. METHODOLOGY Twelve diabetologists and two expert dietitians from India were chosen to ensure diversity of the members both in professional interest and cultural background. The authors convened virtually for one group meeting and actively participated in a detailed discussion. Multiple reviews of the draft document followed by focused teleconference calls & email helped to reach consensus on final recommendations between Aug 2021 and Dec 2021. RESULTS Evidence has shown that medical nutrition therapy (MNT) is a valuable approach and an essential component of T2DM prevention and management. Studies have shown that fiber rich diabetes nutrition (FDN) has multi-systemic health benefits, including, improvement in glycemic control, reduction in glucose spikes, decrease in hyperinsulinemia, improvement in plasma lipid concentrations and weight management in T2DM patients. CONCLUSION A high fiber diet is vital for people with diabetes and associated conditions. Increasing fiber intake, preferably through food or through dietary supplement, may help. Fiber rich diabetes nutrition (FDN) is recommended in order to prevent and manage T2DM.
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Sodium-glucose Cotransporter-2 Inhibitors in Primary and Secondary Prevention of Cardiovascular and Renal Outcomes in Patients with Type 2 Diabetes Mellitus: A Meta-analysis.
Kovil, R, Chawla, M, Shah, T, Sahoo, A, Makkar, B, Kesavadev, J, Seshadri, K, Tiwaskar, M, Rajput, R, Phatak, S, et al
The Journal of the Association of Physicians of India. 2022;(8):11-12
Abstract
BACKGROUND The available evidence was systematically reviewed to evaluate the effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors (SGLT2i) on cardiovascular (CV) and renal outcomes in people with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors (MRF), with or without heart failure (HF), and per estimated glomerular filtration rate (eGFR) rate at baseline. METHODS We comprehensively searched three electronic databases to retrieve publications up to 30th November 2019, which were screened for inclusion. The data extracted for the outcomes according to baseline ASCVD, HF, and eGFR levels were meta-analyzed using fixed effects model. RESULTS Of the 735 screened citations, 15 primary and secondary publications from five CV or renal outcome trials were included. SGLT2is reduced the risk of CV death or hospitalization for HF (HHF), HHF alone, and composite renal-specific outcome, irrespective of ASCVD and HF at baseline. The three-point major adverse cardiovascular events (3P-MACE) risk was reduced by 14% (p<0.001) in patients with ASCVD and by 10% (p = 0.018) in those without baseline HF compared with their counterparts. SGLT2is significantly reduced the risk of MACE (18%) in patients with mild kidney dysfunction (eGFR within the range of 60-<90 mL/min/1.73 m2 and <60 mL/min/1.73 m2 ). CONCLUSION SGLT2is are effective for both secondary and primary prevention of composite CV outcomes, and secondary prevention of MACE. The upcoming evidence may strengthen the primary prevention benefits of SGLT2is.
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Time-in-range and frequency of continuous glucose monitoring: Recommendations for South Asia.
Kesavadev, J, Misra, A, Saboo, B, Agarwal, S, Sosale, A, Joshi, SR, Hussain, A, Somasundaram, N, Basit, A, Choudhary, P, et al
Diabetes & metabolic syndrome. 2022;(1):102345
Abstract
BACKGROUND AND AIM The prevalence of diabetes is on its rise and South Asia bears a huge burden. Several factors such as heterogeneity in genetics, socio-economic factors, diet, and sedentary behavior contribute to the heightened risk of developing diabetes, its rapid progression, and the development of complications in this region. Even though there have been considerable advances in glucose monitoring technologies, diabetes treatments and therapeutics, glycemic control in South Asia remains suboptimal. The successful implementation of treatment interventions and metrics for the attainment of glycemic goals depends on appropriate guidelines that accord with the characteristics of the diabetes population. METHOD The data were collected from studies published for more than the last ten years in the electronic databases PubMed and Google Scholar on the various challenges in the assessment and achievement of recommended TIR targets in the SA population using the keywords: Blood glucose, TIR, TAR, TBR, HbA1c, hypoglycemia, CGM, Gestational diabetes mellitus (GDM), and diabetes. RESULTS The objective of this recommendation is to discuss the limitations in considering the IC-TIR Expert panel recommendations targets and to propose some modifications in the lower limit of TIR in older/high-risk population, upper limit of TAR, and flexibility in the percentage of time spent in TAR for pregnant women (GDM, T2DM) for the South Asian population. CONCLUSION The review sheds insights into some of the major concerns in implementing the IC-TIR recommendations in South Asian population where the prevalence of diabetes and its complications are significantly higher and modifications to the existing guidelines for use in routine clinical practice.
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Blood glucose levels should be considered as a new vital sign indicative of prognosis during hospitalization.
Kesavadev, J, Misra, A, Saboo, B, Aravind, SR, Hussain, A, Czupryniak, L, Raz, I
Diabetes & metabolic syndrome. 2021;(1):221-227
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BACKGROUND AND AIMS The measurement of vital signs is an important part of clinical work up. Presently, measurement of blood glucose is a factor for concern mostly when treating individuals with diabetes. Significance of blood glucose measurement in prognosis of non-diabetic and hospitalized patients is not clear. METHODS A systematic search of literature published in the Electronic databases, PubMed and Google Scholar was performed using following keywords; blood glucose, hospital admissions, critical illness, hospitalizations, cardiovascular disease (CVD), morbidity, and mortality. This literature search was largely restricted to non-diabetic individuals. RESULTS Blood glucose level, even when in high normal range, or in slightly high range, is an important determinant of morbidity and mortality, especially in hospitalized patients. Further, even slight elevation of blood glucose may increase mortality in patients with COVID-19. Finally, blood glucose variability and hypoglycemia in critically ill individuals without diabetes causes excess in-hospital complications and mortality. CONCLUSION In view of these data, we emphasize the significance of blood glucose measurement in all patients admitted to the hospital regardless of presence of diabetes. We propose that blood glucose be included as the "fifth vital sign" for any hospitalized patient.
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Effects of a Technology-Assisted Integrated Diabetes Care Program on Cardiometabolic Risk Factors Among Patients With Type 2 Diabetes in the Asia-Pacific Region: The JADE Program Randomized Clinical Trial.
Lim, LL, Lau, ESH, Fu, AWC, Ray, S, Hung, YJ, Tan, ATB, Chamnan, P, Sheu, WHH, Chawla, MS, Chia, YC, et al
JAMA network open. 2021;(4):e217557
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IMPORTANCE Many health care systems lack the efficiency, preparedness, or resources needed to address the increasing number of patients with type 2 diabetes, especially in low- and middle-income countries. OBJECTIVE To examine the effects of a quality improvement intervention comprising information and communications technology and contact with nonphysician personnel on the care and cardiometabolic risk factors of patients with type 2 diabetes in 8 Asia-Pacific countries. DESIGN, SETTING, AND PARTICIPANTS This 12-month multinational open-label randomized clinical trial was conducted from June 28, 2012, to April 28, 2016, at 50 primary care or hospital-based diabetes centers in 8 Asia-Pacific countries (India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam). Six countries were low and middle income, and 2 countries were high income. The study was conducted in 2 phases; phase 1 enrolled 7537 participants, and phase 2 enrolled 13 297 participants. Participants in both phases were randomized on a 1:1 ratio to intervention or control groups. Data were analyzed by intention to treat and per protocol from July 3, 2019, to July 21, 2020. INTERVENTIONS In both phases, the intervention group received 3 care components: a nurse-led Joint Asia Diabetes Evaluation (JADE) technology-guided structured evaluation, automated personalized reports to encourage patient empowerment, and 2 or more telephone or face-to-face contacts by nurses to increase patient engagement. In phase 1, the control group received the JADE technology-guided structured evaluation and automated personalized reports. In phase 2, the control group received the JADE technology-guided structured evaluation only. MAIN OUTCOMES AND MEASURES The primary outcome was the incidence of a composite of diabetes-associated end points, including cardiovascular disease, chronic kidney disease, visual impairment or eye surgery, lower extremity amputation or foot ulcers requiring hospitalization, all-site cancers, and death. The secondary outcomes were the attainment of 2 or more primary diabetes-associated targets (glycated hemoglobin A1c <7.0%, blood pressure <130/80 mm Hg, and low-density lipoprotein cholesterol <100 mg/dL) and/or 2 or more key performance indices (reduction in glycated hemoglobin A1c≥0.5%, reduction in systolic blood pressure ≥5 mm Hg, reduction in low-density lipoprotein cholesterol ≥19 mg/dL, and reduction in body weight ≥3.0%). RESULTS A total of 20 834 patients with type 2 diabetes were randomized in phases 1 and 2. In phase 1, 7537 participants (mean [SD] age, 60.0 [11.3] years; 3914 men [51.9%]; 4855 patients [64.4%] from low- and middle-income countries) were randomized, with 3732 patients allocated to the intervention group and 3805 patients allocated to the control group. In phase 2, 13 297 participants (mean [SD] age, 54.0 [11.1] years; 7754 men [58.3%]; 13 297 patients [100%] from low- and middle-income countries) were randomized, with 6645 patients allocated to the intervention group and 6652 patients allocated to the control group. In phase 1, compared with the control group, the intervention group had a similar risk of experiencing any of the primary outcomes (odds ratio [OR], 0.94; 95% CI, 0.74-1.21) but had an increased likelihood of attaining 2 or more primary targets (OR, 1.34; 95% CI, 1.21-1.49) and 2 or more key performance indices (OR, 1.18; 95% CI, 1.04-1.34). In phase 2, the intervention group also had a similar risk of experiencing any of the primary outcomes (OR, 1.02; 95% CI, 0.83-1.25) and had a greater likelihood of attaining 2 or more primary targets (OR, 1.25; 95% CI, 1.14-1.37) and 2 or more key performance indices (OR, 1.50; 95% CI, 1.33-1.68) compared with the control group. For attainment of 2 or more primary targets, larger effects were observed among patients in low- and middle-income countries (OR, 1.50; 95% CI, 1.29-1.74) compared with high-income countries (OR, 1.20; 95% CI, 1.03-1.39) (P = .04). CONCLUSIONS AND RELEVANCE In this 12-month clinical trial, the use of information and communications technology and nurses to empower and engage patients did not change the number of clinical events but did reduce cardiometabolic risk factors among patients with type 2 diabetes, especially those in low- and middle-income countries in the Asia-Pacific region. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01631084.
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Steroid use during COVID-19 infection and hyperglycemia - What a physician should know.
Sosale, A, Sosale, B, Kesavadev, J, Chawla, M, Reddy, S, Saboo, B, Misra, A
Diabetes & metabolic syndrome. 2021;(4):102167
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BACKGROUND AND AIMS The COVID-19 pandemic continues to challenge us. Despite several strides in management, steroids remain the mainstay for treating moderate to severe disease and with it arises challenges such as hyperglycemia. The review aims to enhance awareness amongst physicians on steroid use and hyperglycemia. METHODS An advisory document describing various strategies for hyperglycemia management was prepared in the public interest by DiabetesIndia. RESULTS The review provides awareness on steroids and hyperglycemia, adverse outcomes of elevated blood glucose levels and, advice at the time of discharge. CONCLUSIONS The article emphasizes enhancing awareness on effective management of hyperglycemia during COVID-19.
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Sodium-glucose Cotransporter-2 Inhibitors in Combination with Other Glucose-lowering Agents for the Treatment of Type 2 Diabetes Mellitus.
Kalra, S, Kesavadev, J, Chadha, M, Kumar, GV
Indian journal of endocrinology and metabolism. 2018;(6):827-836
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Involvement of multiple physiological pathways and complex pathogenesis is responsible for the onset and progression of type 2 diabetes mellitus (T2DM). Since it is difficult to manage multiple pathophysiological defects by monotherapy, a combination therapy with two or more oral antidiabetic agents (OADs) may help achieve euglycemia in T2DM patients. Choice of OADs is difficult with growing armamentarium of antidiabetic therapy. Ideally, drug combination should aim at reversal of known pathogenic abnormalities and demonstrate improvement in the overall metabolic health rather than simply reduce glycosylated hemoglobin (HbA1c) levels. Increased glucose reabsorption, a faulty pathological mechanism, is targeted by a novel class of drugs, namely, the sodium-glucose cotransporter-2 (SGLT2) inhibitors. Combination of SGLT2 inhibitors and other OADs complement each other due to their unique mechanism of action. In addition, the glucose-lowering effect of SGLT2 inhibitors remains independent of β-cell function and insulin sensitivity which reduces the chances of severe hypoglycemia in patients receiving these agents. Clinical studies from the past favor the use of SGLT2 inhibitors in combination with other agents to achieve better HbA1c levels, weight loss, and blood pressure control. In this review, we have made an attempt to explore the recommended guidelines for combination therapy, its advantages as either combination therapy or fixed-dose combinations therapy, and the role of SGLT2 inhibitors as a choice of drug as a combination with other OADs.