Blockchain-Based Data Access Control and Key Agreement System in IoT Environment.

Recently, with the increasing application of the Internet of Things (IoT), various IoT environments such as smart factories, smart homes, and smart grids are being generated. In the IoT environment, a lot of data are generated in real time, and the generated IoT data can be used as source data for various services such as artificial intelligence, remote medical care, and finance, and can also be used for purposes such as electricity bill generation. Therefore, data access control is required to grant access rights to various data users in the IoT environment who need such IoT data. In addition, IoT data contain sensitive information such as personal information, so privacy protection is also essential. Ciphertext-policy attribute-based encryption (CP-ABE) technology has been utilized to address these requirements. Furthermore, system structures applying blockchains with CP-ABE are being studied to prevent bottlenecks and single failures of cloud servers, as well as to support data auditing. However, these systems do not stipulate authentication and key agreement to ensure the security of the data transmission process and data outsourcing. Accordingly, we propose a data access control and key agreement scheme using CP-ABE to ensure data security in a blockchain-based system. In addition, we propose a system that can provide data nonrepudiation, data accountability, and data verification functions by utilizing blockchains. Both formal and informal security verifications are performed to demonstrate the security of the proposed system. We also compare the security, functional aspects, and computational and communication costs of previous systems. Furthermore, we perform cryptographic calculations to analyze the system in practical terms. As a result, our proposed protocol is safer against attacks such as guessing attacks and tracing attacks than other protocols, and can provide mutual authentication and key agreement functions. In addition, the proposed protocol is more efficient than other protocols, so it can be applied to practical IoT environments.

Expert Opinion by Clinicians on the Use of Insulin Therapy in People with Hepatic Impairment.

People with type 2 diabetes mellitus (T2DM) have a higher risk of developing chronic liver disease (CLD) and its complications. T2DM, obesity, and insulin resistance are all strongly associated with nonalcoholic fatty liver disease (NAFLD). Conversely, people suffering from cirrhosis have reduced glucose tolerance in approximately 60% of cases, diabetes in 20% of cases, and insulin-mediated glucose clearance is lowered by 50% as compared with those who do not have cirrhosis. An exploratory review was conducted using existing published evidence from clinical studies on dosing and titrations of individual insulin formulations in people with CLD to optimize insulin dosage titration for minimizing hypoglycemia risk.pThis article discusses current hyperglycemia treatment techniques for patients with CLD as well as the consensus recommendations on insulin use in special populations with T2DM and hepatic impairment. Based on available evidence and expert diabetologists' recommendations, careful insulin dose titration, customized glycemic targets, and frequent glucose screening are recommended for optimal glycemic management without hypoglycemia in CLD. Long-acting insulin should be avoided or used when short-acting insulin fails to provide adequate glycemic control with raised fasting blood sugar levels. While the patient's glucose profile is being evaluated, the prandial insulin dose can be lowered by 25% initially. The dose can be titrated based on the patient's postprandial glycemic expression and whether their food intake meets the Child-Pugh scores A and B categories. Titrating premixed insulins is difficult for patients in class C since their appetite and overall health are constantly compromised and in flux.

The Scope of Pre- and Probiotics as an Add-on to Proton-pump Inhibitors in Various Clinical Indications.

OBJECTIVE: To understand the national pattern of proton-pump inhibitor (PPI) prescriptions and to disseminate evidence-based recommendations for using probiotics as an adjunct to PPIs across diverse clinical indications. METHODS: Healthcare professionals' (HCPs) inputs and views were collected through a survey (n = 1,007) and four round table meetings (RTMs, n = 4). A standardized questionnaire focusing on the utilization of PPIs in clinical practice was developed, deliberated upon, and assessed by experts specializing in the treatment of diverse acid-related gastrointestinal (GI) conditions across various geographical regions. RESULTS: Of the total 1,007 contributors, most (43.40%) opined that 10-30% of their patients were prescribed PPI for a long duration. The majority of contributors commonly prescribed PPIs for the prophylaxis of gastroesophageal reflux disease (GERD)-induced gastritis (70.90%), peptic ulcer disease (58.39%), and various GI conditions. The majority of contributors (91%) agreed or strongly agreed that long-term use of PPIs disturbs the GI flora. Antibiotic-associated diarrhea (AAD) (78.05%) was the most preferred indication for using pre- and probiotics. The duration for co-prescription varied, with a substantial portion advocating for 1-4 weeks (49.65%), while others supported durations of 4-8 weeks or beyond. Around 85% of contributors/HCPs agreed or strongly agreed on prescribing pre- and probiotics as prophylaxis to prevent GI disturbances. The study emphasized the growing trend of patient-centered co-prescription of PPIs and pre-/probiotics, with a majority of contributors favoring this approach. CONCLUSION: The results underscore the importance of informed prescribing practices, including the co-prescription of probiotics, to mitigate potential side effects associated with long-term PPI use and optimize patient well-being.

SGLT2i as a First-line Antihyperglycemic in the Management of Type 2 Diabetes in the Context of Indians: A Systematic Review and Consensus.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been used for almost a decade and have proven to be effective not only in managing Type 2 diabetes (T2D), but their cardio and renal protective features make them very useful in managing patients with risk of multiple comorbidities. This systematic review was undertaken by the authors because there is no evidence currently available in India that has studied the suitability of SGLT2i as a first-line agent in patients newly diagnosed with T2D in India. MATERIALS AND METHODS: First, literature was searched to identify features that are considered important when deciding on a first-line agent for managing T2D. A total of 5 broad topics were identified-glycemic control, extra glycemic effects, antihyperglycemic combination therapy, safety, and cost-effectiveness. These domains had further subheadings, and a total of 16 domains were identified. Metformin is the drug of choice as a first-line agent in such situations and has been considered the gold standard for evaluating the effects of SGLT2i across these domains. A systematic literature review on each domain was conducted to compare SGLT2i with the gold standard in Indian patients newly diagnosed with T2D. Evidence was graded (levels of evidence (LoE)-A, B, and C), and recommendations (class of recommendation (CoR)-I, II, and III) were classified by the expert group as defined in the methodology. RESULTS: According to the systematic reviews conducted, 11 domains had Level A evidence, 2 domains (impact on lipids and gut microbiome) had Level B, and 3 domains had Level C (ß-cell function, renal protection, and glycemic variability) evidence. Based on evidence and expert opinion, the authors recommend SGLT2i as a first-line agent for managing newly diagnosed patients with T2D with a Class I recommendation for 13 domains and Class II for the remaining 3 (impact on lipids, gut microbiome, and ß-cell function). Although a poorer level of evidence (Level C) was available for the glycemic variability domain, the authors still reported this as Class I recommendations according to their expert opinion and consensus. CONCLUSION: This article advocates adopting SGLT2 inhibitors as the primary treatment choice for treating patients with newly diagnosed T2D in India.

The Bariatric Pyramid: A framework for therapeutic targets.

The Bariatric Pyramid is a model which serves to explain the goals of obesity management, act as a milestone for monitoring of therapy, and to benchmark the utility of various anti-obesity medications and interventions. Built upon a base of sustainability, it lists three more desired aspects of care: sufficiency (sufficient strength) safety and security. Each of the four aspects of the pyramid: sustainability, sufficiency safety and security have three angles, which allows the reader to understand them easily. The model that we propose is useful in training health care professionals, in therapeutic patient education, for assessing various anti-obesity therapies, and in reaching the right decision while managing obesity.

Assessment of Prevalence and Associated Risk Factors of NAFLD in People Living with Diabetes in India: A Retrospective, Multicenter, Electronic Medical Records Based Study.

INTRODUCTION: Nonalcoholic fatty liver disease (NAFLD) has become a leading cause of liver disease worldwide. The prevalence of NAFLD varies depending on population studied and type of diagnostic tools used to screen or diagnose the patients. There is a strong relationship between metabolic syndrome components and NAFLD prevalence. This study aims to understand the prevalence of NAFLD along with the associated risk factors and their interaction with other comorbidities among people living with diabetes in Indian context. MATERIALS AND METHODS: It is a retrospective, observational study based on data retrieved from electronic medical records (EMRs) of people living with diabetes from more than 250 individual diabetes centers located in more than 30 cities across 14 states in India. Medical records of 171,996 adults living with diabetes were included in the analysis. The assessment of prevalence of NAFLD in diabetes was done using algorithm based on alanine transaminase (ALT) and aspartate aminotransferase (AST). RESULTS: Overall, 44.48% of people living with diabetes were found to have NAFLD. A significantly higher proportion of males (58.64%) had NAFLD compared to females (36.91%) (p<0.001). Nonalcoholic fatty liver disease prevalence was >50% in seven of the states. People living with diabetes along with dyslipidemia and hypertension had a significantly higher prevalence of NAFLD (p<0.001). Obesity (57.1%), dyslipidemia (59.1%), and hypertriglyceridemia (42.3%) had significantly higher odds of NAFLD among people living with diabetes. CONCLUSION: This study highlighted high-risk categories for NAFLD in diabetes, like young, obese, hypertriglyceridemia, poor glycemic control, etc. This information will help health care providers in prioritizing screening among high-risk diabetes population.

An Expert Group Consensus Statement on "Approach and Management of Prediabetes in India".

The prevalence of prediabetes, a forerunner of diabetes is very high, and its conversion to diabetes is also more rapid among Asian Indians. Prediabetes also predisposes to the development of macrovascular and to a lesser extent of microvascular complications of diabetes. In a large community-based epidemiological study, the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB), data reported an overall prevalence of prediabetes of 10.3%, derived from 15 Indian states. This shows that the diabetes epidemic is far from over as many of them may soon convert to diabetes. Prediabetes, however, should not be considered a path to diabetes rather it should be a window of opportunity for the prevention of diabetes. This early screening, detection, and treatment of prediabetes should be made a national priority. Several countries have introduced lifestyle programs to prevent diabetes and, when indicated, pharmacological intervention with metformin as well. This consensus statement outlines the approaches to screening and lifestyle and pharmacological management of prediabetes in Asian Indians.

Indian Reality of Clinical Practice and Patient Profile in Diabetes Care: Lessons from the IMPACT survey.

India shoulders a heavy burden of diabetes mellitus (DM), the management of which is suboptimal globally.& Objectives: Insulin Management: Practical Aspects in Choice of Therapy (IMPACT) survey was designed to gain insight into the ground (in-clinic) reality of DM management by physicians in India. METHODS: A survey consisting of 12 multiple-choice questions was conducted by SurveyMonkey® , focusing on practice profile, patient profile, and other aspects of DM management. RESULTS: The survey included 2424 physicians. Majority of them were general physicians (58.5%) followed by diabetologists (31.1%). Most (49.2%) of the respondents specified that the ideal time for a DM consultation is 15 min. However, 73.4% of them provided consultation of <10& min because of heavy patient load. Nearly half of the respondents reported that their patients consumed a diet with carbohydrate content of 60% to 80%, and 79.4% of them admitted that <50% of their patients adhered to dietary advice. About 73.5% of the respondents believed controlling fasting plasma glucose (FPG) level alone would not adequately control postprandial plasma glucose (PPG) level, and 93.0% of them preferred an insulin therapy at the initiation that controls both FPG and PPG levels. CONCLUSION: Limited consultation time, high-carbohydrate diet, and a need for choosing insulin regimens that provide control for both PPG and FPG levels are some ground realities of DM management in India. These realities need to be factored in while choosing treatment options to achieve the desired glycemic control and improve the status of diabetes care.

Dysbiosis of salivary microbiome and cytokines influence oral squamous cell carcinoma through inflammation.

Advanced combinatorial treatments of surgery, chemotherapy, and radiotherapy do not have any effect on the enhancement of a 5-year survival rate of oral squamous cell carcinoma (OSCC). The discovery of early diagnostic non-invasive biomarkers is required to improve the survival rate of OSCC patients. Recently, it has been reported that oral microbiome has a significant contribution to the development of OSCC. Oral microbiome induces inflammatory response through the production of cytokines and chemokines that enhances tumor cell proliferation and survival. The study aims to develop saliva-based oral microbiome and cytokine biomarker panel that screen OSCC patients based on the level of the microbiome and cytokine differences. We compared the oral microbiome signatures and cytokine level in the saliva of OSCC patients and healthy individuals by 16S rRNA gene sequencing targeting the V3/V4 region using the MiSeq platform and cytokine assay, respectively. The higher abundance of Prevotella melaninogenica, Fusobacterium sp., Veillonella parvula, Porphyromonas endodontalis, Prevotella pallens, Dialister, Streptococcus anginosus, Prevotella nigrescens, Campylobacter ureolyticus, Prevotella nanceiensis, Peptostreptococcus anaerobius and significant elevation of IL-8, IL-6, TNF-α, GM-CSF, and IFN-γ in the saliva of patients having OSCC. Oncobacteria such as S. anginosus, V. parvula, P. endodontalis, and P. anaerobius may contribute to the development of OSCC by increasing inflammation via increased expression of inflammatory cytokines such as IL-6, IL-8, TNF-α, IFN-γ, and GM-CSF. These oncobacteria and cytokines panels could potentially be used as a non-invasive biomarker in clinical practice for more efficient screening and early detection of OSCC patients.

An Efficient, Anonymous and Robust Authentication Scheme for Smart Home Environments.

In recent years, the Internet of Things (IoT) has exploded in popularity. The smart home, as an important facet of IoT, has gained its focus for smart intelligent systems. As users communicate with smart devices over an insecure communication medium, the sensitive information exchanged among them becomes vulnerable to an adversary. Thus, there is a great thrust in developing an anonymous authentication scheme to provide secure communication for smart home environments. Most recently, an anonymous authentication scheme for smart home environments with provable security has been proposed in the literature. In this paper, we analyze the recent scheme to highlight its several vulnerabilities. We then address the security drawbacks and present a more secure and robust authentication scheme that overcomes the drawbacks found in the analyzed scheme, while incorporating its advantages too. Finally, through a detailed comparative study, we demonstrate that the proposed scheme provides significantly better security and more functionality features with comparable communication and computational overheads with similar schemes.

A Smart Waste Management Solution Geared towards Citizens.

Global industry is undergoing major transformations with the genesis of a new paradigm known as the Internet of Things (IoT) with its underlying technologies. Many company leaders are investing more effort and money in transforming their services to capitalize on the benefits provided by the IoT. Thereby, the decision makers in public waste management do not want to be outdone, and it is challenging to provide an efficient and real-time waste management system. This paper proposes a solution (hardware, software, and communications) that aims to optimize waste management and include a citizen in the process. The system follows an IoT-based approach where the discarded waste from the smart bin is continuously monitored by sensors that inform the filling level of each compartment, in real-time. These data are stored and processed in an IoT middleware providing information for collection with optimized routes and generating important statistical data for monitoring the waste collection accurately in terms of resource management and the provided services for the community. Citizens can easily access information about the public waste bins through the Web or a mobile application. The creation of the real prototype of the smart container, the development of the waste management application and a real-scale experiment use case for evaluation, demonstration, and validation show that the proposed system can efficiently change the way people deal with their garbage and optimize economic and material resources.

Designing Efficient Sinkhole Attack Detection Mechanism in Edge-Based IoT Deployment.

The sinkhole attack in an edge-based Internet of Things (IoT) environment (EIoT) can devastate and ruin the whole functioning of the communication. The sinkhole attacker nodes ( S H A s) have some properties (for example, they first attract the other normal nodes for the shortest path to the destination and when normal nodes initiate the process of sending their packets through that path (i.e., via S H A ), the attacker nodes start disrupting the traffic flow of the network). In the presence of S H A s, the destination (for example, sink node i.e., gateway/base station) does not receive the required information or it may receive partial or modified information. This results in reduction of the network performance and degradation in efficiency and reliability of the communication. In the presence of such an attack, the throughput decreases, end-to-end delay increases and packet delivery ratio decreases. Moreover, it may harm other network performance parameters. Hence, it becomes extremely essential to provide an effective and competent scheme to mitigate this attack in EIoT. In this paper, an intrusion detection scheme to protect EIoT environment against sinkhole attack is proposed, which is named as SAD-EIoT. In SAD-EIoT, the resource rich edge nodes (edge servers) perform the detection of different types of sinkhole attacker nodes with the help of exchanging messages. The practical demonstration of SAD-EIoT is also provided using the well known NS2 simulator to compute the various performance parameters. Additionally, the security analysis of SAD-EIoT is conducted to prove its resiliency against various types of S H A s. SAD-EIoT achieves around 95 . 83 % detection rate and 1 . 03 % false positive rate, which are considerably better than other related existing schemes. Apart from those, SAD-EIoT is proficient with respect to computation and communication costs. Eventually, SAD-EIoT will be a suitable match for those applications which can be used in critical and sensitive operations (for example, surveillance, security and monitoring systems).

Assessment and clinicopathological correlation of matrix metalloproteinase 9 expression in nasopharyngeal carcinoma.

INTRODUCTION: Nasopharyngeal cancer is not a common disease in most parts of the world. In India also, nasopharyngeal carcinoma (NPC) is not a common cancer, except for the Northeastern region of the country. Expression of matrix metalloproteinase 9 (MMP9) in the tumor cells is related to tumor invasion and metastasis. The aim of the present study is to analyze the expression of MMP9 in NPC and evaluate its prognostic implications. MATERIALS AND METHODS: A total of 32 histologically confirmed tissue samples of NPC were examined by immunohistochemical staining to assess the expression of MMP9. Clinicopathological parameters and levels of MMP9 expression in the tumor tissue were analyzed using Chi-square test. Survival analysis was done using the Kaplan-Meier method and was compared using log-rank test. P <0.05 was considered statistically significant. RESULTS: Of the 32 tissue samples of NPC, 23 (71.9%) were male and 9 (28.1%) were female. 7 (21.9%) patients presented in T1 Stage, 8 (25.0%) in T2, 12 (37.5%) in T3, and 5 (15.6%) in T4 Stages, respectively. 29 (90.6%) patients presented with lymph node metastasis. MMP9 expression level was significantly correlated with patient's age (P = 0.033), tumor histology (P = 0.017), tumor stage (P = 0.021), and lymph node metastasis (P = 0.011). The 5-year overall survival is higher for low-level expression as compared to high-level expression of MMP9 (P = 0.046). CONCLUSION: MMP9 is an important prognostic factor for NPC. High expression of MMP9 is associated with cervical lymph nodes metastasis and poor survival outcome.

LDAKM-EIoT: Lightweight Device Authentication and Key Management Mechanism for Edge-Based IoT Deployment.

In recent years, edge computing has emerged as a new concept in the computing paradigm that empowers several future technologies, such as 5G, vehicle-to-vehicle communications, and the Internet of Things (IoT), by providing cloud computing facilities, as well as services to the end users. However, open communication among the entities in an edge based IoT environment makes it vulnerable to various potential attacks that are executed by an adversary. Device authentication is one of the prominent techniques in security that permits an IoT device to authenticate mutually with a cloud server with the help of an edge node. If authentication is successful, they establish a session key between them for secure communication. To achieve this goal, a novel device authentication and key management mechanism for the edge based IoT environment, called the lightweight authentication and key management scheme for the edge based IoT environment (LDAKM-EIoT), was designed. The detailed security analysis and formal security verification conducted by the widely used "Automated Validation of Internet Security Protocols and Applications (AVISPA)" tool prove that the proposed LDAKM-EIoT is secure against several attack vectors that exist in the infrastructure of the edge based IoT environment. The elaborated comparative analysis of the proposed LDAKM-EIoT and different closely related schemes provides evidence that LDAKM-EIoT is more secure with less communication and computation costs. Finally, the network performance parameters are calculated and analyzed using the NS2 simulation to demonstrate the practical facets of the proposed LDAKM-EIoT.

From Individualized to Personalized Medicine in Diabetes: An Expert Overview.

Personalized medicine is an individualized and stratified approach to the management of a disease. Personalized medicine can reform the prevention, prediction, and management of diabetes. Use of genetic information in polygenic and monogenic forms of diabetes can help to identify genetic variants and reclassify patients into pathophysiological subgroups. Targeted diagnostic, preventive, and therapeutic interventions can be defined for these groups for effective management of diabetes. Pharmacogenetics combines genotypic and phenotypic factors to develop personalized care in various pathophysiological subgroups of persons with diabetes. Personalized medicine finds wider utility in monogenic (especially Maturity Onset Diabetes of the Young (MODY) and Neonatal Diabetes Mellitus [NDM]) than in polygenic, diabetes. The most frequently mutated genes in MODY include HNF1A and HNF3A. the common genes responsible for NDM include KCNJ11 and ABCC8 (SUR) genes. These genes influence various aspects of glucose metabolism such as ß-cell K-ATP channel modulation, production of insulin and development of pancreas. The Madras Diabetes Research Foundation has fostered research in personalized medicine for diabetes based upon genetic information and has developed a national registry for neonatal diabetes and other monogenic form of diabetes.

IMPACT India: Insights for Insulin Therapy in Routine Clinical Practice.

OBJECTIVE: Widely used in the management of diabetes, insulin therapy is influenced by several patient preferences and physician choices. This article reports the findings of the IMPACT survey, designed to assess insights on various factors which influence the choice of insulin therapy in India. METHODS: We administered a questionnaire which focused on the practice and patient profiles and the preferred regimens in specific clinical situations using a case scenario. Respondents were asked about preferred insulin regimens for various phases of life, comorbid conditions, dietary choices and psychological factors. RESULTS: Overall, 314 doctors participated in the survey. Majority were general physicians (51%) and diabetologists (37%). In clinical practice, the most preferred regimens included premix insulin BD in adults (59%) and elderly (53%), and basal bolus therapy in pregnant women (>47%) and in acute illness (62%). Both regimens were equally preferred for symptomatic patients (41% basal bolus and 38% premix insulin) and those with renal or hepatic failure (36% each). Premix insulin was preferred for patients with high carbohydrate intake (73%) while basal bolus was preferred for patients with variable meal timings (39%) and in pronounced postprandial glucose excursions (45%). Insulin co-formulation and high-mix insulins were not a part of the survey questionnaire. SUMMARY: Indian physicians exercise logic in the choice of insulin regimens. Preference is based on patient characteristics including glucophenotype, dietary patterns, psychosocial needs, clinical situations, and comorbid conditions.

Targeting Glycemic Level in Gestational Diabetes Mellitus to that of Normal Pregnancy would result in a better Maternal-Fetal Outcome.

ABSTRACT: Women with a history of Gestational Diabetes Mellitus (GDM) are at increased risk of future diabetes and related Non-Communicable Diseases (NCD) as are their offspring. "Transgenerational transmission occurs". Independent of genetic risk, offspring of hyperglycaemic pregnancies are at increased risk of early onset type 2 diabetes mellitus (Type 2 DM) and obesity. Differences exist in offspring risk of diabetes and obesity based on time and type of diabetes exposure in utero. There is a risk gradient, wherein type 2 DM exposure confers greater risk and reduces time to development of type 2 DM in the offspring compared with exposure to GDM and no diabetes exposure. These data suggest, glucose dose dependence in risk transmission. Given that the age of onset of prediabetes and type 2 DM is declining many reproductive age women may have undiagnosed diabetes or dysglycaemia when they become pregnant. This has great public health significance and it has become imperative that all pregnant women should be screened for hyperglycemia even if they have no symptoms. Ministry of Health, Government of India has developed the national guidelines for testing, diagnosis and management of hyperglycemia in pregnancy. These guidelines recommend early testing at booking, to be repeated again between 24-28 weeks if negative at first testing. The guideline also recommends that GDM can be diagnosed if the 2 hr PG is ≥140mg/dl after 75 gm of oral glucose administration without regard to the time of the last meal (i.e., fasting or non-fasting). This approach has also been endorsed by International Diabetes Federation (IDF), World Health Organization (WHO) and International Federation of Gynaecology and Obstetrics (FIGO) for resource constrained settings.The aim should be to target new born baby's birth weight, appropriate for gestational age (2.5 to 3.5 kg) to prevent the offspring developing NCD in the future. For this to happen early diagnosis and tight maternal glucose control during pregnancy similar to glycaemic level in the normal pregnancy, (FPG between 80 and 90 mg, 2 hr. post prandial between 110 and 120 mg) is necessary.

Epidemiologic Surveillance of Glycemic Response to a Scored, Breakable, Extended Release, Fixed Dose Combination of Gliclazide and Metformin in Persons with Type 2 Diabetes.

BACKGROUND: The combination of metformin and a sulphonylurea has been recommended for treatment of type 2 diabetes. A, scored, breakable, extended release, once daily fixed dose combination (FDC) of gliclazide and metformin is available in India. OBJECTIVE: To assess the initial blood glucose lowering efficacy, glycemic control and patient acceptability of the fixed dose combination of original gliclazide 60mg and metformin 500mg in an extended release, scored and breakable formulation (in a range of 1, 1½, and 2 tablets) among Indian patients in day to day practice. METHODS: In a multi-center epidemiologic surveillance protocol of 60 days, patients with type 2 diabetes were prospectively prescribed 1 to 2 tablet of gliclazide 60mg + metformin 500mg during the course of study. The possibility of breaking the tablet in two equal halves enabled administration of 1½ tablets wherever required. Primary data on fasting plasma glucose response and adverse events was extracted for analysis from the case records of patients kept with the investigators. The primary outcome was the proportion of patients achieving glycemic control, defined as fasting plasma glucose of 90-130 mg/dl at the end of the study. RESULTS: Of the 759 patients treated with an extended release FDC of gliclazide 60mg + metformin 500mg, the number (%, 95% CI) which achieved glycemic control was 474/759 (62.5%, 59.0% to 65.8%). The proportion controlled with 1 tablet was, 252/759 (33.2%, 29.9% to 36.6%); with 1½ tablets, 149/298, (50.0%, 44.3% to 55.6%); and with 2 tablets, 73/94, (77.5%, 68.2% to 85.0%). Mean (95% CI) FPG mg/dl decreased from baseline by 48.7 (45.0 to 51.4) with 1 tablet; by 71.3 (66.0 to 76.6) with 1½ tablets; and by 86.3 (75.7 to 96.9) with 2 tablets. Frequency of hypo-glycaemia was 0.7%. CONCLUSIONS: Extended release FDC of gliclazide 60mg + metformin 500mg, a scored, breakable, once daily, formulation was effective in controlling blood glucose in a large proportion of type 2 diabetes with a low risk of hypoglycaemia.

Consensus on "Basal insulin in the management of Type 2 Diabetes: Which, When and How?"

INTRODUCTION: Type 2 diabetes mellitus (T2DM) has attained epidemic proportions and continues to increase despite the availability of a number of oral antidiabetic medications and major advances made in insulin delivery since its discovery nearly a hundred years ago. One, amongst many other reasons responsible for the inability to achieve adequate glycaemic control in a substantial proportion of T2DM patients is the delayed initiation and inappropriate intensification of insulin treatment. Appropriate initiation and intensification of insulin is critical for the successful achievement of tight glycaemic control. OBJECTIVE: To provide simple and easily implementable guidelines to primary care physicians on basal insulin initiation and intensification, along with use of basal insulin in special situations (hepatic failure, renal failure and gestational diabetes mellitus). METHODS: Each consensus statement on basal insulin initiation, intensification and use of basal insulin in special situations was evaluated for dosing and titration based on established guidelines, data from approved pack inserts, prescribing information or summary of product characteristics for each insulin type, and published scientific literature. These evaluations were then factored into the national context based not only on the clinical experience of the expert committee representatives' but also based on the common therapeutic practices followed in India to successfully achieve optimal glucose control. RESULTS: Recommendations on initiation and intensification of basal insulin, and its use in special situations, have been developed. The key recommendations are to initiate basal insulin when 2 or 3 oral antidiabetic medications fail to achieve target glycaemic control, or in symptomatic patients with glycated haemoglobin value greater than 9%. Depending upon patient characteristics, any of the four available basal insulins [Neutral protamine Hagedorn (NPH), Glargine (IGlar), Detemir (IDet), Degludec (IDeg)] can be used. However, IDeg has a longer duration of action, comparatively lesser hypoglycaemia (both overall and nocturnal) and more flexibility in administration timing compared to IGlar) and IDet. Inability to maintain glycaemic control should lead to prompt intensification of basal insulin treatment by adding mealtime insulin, consisting of one to three injections of either rapid-acting insulin analog or regular insulin; depending upon patient characteristics, intensification can also be achieved by transition from basal insulin to twice daily premixed insulin analogs/premixed human insulin/insulin co-formulations. IDeg/IDet can be used in all grades of renal and hepatic impairment; and IDet has been approved for use in gestational diabetes mellitus. CONCLUSIONS: We hope that these consensus based recommendations shall be a useful reference tool for health care practitioners and help them in initiating and intensifying insulin therapy in T2DM patients in order to achieve optimal glycaemic control.

Consensus on Initiation and Intensification of Premix Insulin in Type 2 Diabetes Management.

INTRODUCTION: Premix insulin is the most commonly used insulin preparation in India. The first Indian premix guidelines were developed in 2009 and thereafter were updated in 2013. There is a need to revisit the Indian premix insulin guidelines, in view of emerging evidence and introduction of newer co-formulations. OBJECTIVE: The present consensus has been developed to evaluate available premix formulations, examine existing evidence related to premix formulations, and evolve consensus statement of recommendations on the topic. METHODS: A meeting of experts from across India was conducted at Chennai in July 2016. The expert committee evaluated each premix insulin regimen with reference to 1) Current recommendations by various guidelines, 2) Approved pack inserts and 3) Published scientific literature. The information was debated and discussed within the expert group committee, to arrive at seven consensus-based recommendations for initiation and intensification with premix insulin. RESULTS: Recommendations based on consensus on initiation and intensification of premix insulin in type 2 diabetes mellitus (T2DM) management were developed for the following situations. 1) Initiation of premix insulin co-formulation at diagnosis, 2) Initiation of once daily (OD) premix insulin/co-formulation, 3) Initiation of twice daily (BID) premix insulin/co-formulation 4) Intensification with BID and thrice daily (TID) premix insulin/co-formulation. Three recommendations pertained to the use of premix insulin in other forms of diabetes, or in specific situations: 5) Use of premix insulin in gestational diabetes mellitus 6) Use of premix insulin in type 1 Diabetes Mellitus (T1DM) 7) Premix insulin use during Ramadan. CONCLUSIONS: In the setting of high carbohydrate consumption in India, or in patients with predominant post prandial hyperglycemia, premix insulin/co-formulation can offer effective and convenient glycemic control. This paper will help healthcare practitioners initiate and intensify premix insulin effectively.