Health care delivery model in India with relevance to diabetes care.

The Indian healthcare scenario presents a spectrum of contrasting landscapes. Socioeconomic factors, problems with medical infrastructure, insufficiency in the supply of medical requisites, economic disparities due to major differences in diabetes care delivery in the government and private sectors and difficulty in accessing quality health care facilities challenges effective diabetes care in India. The article gives insights into the practical solutions and the proposed White paper model to resolve major challenges faced by the Indian diabetes care sector for effective diabetes care delivered at Jothydev's Diabetes Educational Forum Global Diabetes Convention 2019.

First-in-Class Oral Semaglutide: Overcoming Barriers of Incretinisation in the Indian Context.

Despite the availability of multiple therapeutic options and strategies, patients with type 2 diabetes mellitus (T2DM) the world over have inadequate glycaemic control and India is no exception. Patients with T2DM in India have benefitted from glucagon-like peptide-1 analogues similar to that of patients from other parts of the world. However, subcutaneous treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is limited by their injectable mode of administration. The present review highlights barriers to incretinisation with GLP-1RAs and the role of first-in-class oral semaglutide in the Indian context and provides guidance to physicians on its initiation and uses.

Diagnosis and principles of management of gestational diabetes mellitus in the prevailing COVID-19 pandemic.

BACKGROUND: Limited medical facilities are available due to Covid-19 pandemic. Nevertheless, all efforts should be made in planning judicial and possible methods of delivering health care, particularly to pregnant woman with GDM. GDM may play a crucial role in the increasing prevalence of diabetes and obesity and also may be the origin of cardiometabolic diseases. METHODS: It is mandatary to diagnose and care pregnant woman with GDM. The test suggested to diagnose GDM has to be evidence based and in this regard "a single test procedure" evaluated meets this requirement. This doable test has been accepted by the Diabetes in Pregnancy Study Group India (DIPSI) and approved by MHFW-GOI, WHO, International Diabetes Federation, and International Federation of Obstetricians and Gynecologists. MHFW-GOI also recommends testing at first antenatal visit and then at 24-28 weeks of gestation. This opportunity can also be utilized for performing ultrasonography for assessing fetal development. RESULT: The first-line management is MNT and life style modifications. Non-responders may require insulin or OHA. The target glycemic control is FPG ~ 5.0 mmol/dl (90 mg/dl) and 2 h PPPG ~ 6.7 mmol/dl (120 mg/dl). The goal is to obtain newborns birth weight appropriate for gestational age between 2.5 and 3.5 kg, a step to prevent offspring developing diabetes. CONCLUSION: The essential precaution required during COVID pandemic is to wear face mask, avoid crowded places, and maintain social distancing. Finally, the economical and evidence based "single test procedure" of DIPSI is most appropriate for screening during the COVID pandemic.

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.

Consensus recommendations on exploring effective solutions for the rising cost of diabetes.

Diabetes remains asymptomatic for a long period of time and its real burden gets noticed only once the complications set in. The number of individuals affected with the disease is also on the rise and more so in the low income countries. This scenario calls for urgent precautionary measures that need to be undertaken to equip ourselves to fight against this chronic disease. Individuals with financial constraints cannot afford to access even the basic treatment facilities and thus stands the most burdened. The International Diabetes Federation calls for 'Eyes on Diabetes' for the society to focus on early screening and early intervention. The rising cost of diabetes results from delayed and denied treatment. The panel discussion organized as a part of 4th Annual global diabetes convention of Jothydev's Professional Education Forum (JPEF, 2016) facilitated a platform to address diabetes as a serious health concern that needs to be given immediate priority by the policymakers as well as public and also to discuss about the feasible measures that will help achieve cost effective and affordable diabetes treatment. This was followed by in-depth literature search and finally a set of recommendations have been arrived at by the key opinion leaders to realize the dream of affordable diabetes care to all deserving individuals.

Pioglitazone and the risk of bladder cancer: An Indian retrospective cohort study.

AIM: To determine whether pioglitazone is associated with an increased risk of bladder cancer among Indian type 2 diabetic patients. METHODS: A retrospective data analysis of 2222 type 2 diabetic patients was conducted. The study subjects were divided into two equal groups: 1111 pioglitazone users and 1111 pioglitazone non-users. The safety of pioglitazone therapy was analyzed in terms of occurrence of bladder and other types of cancers along with its efficacy in terms of glycemic control. Parameters for assessing safety were duration of disease, duration of usage and total dose of pioglitazone consumed across age groups, glycemic control, obesity and family history of any cancer. Bladder cancer prevalence was analyzed on the basis of urinary cytology, urine routine and microscopy, hematuria, urinary nuclear matrix protein 22 analysis and ultrasonography. RESULTS: Of the 2222 cases analysed, there was no evidence of bladder cancer in any of the studied groups, (p=not significant) which was also evident among 1111 patients on Pioglitazone therapy with a cumulative dose consumption of 2737 mg to 1,31,400 mg. On subgroup analysis, there was no evidence of bladder cancer amongst patients with age >60 years, duration of diabetes > 10 years and uncontrolled diabetics (HbA1c >8%) with cumulative pioglitazone consumption of >28,000 mg. A significant number of patients achieved good glycemic control (HbA1c <7.5%) with pioglitazone therapy. CONCLUSION: Pioglitazone therapy was not associated with occurrence of bladder cancer among Indian type 2 diabetic patients and demonstrated good glycemic control.

Current status of management, control, complications and psychosocial aspects of patients with diabetes in India: Results from the DiabCare India 2011 Study.

OBJECTIVES: DiabCare India 2011 was a cross-sectional study in patients with diabetes mellitus, undertaken to investigate the relationship between diabetes control, management and complications in a subset of urban Indian diabetes patients treated at referral diabetes care centres in India. MATERIALS AND METHODS: This was a cross-sectional, multicentre (330 centres) survey in 6168 diabetes patients treated at general hospitals, diabetes clinics and referral clinics across India. Patient data, including medical and clinical examination reports during the past year were collected during their routine visit. The patients' and physicians' perceptions about diabetes management were recorded using a questionnaire. RESULTS: A total of 6168 subjects with diabetes (95.8% type 2), mean age 51.9 ± 12.4 years and mean duration of diabetes, 6.9 ± 6.4 years were included. Mean HbA1c was 8.9 ± 2.1% and the mean fasting (FPG), post prandial (PPG) and random (RBG) plasma glucose levels were 148 ± 50 mg/dl 205 ± 66 mg/dl and 193 ± 68mg/dl respectively. Neuropathy was the most common complication (41.4%); other complications were: Foot (32.7%), eye (19.7%), cardiovascular (6.8%) and nephropathy (6.2%). The number of diabetic complications increased with mean duration of diabetes. Most (93.2%) of the patients were on oral anti-diabetic drugs (OADs) and 35.2% were on insulin (±OADs). More than 15% physicians felt that the greatest barrier to insulin therapy from patient's perspective were pain and fear of using injectable modality; 5.2% felt that the greatest barrier to insulin therapy from physician's perspective was the treatment cost; 4.8% felt that the major barriers to achieve optimum diabetic care in practice was loss to follow-up followed by lack of counselling (3.9%) and treatment compliance (3.6%). CONCLUSION: DiabCare India 2011 has shown that type 2 diabetes sets in early in Indians and glycaemic control is often sub-optimal in these patients. These results indicate a need for more structured intervention at an early stage of the disease and need for increased awareness on benefits of good glycaemic control. It cannot be overemphasized that the status of diabetes care in India needs to be further improved. (ClinTrials.gov identifier: NCT01351922).

Consensus evidence-based guidelines for management of gestational diabetes mellitus in India.

Gestational diabetes mellitus represents both a clear pathological condition of glycaemic dysregulation and a factor aggravating the risk of future diabetes in both the mother and child. Thus it is of paramount importance to control and manage pregnancy complicated by diabetes to improve the health and well-being of the mother and avert the risk of diabetes across generations. Currently, a wide variety of national and international guidelines address clinical questions pertinent to diabetes management during pregnancy. Of them, the pioneering Diabetes in Pregnancy Study Group India (DIPSI) guideline for the management of diabetes during pregnancy has previously set new standards for quality diabetes care in India and around the world. The advent of insulin analogues, pen delivery devices and insulin pumps, has enriched our armamentarium to manage diabetes and thus warrants our due attention. The current guideline is an attempt to present an overview of current knowledge relating to the management of diabetes in pregnancy and to update available guidelines in view of advances in insulin therapy. These guidelines represent the amalgamation of updated clinical evidence with expert inputs in the context of Indian clinical practice.

Addition of insulin aspart with basal insulin is associated with improved glycemic control in Indian patients with uncontrolled type 2 diabetes mellitus: the A1chieve observational study.

Insulin aspart (IAsp) has been used in patients for more than a decade. A plethora of data is available, from clinical trials, to document its efficacy and safety and suggest that IAsp is a favorable choice to be used in a basal-bolus regimen. The A1chieve@ was a non-interventional study that explored the safety and effectiveness of initiating or switching to insulin analogues in routine clinical practice in more than 60,000 patients from 28 different countries. In this manuscript, we discuss the findings from the subgroup of the Indian cohort who were treated with insulin aspart (IAsp), in addition to a basal insulin analogue (insulin detemir, IDet). In a cohort of 343, who were on IAsp + IDet, 175 (51%) were insulin naive and 168 (49%) had been on insulin therapy earlier. Glycaemic parameters were high at baseline. Mean HbA1c was 9.3% in them and was comparable in both insulin naive and insulin experienced groups. After 24 weeks of therapy with IAsp + basal insulin, there were reductions in HbA1c in both the insulin naive group, (-1.6) and insulin experienced group (-1.5). Fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) levels were also reduced significantly from baseline (-77 and - 110 mg/dL, respectively, p < 0.001). Overall, hypoglycaemia decreased from 0.97 (baseline) to 0.18 events/patient years (24 weeks). There was also an increase in quality of life score as evaluated by EQ-5D questionnaire. Addition of IAsp with a basal insulin in patients with poor glycaemic control leads to an improvement in glycaemic profile with no major hypoglycaemia or clinically significant weight gain along with an improvement in the quality of life in patients with type 2 diabetes.

Diagnosis of gestational diabetes mellitus in the community.

BACKGROUND AND OBJECTIVE: Diabetes in Pregnancy Study Group India (DIPSI) recommends 2-h Plasma glucose (PG) > or = 140 mg/dL with 75g oral glucose load to diagnose GDM, akin to WHO criteria. Recently, International Association of Diabetes in Pregnancy Study Group (IADPSG) recommends any one value of Fasting plasma glucose (FPG) > or = 92 mg/ dL, 1-h PG > or = 180 mg/dL or 2-h PG > or = 153 mg/dL to diagnose GDM. The objective of this study was to find out whether DIPSI guidelines could still be continued to diagnose GDM in our country, as this requires one blood test compared to three tests of IADPSG, which is expensive. METHOD: Consecutive pregnant women (N = 1463) underwent 75g oral glucose tolerance test (OGTT). The proportion of GDM was computed based on IADPSG and DIPSI criteria and the discordant pair of diagnosing GDM was examined by McNemar test. Analysis was two tailed and P-value <0.05 was considered for statistical significance. RESULT: The prevalence of GDM was 14.6% (N = 214) by IADPSG criteria and 13.4% (n = 196) by DIPSI criteria. The discordant pair between the two criteria examined by McNemar's test indicated that there was no statistical significance (P = 0.21) and thereby implying a close agreement between these two procedures. CONCLUSION: DIPSI procedure is cost-effective, without compromising the clinical equipoise and can be continued to diagnose GDM in our country, as well as other less resource countries.

Status of carotid intima-media thickness and associated risk factors in diabetic, prediabetic and non-diabetic acute stroke.

OBJECTIVE: Measure carotid intima-medial thickness (CIMT), its variability, risk factors, their correlation, in type 2 diabetic (DM), pre-diabetic (PDM) and non-diabetic (NDM) acute strokes. METHODS: Twenty four DM and a matched population of 14 patients each of PDM and NDM strokes were studied. Each group was compared as whole and by gender and stroke segregation. Study parameters were right and left CIMTs (CIMTR, CIMTL), insulin resistance (IR), age, BMI and lipids, correlations between CIMTs and CIMTs with risk markers. RESULTS: CIMTR was higher in DM and PDM compared to NDM, but CIMTLs did not differ. CIMTs were similar in genders and stroke types of each group. The IR was significantly high only in DM. Age and BMI correlations were predominantly positive and lipids variable except in PDM. Age and IR had better impacts on CIMTs in DM while BMI was poor. Females and infarcts had a more congruous CIMT increment in DM and PDM but male and haemorrhage in NDM. CONCLUSION: With similar levels of risk markers, their impacts on the CIMTs are highly variable at various levels of glycaemia. CIMTs were similar in the genders and stroke types of each group, irrespective of the glycemic status. The pre-diabetes group had distinct features.

Comparative evaluation of ophthalmoscopy and angiography for the assessment of retinopathy in type 2 diabetes mellitus.

Diabetic retinopathy (DR) is emerging as a common cause of visual loss. This study was aimed at comparing the relative utility of fundus fluorescein angiography (FFA) with ophthalmoscopy (OPT) in its diagnosis with a cross-sectional cohort. A total of 100 patients of type 2 diabetes mellitus was divided into 3 groups depending on the duration from initial diagnosis and matched by important risk factors. Group A was < 5 years duration and had 31 patients; group B ranged between 5 and 15 years and had 40 patients; and group C were > 15 years with 29 patients. Parameters compared were: Normal retina (NR), background diabetic retinopathy (BDR), preproliferative diabetic retinopathy (PPR), proliferative diabetic retinopathy (PDR); and clinically significant maculopathy (MAC). Dye leakage (DL) and micro-aneurysms (MA) were assessed separately as they are recognised early markers of DR. Result analysis revealed that FFA is well correlated with OPT (0.99) for all groups except group A, where DL (35.5%) played a significant role in altering the correlation (0.85 versus 0.98--OPT versus FFA); 8% of total patients revealed a worse grade with FFA compared to OPT, so appropriate grading of retinopathy is better with FFA at any duration. Less severe varieties of DR predominate in all the groups (BDR-77.4%, 80%, 24.1% respectively), more severe varieties dominate in group C (17.2% and 58.6% of PPR and PDR respectively). MAC is present significantly in group C. FFA is strongly advised, at least in the high-risk groups, at initial diagnosis for detection of DL and also appropriate grading. OPT is a simple and adequate option beyond 5 years of duration. OPT is as good as FFA for the diagnosis of MAC.