Screening for diabetes in India should be initiated at 25 years age.

BACKGROUND: Current guidelines state that screening for diabetes should be done at 30 years of age in India. METHODS: Investigators from multiple sites in India were involved in providing data regarding patients with type 2 diabetes (T2D) aged 30 years or less. Other relevant studies were also reviewed. RESULTS: Overview of published and unpublished data show increasing prevalence of T2D in individuals 30 years and less. About 3/4th of them had overweight/obesity. CONCLUSION: Screening for diabetes in India should start at 25 years in non-pregnant adults instead of 30 years as currently stipulated.

Screening, prevalence, treatment and control of kidney disease in patients with type 1 and type 2 diabetes in low-to-middle-income countries (2005-2017): the International Diabetes Management Practices Study (IDMPS).

AIMS/HYPOTHESIS: Diabetes is the leading cause of kidney disease worldwide. There is limited information on screening, treatment and control of kidney disease in patients with diabetes in low-to-middle-income countries (LMICs). METHODS: The International Diabetes Management Practices Study is an ongoing, non-interventional study of clinical profiles and practices among patients receiving outpatient care mainly by internal medicine physicians and endocrinologists in LMICs. We examined screening, prevalence, treatment and control of kidney disease across seven waves (W) of data collection between 2005 and 2017. RESULTS: Among 15,079 patients with type 1 and 66,088 patients with type 2 diabetes, screening for kidney disease increased between W2 and W3 followed by a plateau (type 1 diabetes: W2, 73.7%; W3, 84.1%; W7, 83.4%; type 2 diabetes: W2, 65.1%; W3, 82.6%; W7, 86.2%). There were also decreasing proportions of patients with microalbuminuria (type 1 diabetes: W1, 27.1%; W3, 14.7%; W7, 13.8%; type 2 diabetes: W1, 24.5%; W3, 12.6%; W7, 11.9%) and proteinuria (type 1 diabetes: W1, 14.2%; W3, 8.7%; W7, 8.2%; type 2 diabetes: W1, 15.6%; W3, 9.3%; W7, 7.6%). Fewer patients were reported as receiving dialysis for both type 1 diabetes (W2, 1.4%; W7, 0.3%) and type 2 diabetes (W2, 0.9%; W7, 0.2%) over time. While there was no change in mean HbA1c or prevalence of diagnosed hypertension (type 1 diabetes: W1, 22.7%; W7, 19.9%; type 2 diabetes: W1, 60.9%; W7, 66.2%), the use of statins had increased among patients diagnosed with dyslipidaemia (type 1 diabetes: W1, 77.7%; W7, 90.7%; type 2 diabetes: W1, 78.6%; W7, 94.7%). Angiotensin II receptor blockers (type 1 diabetes: W1, 18.0%; W7, 30.6%; type 2 diabetes: W1, 24.2%; W7, 43.6%) were increasingly used over ACE inhibitors after W1 (type 1 diabetes: W1, 65.0%; W7, 55.9%; type 2 diabetes: W1, 55.7%, W7, 41.1%) among patients diagnosed with hypertension. CONCLUSIONS/INTERPRETATION: In LMICs, real-world data suggest improvement in screening and treatment for kidney disease in patients with type 1 and type 2 diabetes attending non-nephrology clinics. This was accompanied by decreasing proportions of patients with microalbuminuria and proteinuria, with fewer patients who reported receiving dialysis over a 12-year period.

Effects of dietary and physical activity interventions on the risk of type 2 diabetes in South Asians: meta-analysis of individual participant data from randomised controlled trials.

AIMS/HYPOTHESIS: Individuals of South Asian origin have a high risk of type 2 diabetes and of dying from a diabetes-attributable cause. Lifestyle modification intervention trials to prevent type 2 diabetes in high-risk South Asian adults have suggested more modest effects than in European-origin populations. The strength of the evidence of individual studies is limited, however. We performed an individual participant data meta-analysis of available RCTs to assess the effectiveness of lifestyle modification in South Asian populations worldwide. METHODS: We searched PubMed, EMBASE, Cochrane Library and Web of Science (to 24 September 2018) for RCTs on lifestyle modification interventions incorporating diet and/or physical activity in South Asian adults. Reviewers identified eligible studies and assessed the quality of the evidence. We obtained individual participant data on 1816 participants from all six eligible trials (four from Europe and two from India). We generated HR estimates for incident diabetes (primary outcome) and mean differences for fasting glucose, 2 h glucose, weight and waist circumference (secondary outcomes) using mixed-effect meta-analysis overall and by pre-specified subgroups. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to rate the quality of evidence of the estimates. The study is registered with the International Prospective Register of Systematic Reviews ([PROSPERO] CRD42017078003). RESULTS: Incident diabetes was observed in 12.6% of participants in the intervention groups and in 20.0% of participants in the control groups. The pooled HR for diabetes incidence was 0.65 (95% CI 0.51, 0.81; I2 = 0%) in intervention compared with control groups. The absolute risk reduction was 7.4% (95% CI 4.0, 10.2), with no interactions for the pre-specified subgroups (sex, BMI, age, study duration and region where studies were performed). The quality of evidence was rated as moderate. Mean difference for lifestyle modification vs control groups for 2 h glucose was -0.34 mmol/l (95% CI -0.62, -0.07; I2 = 50%); for weight -0.75 kg (95% CI -1.34, -0.17; I2 = 71%) and for waist -1.16 cm (95% CI -2.16, -0.16; I2 = 75%). No effect was found for fasting glucose. Findings were similar across subgroups, except for weight for European vs Indian studies (-1.10 kg vs -0.08 kg, p = 0.02 for interaction). CONCLUSIONS/INTERPRETATION: Despite modest changes for adiposity, lifestyle modification interventions in high-risk South Asian populations resulted in a clinically important 35% relative reduction in diabetes incidence, consistent across subgroups. If implemented on a large scale, lifestyle modification interventions in high-risk South Asian populations in Europe would reduce the incidence of diabetes in these populations.

Metformin in Prevention of Type 2 Diabetes.

Identification and treatment of individuals with prediabetes is crucial. Effective interventional strategies are key to reducing the diabetes risk at the population level. Lifestyle intervention is found to be more effective but more expensive. Evidence of potential benefits from pharmacotherapy is accumulating. The choice of a pharmacologic intervention to reduce the progression of type 2 diabetes (T2DM) in high risk individuals must consider the balance between the benefit to risk ratio. A meta-analysis of the results of the three important studies has shown that metformin used for up to three years decrease the likelihood of progression to diabetes. Metformin showed greater beneficial effect in people with higher baseline Body Mass Index (BMI) and higher Fasting Plasma Glucose (FPG) than in leaner prediabetic counterparts with low FPG concentrations. Besides diabetes risk reduction, the drug has also proved to be cancer and cardio-protective. The National Institute for Clinical Excellence, UK has recommended the use of metformin in prevention of T2DM in adults at high risk on failure to adhere to lifestyle changes. In view of the long standing safety and tolerability, metformin could be prescribed to people who are unable to comply with lifestyle advice.

Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK.

BACKGROUND: Type 2 diabetes is a serious clinical problem in both India and the UK. Adoption of a healthy lifestyle through dietary and physical activity modification can help prevent type 2 diabetes. However, implementing lifestyle modification programmes to high risk groups is expensive and alternative cheaper methods are needed. We are using a short messaging service (SMS) programme in our study as a tool to provide healthy lifestyle advice and an aid to motivation. The aim of the study is to assess the efficacy and user acceptability of text messaging employed in this way for people with pre-diabetes (HbA1c 6.0% to ≤6.4%; 42-47 mmol/mol) in the UK and India. METHODS/DESIGN: This is a randomised, controlled trial with participants followed up for 2 years. After being screened and receiving a structured education programme for prediabetes, participants are randomised to a control or intervention group. In the intervention group, text messages are delivered 2-3 times weekly and contain educational, motivational and supportive content on diet, physical activity, lifestyle and smoking. The control group undergoes monitoring only. In India, the trial involves 5 visits after screening (0, 6, 12, 18 and 24 months). In the UK there are 4 visits after screening (0, 6, 12 and 24 months). Questionnaires (EQ-5D, RPAQ, Transtheoretical Model of Behavioural Change, and food frequency (UK)/24 h dietary recall (India)) and physical activity monitors (Actigraph GT3X+ accelerometers) are assessed at baseline and all follow-up visits. The SMS acceptability questionnaires are evaluated in all follow-up visits. The primary outcome is progression to type 2 diabetes as defined by an HbA1c of 6.5% or over(India) and by any WHO criterion(UK). Secondary outcomes are the changes in body weight, body mass index, waist circumference, blood pressure, fasting plasma glucose; lipids; proportion of participants achieving HbA1c ≤6.0%; HOMA-IR; HOMA-ß; acceptability of SMS; dietary parameters; physical activity and quality of life. DISCUSSION: The study is designed to assess the efficacy of tailored text messaging in addition to standard lifestyle advice to reduce the progression from prediabetes to type 2 diabetes in the two different countries. TRIAL REGISTRATION: ClinicalTrials.gov ; NCT01570946 , 4th April 2012 (India); NCT01795833 , 21st February 2013 (UK).

Hallux plantar flexor strength in people with diabetic neuropathy: Validation of a simple clinical test.

AIM: To validate the paper grip test for assessing plantar flexion strength of the hallux. METHODS: Plantar flexor strength for 69 people with diabetic neuropathy was assessed: (a) using the paper grip test while simultaneously a plantar pressure platform quantified the force under the hallux, and (b) using a hand-held dynamometer. Following testing, participants were divided into groups: (1) passed vs. failed paper grip test (2) males vs. females. Statistical analyses determined if differences were evident between the groups and assessed the relationship between the paper grip test and the hand-held dynamometer. The discrimination ability, sensitivity, specificity, and reproducibility of the paper grip test was established. RESULTS: Participants who passed the paper grip test demonstrated greater grip force at the hallux than those who failed, and they also exhibited greater isometric maximum force during the hand-held dynamometry test (p ≤ 0.05). Grip force for males was significantly higher than for females. A moderate positive correlation between the paper grip test and the hand-held dynamometer was evident. CONCLUSIONS: In the population examined the paper grip test was found to be a valid clinical tool; it offers a non-invasive, inexpensive, and quick method to assess plantar flexion strength of the hallux.

The post-trial analysis of the Indian SMS diabetes prevention study shows persistent beneficial effects of lifestyle intervention.

AIMS: We had shown that mobile phone based text messaging was an effective tool to deliver lifestyle changes among Asian Indian men with a 36% relative risk reduction in incident diabetes over two years. The present analysis investigated whether beneficial effects of intervention on diabetes prevention persisted for an additional three years after withdrawal of active intervention. METHODS: The primary two year randomized controlled trial (2010-2012) compared lifestyle changes with use of automated text messaging reminders in the intervention (n = 271) versus standard care advice (n = 266) at baseline. At the end of the study, both groups received additional advice on lifestyle changes by a trained dietician. Participants free of diabetes (n = 394) were invited three years later to ascertain the sustained effect of intervention. The primary outcome was incidence of type 2 diabetes. This trial is registered with ClinicalTrials.gov,number NCT02848547. RESULTS: During the mean follow-up of 5 years, 346 out of 394 (87.8%) men were reviewed. Incidence of diabetes was reduced by 30% in the intervention group, with declining gap between-group differences over time (Kaplan-Meier analysis). Significant improvement in dietary adherence occurred in the intervention group at 2nd and 5th year follow up (trend χ2 = 21.35, p < 0.0001). Cox regression analysis showed that the 5th year incidence of diabetes was significantly reduced in the intervention group. Higher body mass index and 2 h plasma glucose at 24 months increased the incidence of diabetes. CONCLUSIONS: Sustained reduction in incident diabetes was apparent after cessation of active lifestyle intervention. This was possibly associated with continuing practice of improved lifestyle.

Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis.

BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists are effective glucose-lowering drugs. Findings from cardiovascular outcome trials showed cardiovascular safety of GLP-1 receptor agonists, but results for cardiovascular efficacy were varied. We aimed to examine overall cardiovascular efficacy for lixisenatide, liraglutide, semaglutide, and extended-release exenatide. METHODS: In this systematic review and meta-analysis, we analysed data from eligible trials that assessed the safety and efficacy of GLP-1 receptor agonists compared with placebo in adult patients (aged 18 years or older) with type 2 diabetes and had a primary outcome including, but not limited to, cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke. We searched PubMed and MEDLINE without language restrictions up to Sept 18, 2017, for eligible trials. We did a meta-analysis of available trial data using a random-effects model to calculate overall hazard ratios (HRs) for cardiovascular efficacy outcomes and odds ratios for key safety outcomes. FINDINGS: Of 12 articles identified in our search and screened for eligibility, four trials of cardiovascular outcomes of GLP-1 receptor agonists were identified: ELIXA (lixisenatide), LEADER (liraglutide), SUSTAIN 6 (semaglutide), and EXSCEL (extended-release exenatide). Compared with placebo, GLP-1 receptor agonist treatment showed a significant 10% relative risk reduction in the three-point major adverse cardiovascular event primary outcome (cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke; HR 0·90, 95% CI 0·82-0·99; p=0·033), a 13% RRR in cardiovascular mortality (0·87, 0·79-0·96; p=0·007), and a 12% relative risk reduction in all-cause mortality (0·88, 0·81-0·95; p=0·002), with low-to-moderate between-trial statistical heterogeneity. No significant effect of GLP-1 receptor agonists was identified on fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, hospital admission for unstable angina, or hospital admission for heart failure. Overall, no significant differences were seen in severe hypoglycaemia, pancreatitis, pancreatic cancer, or medullary thyroid cancer reported between GLP-1 receptor agonist treatment and placebo. INTERPRETATION: Our findings show cardiovascular safety across all GLP-1 receptor agonist cardiovascular outcome trials and suggest that drugs in this class can reduce three-point major adverse cardiovascular events, cardiovascular mortality, and all-cause mortality risk, albeit to varying degrees for individual drugs, without significant safety concerns. GLP-1 receptor agonists have a favourable risk-benefit balance overall, which should allow the choice of drug to be individualised to each patient's needs. FUNDING: Amylin Pharmaceuticals (AstraZeneca).

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .).

Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

BACKGROUND: EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. METHODS: Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. RESULTS: Of a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0%) patients were enrolled in Europe; 3,708 (25.1%), North America; 2,727 (18.5%), Latin America; and 1,529 (10.4%), Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%). CONCLUSIONS: EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338.

A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India-Outcome of screening.

AIMS: We describe a two-step screening approach using non-invasive risk assessment and glycated hemoglobin (HbA1c) to identify participants for a diabetes prevention trial. METHODS: A total of 6030 non-diabetic persons of 35-55 years were screened using risk assessment for diabetes. Those with three or more risk factors were screened using point of care HbA1c test. For this study, participants in HbA1c categories of 6.0% (42.1 mmol/mol)-6.4% (46.4 mmol/mol) were selected and their characteristics were analyzed. RESULTS: Among 6030 persons, 2835 (47%) had three or more risk factors for diabetes. Among those screened with HbA1c, 43.2% (1225) had HbA1c values of <6.0% (42.1 mmol/mol), 46.8% (1327) had HbA1c values between 6.0% (42.1 mmol/mol) and ≤ 6.4% (46.4 mmol/mol) and 10% (283) had undiagnosed diabetes with ≥6.5% (47.5 mmol/mol). Positive family history was present in 53.2%, 81.7% were obese and 14.8% were overweight. CONCLUSIONS: Opportunistic screening using a two-step approach: diabetes risk profile and HbA1c measurement detected a large percentage of individuals with prediabetes. Prediabetic persons recruited to the trial had higher percentage of obesity and presence of positive family history than those who had lower HbA1c values. Outcomes from this trial will enable comparisons with the previous prevention studies that used blood glucose levels as the screening criteria.

Adiponectin, leptin, interleukin-6 and HbA1c in the prediction of incident type 2 diabetes: A nested case-control study in Asian Indian men with impaired glucose tolerance.

AIMS: The aims of this study were: (1) to assess the association of adiponectin, leptin and interleukin-6 (IL-6) with incidence of type 2 diabetes (T2DM) in Asian Indian men with impaired glucose tolerance (IGT) and (2) to evaluate the additional contribution of these with the well-established glycaemic marker HbA1c. METHODS: This is an ancillary analyses of a nested case-control study derived from a prospective, prevention trial in India. All the participants had IGT at baseline. For this subanalysis a total of 147 (T2DM: 71; nondiabetic: 76) participants were selected based on the final glycemic outcomes. Association of these selected adipokines with T2DM were assessed using logistic regression analyses. Clinical usefulness of adding adipokine markers with HbA1c on prediction of T2DM was assessed using the area under the curve (AUC) of the receiver operating characteristics. RESULTS: Baseline levels of adiponectin were lower and the levels of IL-6 were higher in T2DM cases when compared with non-diabetic cases (P<0.05). Levels of leptin were similar in both groups. In fully adjusted models, adiponectin (odds ratio (OR): 0.55 [95%CI: 0.33-0.91]; P=0.019) and IL-6 (OR: 2.27 [95%CI: 1.40-3.691]; P=0.001) were associated with diabetes. Addition of adiponectin to HbA1c improved the AUC (ΔAUC: 0.0619; P=0.0251), whereas addition of IL-6 did not improve the predictive power of HbA1c alone. CONCLUSIONS: Adiponectin and IL-6 are independently associated with incident diabetes. However, they are unlikely to serve as simple tools to predict future risk of diabetes but may have a role in understanding the pathogenesis.

Improvement in diet habits, independent of physical activity helps to reduce incident diabetes among prediabetic Asian Indian men.

AIMS: To assess the beneficial effects of the components of lifestyle intervention in reducing incidence of diabetes in Asian Indian men with impaired glucose tolerance (IGT) in India. METHODS: This analysis was based on a 2 year prospective, randomized controlled primary prevention trial in a cohort of Asian Indian men with IGT (n=537) (Clinical Trial No: NCT00819455). Intervention and control groups were given standard care advice at baseline. Additionally, the intervention group received frequent, mobile phone based text message reminders on healthy lifestyle principles. Dietary intake and physical activity habits were recorded by validated questionnaires. The lifestyle goals were: reductions in consumption of carbohydrates, oil, portion size and body mass index of at least 1 unit (1 kg/m(2)) from baseline and maintenance of good physical activity. The association between diabetes and lifestyle goals achieved was assessed using multiple logistic regression analyses. Changes in insulin sensitivity (Matsuda's insulin sensitivity index) and oral disposition index during the follow-up were assessed. RESULTS: At the end of the study, 123 (23.8%) participants developed diabetes. The mean lifestyle score was higher in the intervention group compared with control (2.59 ± 1.13 vs. 2.28 ± 1.17; P=0.002). Among the 5 lifestyle variables, significant improvements in the 3 dietary goal were seen with intervention. Concomitant improvement in insulin sensitivity and oral disposition index was noted. Higher lifestyle score was associated with lower risk of developing diabetes (odds ratio: 0.54 [95% CI: 0.44-0.70]; P<0.0001). CONCLUSIONS: Beneficial effects of intervention were associated with increased compliance to lifestyle goals. The plausible mechanism is through improvement in insulin sensitivity and beta cell preservation.

Screening among male industrial workers in India shows high prevalence of impaired glucose tolerance, undetected diabetes and cardiovascular risk clustering.

OBJECTIVE: To study the magnitude of undetected diabetes, impaired glucose tolerance (IGT) and clustering of cardiometabolic risk factors among male industrial workers. METHODS: Measurements of 2h post glucose blood glucose (2h PG), blood pressure, body mass index (BMI) and waist circumference (WC) were done in 8741 non-diabetic men of 35-55 years. Presence of family history of diabetes (FH) was noted. Risk associations with diabetes and IGT were studied using multiple logistic regression analysis. Clustering of overweight/obesity, abdominal obesity, hypertension was noted. RESULTS: Prevalence of undetected diabetes (14.9%) and IGT (31.4%) were high. FH, age, hypertension and BMI showed strong associations with diabetes and IGT. More than 40% had clustering of risk factors. CONCLUSION: High prevalence of undetected diabetes, IGT and clustering of cardiometabolic risk factors among young industrial workers mandates that regular screening for metabolic disorders should be undertaken to prevent development of severe morbidity in the productive years of life.

Basal insulin and cardiovascular and other outcomes in dysglycemia.

BACKGROUND: The provision of sufficient basal insulin to normalize fasting plasma glucose levels may reduce cardiovascular events, but such a possibility has not been formally tested. METHODS: We randomly assigned 12,537 people (mean age, 63.5 years) with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes to receive insulin glargine (with a target fasting blood glucose level of ≤95 mg per deciliter [5.3 mmol per liter]) or standard care and to receive n-3 fatty acids or placebo with the use of a 2-by-2 factorial design. The results of the comparison between insulin glargine and standard care are reported here. The coprimary outcomes were nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and these events plus revascularization or hospitalization for heart failure. Microvascular outcomes, incident diabetes, hypoglycemia, weight, and cancers were also compared between groups. RESULTS: The median follow-up was 6.2 years (interquartile range, 5.8 to 6.7). Rates of incident cardiovascular outcomes were similar in the insulin-glargine and standard-care groups: 2.94 and 2.85 per 100 person-years, respectively, for the first coprimary outcome (hazard ratio, 1.02; 95% confidence interval [CI], 0.94 to 1.11; P=0.63) and 5.52 and 5.28 per 100 person-years, respectively, for the second coprimary outcome (hazard ratio, 1.04; 95% CI, 0.97 to 1.11; P=0.27). New diabetes was diagnosed approximately 3 months after therapy was stopped among 30% versus 35% of 1456 participants without baseline diabetes (odds ratio, 0.80; 95% CI, 0.64 to 1.00; P=0.05). Rates of severe hypoglycemia were 1.00 versus 0.31 per 100 person-years. Median weight increased by 1.6 kg in the insulin-glargine group and fell by 0.5 kg in the standard-care group. There was no significant difference in cancers (hazard ratio, 1.00; 95% CI, 0.88 to 1.13; P=0.97). CONCLUSIONS: When used to target normal fasting plasma glucose levels for more than 6 years, insulin glargine had a neutral effect on cardiovascular outcomes and cancers. Although it reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

A new non-invasive technology to screen for dysglycaemia including diabetes.

OBJECTIVE: Assess the ability of a new device based on electrochemical principles using iontophoresis (the EZSCAN) to detect impaired glucose tolerance (IGT) and type 2 diabetes mellitus (DM). METHODS: Eligible Asian Indian subjects, n=212, had anthropometric and blood pressure measurements, followed by an OGTT, HbA1c, serum lipids tests and EZSCAN measurement. RESULTS: Biochemically, 24 subjects were diagnosed with DM, 30 with IGT, 57 subjects had normal glucose tolerance (NGT) with metabolic syndrome (MS) and 101 had NGT without MS. Fasting plasma glucose (FPG) and HbA1c levels were highest in the DM group (p<0.0001 for both). HDL-C levels were different (p=0.015). FPG at a cut-off level of 7.0 mmol/L had a low sensitivity to detect DM (29%) EZSCAN had a 75% sensitivity to detect DM, 70% for IGT and 84% for NGT with MS at threshold >50%. CONCLUSIONS: FPG had low sensitivity to detect DM in the study group. EZSCAN demonstrated good sensitivity to detect IGT and DM and also identified NGT with MS. The concept of measuring ion fluxes through the skin appears to be a powerful method for early detection of MS, IGT and DM.

Current scenario of diabetes in India.

India, a country experiencing rapid socioeconomic progress and urbanization, carries a considerable share of the global diabetes burden. Studies in different parts of India have demonstrated an escalating prevalence of diabetes not only in urban populations, but also in rural populations as a result of the urbanization of lifestyle parameters. The prevalence of prediabetes is also high. Recent studies have shown a rapid conversion of impaired glucose tolerance to diabetes in the southern states of India, where the prevalence of diabetes among adults has reached approximately 20% in urban populations and approximately 10% in rural populations. Because of the considerable disparity in the availability and affordability of diabetes care, as well as low awareness of the disease, the glycemic outcome in treated patients is far from ideal. Lower age at onset and a lack of good glycemic control are likely to increase the occurrence of vascular complications. The economic burden of treating diabetes and its complications is considerable. It is appropriate that the Indian Government has initiated a national program for the management and prevention of diabetes and related metabolic disorders. Lifestyle modification is an effective tool for the primary prevention of diabetes in Asian Indians. The primary prevention of diabetes is urgently needed in India to curb the rising burden of diabetes.

Increasing expenditure on health care incurred by diabetic subjects in a developing country: a study from India.

OBJECTIVE: This study aimed to assess the direct cost incurred by diabetic subjects who were in different income groups in urban and rural India, as well as to examine the changing trends of costs in the urban setting from 1998 to 2005. RESEARCH DESIGN AND METHODS: A total of 556 diabetic subjects from various urban and rural regions of seven Indian states were enrolled. A brief uniform coded questionnaire (24 items) on direct cost was used. RESULTS: Annual family income was higher in urban subjects (rupees [Rs] 100,000 or $2,273) than in the rural subjects (Rs 36,000 or $818) (P < 0.001). Total median expenditure on health care was Rs 10,000 ($227) in urban and Rs 6,260 ($142) in rural (P < 0.001) subjects. Treatment costs increased with duration of diabetes, presence of complications, hospitalization, surgery, insulin therapy, and urban setting. Lower-income groups spent a higher proportion of their income on diabetes care (urban poor 34% and rural poor 27%). After accounting for inflation, a secular increase of 113% was observed in the total expenses between 1998 and 2005 in the urban population. The highest increase in percentage of household income devoted to diabetes care was in the lowest economic group (34% of income in 1998 vs. 24.5% in 2005) (P < 0.01). There was a significant improvement in urban subjects in medical reimbursement from 2% (1998) to 21.3% (2005). CONCLUSIONS: Urban and rural diabetic subjects spend a large percentage of income on diabetes management. The economic burden on urban families in developing countries is rising, and the total direct cost has doubled from 1998 to 2005.