Automatic identification of type 2 diabetes, hypertension, ischaemic heart disease, heart failure and their levels of severity from Italian General Practitioners' electronic medical records: a validation study Validation of the IMS CORE Diabetes Model. Systemic Cytokines in Type 2 Diabetes Mellitus and Chronic Periodontitis. Development and Validation of a Computer Application to Aid the Physician's Decision-Making Process at the Start of and during Treatment with Insulin in Type 2 Diabetes: A Randomized and Controlled Trial The effectiveness of yoga to prevent diabetes mellitus type 2 Intake of different types of dairy and its prospective association with risk of type 2 diabetes: The Rotterdam Study. Changes in red meat consumption and subsequent risk of type 2 diabetes mellitus: three cohorts of US men and women. A Bayesian latent class approach for EHR‐based phenotyping Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study Safety and Efficacy of Roux-en-Y Gastric Bypass to Treat Type 2 Diabetes Mellitus in Non-severely Obese Patients Long-chain omega-3 fatty acids, fish intake, and the risk of type 2 diabetes mellitus. Short-term efficacy and safety of repaglinide versus glimepiride as augmentation of metformin in treating patients with type 2 diabetes mellitus Predicting 6-Year Mortality Risk in Patients With Type 2 Diabetes Type 2 diabetes mellitus: a high-risk condition for cardiovascular disease irrespective of the different degrees of obesity. Long term effect and safety of Wharton's jelly-derived mesenchymal stem cells on type 2 diabetes. DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial - DRKS00004550 Increased Risk of Severe Hypoglycemic Events with Increasing Frequency of Non-severe Hypoglycemic Events in Patients with Type 1 and Type 2 Diabetes Type 2 diabetes mellitus, insulin-use and risk of bladder cancer in a large cohort study. Resveratrol Ameliorates Arterial Stiffness Assessed by Cardio-Ankle Vascular Index in Patients With Type 2 Diabetes Mellitus. HeLP-Diabetes: randomised controlled trial protocol Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care Willingness to pay for improvements in chronic long-acting insulin therapy in individuals with type 1 or type 2 diabetes mellitus.
Objectives The Italian project MATRICE aim ed to assess how well cases of type 2 diabetes ( T2DM ) , hypertension , ischaemic heart disease ( IHD ) and heart failure ( HF ) and their levels of severity can be automatically extracted from the Health Search /CSD Longitudinal Patient Data base ( HSD ) . From the medical records of the general practitioners ( GP ) who volunteered to participate , cases were extracted by algorithms based on diagnosis codes , keywords , drug prescriptions and results of diagnostic tests . A r and om sample of identified cases was vali date d by interviewing their GPs . Setting HSD is a data base of primary care medical records . A panel of 12 GPs participated in this validation study . Participants 300 patients were sample d for each disease , except for HF , where 243 patients were assessed . Outcome measures The positive predictive value ( PPV ) was assessed for the presence/absence of each condition against the GP 's response to the question naire , and Cohen 's κ was calculated for agreement on the severity level . Results The PPV was 100 % ( 99 % to 100 % ) for T2DM and hypertension , 98 % ( 96 % to 100 % ) for IHD and 55 % ( 49 % to 61 % ) for HF . Cohen 's kappa for agreement on the severity level was 0.70 for T2DM and 0.69 for hypertension and IHD . Conclusions This study shows that individuals with T2DM , hypertension or IHD can be validly identified in HSD by automated identification algorithms . Automatic queries for levels of severity of the same diseases compare well with the corresponding clinical definitions , but some misclassification occurs . For HF , further research is needed to refine the current algorithm BACKGROUND The IMS CORE Diabetes Model ( CDM ) is a widely published and vali date d simulation model applied in both type 1 diabetes mellitus ( T1DM ) and type 2 diabetes mellitus ( T2DM ) analyses . Validation to external studies is an important part of demonstrating model credibility . OBJECTIVE Because the CDM is widely used to estimate long-term clinical outcomes in diabetes patients , the objective of this analysis was to vali date the CDM to contemporary outcomes studies , including those with long-term follow-up periods . METHODS A total of 112 validation simulations were performed , stratified by study follow-up duration . For long-term results ( ≥15-year follow-up ) , simulation cohorts representing baseline Diabetes Control and Complications Trial ( DCCT ) and United Kingdom Prospect i ve Diabetes Study ( UKPDS ) cohorts were generated and intensive and conventional treatment arms were defined in the CDM . Predicted versus observed macrovascular and microvascular complications and all-cause mortality were assessed using the coefficient of determination ( R(2 ) ) goodness-of-fit measure . RESULTS Across all validation studies , the CDM simulations produced an R(2 ) statistic of 0.90 . For validation studies with a follow-up duration of less than 15 years , R(2 ) values of 0.90 and 0.88 were achieved for T1DM and T2DM respectively . In T1DM , validating against 30-year outcomes data ( DCCT ) result ed in an R(2 ) of 0.72 . In T2DM , validating against 20-year outcomes data ( UKPDS ) result ed in an R(2 ) of 0.92 . CONCLUSIONS This analysis supports the CDM as a credible tool for predicting the absolute number of clinical events in DCCT- and UKPDS-like population s. With increasing incidence of diabetes worldwide , the CDM is particularly important for health care decision makers , for whom the robust evaluation of health care policies is essential BACKGROUND Cytokine dysregulation plays an important role in Type 2 Diabetes Mellitus ( T2DM ) and Chronic Periodontitis ( CP ) with a commonality in pathogenic mechanisms . CP is considered the sixth complication of diabetes and may have an increased influence on systemic levels of cytokines in individuals with T2DM . OBJECTIVE This study investigated two pro- , and two presumed anti-inflammatory cytokines and their ratios in the serum of healthy individuals , in chronic periodontitis with and without T2DM with , and without CP and in CP alone aim ed at evaluating the systemic inflammatory burden of a local oral infection . METHODS Eighty participants were divided equally into four groups as healthy volunteers ( H ) and patients having T2DM with , and without CP ( T2DM+CP , and T2DM ) and only CP ( CP ) . Serum sample s were collected to measure glycated hemoglobin ( HbA1c ) , R and om Blood Sugar ( RBS ) and also Tumor Necrosis Factor (TNF)-α , Interleukin (IL)-4 , -6 - 10 were assessed using commercially available ELISA kits . RESULTS The cytokines were detected in all groups . Significant differences were observed between groups for all the clinical , biochemical parameters and cytokines . Cytokine levels and the ratios showed significant correlations . The ratios of the cytokines differed significantly amongst groups , were highest in T2DM+CP . CONCLUSION In this study , the cytokine ratios provided a qualitative profile along with the absolute levels in T2DM with periodontitis , indicative of an intensified systemic inflammatory state Background : Achieving optimum blood glucose control in patients with type 2 diabetes mellitus ( T2DM ) is difficult . Some primary care physicians ( PCPs ) delay the start of insulin use because of the uncertainty in intensifying insulin therapy . The objective was to develop and vali date a computer application ( CA ) that helps PCPs to make decisions about insulin therapy in order to achieve a significant improvement in glycated hemoglobin ( HbA1c ) . Methods : This was a cluster-r and omized clinical trial . Fourteen primary care centers ( PCCs ) in Madrid with 66 PCPs and 697 T2DM patients on insulin therapy were r and omly divided into two groups of seven PCCs each . In the intervention group , seven PCCs included 39 PCPs and 365 T2DM patients on insulin therapy . These PCPs were free to use the CA . A further seven PCCs were assigned to the control group with 27 PCPs and 332 T2DM patients on insulin therapy . The control group did not use the CA . The duration of the trial was 18 months to vali date the CA . The outcome was a change in HbA1c from baseline . Results : In the intervention group , the final HbA1c was 7.19 % ( st and ard deviation [ SD ] ± 0.93 ) , with a difference from the start of −0.69 % ( p = .001 ) . In the control group , it was 7.71 % ( SD ± 1.37 ) , with a difference from the start of −0.09 % ( p not significant ) . Conclusions : This CA helps to improve HbA1c figures of T2DM patients with insulin when it is used by PCPs to make decisions when starting , continuing , or changing insulin and its dosage Background : Type 2 diabetes mellitus ( T2DM ) is becoming a leading problem worldwide . Emerging reports reveal alarming evidence of increasing prevalence of T2DM that has reached p and emic levels . Despite the significant incidence , there are limited reliable data re sources and comprehensive systematic review and meta- analysis on the effects of yoga on people who are a prediabetic or high risk for developing T2DM . Objective : The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the effects of yoga on people who are prediabetes or high risk of developing T2DM . Methods : The articles enrolled in the study will be retrieved from the online data bases between 2002 and the date the search es are executed . The search es will be repeated just before the final analyses and further relevant studies for inclusion . We will conduct a bibliographic search in data bases : Medline / PubMed , Scopus , Cochrane Library , EBSCO , and IndMED using keywords including prediabetes state , high risk for diabetes , metabolic syndrome , and yoga . A defined search strategy will be implemented along with selection criteria to obtain full-text articles of relevant studies . This study protocol was prepared according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis for Protocol s 2015 guidelines . There will be no language restrictions . Ethics and dissemination : The proposed study will be based on published studies and publicly available anonymized data without directly involving human participants and therefore requires neither formal human ethical review nor approval by a human research ethics committee . We published an outline of the protocol in the International Prospect i ve Register of Systematic Review s ( PROSPERO ) in 2018 . We plan to disseminate the findings of this systematic review and meta- analysis through publication in a peer- review ed journal and presentation at relevant conference proceedings . In addition , we believe the results of the systematic review will have implication s for policy and practice . We will prepare policymaker summary using a vali date d format , disseminate through social media and email discussion groups . Review registration number : PROSPERO registration number CRD BACKGROUND AND AIMS The prevalence of type 2 diabetes ( T2DM ) is increasing . Several studies have suggested a beneficial effect of several major dairy nutrients on insulin production and sensitivity . Conversely , harmful effects have been suggested as well . This study aim ed to investigate the impact of the full-range of dairy products and its association with incidence T2DM in Dutch adults aged ≥55 years participating in the Rotterdam Study . METHODS AND RESULTS  Dairy intake was assessed with a vali date d FFQ , including total , skimmed , semi-skimmed , full-fat , fermented , and non-fermented dairy , and subclasses of these product groups . Verified prevalent and incident diabetes were documented . Cox proportional hazards regression and spline regression were used to analyse data , adjusting for age , sex , alcohol , smoking , education , physical activity , body mass index , intake of total energy , energy-adjusted meat , and energy-adjusted fish intake . Median total dairy intake was 398 g/day ( IQR 259 - 559 g/day ) . Through 9.5 ± 4.1 years of follow-up , 393 cases of incident T2DM were reported . Cox and spline regression did not point towards associations of total dairy consumption , dairy consumption based on fat content , non-fermented or fermented dairy consumption , or individual dairy product consumption with incident T2DM . The HR for total dairy intake and T2DM was 0.93 ( 95 % CI : 0.70 - 1.23 ) in the upper quartile ( P-for trend 0.76 ) . CONCLUSIONS This prospect i ve cohort study did not point towards an association between dairy consumption and T2DM IMPORTANCE Red meat consumption has been consistently associated with an increased risk of  type 2 diabetes mellitus ( T2DM ) . However , whether changes in red meat intake are related to subsequent T2DM risk remains unknown . OBJECTIVE To evaluate the association between changes in red meat consumption during a 4-year period and subsequent 4-year risk of T2DM in US adults . DESIGN AND SETTING Three prospect i ve cohort studies in US men and women . PARTICIPANTS We followed up 26,357 men in the Health Professionals Follow-up Study ( 1986 - 2006 ) , 48,709 women in the Nurses ' Health Study ( 1986 - 2006 ) , and 74,077 women in the Nurses ' Health Study II ( 1991 - 2007 ) .  Diet was assessed by vali date d food frequency question naires and up date d every 4 years . Time-dependent Cox proportional hazards regression models were used to calculate hazard ratios with adjustment for age , family history , race , marital status , initial red meat consumption , smoking status , and initial and changes in other lifestyle factors ( physical activity , alcohol intake , total energy intake , and diet quality ) . Results across cohorts were pooled by an inverse variance-weighted , fixed-effect meta- analysis . MAIN OUTCOMES AND MEASURES Incident T2DM cases vali date d by supplementary question naires . RESULTS During 1,965,824 person-years of follow-up , we documented 7540 incident T2DM cases . In the multivariate-adjusted models , increasing red meat intake during a 4-year interval was associated with an elevated risk of T2DM during the subsequent 4 years in each cohort ( all P < .001 for trend ) . Compared with the reference group of no change in red meat intake , increasing red meat intake of more than 0.50 servings per day was associated with a 48 % ( pooled hazard ratio , 1.48 ; 95 % CI , 1.37 - 1.59 ) elevated risk in the subsequent 4-year period , and the association was modestly attenuated after further adjustment for initial body mass index and concurrent weight gain ( 1.30 ; 95 % CI , 1.21 - 1.41 ) . Reducing red meat consumption by more than 0.50 servings per day from baseline to the first 4 years of follow-up was associated with a 14 % ( pooled hazard ratio , 0.86 ; 95 % CI , 0.80 - 0.93 ) lower risk during the subsequent entire follow-up through 2006 or 2007 . CONCLUSIONS AND RELEVANCE Increasing red meat consumption over time is associated with an elevated subsequent risk of T2DM , and the association is partly mediated by body weight . Our results add further evidence that limiting red meat consumption over time confers benefits for T2DM prevention Phenotyping , ie , identification of patients possessing a characteristic of interest , is a fundamental task for research conducted using electronic health records . However , challenges to this task include imperfect sensitivity and specificity of clinical codes and inconsistent availability of more detailed data such as laboratory test results . Despite these challenges , most existing electronic health records – derived phenotypes are rule‐based , consisting of a series of Boolean arguments informed by expert knowledge of the disease of interest and its coding . The objective of this paper is to introduce a Bayesian latent phenotyping approach that accounts for imperfect data elements and missing not at r and om missingness patterns that can be used when no gold‐st and ard data are available . We conducted simulation studies to compare alternative phenotyping methods under different patterns of missingness and applied these approaches to a cohort of 68 265 children at elevated risk for type 2 diabetes mellitus ( T2DM ) . In simulation studies , the latent class approach had similar sensitivity to a rule‐based approach ( 95.9 % vs 91.9 % ) while substantially improving specificity ( 99.7 % vs 90.8 % ) . In the PEDSnet cohort , we found that biomarkers and clinical codes were strongly associated with latent T2DM status . The latent T2DM class was also strongly predictive of missingness in biomarkers . Glucose was missing in 83.4 % of patients ( odds ratio for latent T2DM status = 0.52 ) while hemoglobin A1c was missing in 91.2 % ( odds ratio for latent T2DM status = 0.03 ) , suggesting missing not at r and om missingness . The latent phenotype approach may substantially improve on rule‐based phenotyping Background Type 2 diabetes ( T2DM ) affects 113.9 million people in China , the largest number of any country in the world ( JAMA 310:948–59 , 2013 ) . T2DM prevalence has risen dramatically from around 1 % in the 1980s to now over 10 % and is expected to continue rising . Despite the growing disease burden , few people with T2DM are achieving adequate management targets to prevent complications . Health system infrastructure in China is struggling to meet these gaps in care , and innovative , cost-effective and affordable solutions are needed . One promising strategy that may be particularly relevant to the Chinese context is improving support for lay family members to care for their relatives with T2DM . Methods We hypothesise that an interactive mobile health management system can support lay family health promoters ( FHP ) and healthcare staff to improve clinical outcomes for family members with T2DM through medical assessment , regular monitoring , lifestyle advice and the prescribing of guidelines recommended medications . This intervention will be implemented as a cluster r and omised controlled trial involving 80 communities ( 40 communities in Beijing and 40 rural villages in Hebei province ) and 2000 people with T2DM . Outcome analyses will be conducted blinded to intervention allocation . The primary outcome is the proportion of patients achieving ≥2 “ ABC ” goals ( HbA1c < 7.0 % , blood pressure ( BP ) < 140/80 mmHg and LDL cholesterol < 100 mg/dl or 2.6 mmol/L ) at the end of follow-up ( Diabetes Care 36(Supplement 1):S11-S66 , 2013 ) . Secondary outcomes include the proportion of patients achieving individual ABC targets ; mean changes in HbA1c , BP , LDL , renal function ( serum creatinine and urinary albumin ) , body mass index , quality of life ( QOL , EQ-5D ) , and healthcare utilisation from baseline ; and cost-effectiveness/utility of intervention . Trial outcomes will be accompanied by detailed process and economic evaluations . Discussion The Chinese government has prioritised prevention and treatment of diabetes as 1 of 11 National Basic Public Health Services . Despite great promise for mHealth interventions to improve access to effective health care , there remains uncertainty about how this can be successfully achieved . The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China . Trial registration Clinical trials.gov Background Women who are diagnosed with gestational diabetes mellitus ( GDM ) are at increased risk for developing prediabetes and type 2 diabetes mellitus ( T2DM ) . To date , there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM . This paper describes the rationale , design and methodology of a 2-year , r and omized , controlled study being conducted in North Carolina . Methods / Design Using a two-group , repeated measures , experimental design , we will test a 14- week intensive intervention on the benefits of breastfeeding , underst and ing gestational diabetes and risk of progression to prediabetes and T2DM , nutrition and exercise education , coping skills training , physical activity ( Phase I ) , educational and motivational text messaging and 3 months of continued monthly contact ( Phase II ) . A total of 100 African American , non-Hispanic white , and bilingual Hispanic women between 22–36 weeks of pregnancy who are diagnosed with GDM and their infants will be r and omized to either the experimental group or the wait-listed control group . The first aim of the study is to determine the feasibility of the intervention . The second aim of study is to test the effects of the intervention on maternal outcomes from baseline ( 22–36 weeks pregnant ) to 10 months postpartum . Primary maternal outcomes will include fasting blood glucose and weight ( BMI ) from baseline to 10 months postpartum . Secondary maternal outcomes will include clinical , adiposity , health behaviors and self-efficacy outcomes from baseline to 10 months postpartum . The third aim of the study is to quantify the effects of the intervention on infant feeding and growth . Infant outcomes will include weight status and breastfeeding from birth through 10 months of age . Data analysis will include general linear mixed-effects models . Safety endpoints include adverse event reporting . Discussion Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory , reducing the burden of metabolic disease across two generations . Trial registration The efficacy of Roux-en-Y gastric bypass ( RYGB ) to control  type 2 diabetes mellitus ( T2DM )  has been demonstrated in morbidly obese patients . Surgical procedures primarily focused on T2DM control in patients with body mass index ( BMI ) < 35 kg/m2 have shown to effectively induce remission of T2DM . However , only few reports have evaluated the safety and efficacy of RYGB in this group of patients . The aim of this study is to assess the safety and efficacy of RYGB in TD2 M patients with BMI < 35 kg/m2 . All T2DM patients with BMI < 35 kg/m2 and at least 12 months of follow-up who underwent laparoscopic RYGB were included . Safety of the procedure was evaluated according to mortality , need of reoperation/conversion , and complication rates . Metabolic parameters were evaluated at baseline and 6 , 12 , and 24 months after surgery . Thirty patients were included . Seventeen ( 56.6 % ) were women . Age , BMI , and duration of diabetes were 48 ± 9 years , 33.7 ± 1.2 kg/m2 , 4 ± 2.9 years , respectively . No mortality was observed . No conversion/reoperation was needed . Average length of stay was 3.2 ± 0.9 days . Early and late postoperative complications were observed in five ( 16.6 % ) and five ( 16.6 % ) patients , respectively . Twelve months after surgery , remission was observed in 25 of 30 patients ( 83.3 % ) . After 2 years , remission was achieved in 13 of 20 patients ( 65 % ) , and hemoglobin A1c decreased from 8.1 ± 1.8 % to 5.9 ± 1.1 % and homeostasis model assessment of insulin resistance from 5.7 ± 3.2 to 1.9 ± 0.8 after 12 months . RYGB is a safe and effective procedure to induce T2DM remission in otherwise not eligible patients for bariatric surgery . Evidence from prospect i ve studies is needed to vali date this approach BACKGROUND Diet is a key component of a healthy lifestyle in the prevention of  type 2 diabetes mellitus ( T2DM ) . The role of long-chain omega-3 ( n-3 ) fatty acids ( LCFAs ) in the development of T2DM remains unresolved . OBJECTIVE We examined the association between dietary LCFAs and incidence of T2DM in 3 prospect i ve cohorts of women and men . DESIGN We followed 195,204 US adults ( 152,700 women and 42,504 men ) without preexisting chronic disease at baseline for 14 to 18 y.  Fish and LCFA intakes  were assessed at baseline and up date d at 4-y intervals by using a vali date d food-frequency question naire . RESULTS During nearly 3 million person-years of follow-up , 9380 new cases of T2DM were documented . After adjustment for other dietary and lifestyle risk factors , LCFA intake was positively related to incidence of T2DM . The pooled multivariate relative risks in 3 cohorts across increasing quintiles of LCFAs were as follows : 1 ( reference ) , 1.00 ( 95 % CI : 0.91 , 1.09 ) , 1.05 ( 95 % CI : 0.97 , 1.13 ) , 1.17 ( 95 % CI : 1.07 , 1.28 ) , and 1.24 ( 95 % CI : 1.09 , 1.40 ) ( P for trend < 0.001 ) . Compared with those who consumed fish less than once per month , the relative risk of T2DM was 1.22 ( 95 % CI : 1.08 , 1.39 ) for women who consumed > or = 5 servings fish/wk ( P for trend < 0.001 ) . CONCLUSIONS We found no evidence that higher consumption of LCFAs and fish reduces the risk of T2DM . Instead , higher intakes may modestly increase the incidence of this disease . Given the beneficial effects of LCFA intake on many cardiovascular disease risk factors , the clinical relevance of this relation and its possible mechanisms require further investigation Background : Consistent evidence is still lacking on which one , glimepiride plus metformin or repaglinide plus metformin , is better in treating type 2 diabetes mellitus ( T2DM ) . Therefore , this study was conducted to compare the short-term efficacy and safety of these two methods in treating T2DM . Methods : The literature research dating up to August 2018 was conducted in the electronic data bases . The r and omized controlled trials ( RCTs ) comparing the short-term ( treatment period ≤12 weeks ) efficacy and safety of these two methods in treating patients with T2DM were included . No language limitation was used in this study . The decreased hemoglobin A1c ( HbA1c ) , fasting plasma glucose ( FPG ) , and 2h plasma glucose ( 2hPG ) levels were used as the primary outcome to assess the efficacy , and the adverse events and hypoglycemia were used as the secondary outcome to assess the safety . Results : In total , 11 RCTs composed of 844 T2DM patients were included . The results showed that there were no significant differences in decreasing HbA1c and FPG levels between the two methods , but the estimated st and ardized mean differences favored the repaglinide plus metformin . Meanwhile , the repaglinide plus metformin was significantly more effective in decreasing 2hPG levels than glimepiride plus metformin . In addition , fewer patients reported adverse events and experienced hypoglycemia in the repaglinide plus metformin group . Conclusion : These results indicated that the repaglinide plus metformin might have some advantages over glimepiride plus metformin in the short-term treatment of patients with T2DM , and should be further explored OBJECTIVE —The objective of this study was to create a tool that predicts the risk of mortality in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS —This study was based on a cohort of 33,067 patients with type 2 diabetes identified in the Clevel and Clinic electronic health record ( EHR ) who were initially prescribed a single oral hypoglycemic agent between 1998 and 2006 . Mortality was determined in the EHR and the Social Security Death Index . A Cox proportional hazards regression model was created using medication class and 20 other predictor variables chosen for their association with mortality . A prediction tool was created using the Cox model coefficients . The tool was internally vali date d using repeated , r and om subsets of the cohort , which were not used to create the prediction model . RESULTS —Follow-up in the cohort ranged from 1 day to 8.2 years ( median 28.6 months ) , and 3,661 deaths were observed . The prediction tool had a concordance index ( i.e. , c statistic ) of 0.752 . CONCLUSIONS —We successfully created a tool that accurately predicts mortality risk in patients with type 2 diabetes . The incorporation of medications into mortality predictions in patients with type 2 diabetes should improve treatment decisions BACKGROUND Measurement of body weight with body mass index ( BMI ) is often utilized to stratify cardiovascular disease ( CVD ) risk . AIM To determine CVD risk profile and disease burden in subjects with type 2 diabetes mellitus ( T2DM ) across different categories of body weight as defined by BMI . DESIGN Prospect i ve observational study . METHODS CVD risk including metabolic syndrome ( MetS ) and prevalence of macrovascular complications were determined for each category of body weight as defined by the World Health Organisation ( WHO ) classification . RESULTS A total of 390 subjects were included in this study of which 35.9 % were non-obese ( BMI < 30 kg/m(2 ) ) . Although increasing obesity as defined by BMI was associated with higher prevalence of central abdominal obesity , hypertension and MetS ( P < 0.05 ) , dyslipidaemia and macrovascular complications were not significantly different across the various body weight categories ( P = NS ) . Similar observation was seen in non-obese ( BMI < 30 kg/m(2 ) ) and obese subjects ( BMI > 30 kg/m(2 ) ) . Among non-obese ( including normal weight ) cohort , the majority of these subjects had adverse CVD risk profile including presence of at least two co-existing risk factors . CONCLUSION Subjects with T2DM possess adverse CVD risk factors with significant burden of macrovascular disease irrespective of their baseline body weight Cellular therapies offer novel opportunities for the treatment of type 2 diabetes mellitus ( T2DM ) . The present study evaluated the long-term efficacy and safety of infusion of Wharton 's jelly-derived mesenchymal stem cells ( WJ-MSC ) on T2DM . A total of 61 patients with T2DM were r and omly divided into two groups on the basis of basal therapy ; patients in group I were administered WJ-MSC intravenous infusion twice , with a four-week interval , and patients in group II were treated with normal saline as control . During the 36-month follow-up period , the occurrence of any adverse effects and the results of clinical and laboratory examinations were recorded and evaluated . The lack of acute or chronic adverse effects in group I was consistent with group II .. Blood glucose , glycosylated hemoglobin , C-peptide , homeostasis model assessment of pancreatic islet β-cell function and incidence of diabetic complications in group I were significantly improved , as compared with group II during the 36-month follow-up . The results of the present study demonstrated that infusion of  WJ-MSC improved the function of islet β-cells and reduced the incidence of diabetic complications , although the precise mechanisms are yet to be eluci date d. The infusion of WJ-MSC may be an effective option for the treatment of patients with type 2 diabetes Background Type 2 diabetes mellitus ( T2DM ) is a disease with high prevalence , associated with severe co-morbidities as well as being a huge burden on public health . It is known that glycemic control decreases long-term morbidity and mortality . The current st and ard therapy for T2DM is medical treatment . Several r and omized controlled trials ( RCTs ) performed in obese patients showed remission of T2DM after bariatric surgery . Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese , insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM . This study aims at investigating whether Roux-en-Y gastric bypass ( RYGB ) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality . Methods The DiaSurg 2 trial is a multicenter , open r and omized controlled trial comparing RYGB including st and ardized medical treatment if needed to exclusive st and ardized medical treatment of T2DM ( control group ) . The primary endpoint is a composite time-to-event endpoint ( cardiovascular death , myocardial infa rct ion , coronary bypass , percutaneous coronary intervention , non-fatal stroke , amputation , surgery for peripheral atherosclerotic artery disease ) , with a follow-up period of 8 years . Insulin-dependent T2DM patients aged between 30 and 65 years will be included and r and omly assigned to one of the two groups . The experimental group will receive RYGB and , if needed , st and ardized medical care , whereas the control group will receive exclusive st and ardized medical care , both according to the national treatment guidelines for T2DM . Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population . Assuming a loss to follow-up rate of 20 % , 200 patients will be r and omly allocated to the comparison groups . A total sample size of n = 400 is sufficient to ensure 80 % power in a two-tailed significance test at alpha = 5 % . Discussion The DiaSurg2 trial will yield long-term data ( 8 years ) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or st and ardized medical care . Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004550 Introduction  Severe hypoglycemic events ( SHEs ) are associated with significant morbidity , mortality and costs . However , the more common non-severe  hypoglycemic events ( NSHEs ) are less well explored . We investigated the association between reported frequency of NSHEs and SHEs among patients with type 1 diabetes mellitus ( T1DM ) and type 2 diabetes mellitus ( T2DM ) in the PREDICTIVE study . Methods PREDICTIVE was a global , prospect i ve , observational study . Patients with T1DM ( n = 7,420 ) or T2DM ( n = 12,981 ) , starting treatment with insulin detemir  , reported the number of NSHEs and SHEs experienced during the 4 weeks prior to baseline and follow-up visits ( mean 14.4 weeks ) . Logistic regression was used to determine the odds ratio ( OR ) of experiencing ≥1 SHE , in patients having 1–4 or ≥5 NSHEs , versus those having 0 NSHEs , while controlling for baseline covariates . Results Hypoglycemia rates were lower at follow-up than baseline . At baseline 59.2 % ( T1DM ) and 18.8 % ( T2DM ) reported any hypoglycemia and at follow-up 39.5 % ( T1DM ) and 8.6 % ( T2DM ) . There was a significant ( P < 0.0001 ) increase in the odds of ≥1 SHEs with increasing frequency of NSHEs in T1DM and T2DM , for both crude and adjusted estimates . At baseline , in T1DM , ORs for ≥1 SHE were 1.92 and 2.13 for 1–4 and ≥5 NSHEs , respectively ; the corresponding ORs in T2DM were 10.83 and 15.36 , respectively . At follow-up , the ORs for ≥1 SHE were 2.01 and 3.20 ( T1DM ) and 18.99 and 24.29 ( T2DM ) for 1–4 and ≥5 NSHEs , respectively . Conclusion A statistically significant association between NSHE and SHE frequency was found in T1DM and T2DM . These data provide a clear rationale for the reduction of hypoglycemic events , regardless of severity , while striving for optimal glycemic control Type 2 diabetes mellitus ( T2DM ) is associated with increased  bladder cancer  incidence in some , but not all , studies . Many studies had limited statistical power and few examined risk by insulin-use , duration of diabetes or cancer stage . We examined the association between T2DM and bladder cancer incidence in the Cancer Prevention Study II Nutrition Cohort , a large prospect i ve study with information on insulin-use and duration of diabetes . Diabetes and insulin-use were ascertained from a question naire at study enrollment in 1992 or 1993 and up date d in 1997 and every 2 years thereafter . During follow-up through 2007 , 1,852 cases of incident bladder cancer were identified among 172,791 participants .  Multivariable adjusted relative risks ( RRs ) and 95 % confidence intervals ( CIs ) were estimated using extended Cox regression modeling . There were no associations of T2DM with the risk of bladder cancer overall ( RR = 1.01 , 95 % CI : 0.87 - 1.17 ) , noninvasive disease ( RR = 0.93 , 95 % CI : 0.76 - 1.14 ) or invasive disease ( RR = 1.13 , 95 % CI : 0.91 - 1.40 ) . Compared to participants without T2DM , risk of invasive bladder cancer was higher among participants who had had T2DM for > 15 years ( RR = 1.63 , 95 % CI : 1.09 - 2.43 ) and among those using insulin ( RR = 1.64 , 95 % CI : 1.18 - 2.27 ) . These results do not support an association of T2DM with overall bladder cancer incidence , but do suggest positive associations of long-term T2DM and insulin-use or other factors correlated with severe diabetes , with invasive bladder cancer incidence Resveratrol has been reported to have potent anti-atherosclerotic effects in animal studies . However , there are few interventional studies in human patients with atherosclerogenic diseases . The cardio-ankle vascular index ( CAVI ) reflects arterial stiffness and is a clinical surrogate marker of atherosclerosis . The aim of the present study was to investigate the effect of resveratrol on arterial stiffness assessed by CAVI in patients with type 2 diabetes mellitus (T2DM).In this double-blind , r and omized , placebo-controlled study , 50 patients with T2DM received supplement of a 100 mg resveratrol tablet ( total resveratrol : oligo-stilbene 27.97 mg/100 mg/day ) or placebo daily for 12 weeks . CAVI was assessed at baseline and the end of study . Body weight ( BW ) , blood pressure ( BP ) , glucose and lipid metabolic parameters , and diacron-reactive oxygen metabolites ( d-ROMs ; an oxidative stress marker ) were also measured . Resveratrol supplementation decreased systolic BP ( -5.5 ± 13.0 mmHg ) , d-ROMs ( -25.6 ± 41.8 U.CARR ) , and CAVI ( -0.4 ± 0.7 ) significantly ( P < 0.05 ) and decreased BW ( -0.8 ± 2.1 kg , P = 0.083 ) and body mass index ( -0.5 ± 0.8 kg/m2 , P = 0.092 ) slightly compared to baseline , while there were no significant changes in the placebo group . Decreases in CAVI and d-ROMs were significantly greater in the resveratrol group than in the placebo group . Multivariate logistic regression analysis identified resveratrol supplementation as an independent predictor for a CAVI decrease of more than 0.5.In conclusion , 12-week resveratrol supplementation may improve arterial stiffness and reduce oxidative stress in patients with T2DM . Resveratrol may be beneficial in preventing the development of atherosclerosis induced by diabetes . However , a large-scale cohort study is required to vali date the present findings Background Type 2 Diabetes Mellitus ( T2DM ) is common , affecting nearly 400 million people worldwide . Achieving good health for people with T2DM requires active self-management ; however , uptake of self-management education is poor , and there is an urgent need to find better , more acceptable , cost-effective methods of providing self-management support . Web-based self-management support has many potential benefits for patients and health services . The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM . Methods This will be a multi-centre individually r and omised controlled trial in primary care , recruiting adults with T2DM who are registered with participating general practice s in Engl and . Participants will be r and omised to receive either an evidence -based , theoretically informed , web-based self-management programme for people with T2DM which addresses medical , emotional , and role management , called Healthy Living for People with type 2 Diabetes ( HeLP-Diabetes ) or a simple information website . The joint primary outcomes are glycated haemoglobin ( HbA1c ) and diabetes-related distress , measured by the Problem Areas In Diabetes ( PAID ) question naire . Secondary outcomes include cardiovascular risk factors , depression and anxiety , and self-efficacy for self-management of diabetes . Health economic data include health service use , costs due to the intervention , and EQ-5D for calculation of Quality Adjusted Life Years ( QALYS ) . Data will be collected at baseline , 3 months and 12 months , with the primary endpoint at 12 months . Practice nurses , blinded to patient allocation , collect clinical data ; patients complete online question naires for patient reported measures . A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c ( both small effect sizes ) . The analysis will follow a pre-specified analysis plan , based on comparing the groups as r and omised ( intention-to-treat ) . Discussion The findings of this trial are likely to be of interest to policy makers , clinicians , and commissioners , all of whom are actively seeking additional forms of self-management support for people with T2DM.Trial registration The Trial Registration number is IS RCT N02123133 ; date of registration 14.2.13 The profound effects of bariatric surgery on glycemic control are well established in many studies , including several r and omized trials that compared surgery versus intensive medical and lifestyle treatment of type 2 diabetes mellitus ( T2DM ) ( 17 ) . Remission of T2DM is common after bariatric surgery , and Roux-en-Y gastric bypass ( RYGB ) outperforms sleeve gastrectomy ( SG ) in most reports ( 4 , 8 , 9 ) . More important than improvements in glycemic control is whether these glycemic changes reduce the incidence of major complications , such as microvascular events . In the United States , T2DM is the primary cause of nephropathy , end-stage renal disease , adult blindness , and neuropathy , which together lead to significant downstream costs and decreased quality of life ( 1012 ) . Thus , a major goal of diabetes treatment is to mitigate the risk for these long-term sequelae ( 13 ) . We have previously shown that in patients with T2DM who have bariatric surgery  , risk for incident microvascular disease is reduced for every year of remission from T2DMeven if patients eventually relapse back to T2DM ( indicating a legacy effect ) ( 14 ) . However , a detailed 2016 review of long-term microvascular outcomes of diabetes concluded that data were inadequate to support a superior effect of bariatric surgery compared with medical therapy ( 15 ) . Two recently published studies help inform this question ( 4 , 16 ) . The STAMPEDE ( Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently ) trial ( 4 ) r and omly assigned 150 patients with obesity and T2DM to have RYGB , SG , or an intensive medical and lifestyle intervention . After 5 years , urinary albumincreatinine ratios had decreased in the SG group only . Retinopathy did not change in any group , and neuropathy was not examined . STAMPEDE was limited by a relatively small sample size , which made it underpowered for rare outcomes . The prospect i ve SOS ( Swedish Obesity Subjects ) matched cohort study ( 16 ) followed 2010 patients who had bariatric surgery ( 13 % RYGB , 19 % gastric b and ing , and 68 % vertical-b and ed gastroplasty ) and 2037 matched patients who received usual care .  The incidence of microvascular disease after 15 years of follow-up was significantly lower in the surgery group than the control group ( hazard ratio [ HR ] , 0.56 [ 95 % CI , 0.48 to 0.66 ] ) , including among subgroups with prediabetes ( HR , 0.18 [ CI , 0.11 to 0.30 ] ) , established diabetes ( HR , 0.54 [ CI , 0.40 to 0.72 ] ) , and normoglycemia ( HR , 0.63 [ CI , 0.48 to 0.81 ] ) at baseline . The SOS study was limited by the small number of RYGB procedures and lack of SG procedures , which are now the 2 most common bariatric procedures worldwide ( 17 ) . To address these gaps in the literature , we did a matched cohort study to determine whether bariatric surgery was associated with lower incidence of microvascular disease than usual care for severe obesity and T2DM . We hypothesized that patients having  bariatric surgery would have lower risk for any incident microvascular disease ( composite of the first occurrence of retinopathy , neuropathy , or nephropathy ) . We further hypothesized that patients having bariatric surgery would have lower risk for incident retinopathy , nephropathy , and neuropathy than nonsurgical patients . Methods Setting s We did a retrospective observational cohort study of adults with T2DM who had bariatric surgery between 2005 and 2011 while enrolled in 1 of 4 integrated health care systems from the Health Care Systems Research Network : Kaiser Permanente ( KP ) Washington in Washington state , HealthPartners in Minnesota , KP Northern California , and KP Southern California . All study procedures were review ed and approved by the institutional review board at each site , and we were permitted to do the research without explicit consent from participants . Data Sources At each study site , staff used st and ardized electronic medical records , insurance cl aims , and other data systems ( 18 ) to extract enrollee data , including enrollment and insurance coverage ; demographics ; blood pressure ; height ; weight ; laboratory values ; medications dispensed ; deaths ; outpatient , inpatient , and emergency department use ; and inpatient and outpatient diagnosis and procedure codes . Surgical Participants The bariatric population included adults ( aged 19 to 79 years ) with severe obesity ( body mass index [ BMI ] 35 kg/m2 ) and T2DM who had a primary ( first observed ) bariatric surgical procedure between 1 January 2005 and 31 December 2011 . Following an approach adopted in prior studies ( 14 , 19 , 20 ) , we used a combination of bariatric registries ; review of medical records ; codes from the International Classification of Diseases , Ninth Revision ( ICD-9 ) ( 43.89 , 44.31 , 44.38 , 44.39 , 44.68 , 44.69 , and 44.95 ) ; and Current Procedural Terminology codes ( 43633 , 43644 , 43645 , 43659 , 43770 , 43775 , 43842 , 43843 , 43844 , 43845 , 43846 , and 43847 ) to identify bariatric procedures .  Patients were classified as having T2DM if they had a hemoglobin A1c ( HbA1c ) level of at least 6.5 % or fasting plasma glucose level of at least 6.99 mmol/L ( 126 mg/dL ) at the most recent measurement within 2 years before surgery , or a current prescription for any diabetes medication . After selecting the population , we applied the following exclusion criteria based on information in the 2 years before surgery : less than 1 full year of continuous enrollment ; history of gastrointestinal surgery for cancer ; pregnancy in the year before surgery ; gestational diabetes as the sole diabetes diagnosis ; metformin as the sole indicator of possible T2DM ( that is , no other T2DM medications , laboratory values , or diagnoses ) ; preexisting neuropathy , retinopathy , or nephropathy ( defined in Outcome and Censoring Definitions ) ; and maximum preoperative BMI less than 35 kg/m2 . This left 4972 patients . We further excluded 850 patients who were missing values for BMI , HbA1c level , or serum creatinine concentration in the 2 years before surgery . Surgical patients who were missing these values differed from those who had complete data ( Appendix Table 1 ) . Specifically , they were more likely to be non-Hispanic white , to be from the HealthPartners site , to have had their procedure in the first year of our study ( 2005 ) , and to have had a shorter observed duration of T2DM at the time of surgery . Of the remaining 4122 patients , 4024 could be matched to at least 1 nonsurgical patient ( Figure 1 ) . Figure 1 . Flow diagram for identification of eligible patients with T2DM and no history of microvascular disease who had bariatric surgery .  BMI = body mass index ; EHR= electronic health record ; HbA1c= hemoglobin A1c ; T2DM= type 2 diabetes mellitus . * Adults aged 2079 y who had a primary ( first observed ) bariatric surgical procedure between 1 January 2005 and 31 December 2011 .  Bariatric procedures were identified using a combination of bariatric registries ; review of medical records ; International Classification of Diseases , Ninth Revision , codes ( 43.89 , 44.31 , 44.38 , 44.39 , 44.68 , 44.69 , and 44.95 ) ; and Current Procedural Terminology codes ( 43633 , 43644 , 43645 , 43659 , 43770 , 43775 , 43842 , 43843 , 43844 , 43845 , 43846 , and 43847 ) . We excluded patients with any of the following : < 1 y of continuous enrollment ; history of gastrointestinal surgery for cancer ; pregnancy in the year before surgery ; gestational diabetes as the sole diabetes diagnosis ; preexisting neuropathy , nephropathy , or retinopathy ; metformin as the sole indicator of possible T2DM ( no other T2DM medications , laboratory values , or diagnoses ) ; or maximum BMI < 35 kg/m2 . Patients may have > 1 type of missing data ( BMI , creatinine concentration , or HbA1c level ) or have no follow-up time after surgery . 98 surgical patients could not be matched to a nonsurgical patient on site , age , BMI , insulin use , HbA1c level , and sex . Appendix Table 1 . Comparison of Characteristics of Surgical Patients Who Were Missing Values for BMI , HbA1c , or Serum Creatinine at Baseline Versus Those Who Had Complete Information on These Values at Baseline Matched Nonsurgical Participants For each surgical patient , we identified up to 3 matched nonsurgical control participants via a 2-step process . First , among all patients with diabetes and at least 1 BMI measurement of 35 kg/m2 or greater who did not have bariatric surgery during the study ( n= 320345 ) , we identified a pool of potential control participants who were enrolled at the time of the surgery ; satisfied the study inclusion criteria ; and matched the surgical patient on the basis of study site , sex , age ( 10 years ) , BMI ( 5 kg/m2 ) , HbA1c level ( 1.5 percentage points ) , and insulin use . Second , for each control participant in the pool , we calculated Mahalanobis distance from the surgical patient on the basis of age , BMI , HbA1c level , diabetes duration , and total days of health care use in the 7 to 24 months before the date of surgery ( 21 ) . Finally , up to 3 control participants were selected on the basis of the shortest Mahalanobis distance . Throughout , nonsurgical patients could be used as a control for only 1 surgical patient ( matching without replacement ) . The Appendix gives additional details on the process we used to establish the matched cohort . Outcome and Censoring Definitions The primary outcome measure was time to incident microvascular disease ( composite of the first occurrence of retinopathy , neuropathy , or nephropathy ) . Retinopathy was defined by the first appearance of either ICD-9 code 362.0x ( diabetic retinopathy ) or both a retinal surgical procedure code or other retinopathic code ( Appendix Table 2 ) and ICD-9 code 250.5x ( diabetes with ophthalmic manifestations ) . Neuropathy was identified on the basis of the first occurrence of ICD-9 code 250.6 ( diabetes with neurologic manifestations ) or 357.2 ( polyneuropathy in diabetes ) . Finally , nephropathy was defined by at least 2 measures of estimated glomerular filtration rate less than 60 mL/min/1.73 m2 separated by at least 90 days without any intervening values of 60 mL/min/1.73 m2 or greater . We approximated BACKGROUND Long-acting insulin treatments with varying clinical benefits are currently available for patients with type 1 diabetes mellitus ( T1DM ) and type 2 diabetes mellitus ( T2DM ) . The current evidence base demonstrates the efficacy of treatments , but it is critical also to underst and patient preferences regarding treatments and how they are determined . OBJECTIVE This study aim ed to measure the willingness to pay ( WTP ) of individuals with diabetes in the United Kingdom for different attributes of long-acting insulin therapy . METHODS A survey based on discrete choice experiment methodology was developed to elicit the preferences and values of adults with T1DM or insulin-dependent T2DM regarding different aspects of their therapy . Participants were presented with a series of 27 paired choices and asked which they preferred . WTP values were calculated for relevant attribute levels . RESULTS A total of 252 participants completed the question naire ( 52 % response rate ) ; 143 had T1DM and 109 had insulin-treated T2DM . The highest WTP values in participants with T1DM were avoiding 2-kg or 4-kg weight gain ( £ 29 and £ 58 , respectively ) , avoiding major difficulties with the injection device ( £ 49 ) , increasing the number of days per week when blood glucose levels are in the target range from 2 to 6 ( £ 40 ) , reducing the number of daily injections from 3 to 1 ( £ 39 ) , and avoiding nighttime hypoglycemia ( £ 33 ) . In participants with T2DM , similar factors had the highest WTP . CONCLUSIONS This is the first study to assess WTP  for long-acting insulin therapy and could have implication s for future guidelines on diabetes management , however some limitations , notably in sample selection , could affect generalizability of the results . In both T1DM and T2DM , the highest WTP values were for avoidance of weight gain , and reduction in the number of injections and hypoglycemia
The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions .
INTRODUCTION The increasing prevalence of type 2 diabetes mellitus ( T2DM ) presents a significant burden on affected individuals and healthcare systems internationally .
There is , however , no agreed vali date d measure to infer diabetes severity from electronic health records ( EHRs ) .
We aim to quantify T2DM severity and vali date it using clinical adverse outcomes .