A culturally competent intervention of education and care for black women with type 2 diabetes. HeLP-Diabetes: randomised controlled trial protocol The effectiveness of yoga to prevent diabetes mellitus type 2 Factors associated with the clinical response to nonsurgical periodontal therapy in people with type 2 diabetes mellitus. 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 The differential associations of depression and diabetes distress with quality of life domains in type 2 diabetes Patients' education, and its impact on care outcomes, resource consumption and working conditions: data from the International Diabetes Management Practices Study (IDMPS). Patients with Type 2 Diabetes experiences of making multiple lifestyle changes: a qualitative study. Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial Effectiveness of individual and group interventions for people with type 2 diabetes1 ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial Outcome of intensive integrated intervention in participants with impaired glucose regulation in China Validation of the IMS CORE Diabetes Model. The Influence of Type 1 and Type 2 Diabetes on Periodontal Disease Progression Type 2 diabetes mellitus, insulin-use and risk of bladder cancer in a large cohort study. Impact on psychosocial outcomes of a nationally available weight management program tailored for individuals with type 2 diabetes: Results of a randomized controlled trial. Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program
This article reports on the development and pilot feasibility testing of a culturally competent intervention of education and care for black women with type 2 diabetes mellitus ( T2DM ) . Using a one group , pretest posttest quasi-experimental design , the intervention was tested with a convenience sample of 25 community black women with T2DM . The conceptual basis , process , and content of the intervention as well as the feasibility and acceptability of study material s and methods are described . Significant improvements from baseline to 3 months were observed in measures of glycemic control , weight , body mass index , and diabetes-related emotional distress . The findings suggest that a culturally sensitive intervention of nurse practitioner diabetes care and education is beneficial for black women with T2DM , result ing in program attendance , kept appointments , improved glycemic control and weight , and decreased diabetes-related emotional distress 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 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 Type 2 diabetes mellitus ( T2DM ) is a growing health problem worldwide . People with T2DM are at risk of experiencing periodontitis and likely require treatment . Using data from the national multicenter Diabetes and Periodontal Therapy Trial ( DPTT ) , the authors assessed patient-based characteristics associated with the clinical response to nonsurgical therapy . METHODS The DPTT investigators r and omly assigned adults with T2DM ( hemoglobin A1c [ HbA1c ] ≥ 7 percent and < 9 percent ) and moderate to advanced periodontitis to  receive immediate or delayed therapy ( scaling and root planing , oral hygiene instruction , chlorhexidine rinse ) . The investigators assessed probing depth ( PD ) , clinical attachment level ( CAL ) , bleeding on probing ( BOP ) , and medical conditions at baseline , three months and six months . Six-month changes in mean PD , CAL and BOP defined the treatment response . Complete data were available for 473 of 514 DPTT participants . The authors used multiple regression models to evaluate participant-level factors associated with the response . RESULTS More severe baseline PD , CAL and BOP were associated with greater improvements in these same measurements ( P < .0001 ) . Hispanic participants experienced greater improvements in PD and CAL than did non-Hispanic participants ( P < .0001 ) . Obese participants ( those with a body mass index > 30 kilograms per square meter ) experienced greater reductions in PD and BOP than did participants who were not obese ( P < .001 ) . Age , sex , HbA1c values , diabetes duration , and smoking were not associated with change in any outcome ( P > .1 ) . CONCLUSIONS In patients with T2DM , baseline disease severity was associated with the clinical response to nonsurgical periodontal therapy . Body mass index and Hispanic ethnicity-but not glycemic control , diabetes duration or smoking-also may be useful in predicting clinical changes in this population 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 The present investigation aim ed to underst and quality of life domains relevant to adults with type 2 diabetes mellitus ( T2DM ) , and the relative associations of depression and diabetes distress with these domains . Participants were 146 individuals with T2DM who were recruited for entry into a r and omized controlled trial of cognitive behavioral therapy for adherence and depression . We conducted an exploratory factor analysis on the  Quality of Life Inventory ( QOLI ) to establish domains of quality of life relevant to this patient population . Hierarchical multiple regression models were evaluated for each domain that emerged to determine independent associations of depression severity and diabetes distress with quality of life independent of demographic and illness factors . Results suggested four quality of life domains : achievement , psychosocial growth , interpersonal relationships , and environment , accounting for 60.1 % of variance in total QOLI scores . Depression severity was associated with poorer quality of life on the achievement , psychosocial growth , and environment domains ( p ’s < 0.01 ) , while diabetes distress was associated with poorer quality of life on the achievement ( p < 0.001 ) domain and marginally associated with quality of life on the psychosocial growth ( p < 0.10 ) domain . Interventions design ed to address both depression and diabetes distress may lead to better quality of life outcomes than a generalized depression intervention or an intervention for diabetes alone AIM To evaluate the impact of diabetes education provided to patients with type 2 diabetes mellitus ( T2DM ) in non-controlled studies ( " real-world conditions " ) on quality of care , re source consumption and conditions of employment . METHODS This cross-sectional study and longitudinal follow-up describe the data ( demographic and socioeconomic profiles , clinical characteristics , treatment of hyperglycaemia and associated cardiovascular risk factors , re source consumption ) collected during the second phase ( 2006 ) of the International Diabetes Management Practice s Study ( IDMPS ) . Patients received diabetes education directly from the practice nurse , dietitian or educator , or were referred to ad hoc group-education programmes ; all programmes emphasized healthy lifestyle changes , self-care and active participation in disease control and treatment . Educated vs non-educated T2DM patients ( n=5692 in each group ) , paired by age , gender and diabetes duration , were r and omly recruited for the IDMPS by participating primary -care physicians from 27 countries in Eastern Europe , Asia , Latin America and Africa . Outcome measures included clinical ( body weight , height , waist circumference , blood pressure , foot evaluation ) , metabolic ( HbA(1c ) levels , blood lipid profile ) and biochemical control measures . Treatment goals were defined according to American Diabetes Association guidelines . RESULTS T2DM patients ' education significantly improved the percentage of patients achieving target values set by international guidelines . Educated patients increased their insulin use and self-care performance , had a lower rate of chronic complications and a modest increase in cost of care , and probably higher salaries and slightly better productivity . CONCLUSION Diabetes education is an efficient tool for improving care outcomes without having a major impact on healthcare costs OBJECTIVES To explore patients newly diagnosed with Type 2 Diabetes Mellitus ( T2DM ) experiences of making single ( diet ) or multiple ( diet and physical activity ) changes in order to ( 1 ) assess whether patients experienced increases in physical activity as supporting or hindering dietary changes and vice versa , and ( 2 ) whether patients found making multiple lifestyle changes counterproductive or beneficial . METHODS In-depth interviews with 30 individuals taking part in a r and omised controlled trial that aim ed to determine the effect of diet and physical activity on T2DM . Interviewees had been r and omised to receive usual care , intensive dietary advice , or intensive dietary advice plus information on physical activity . Respondents were interviewed 6 and 9 months post-r and omisation . They were asked about their experiences of making lifestyle changes . Data were analysed thematically . RESULTS Findings suggest providing diet and physical activity information together encourages patients to use physical activity in strategic ways to aid disease management and that most patients find undertaking multiple lifestyle changes helpful . CONCLUSION Increasing physical activity can act as a gateway behaviour , i.e. behaviour that produces positive effects in other behaviours . PRACTICE IMPLICATION S Practitioners should provide diet and physical activity information together to encourage patients to use physical activity strategically to maintain dietary changes 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 OBJECTIVE : to compare the effectiveness of two educational interventions used by a healthcare provider in the monitoring of individuals with type 2 diabetes mellitus ( T2DM ) , regarding knowledge of the disease , impact on quality of life and adoption of self-care actions . METHODS : comparative , longitudinal , prospect i ve study performed with 150 subjects with type 2 diabetes , analyzed according to the type of participation in the program ( individual and /or group ) . Participants of the individual intervention ( II ) received nursing consultations every six months and those of the group intervention ( GI ) took part in weekly meetings for three months . Data were collected through four question naires : Identification question naire , Problem Areas in Diabetes Question naire ( PAID ) , Summary of Diabetes Self-Care Activities Question naire ( SDSCA ) and the Diabetes Knowledge Scale ( DKN-A ) . Data were analyzed using the Friedman and Mann Whitney tests , considering a statistical significance of p ≤ 0.05 . RESULTS : there was an increase in knowledge about the disease in the II ( p<0.003 ) and GI ( p<0.007 ) , with reduction of the impact on the quality of life in the II ( p<0.007 ) and improvement in self-care actions in the GI ( p<0.001 ) . CONCLUSION : in both intervention models improvements were observed in the indicators , over the six month monitoring period Background Prediabetes is an asymptomatic condition in which patients ’ blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus ( T2DM ) . A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes , yet the effects of this screening and brief counseling are unknown . Methods In this parallel- design r and omized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center ( AAVA ) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA , but have not had a hemoglobin A1c ( HbA1c ) test to screen for T2DM in the previous 12 months . After informed consent , participants will complete a baseline survey and be r and omly assigned to , at the time of their next primary care appointment , one of two arms : ( 1 ) to have a hemoglobin A1c ( HbA1c ) test to screen for T2DM and receive brief , st and ardized counseling about these results or ( 2 ) to review a brochure about clinical preventive services . Participants will complete surveys 2 weeks , 3 months , and 12 months after their primary care appointment , and a weight measurement 12 months after their primary care appointment . The primary outcome is weight change after 12 months . The secondary outcomes are changes in perception of risk for T2DM ; knowledge of T2DM prevention ; self-efficacy and motivation to prevent T2DM ; use of pharmacotherapy for T2DM prevention ; physical activity ; participation in weight management programs ; and mental health . Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm . Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their underst and ing of and reactions to receiving a prediabetes diagnosis . Discussion This trial will generate foundational data on the effects of a prediabetes diagnosis and brief counseling on patients ’ preventive behaviors and mediators of these behaviors that will enable the development of novel strategies to improve patient engagement in T2DM prevention . Trial registration Clinical Trials.gov , NCT02747108 . Registered on 18 April 2016 Introduction This study investigated the outcomes and identified influencing factors of intensive integrated intervention over 2 years in Chinese patients with impaired glucose regulation ( IGR ) . Methods Adults in Beijing , China , were screened for IGR using the 75 g oral glucose tolerance test . Participants with IGR received lifestyle and health education ; those who still had IGR after 1 year were r and omly assigned to either a routine care group or to an intensive integrated intervention group . Results Of 2344 adults screened , 463 had IGR . Of these , 210 adults had IGR after 1 year and were therefore recruited and r and omized to an intensive integrated intervention group ( n=106 ) or a control group ( n=104 ) . The percentage of patients who reached the set targets of plasma glucose , blood pressure , body mass index , or triglycerides was significantly higher in the intensive integrated intervention group . None of the patients within the intensive integrated intervention group progressed to diabetes , whereas eight ( 9.3 % ) cases of the control group developed type 2 diabetes mellitus ( T2DM ) . Logistic regression analysis showed that both an increase in waist circumference and systolic blood pressure ( SBP ) were positively correlated with the development of T2DM , whereas improvement in islet beta cell function was negatively correlated with the development of T2DM . Conclusions Intensive integrated intervention may significantly decrease the conversion rate of IGR to T2DM , and increase the conversion ratio to normal glucose tolerance . The increase of waist circumference or SBP and the deterioration of islet beta cell function may be important risk factors for progression from prediabetes to diabetes 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 OBJECTIVE To explore associations between diabetes etiology ( type 1 diabetes mellitus [ T1DM ] vs. T2DM ) and glycemic control in the prediction of 5-year periodontal status change . RESEARCH DESIGN AND METHODS The Study of Health in Pomerania ( SHIP ) is a population -based stratified sample of German men and women . Healthy participants and those determined to have T2DM arose from the SHIP cohort , and T1DM participants were recruited from diabetes clinics in the catchment area that gave rise to SHIP . Dentate participants ( n = 2,626 ; 53 % women ; 20–81 years of age ) were included . Diabetes was determined via physician diagnosis and /or HbA1c ≥6.5 % ( uncontrolled diabetes > 7.0 % ) . Examiners blinded to diabetes status performed r and om half-mouth periodontal examinations  , assessing probing depth ( PD ) and attachment loss ( AL ) ( four sites/tooth ) at baseline and follow-up . Participants were categorized into six groups as follows : 1 ) diabetes free ( n = 2,280 ) , 2 ) incident T2DM ( n = 79 ) , 3 ) controlled T2DM ( n = 80 ) , 4 ) uncontrolled T2DM ( n = 72 ) , 5 ) controlled T1DM ( n = 43 ) , and 6 ) uncontrolled T1DM ( n = 72 ) . In multivariable regressions , mean PD change ( ΔMPD ) , mean AL change ( ΔMAL ) , or incident tooth-loss values were regressed across the aforementioned diabetes categories . RESULTS Mean ( SD ) ΔMPD and ΔMAL values among all participants were −0.08 ± 0.5 mm and 0.08 ± 1.03 mm , respectively , and 34 % lost one or more teeth . Relative to diabetes-free participants , those with uncontrolled T2DM experienced greater ΔMPD ± SE ( P < 0.05 ) , whereas participants with either uncontrolled T1DM or uncontrolled T2DM realized greater ΔMAL ( P < 0.05 ) . Uncontrolled T1DM and T2DM were both associated with an increased risk of future tooth loss ( P < 0.05 ) . CONCLUSIONS Diabetes control , but not etiology , was associated with future tooth loss and accelerated AL progression 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 AIMS Type 2 diabetes mellitus ( T2DM ) can substantially decrease quality of life ( QOL ) . This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM . METHODS A year-long multi-site r and omized clinical trial compared the Weight Watchers ( WW ) approach , supplemented with phone and email counseling with a certified diabetes educator ( CDE ) , to brief st and ard diabetes nutrition counseling and education ( St and ard Care ; SC ) . Participants were 400 women and 163 men ( N=279 WW ; 284 SC ) with T2DM [ mean ( ±SD ) HbA1c 8.32±1 % ; BMI = 37.1±5.7kg/m2 ; age=55.1 ± 9.1years ] . Psychosocial outcomes were assessed at baseline , month 6 , and month 12 using a diabetes specific psychosocial measure ( Diabetes Distress Scale [ DDS ] ) , Impact of Weight on Quality of Life-Lite scale ( IWQOL ) , a generic QOL measure ( SF-36 ) , and a depression screen ( PHQ-9 ) . RESULTS WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function , sex life and work domains ( all ps<.05 ) . There was no significant treatment effect on SF-36 scores or PHQ-9 . CONCLUSIONS WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity . Available commercial WL programs , combined with scalable complementary program-specific diabetes counseling , may have benefits that extend to diabetes-related distress and weight-relevant QOL Background India currently has more than 60 million people with Type 2 Diabetes Mellitus ( T2DM ) and this is predicted to increase by nearly two-thirds by 2030 . While management of those with T2DM is important , preventing or delaying the onset of the disease , especially in those individuals at ‘ high risk ’ of developing T2DM , is urgently needed , particularly in re source -constrained setting s. This paper describes the protocol for a cluster r and omised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala , India . Methods / design A total of 60 polling booths are r and omised to the intervention arm or control arm in rural Kerala , India . Data collection is conducted in two steps . Step 1 ( Home screening ) : Participants aged 30–60 years are administered a screening question naire . Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic ( Step 2 ) . At the mobile clinic , participants complete question naires , undergo physical measurements , and provide blood sample s for biochemical analysis . Participants identified with T2DM at Step 2 are excluded from further study participation . Participants in the control arm are provided with a health education booklet containing information on symptoms , complications , and risk factors of T2DM with the recommended levels for primary prevention . Participants in the intervention arm receive : ( 1 ) eleven peer-led small group sessions to motivate , guide and support in planning , initiation and maintenance of lifestyle changes ; ( 2 ) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors , prevention and management ; ( 3 ) a participant h and book containing information primarily on peer support and its role in assisting with lifestyle modification ; ( 4 ) a participant workbook to guide self-monitoring of lifestyle behaviours , goal setting and goal review ; ( 5 ) the health education booklet that is given to the control arm . Follow-up assessment s are conducted at 12 and 24 months . The primary outcome is incidence of T2DM . Secondary outcomes include behavioural , psychosocial , clinical , and biochemical measures . An economic evaluation is planned . Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other re source -constrained setting s . Trial registration Australia and New Zeal and Clinical Trials Registry : ACTRN12611000262909
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 .