title: Prevention of type 2 diabetes in adults with impaired glucose tolerance: the European Diabetes Prevention RCT in Newcastle upon Tyne, UK The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial. Lifestyle Counseling for Type 2 Diabetes Risk Reduction in Dutch Primary Care Effects of lifestyle intervention and meal replacement on glycaemic and body-weight control in Chinese subjects with impaired glucose regulation: a 1-year randomised controlled trial. Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. Effect of Intervention in Subjects with High Risk of Diabetes Mellitus in Pakistan The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. The Cost-Effectiveness of Lifestyle Modification or Metformin in Preventing Type 2 Diabetes in Adults with Impaired Glucose Tolerance Clinical Outcomes and Cost-Effectiveness of Strategies for Managing People at High Risk for Diabetes Prevention of type 2 diabetes in a primary healthcare setting: Three-year results of lifestyle intervention in Japanese subjects with impaired glucose tolerance Effectiveness of a Pragmatic Education Program Designed to Promote Walking Activity in Individuals With Impaired Glucose Tolerance Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lifestyle intervention to prevent diabetes in men and women with impaired glucose tolerance is cost-effective. Results of a pilot diabetes prevention intervention in East Harlem, New York City: Project HEED. The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1) Cost-effectiveness of a lifestyle intervention in preventing Type 2 diabetes. Prevention of Type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise The 6-year Malmö feasibility study Effects of Diet and Exercise in Preventing NIDDM in People With Impaired Glucose Tolerance: The Da Qing IGT and Diabetes Study A community based primary prevention programme for type 2 diabetes integrating identification and lifestyle intervention for prevention: the Let's Prevent Diabetes cluster randomised controlled trial. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. Effectiveness and cost-effectiveness of diabetes prevention among adherent participants. Effect of a lifestyle intervention on weight change in south Asian individuals in the UK at high risk of type 2 diabetes: a family-cluster randomised controlled trial. Cost-Effectiveness of the Interventions in the Primary Prevention of Diabetes Among Asian Indians Delaying progression to type 2 diabetes among high-risk Spanish individuals is feasible in real-life primary healthcare settings using intensive lifestyle intervention Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project. Randomised controlled trial evaluating lifestyle interventions in people with impaired glucose tolerance. Lifestyle modification and prevention of type 2 diabetes in overweight Japanese with impaired fasting glucose levels: a randomized controlled trial.
abstract: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups .  The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values < 0.01 . CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity OBJECTIVE To study the overall effect of the Active Prevention in High-Risk Individuals of Diabetes Type 2 in and Around Eindhoven ( APHRODITE ) lifestyle intervention on type 2 diabetes risk reduction in Dutch primary care after 0.5 and 1.5 years and to evaluate the variability between general practice s. RESEARCH DESIGN AND METHODS Individuals at high risk for type 2 diabetes ( Finnish Diabetes Risk Score ≥13 ) were r and omly assigned into an intervention group ( n = 479 ) or a usual-care group ( n = 446 ) . Comparisons were made between study groups and between general practice s regarding changes in clinical and lifestyle measures over 1.5 years . Participant , general practitioner , and nurse practitioner characteristics were compared between individuals who lost weight or maintained a stable weight and individuals who gained weight . RESULTS Both groups showed modest changes in glucose values , weight measures , physical activity , energy intake , and fiber intake . Differences between groups were significant only for total physical activity , saturated fat intake , and fiber intake . Differences between general practice s were significant for BMI and 2-h glucose but not for energy intake and physical activity . In the intervention group , the nurse practitioners ’ mean years of work experience was significantly longer in individuals who were successful at losing weight or maintaining a stable weight compared with unsuccessful individuals . Furthermore , successful individuals more often had a partner . CONCLUSIONS Risk factors for type 2 diabetes could be significantly reduced by lifestyle counseling in Dutch primary care . The small differences in changes over time between the two study groups suggest that additional intervention effects are modest . In particular , the level of experience of the nurse practitioner and the availability of partner support seem to facilitate intervention success The purpose of the present study was to evaluate the impact of a lifestyle intervention programme , combined with a daily low-glycaemic index meal replacement , on body-weight and glycaemic control in subjects with impaired glucose regulation ( IGR ) . Subjects with IGR were r and omly assigned to an intervention group ( n 46 ) and a control group ( n 42 ) . Both groups received health counselling at baseline . The intervention group also received a daily meal replacement and intensive lifestyle intervention to promote healthy eating habits during the first 3 months of the study , and follow-up visits performed monthly until the end of the 1-year study . Outcome measurements included changes in plasma glucose , glycated Hb ( HbA1c ) , plasma lipids , body weight , blood pressure and body composition ( such as body fat mass and visceral fat area ) . The results showed that body-weight loss after 1 year was significant in the intervention group compared with the control group ( -1·8 ( SEM 0·35 ) v. -0·6 ( SEM 0·40 ) 2·5 kg , P<0·05 ) . The 2 h plasma glucose concentration decreased 1·24 mmol/l in the intervention group and increased 0·85 mmol/l in the control group ( P<0·05 ) compared with their baseline , respectively . A 5 kg body-weight loss at 1 year was associated with a decrease of 1·49 mmol/l in 2 h plasma glucose ( P<0·01 ) . The incidence of normal glucose regulation ( NGR ) in the two groups was significantly different ( P=0·001 ) . In conclusion , the combination of regular contact , lifestyle advice and meal replacement is beneficial in promoting IGR to NGR Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of < 24.0 kg/m2 and of < 22.0 kg/m2 , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every 3 - 4 months during hospital visits . Diabetes was judged to have developed when two or more consecutive fasting plasma glucose ( FPG ) values exceeded 140 mg/dl . A 100 g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance . The subjects were seen in an ordinary outpatient clinic . The cumulative 4-year incidence of diabetes was 9.3 % in the control group , versus 3.0 % in the intervention group , and the reduction in risk of diabetes was 67.4 % ( P < 0.001 ) . Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group ( P < 0.001 ) . The control group was subclassified according to increase and decrease in body weight . The incidence of diabetes was positively correlated with the changes in body weight , and the improvement in glucose tolerance was negatively correlated . Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG . Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes , but the differences were not significant . Subjects with a low insulinogenic index ( DeltaIRI/DeltaPG 30 min after an oral glucose load ) developed diabetes at a significantly higher rate than those with a normal insulinogenic index . Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values , with the exception of the DaQing Study . However , the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI , suggesting that the effect of lifestyle intervention can not be solely ascribed to the body weight reduction . We conclude that lifestyle intervention aim ed at achieving ideal body weight in men with IGT  is effective and can be conducted in an outpatient clinic setting BACKGROUND The Diabetes Prevention Program ( DPP ) lifestyle intervention reduced the incidence of type 2 diabetes mellitus ( DM ) among high-risk adults by 58 % , with weight loss as the dominant predictor . However , it has not been adequately translated into primary care . METHODS We evaluated 2 adapted DPP lifestyle interventions  among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and /or metabolic syndrome . Participants were r and omized to ( 1 ) a coach-led group intervention ( n = 79 ) , ( 2 ) a self-directed DVD intervention ( n = 81 ) , or ( 3 ) usual care ( n = 81 ) . During a 3-month intensive intervention phase , the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD . During the maintenance phase , participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring . The primary outcome was change in body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) from baseline to 15 months . RESULTS At baseline , participants had a mean ( SD ) age of 52.9 ( 10.6 ) years and a mean BMI of 32.0 ( 5.4 ) ; 47 % were female ; 78 % , non-Hispanic white ; and 17 % , Asian/Pacific Isl and er . At month 15 , the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group ( P < .001 ) and -1.6 ± 0.3 in the self-directed group vs usual care ( P = .02 ) . The percentages of participants who achieved the 7 % DPP-based weight-loss goal were 37.0 % ( P = .003 ) and 35.9 % ( P = .004 ) in the coach-led and self-directed groups , respectively , vs 14.4 % in the usual care group . Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level . CONCLUSION Proven effective in a primary care setting , the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00842426 Aims . To observe the rate of conversion from impaired glucose tolerance ( IGT ) to diabetes following lifestyle modification ( LSM ) or a combination of lifestyle and metformin compared to a control population with 18-month followup . Methods . Forty screening camps were organized , which 5000 people attended . Around 2300 persons filled the question naire and 1825 subjects were identified as high risk . Of 1739 subjects who took the oral glucose tolerance test , 317 subjects were identified as IGT . The 317 IGT subjects were r and omized into three groups : control group was given st and ard medical advice , LSM group was given intensive lifestyle modification advice , while LSM + drug group was given intensive lifestyle advice and metformin 500 mg twice daily . Results . At the end , 273 subjects completed the study , giving a compliance rate of 86 % . Total of 47 incident cases of diabetes were diagnosed ( overall incidence was 4 cases per 1000 person-months with the incidence of 8.6 cases in control group , 2.5 cases in the LSM , and 2.3 cases in the LSM + drug groups ) . Conclusions . Study showed that lifestyle intervention had a major impact in preventing diabetes among IGT subjects in this region . Adding drug did not show any improved results . We recommend lifestyle advice and followup should be incorporated in primary health care OBJECTIVE To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study , 2 ) short- and long-term changes in diet and exercise behavior , and 3 ) effect of the intervention on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS There were 522 middle-aged , overweight subjects with impaired glucose tolerance who were r and omized to either a usual care control group or an intensive lifestyle intervention group .  The control group received general dietary and exercise advice at baseline and had an annual physician 's examination . The subjects in the intervention group received additional individualized dietary counseling from a nutritionist . They were also offered circuit-type resistance training sessions and advised to increase overall physical activity .  The intervention was the most intensive during the first year , followed by a maintenance period . The intervention goals were to reduce body weight , reduce dietary and saturated fat , and increase physical activity and dietary fiber . RESULTS The intervention group showed significantly greater improvement in each intervention goal . After 1 and 3 years , weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group , respectively . Measures of glycemia and lipemia improved more in the intervention group . CONCLUSIONS The intensive lifestyle intervention produced long-term beneficial changes in diet , physical activity , and clinical and biochemical parameters and reduced diabetes risk . This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system Context The Diabetes Prevention Program ( DPP ) showed that lifestyle changes or metformin effectively decreased the development of  type 2 diabetes in adults with impaired glucose tolerance . The economics of these interventions is important to policymakers . Contribution This cost-effectiveness model estimates that the DPP life-style intervention would cost society about $ 8800 and metformin would cost about $ 29900 per quality -adjusted life-year saved . While lifestyle intervention had a favorable cost-effectiveness profile at any adult age , metformin was not cost-effective after age 65 years . Implication s The cost-effectiveness of lifestyle intervention to prevent type 2 diabetes  in high-risk individuals is within the range that American society typically finds acceptable for health care interventions . The Editors During the past half century , the number of persons with diagnosed diabetes in the United States has increased 4- to 6-fold ( 1 ) . Recent large clinical trials from Asia , Europe , and North America have demonstrated that behavioral and medication interventions can delay or prevent the development of type 2 diabetes in persons with impaired glucose tolerance , which is defined by a plasma glucose level between 7.77 mmol/L ( 140 mg/dL ) and 11.04 mmol/L ( 199 mg/dL ) 2 hours after a 75-g oral glucose load ( 2 - 6 ) . The Diabetes Prevention Program ( DPP ) r and omly assigned 3234 nondiabetic persons 25 years of age or older with impaired glucose tolerance and fasting glucose levels between 5.27 mmol/L ( 95 mg/dL ) and 6.94 mmol/L ( 125 mg/dL ) to placebo ; a lifestyle-modification program with the goals of at least a 7 % weight loss and 150 minutes of physical activity per week ; or metformin , 850 mg twice daily ( 4 ) . The mean age of participants was 51 years , and the mean body mass index was 34.0 kg/m2 ; 68 % were women and 45 % were members of minority groups ( 4 ) . The average follow-up was 2.8 years . Compared with the placebo intervention , the lifestyle intervention reduced the incidence of type 2 diabetes by 58 % and the metformin intervention reduced the incidence of type 2 diabetes by 31 % ( 4 ) . We have previously described the costs of the DPP interventions and their cost-effectiveness within the 3-year trial period ( 7 , 8) . In this analysis , we project the costs , health outcomes , and cost-effectiveness of the DPP lifestyle and metformin interventions over a lifetime relative to the placebo intervention . Methods Clinical Trial The lifestyle intervention involved a healthy , low-calorie , low-fat diet and moderate physical activity , such as brisk walking . The lifestyle intervention was implemented with a 16-lesson core curriculum covering diet , exercise , and behavior modification that was taught by case managers on a one-on-one basis , followed by individual sessions ( usually monthly ) and group sessions with case managers ( 9 ) . At the end of the study , 38 % of participants in the lifestyle intervention group had lost at least 7 % of their initial body weight .  The metformin and placebo interventions were initiated at a dosage of 850 mg once a day . At 1 month , the dosage of metformin or placebo was increased to 850 mg twice daily . Case managers reinforced adherence during individual quarterly sessions ( 10 ) . At the end of the study , 72 % of participants in the metformin intervention group and 77 % of participants in the placebo intervention group took at least 80 % of the prescribed dose . All participants received st and ard lifestyle recommendations through written information and an annual 20- to 30-minute individual session that emphasized the importance of a healthy lifestyle ( 10 ) . Simulation Model We assessed the progression from impaired glucose tolerance to onset of diabetes to clinical ly diagnosed diabetes to diabetes with complications and death by using a lifetime simulation model originally developed by the Centers for Disease Control and Prevention and Research Triangle Institute International . The model has a Markov structure and includes annual transition probabilities between disease states ( 11 ) . In addition to disease progression , the model tracks costs and quality -adjusted life-years ( QALYs ) . The model has been described elsewhere ( 11 ) . For our analyses , we modified the model to include data from the DPP on progression , costs , and quality of life associated with impaired glucose tolerance , data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) on diabetes progression and complications , and new data on cost and quality of life associated with diabetes . A technical report describing the model is available . Supplement . Technical Report Disease Progression , Complications , and Comorbid Conditions Impaired Glucose Tolerance to Onset of Type 2 Diabetes We analyzed data from the DPP to assess the annual hazard of diabetes onset in the lifestyle , metformin , and placebo intervention groups . For patients receiving the placebo intervention , the annual hazard of diabetes onset was 10.8 per 100 person-years . At 3 years of follow-up , the risk reductions for the lifestyle and metformin interventions were 55.8 % and 29.9 % , respectively . In the base-case analysis , we assumed that the lifestyle and metformin interventions would be applied until diabetes onset and that the health and quality -of-life benefits associated with the interventions persisted until diabetes onset . Complications and Comorbid Conditions Associated with Impaired Glucose Tolerance We analyzed data from the DPP and other published sources to assess the prevalence of complications and comorbid conditions in participants with impaired glucose tolerance . At baseline , 6.0 % of DPP participants had microalbuminuria and 0.4 % had nephropathy .  The DPP did not measure peripheral neuropathy , but previous studies found that the prevalence of neuropathy in persons with impaired glucose tolerance was 74 % of that in persons with newly diagnosed type 2 diabetes ( 12 ) and 12.3 % of persons with newly diagnosed type 2 diabetes have neuropathy ( 13 ) . Therefore , we assumed that at baseline , 8.5 % of DPP participants had clinical neuropathy . At baseline , 28 % of DPP participants had hypertension , 45 % had dyslipidemia , 7 % were smokers , 1.1 % had a history of cerebrovascular disease , and 2.0 % had a history of myocardial infa rct ion . No other complications were present . We assumed that during impaired glucose tolerance , microvascular or neuropathic complications would not progress . We assumed that hypertension and dyslipidemia developed at the rates observed in the DPP . On the basis of 2 large studies ( 14 , 15 ) , we assumed that the incidences of coronary heart disease and cerebrovascular disease in patients with impaired glucose tolerance were 58 % and 56 % , respectively , of those observed in patients with type 2 diabetes . We further assumed that nondiabetes-related mortality for persons with impaired glucose tolerance was the same as for persons with diabetes ( 16 ) . Onset of Type 2 Diabetes to Clinical Diagnosis of Type 2 Diabetes In the DPP , participants were tested for diabetes every 6 months ; diabetes was diagnosed at onset . In routine clinical practice , type 2 diabetes is estimated to develop 8 to 12 years before its clinical diagnosis ( 17 , 18 ) . In our base-case analysis , we therefore assumed that a 10-year delay occurred between the onset and clinical diagnosis of diabetes . Participants in the DPP  had a mean hemoglobin A1c level of 6.4 % at the onset of diabetes . Participants in the UKPDS had a mean hemoglobin A1c of 7.1 % after a dietary run-in period but before r and omization ( 13 ) . Both DPP placebo participants and UKPDS participants received st and ard lifestyle recommendations . Accordingly , we assumed that during the 10-year interval between onset and clinical diagnosis of diabetes , patients were treated for type 2 diabetes and that hemoglobin A1c level increased at 0.07 % per year from 6.4 % to 7.1 % . Complications and Comorbid Conditions Associated with Undiagnosed Diabetes We further assumed that between onset and clinical diagnosis of diabetes , microvascular and neuropathic complications progressed slowly , such that by clinical diagnosis of type 2 diabetes , their prevalence reached the level observed in the UKPDS cohort at r and omization ( 13 , 19 , 20 ) . We assumed that blood pressure and lipid levels progressed as they did in DPP participants and that cardiovascular complications occurred as they would in type 2 diabetes according to risk factors and hemglobin A1c level ( 21 , 22 ) . Clinical Diagnosis of Type 2 Diabetes to Diabetes with Complications and Death We assumed that after clinical diagnosis , all persons with type 2 diabetes received intensive glycemic management as described in the UKPDS ( 13 ) . We modeled changes in hemoglobin A1c and diabetes treatments to reflect those observed in the UKPDS intensive therapy group . We based risk for retinopathy progression on UKPDS 38 ( 23 ) , risk for nephropathy progression on UKPDS 64 ( 20 ) , and risk for neuropathy progression on UKPDS 33 ( 13 ) . We based risk for cerebrovascular disease on UKPDS 60 ( 22 ) and risk for coronary heart disease on UKPDS 56 ( 21 ) . Costs Costs of Impaired Glucose Tolerance To estimate the total direct medical costs of impaired glucose tolerance , we considered the costs of the DPP interventions ( the cost of identifying participants , implementing and maintaining the interventions , and monitoring and treating the side effects of the interventions ) and the costs of the medical care outside the DPP ( 7 ) . In analyses from the perspective of society , we included both direct medical costs and direct nonmedical costs . We did not include indirect costs because they are captured in the assessment of QALYs ( 24 ) . Table 1 shows the total direct medical costs by treatment group , sex , and year in the DPP ( 7 ) . Costs were higher in the lifestyle and metformin interventions than in the placebo intervention and higher in women than in men . Costs decreased over time in all 3 intervention groups but after year 1 tended to decrease more in the lifestyle than Context A previous Markov modelbased analysis estimated that use of the Diabetes Prevention Program diet and exercise intervention to forestall diabetes in high-risk people would be cost-effective from a societal perspective . Contribution Using a vali date d model design ed to be more complete and realistic than previous models , the authors estimated that the intervention would cost society about $ 62600 per quality -adjusted life-year saved . It would be cost-saving if the annual cost of the intervention decreased from $ 672 to $ 100 . Implication s This model suggests that the Diabetes Prevention Program intervention costs more per quality -adjusted life-year saved than previously estimated , and health plans and insurers may consider it too expensive to cover . The Editors Recent r and omized , controlled studies have shown that diabetes can be prevented or delayed in high-risk individuals by intensive lifestyle modification programs ( 1 , 2 ) or glucose-lowering drugs ( 2 - 4 ) . For example , in the Diabetes Prevention Program ( DPP ) , the relative reductions in the 2.8-year incidence of diabetes were 58 % in the lifestyle modification group and 31 % in the metformin group ( 2 ) . This raises hopes of substantially reducing the morbidity , mortality , and cost of this important disease . However , the trial was too short to observe the effects on microvascular or macrovascular outcomes , and the programs cost several hundred dollars a year ( 5 ) . These findings generate obvious questions : What are the long-term effects of trying to prevent diabetes in high-risk people ? Does lifestyle modification truly prevent or just postpone diabetes ? Is such a prevention program cost-effective ? What is the best strategy ? A previous analysis has suggested that lifestyle modification would be cost-effective over 75 years from a societal perspective ( 6 ) . We used a more thorough , clinical ly realistic , and independently vali date d model to estimate the short- and intermediate-term health and economic effects of different prevention programs for high-risk individuals and health plans , as well as for society . Methods We conducted the analysis by using the Archimedes model , which has been described elsewhere ( 7 - 9 ) . Briefly , it is a simulation model written at a relatively high level of anatomic , physiologic , clinical , and administrative detail . It uses object-oriented programming to create in the model objects that correspond to objects in reality , one-to-one . Among the hundreds of objects are  people , pancreases , cells , plasma glucose levels , coronary arteries , plaque , chest pain , emergency departments , electrocardiograms , aspirin , and angioplasties  . Helpful analogies might be a flight simulator ( in which the objects include the plane and its wings , airports , runways , buildings , and the wind ) , or the SimCity computer game . In the Archimedes model , each individual is simulated down to the level of hepatic glucose production , insulin resistance , -cell fatigue , and similar biological variables . The core of the model is a set of differential equations that represent the anatomy and physiology pertinent to diseases and their complications . Currently , the model includes diabetes , congestive heart failure , coronary artery disease , stroke , hypertension , and asthma in a single integrated model . The structure and equations of the model pertinent to diabetes and its complications are described elsewhere ( 8 , 9 ) . The Appendix and a technical report available through our Web site ( 10 ) describe additional aspects of the model and its validations that are pertinent to this analysis . Calculations are performed by using a distributed computing network . Clinical Events The model includes the biological variables and outcomes relevant to diabetes and its complications . Examples are basal hepatic glucose production ; insulin amount ; insulin resistance ; fasting plasma glucose ; hemoglobin A1c ( HbA1c ) ; 2-hour oral glucose tolerance ; high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , and total cholesterol ; triglycerides ; systolic and diastolic blood pressures and their determinants ( for example , cardiac output , arterial compliance , peripheral resistance ) ; weight and body mass index ( BMI ) ; stenosis of coronary arteries ; retinopathy ( assessed by the Early Treatment of Diabetic Retinopathy scale ) ; urine protein ; creatinine ; peripheral neuropathy ; foot ulcers of varying degrees of severity ; and amputations . The use of differential equations preserves the continuous nature of biological variables as well as the interactions between them . Clinical outcomes are defined in terms of the underlying variables , as occurs in reality . For example , a person is said to have diabetes if his or her fasting plasma glucose level exceeds 6.9375 mmol/L ( 125 mg/dL ) or results on a 2-hour oral glucose tolerance test exceed 11.0445 mmol/L ( 199 mg/dL ) . This enables the model to incorporate different definitions and changes in definitions . The model is continuous : Biological variables are changing and interacting continuously , the natural histories and severity of conditions progress smoothly , any clinical event can occur at any time , and the timing of events is as condensed or drawn out as occurs in reality . The model also includes a detailed representation of the processes and logistics of clinical care and their related costs . Interventions , both to prevent diabetes and to manage it when it occurs , are modeled at the level of the underlying biology . Pertinent to this analysis is that in the model , diet and exercise reduce weight ( 2 ) ; reduce blood pressure ( 11 ) ; improve LDL cholesterol , HDL cholesterol , and total cholesterol levels ( 12 ) ; and decrease fasting plasma glucose levels ( 2 ) . The effects of metformin in the model are to reduce fasting plasma glucose and 2-hour oral glucose tolerance test results ( 2 ) ( by reducing basal hepatic glucose production ) , decrease LDL cholesterol and triglyceride levels ( 13 ) , and retard weight gain . Data used to build the model were derived from basic physiologic studies , surveys , epidemiologic studies , and clinical trials using methods described in the technical report ( 10 ) . Every variable in the model is estimated from at least 1 empirical source ; no variables are simply assumed . We identified specific sources by search ing MEDLINE from 1970 to 28 February 2005 and by consulting textbooks and clinical experts . Because the model includes scores of continuously valued , interacting variables , it does not have simplified states , transitions , or events at discrete time intervals that can be tabulated , as is commonly done for a Markov-type model . The equations themselves are in the technical report ( 10 ) . For nonmathematical readers , we have calculated annualized rates of change of representative biological variables and annualized rates of occurrence of representative clinical events , and compared them with rates for comparable events observed in epidemiologic studies and clinical trials . The Appendix reports those results . Costs The DPP measured the direct medical costs of delivering the lifestyle and metformin interventions  ( for example , personnel , health education material s , medications , and laboratory tests ) . Compared with the placebo group 's costs , costs in the lifestyle group were $ 1356 more per person in the first year , with approximately $ 672 in annual costs thereafter ; for the metformin group , costs were $ 977 in the first year and averaged $ 742 per year thereafter ( 5 ) . Following the completion of the DPP , metformin became generic . When this is considered , the cost of the metformin program is reduced to about $ 780 for 3 years , or about $ 260 a year . In the DPP study , costs apply to the year 2000 . To calculate the routine costs of providing health care to high-risk people before they develop diabetes , as well as to people with diabetes and its complications , the model includes a detailed mathematical representation of a health care system , including such elements as facilities , personnel , tests and treatments , protocol s , and provider behaviors . For the base-case analysis , we obtained itemized costs from Kaiser Permanente , a nonprofit , group- practice , integrated managed care organization that provides comprehensive care ( with no deductibles or copayments ) . The facilities , personnel , protocol s , and costs in the model are based on that organization 's records , at the level of detail at which actual accounts are kept ( for example , 37 different kinds of office visits ) . The model calculates costs by keeping track of the occurrence of every event that has cost implication s and adding them up . The costs assigned to any event or item were calculated by Kaiser Permanente 's cost-accounting department using micro-costing methods ( 14 ) , and they represent the real costs to the organization , not charges , reimbursements , or diagnosis-related groups . Because costs vary from setting to setting , the implication s of different cost structures are examined in the sensitivity analysis . Calculation of costs applies to the year 2000 . Indirect costs , such as lost time from work and decreased productivity , are included in the cost-effectiveness analysis through the Quality of Well-Being Index ( 14 ) . We calculated the effects of lifestyle and metformin interventions  on quality of life . For people who do not yet have diabetes , we used utility weights reported for the participants of the DPP study ( 15 ) . For people who have diabetes and its complications , we used the results of a published survey by Coffey and colleagues ( 16 ) . Both surveys used the Quality of Well-Being Index . The decrements in quality of life were assumed to be additive for people who have 2 or more complications , with a limit that quality of life could not be less than 0 . Use of an additive rule biases the calculation of cost/ quality -adjusted life-year ( QALY ) in favor of a prevention program , making the program appear more cost-effective than would occur if a multiplicative model were used . We discuss the Background A r and omized control trial was performed to test whether a lifestyle intervention program , carried out in a primary healthcare setting using existing re sources , can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance ( IGT ) . The results of 3 years ' intervention are summarized . Methods Through health checkups in communities and workplaces , 304 middle-aged IGT subjects with a mean body mass index ( BMI ) of 24.5 kg/m2 were recruited and r and omized to the intervention group or control group . The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational material s provided by the study group . Results After 1 year , the intervention had significantly improved body weight ( -1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control ; p = 0.023 ) and daily non-exercise leisure time energy expenditure ( 25 ± 113 vs. -3 ± 98 kcal ; p = 0.045 ) . Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years . The 3-year cumulative incidence tended to be lower in the intervention group ( 14.8 % vs.8.2 % , log-rank test : p = 0.097 ) . In a sub- analysis for the subjects with a BMI > 22.5 kg/m2 , a significant reduction in the cumulative incidence was found ( p = 0.027 ) . Conclusions The present lifestyle intervention program using existing healthcare re sources is beneficial in preventing diabetes in Japanese with IGT . This has important implication s for primary healthcare-based diabetes prevention . Trial registration OBJECTIVE To investigate whether a pragmatic structured education program with and without pedometer use is effective for promoting physical activity and improving glucose tolerance in those with impaired glucose tolerance ( IGT ) . RESEARCH DESIGN AND METHODS Overweight and obese individuals with IGT were recruited from ongoing screening studies at the University Hospitals of Leicester , U.K. Participants were r and omly assigned to one of three groups . Group 1 received a 3-h group-based structured education program design ed to promote walking activity using personalized steps-per-day goals and pedometers . Group 2 received a 3-h group-based structured education program design ed to promote walking activity using generic time-based goals . Group 3 received a brief information leaflet ( control condition ) . Outcomes included an oral glucose tolerance test , st and ard anthropometric measures , ambulatory activity , and psychological variables . Follow-up was conducted at 3 , 6 , and 12 months . RESULTS A total of 87 individuals ( 66 % male , mean age 65 years ) were included in this study . At 12 months , significant decreases in 2-h postchallenge glucose and fasting glucose of −1.31 mmol/l ( 95 % CI −2.20 to −0.43 ) and −0.32 mmol/l ( −0.59 to −0.03 ) , respectively , were seen in the pedometer group compared with the control group . No significant improvements in glucose control were seen in those given the st and ard education program . CONCLUSIONS This study suggests that a pragmatic structured education program that incorporates pedometer use is effective for improving glucose tolerance in those with IGT . This result is likely to have important implication s for future primary care – based diabetes prevention initiatives BACKGROUND Type 2 diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive . Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification . We aim ed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes  in Indian Asian men with impaired glucose tolerance . METHODS We did a prospect i ve , parallel-group , r and omised controlled trial between Aug 10 , 2009 , and Nov 30 , 2012 , at ten sites in southeast India . Working Indian men ( aged 35 - 55 years ) with impaired glucose tolerance were r and omly assigned ( 1:1 ) with a computer-generated r and omisation sequence to a mobile phone messaging intervention or st and ard care ( control group ) . Participants in the intervention group received frequent mobile phone messages compared with controls who received st and ard lifestyle modification advice at baseline only . Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators . The primary outcome was incidence of type 2 diabetes , analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00819455 . RESULTS We assessed 8741 participants for eligibility . 537 patients were r and omly assigned to either the mobile phone messaging intervention ( n=271 ) or st and ard care ( n=266 ) . The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls : 50 ( 18 % ) participants in the intervention group developed type 2 diabetes compared with 73 ( 27 % ) in the control group ( hazard ratio 0·64 , 95 % CI 0·45 - 0·92 ; p=0·015 ) . The number needed to treat to prevent one case of type 2 diabetes was 11 ( 95 % CI 6 - 55 ) . One patient in the control group died suddenly at the end of the first year . We recorded no other serious adverse events . INTERPRETATION Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk . FUNDING The UK India Education and Research Initiative , the World Diabetes Foundation OBJECTIVES The Finnish Diabetes Prevention Study ( DPS ) was a r and omized intervention program that evaluated the effect of intensive lifestyle modification on the development of diabetes mellitus type 2 in patients with impaired glucose tolerance . As such , a program is dem and ing in terms of re sources ; it is necessary to assess whether it would be money well spent . This determination was the purpose of this study . METHODS We developed a simulation model to assess the economic consequences of an intervention like the one studied in DPS in a Swedish setting . The model used data from the trial itself to assess the effect of intervention on the risk of diabetes and on risk factors for cardiovascular disease . Results from the United Kingdom Prospect i ve Diabetes Study were used to estimate the risk of cardiovascular disease and stroke . Cost data were derived from Swedish studies . The intervention was assumed to be applied to eligible patients from a population -based screening program of 60-year-olds in the County of Stockholm from which the baseline characteristics of the patients was used . RESULTS The model predicted that implementing the program would be cost-saving from the healthcare payers ' perspective . Furthermore , it was associated with an increase in estimated survival of .18 years . Taking into consideration the increased consumption by patients due to their longer survival , the predicted cost-effectiveness ratio was 2,363 euro per quality -adjusted life-year gained . CONCLUSIONS Lifestyle intervention directed toward high-risk subjects would be cost-saving for the healthcare payer and highly cost-effective for society as a whole OBJECTIVES Our community-academic partnership employed community-based participatory research to develop and pilot a simple , peer-led intervention to promote weight loss  , which can prevent diabetes and eliminate racial/ethnic disparities in incident diabetes among overweight adults with prediabetes . METHODS We recruited overweight adults at community sites , performed oral glucose tolerance testing to identify persons with blood glucose levels in the prediabetes range , and r and omized eligible people to a  peer-led lifestyle intervention group or delayed intervention  in 1 year . Outcomes , including weight , blood pressure , and health behaviors , were measured at baseline and 3 , 6 , and 12 months . RESULTS More than half of those tested ( 56 % , or 99 of 178 ) had prediabetes and enrolled in the study . Participants were predominantly Spanish-speaking , low-income , undereducated women . The intervention group lost significantly more weight than the control group and maintained weight loss at 12 months ( 7.2 versus 2.4 pounds ; P < .01 ) . One fourth ( 24 of 99 ) of participants progressed to diabetes . CONCLUSIONS In underserved minority communities , prediabetes prevalence may be higher than previously reported . Low-cost , community-based interventions can succeed in encouraging weight loss to prevent diabetes Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians .  Both LSM and MET significantly reduced the incidence of diabetes  in Asian Indians with IGT ; there was no added benefit from combining them OBJECTIVES Previous research has suggested people with impaired fasting glucose ( IFG ) are less likely to develop Type 2 diabetes ( T2DM ) if they receive prolonged structured diet and exercise advice . This study examined the within-trial cost-effectiveness of such lifestyle interventions . METHODS Screen-detected participants with either newly diagnosed T2DM or IFG were r and omized 2:1 to intervention versus control ( usual care ) between February and December 2009 , in Norfolk ( UK ) . The intervention consisted of group based education , physiotherapy and peer support sessions , plus telephone contacts from T2DM volunteers . We monitored healthcare re source use , intervention costs , and quality of life ( EQ-5D ) . The incremental cost per quality -adjusted life-year ( QALY ) gain ( incremental cost effectiveness ratio [ ICER ] ) , and cost effectiveness acceptability curves ( CEAC ) were estimated . RESULTS In total , 177 participants were recruited ( 118 intervention , 59 controls ) , with a mean follow-up of 7 months . Excluding screening and recruitment costs , the mean cost was estimated to be £ 551 per participant in the intervention arm , compared with £ 325 in the control arm . The QALY gains were -0.001 and -0.004 , respectively . The intervention was estimated to have an ICER of £ 67,184 per QALY ( 16 percent probability of being cost-effective at the £ 20,000/QALY threshold ) . Cost-effectiveness estimates were more favorable for IFG participants and those with longer follow-up ( ≥ 4 months ) ( ICERs of £ 20,620 and £ 17,075 per QALY , respectively ) . CONCLUSIONS Group sessions to prevent T2DM were not estimated to be within current limits of cost-effectiveness . However , there was a large degree of uncertainty surrounding these estimates , suggesting the need for further research Summary From a previously reported 5-year screening programme of 6,956 47–49-year-old Malmö males , a series of 41 subjects with early-stage Type 2 ( non-insulin-dependent ) diabetes mellitus and 181 subjects with impaired glucose tolerance were selected for prospect i ve study and to test the feasibility aspect of long-term intervention with an emphasis on life-style changes . A 5-year protocol , including an initial 6-months ( r and omised ) pilot study , consisting of dietary treatment and /or increase of physical activity or training with annual check-ups , was completed by 90 % of subjects . Body weight was reduced by 2.3–3.7 % among participants , whereas values increased by 0.5–1.7 % in non-intervened subjects with impaired glucose tolerance and in normal control subjects ( p<0.0001 ) ; maximal oxygen uptake ( ml · min−1 · kg−1 ) was increased by 10–14 % vs decreased by 5–9 % , respectively ( p<0.0001 ) . Glucose tolerance was normalized in > 50 % of subjects with impaired glucose tolerance , the accumulated incidence of diabetes was 10.6 % , and more than 50 % of the diabetic patients were in remission after a mean follow-up of 6 years . Blood pressure , lipids , and hyperinsulinaemia were reduced and early insulin responsiveness to glucose loading preserved . Improvement in glucose tolerance was correlated to weight reduction ( r=0.19 , p<0.02 ) and increased fitness ( r=0.22 , p<0.02 ) . Treatment was safe , and mortality was low ( in fact 33 % lower than in the remainder of the cohort ) . We conclude that long-term intervention in the form of diet and physical exercise is feasible even on a large scale , and that substantial metabolic improvement can be achieved which may contribute to prevent or postpone manifest diabetes OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P < 0.05 ) . When analyzed by clinic , each of the active intervention groups differed significantly from the control clinics ( P < 0.05 ) . The relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI < or ≥ 25 kg/m2 ) . In a proportional hazards analysis adjusted for differences in baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P < 0.03 ) , 46 % ( P < 0.0005 ) , and 42 % ( P < 0.005 ) reductions in risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT OBJECTIVES Prevention of type 2 diabetes ( T2DM ) is a priority in healthcare , but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting . We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM  in people with pre-diabetes . MATERIAL S AND METHODS Forty-four general practice s were r and omised to receive either st and ard care or a 6hour group structured education programme with an annual refresher course , and regular phone contact . Participants were followed up for 3years . The primary outcome was progression to T2DM . RESULTS Eight hundred and eighty participants were included ( 36 % female , mean age 64years , 16 % ethnic minority group ) ; 131 participants developed T2DM . There was a non-significant 26 % reduced risk of developing T2DM in the intervention arm compared to st and ard care ( HR 0.74 , 95 % CI 0.48 , 1.14 , p=0.18 ) . The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant ( HR 0.65 , 0.41 , 1.03 , p=0.07 ) . There were statistically significant improvements in HbA1c ( -0.06 , -0.11 , -0.01 ) , LDL cholesterol ( -0.08 , -0.15 , -0.01 ) , sedentary time ( -26.29 , -45.26 , -7.32 ) and step count ( 498.15 , 162.10 , 834.20 ) when data were analysed across all time points . CONCLUSIONS This study suggests that a relatively low re source , pragmatic diabetes prevention programme result ed in modest benefits to biomedical , lifestyle and psychosocial outcomes , however the reduction to the risk of T2DM did not reach significance . The findings have important implication s for future research and primary care BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program  with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin OBJECTIVES We report the 10-year effectiveness and within-trial cost-effectiveness of the Diabetes Prevention Program ( DPP ) and its Outcomes Study ( DPPOS ) interventions among participants who were adherent to the interventions . STUDY DESIGN DPP was a 3-year r and omized clinical trial followed by 7 years of open-label modified intervention follow-up . METHODS Data on re source utilization , cost , and quality of life were collected prospect ively . Economic analyses were performed from health system and societal perspectives . Lifestyle adherence was defined as achieving and maintaining a 5 % reduction in initial body weight , and metformin adherence as taking metformin at 80 % of study visits . RESULTS The relative risk reduction was 49.4 % among adherent lifestyle participants and 20.8 % among adherent metformin participants compared with placebo . Over 10 years , the cumulative , undiscounted , per capita direct medical costs of the interventions , as implemented during the DPP , were greater for adherent lifestyle participants ( $ 4810 ) than adherent metformin participants ( $ 2934 ) or placebo ( $ 768 ) . Over 10 years , the cumulative , per capita non-interventionrelated direct medical costs were $ 4250 greater for placebo participants compared with adherent lifestyle participants and $ 3251 greater compared with adherent metformin participants . The cumulative quality -adjusted life-years ( QALYs ) accrued over 10 years were greater for lifestyle ( 6.80 ) than metformin ( 6.74 ) or placebo ( 6.67 ) . Without discounting , from a modified societal perspective ( excluding participant time ) and a full societal perspective ( including participant time ) , lifestyle cost < $ 5000 per QALY-gained and metformin was cost saving compared with placebo . CONCLUSIONS Over 10 years , lifestyle intervention and metformin were cost-effective or cost saving compared with placebo . These analyses confirm that lifestyle and metformin represent a good value for money BACKGROUND The susceptibility to type 2 diabetes of people of south Asian descent is established , but there is little trial-based evidence for interventions to tackle this problem . We assessed a weight control and physical activity intervention in south Asian individuals in the UK . METHODS We did this non-blinded trial in two National Health Service ( NHS ) regions in Scotl and ( UK ) . Between July 1 , 2007 , and Oct 31 , 2009 , we recruited men and women of Indian and Pakistani origin , aged 35 years or older , with waist circumference 90 cm or greater in men or 80 cm or greater in women , and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test . Families were r and omised ( using a r and om number generator program , with permuted blocks of r and om size , stratified by location [ Edinburgh or Glasgow ] , ethnic group [ Indian or Pakistani ] , and number of participants in the family [ one vs more than one ] ) to intervention or control . Participants in the same family were not r and omised separately . The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period . The primary outcome was weight change at 3 years . Analysis was by modified intention to treat , excluding participants who died or were lost to follow-up . We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years . This trial is registered , number IS RCT N25729565 . FINDINGS Of 1319 people who were screened with an oral glucose tolerance test , 196 ( 15 % ) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial . Participants were in 156 family clusters that were r and omised ( 78 families with 85 participants were allocated to intervention ; 78 families with 86 participants were allocated to control ) . 167 ( 98 % ) participants in 152 families completed the trial .  Mean weight loss in the intervention group was 1.13 kg ( SD 4.12 ) , compared with a mean weight gain of 0.51 kg ( 3.65 ) in the control group , an adjusted mean difference of -1.64 kg ( 95 % CI -2.83 to -0.44 ) . INTERPRETATION Modest , medium-term changes in weight are achievable as a component of lifestyle-change strategies , which might control or prevent adiposity-related diseases . FUNDING National Prevention Research Initiative , NHS Research and Development ; NHS National Services Scotl and ; NHS Health Scotl and OBJECTIVE —In the Indian Diabetes Prevention Programme ( IDPP ) , a 3-year r and omized , controlled trial , lifestyle modification ( LSM ) and metformin helped to prevent type 2 diabetes in subjects with impaired glucose tolerance ( IGT ) . The direct medical costs and cost-effectiveness of the interventions relative to the control group are reported here . RESEARCH DESIGN AND METHODS —Relative effectiveness and costs of interventions ( LSM , metformin , and LSM and metformin ) in the IDPP were estimated from the health care system perspective . Costs of intervention considered were only the direct medical costs . Direct nonmedical , indirect , and research costs were excluded . The cost-effectiveness of interventions was measured as the amount spent to prevent one case of diabetes within the 3-year trial period . RESULTS —The direct medical cost to identify one subject with IGT was Indian rupees ( INR ) 5,278 ( $ 117 ) . Direct medical costs of interventions over the 3-year trial period were INR 2,739 ( $ 61 ) per subject in the control group , INR 10,136 ( $ 225 ) with LSM , INR 9,881 ( $ 220 ) with metformin , and INR 12,144 ( $ 270 ) with LSM and metformin . The number of individuals needed to treat to prevent a case of diabetes was 6.4 with LSM , 6.9 with metformin , and 6.5 with LSM and metformin . Cost-effectiveness to prevent one case of diabetes with LSM was INR 47,341 ( $ 1,052 ) , with metformin INR 49,280 ( $ 1,095 ) , and with LSM and metformin INR 61,133 ( $ 1,359 ) . CONCLUSIONS —Both LSM and metformin were cost-effective interventions for preventing diabetes among high risk-individuals in India and perhaps may be useful in other developing countries as well . The long-term cost-effectiveness of the interventions needs to be assessed Aims /hypothesisTo assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing  type 2 diabetes within a high-risk Mediterranean population . Methods A prospect i ve cohort study was performed in the setting of Spanish primary care . White-European individuals without diabetes aged 45–75 years ( n = 2,054 ) were screened using the Finnish Diabetes Risk Score ( FINDRISC ) and a subsequent 2 h OGTT . Where feasible , high-risk individuals who were identified were allocated sequentially to st and ard care , a group-based or an individual level intervention ( intensive reinforced DE-PLAN [ Diabetes in Europe — Prevention using Lifestyle , Physical Activity and Nutritional ] intervention ) . The primary outcome was the development of diabetes according to WHO criteria . Analyses after 4-year follow-up were performed based on the intention-to-treat principle with comparison of st and ard care and the combined intervention groups . Results The st and ard care ( n = 219 ) and intensive intervention ( n = 333 ) groups were comparable in age ( 62.0/62.2 years ) , sex ( 64.4/68.2 % women ) , BMI ( 31.3/31.2 kg/m2 ) , FINDRISC score ( 16.2/15.8 points ) , fasting ( 5.3/5.2 mmol/l ) , 2 h plasma glucose ( 7.1/6.9 mmol/l ) and self-reported interest to make lifestyle changes at baseline . Diabetes was diagnosed in 124 individuals : 63 ( 28.8 % ) in the st and ard care group and 61 ( 18.3 % ) in the intensive intervention group . During a 4.2-year median follow-up , the incidences of diabetes were 7.2 and 4.6 cases per 100 person-years , respectively ( 36.5 % relative risk reduction , p < 0.005 ) . The number of participants needed to be treated by intensive intervention for 4 years to reduce one case of diabetes was 9.5 . Conclusions /interpretationIntensive lifestyle intervention is feasible in a primary care setting and substantially reduces diabetes incidence among high-risk individuals . Clinical trial registration : Clinical Trial.gov NCT01519505 Funding : Commission of the European Communities , Institute of Health Carlos III , Spanish Ministry of Health and Department of Health , Generalitat de Catalunya OBJECTIVES We tested the effectiveness of a community-based , literacy-sensitive , and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income , Spanish-speaking Latinos at increased diabetes risk . METHODS Three hundred twelve participants from Lawrence , Massachusetts , were r and omly assigned to lifestyle intervention care ( IC ) or usual care ( UC ) between 2004 and 2007 . The intervention was implemented by trained Spanish-speaking individuals from the community . Each participant was followed for 1 year . RESULTS The participants ' mean age was 52 years ; 59 % had less than a high school education . The 1-year retention rate was 94 % . Compared with the UC group , the IC group had a modest but significant weight reduction ( -2.5 vs 0.63 lb ; P = .04 ) and a clinical ly meaningful reduction in hemoglobin A1c ( -0.10 % vs -0.04 % ; P = .009 ) . Likewise , insulin resistance improved significantly in the IC compared with the UC group . The IC group also had greater reductions in percentage of calories from total and saturated fat . CONCLUSIONS We developed an inexpensive , culturally sensitive diabetes prevention program that result ed in weight loss , improved HbA1c , and improved insulin resistance in a high-risk Latino population AIM To evaluate the effectiveness of lifestyle interventions in people with impaired glucose tolerance ( IGT ) . METHODS Participants with IGT ( n=78 ) , diagnosed on two consecutive oral glucose tolerance tests ( OGTTs ) , were r and omly assigned to a 2-year lifestyle intervention or to a control group . Main outcome measures were changes from baseline in : nutrient intake ; physical activity ; anthropometry , glucose tolerance and insulin sensitivity . Measurements were repeated at 6 , 12 and 24 months follow-up . RESULTS After 24 months follow-up , there was a significant fall in total fat consumption ( difference in change between groups ( Delta intervention-Delta control)= -17.9 , 95 % confidence interval ( CI ) -33.6 to -2.1g/day ) as a result of the intervention . Body mass was significantly lower in the intervention group compared with controls after 6 months ( -1.6 , 95 % CI -2.9 to -0.4 kg ) and 24 months ( -3.3 , 95 % CI -5.7 to -0.89 kg ) . Whole body insulin sensitivity , assessed by the short insulin tolerance test ( ITT ) , improved after 12 months in the intervention group ( 0.52 , 95 % CI 0.15 - 0.89%/min ) . CONCLUSIONS These findings complement the findings of the Finnish Diabetes Prevention Study and the American Diabetes Prevention Study , both of which tested intensive interventions , by showing that pragmatic lifestyle interventions result in improvements in obesity and whole body insulin sensitivity in individuals with IGT , without change in other cardiovascular risk factors BACKGROUND Previous studies demonstrated that intensive lifestyle modification can prevent type 2 diabetes mellitus among those with impaired glucose tolerance , but similar beneficial results have not been proved among those with impaired fasting glucose levels . We investigated the efficacy of lifestyle modification on  type 2 diabetes  incidence among those with impaired fasting glucose levels . METHODS The present study was an unmasked , multicenter , r and omized , controlled trial . A total of 641 overweight Japanese ( aged 30 - 60 years ) with impaired fasting glucose levels were recruited nationwide in Japan and r and omly assigned to a frequent intervention group ( n = 311 ) or a control group ( n = 330 ) . For 36 months after r and omization , the frequent intervention group received individual instructions and follow-up support for lifestyle modification from the medical staff 9 times . The control group received similar individual instructions 4 times at 12-month intervals during the same period . The primary outcome was type 2 diabetes incidence in annual 75-g oral glucose tolerance tests , diagnosed according to World Health Organization criteria . RESULTS There were no significant differences between the allocation groups in baseline characteristics and dropout rates . Estimated cumulative incidences of type 2 diabetes were 12.2 % in the frequent intervention group and 16.6 % in the control group . Overall , the adjusted hazard ratio in the frequent intervention group was 0.56 ( 95 % confidence interval , 0.36 - 0.87 ) . In the post hoc subgroup analyses , the hazard ratio reduced to 0.41 ( 95 % confidence interval , 0.24 - 0.69 ) among participants with impaired glucose tolerance at baseline , and to 0.24 ( 0.12 - 0.48 ) among those with baseline hemoglobin A(1c ) levels of 5.6 % or more ( the Japan Diabetes Society method ) . Such risk reduction was not observed among those with isolated impaired fasting glucose findings or baseline hemoglobin A(1c ) levels of less than 5.6 % . CONCLUSIONS Lifestyle modifications can prevent type 2 diabetes  among overweight Japanese with impaired fasting glucose levels . In addition , identifying individuals with more deteriorated glycemic status by using 75-g oral glucose tolerance test findings or , especially , measurement of hemoglobin A(1c ) levels , could enhance the efficacy of lifestyle modifications . TRIAL REGISTRATION umin.ac.jp/ctr Identifier : UMIN000001959
target: Intervention-only programmes were in general more cost effective than programmes that also included a screening component .
  The longer the period evaluated , the more cost-effective interventions appeared .
  There was insufficient evidence to answer the question of ( 1 ) whether lifestyle programmes are more cost effective than metformin or ( 2 ) whether low-intensity lifestyle interventions are more cost effective than the more intensive lifestyle programmes that were tested in trials .
background: OBJECTIVE Explore the cost-effectiveness of lifestyle interventions and metformin in reducing subsequent incidence of type 2 diabetes  , both alone and in combination with a screening programme to identify high-risk individuals .