The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study Cost-Effectiveness of the Interventions in the Primary Prevention of Diabetes Among Asian Indians General effect on high-risk persons when general practitioners are trained in intensive treatment of type 2 diabetes Let’s prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation The 10-Year Cost-Effectiveness of Lifestyle Intervention or Metformin for Diabetes Prevention The Cost-Effectiveness of Lifestyle Modification or Metformin in Preventing Type 2 Diabetes in Adults with Impaired Glucose Tolerance Comparison of different stepwise screening strategies for type 2 diabetes: Finding from Danish general practice, Addition-DK. Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes. Delaying progression to type 2 diabetes among high-risk Spanish individuals is feasible in real-life primary healthcare settings using intensive lifestyle intervention Effect of screening for type 2 diabetes on healthcare costs: a register-based study among 139,075 individuals diagnosed with diabetes in Denmark between 2001 and 2009 Pleiotropic Action of Short-Term Metformin and Fenofibrate Treatment, Combined With Lifestyle Intervention, in Type 2 Diabetic Patients With Mixed Dyslipidemia Effect of Intervention in Subjects with High Risk of Diabetes Mellitus in Pakistan The epidemic of obesity and diabetes: trends and treatments. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. Costs associated with the primary prevention of type 2 diabetes mellitus in the diabetes prevention program. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. HbA1c as a Predictor of Diabetes and as an Outcome in the Diabetes Prevention Program: A Randomized Clinical Trial The comparative efficacy of lifestyle intervention and metformin by educational attainment in the Diabetes Prevention Program. Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial. The diabetes prevention program and its global implications. Impact of intensive lifestyle and metformin therapy on cardiovascular disease risk factors in the diabetes prevention program. Implementation of a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention delivery Prevention of type 2 diabetes - where is the evidence? A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Preventing type 2 diabetes using combination therapy: design and methods of the CAnadian Normoglycaemia Outcomes Evaluation (CANOE) trial Long-term Effects of Lifestyle Intervention or Metformin on Diabetes Development and Microvascular Complications: the DPP Outcomes Study 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) A clinical trial to maintain glycemic control in youth with type 2 diabetes.
Background The Diabetes Prevention Program ( DPP ) was a r and omized , controlled clinical trial . It demonstrated that among high-risk individuals with impaired glucose tolerance , diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo . During the Diabetes Prevention Program Outcomes Study ( DPPOS ) , all DPP participants were unmasked to their treatment assignments , the original lifestyle intervention group was offered additional lifestyle support , the metformin group continued metformin , and all three groups were offered a group-implemented lifestyle intervention . Over the 10 years of combined DPP/DPPOS follow-up , diabetes incidence was reduced by 34 % in the lifestyle group and 18 % in the metformin group compared to placebo . The purpose of this article is to review and synthesize analyses published by the DPP/DPPOS Research Group that have described the cost-effectiveness of diabetes prevention . Methods We describe the re source utilization and costs of the DPP and DPPOS interventions , the costs of non-intervention-related medical care , the impact of the interventions on diabetes progression and quality -of-life , and the cost-effectiveness of the interventions from health system and societal perspectives . Cost-effectiveness analyses were performed with a 3-year time horizon using DPP data , a lifetime time horizon that simulated 3-year DPP data , and a 10-year time horizon using combined DPP/DPPOS data . Results Although more expensive than the placebo intervention , the greater costs of the lifestyle and metformin interventions were offset by reductions in the costs of nonintervention-related medical care . Every year after r and omization , quality -of-life was better for participants in the lifestyle intervention compared to those in the metformin or placebo intervention . In both the simulated lifetime analysis and the 10-year within trial economic analysis , lifestyle and metformin were extremely cost-effective ( that is , improved outcomes at a low incremental cost ) or even cost-saving ( that is , improved outcomes and reduced total costs ) compared to the placebo intervention . Conclusions The implementation of diabetes prevention programs in high-risk individuals will result in important health benefits and represents a good value for money . Trial registration NCT00004992 ( DPP ) and NCT00038727 ( DPPOS ) 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 Objective . Within the frame of a r and omized clinical trial to examine whether training of general practitioners ( the intervention group ) in intensive lifestyle modification and pharmacological treatment of patients with type 2 diabetes has a spillover effect on individuals with impaired fasting glycaemia ( IFG ) or impaired glucose tolerance ( IGT ) . Design . A high-risk screening study for type 2 diabetes with an intervention programme , where general practice s were r and omized to provide st and ard treatment versus intensive lifestyle modification and pharmacological treatment to newly diagnosed diabetic patients . Setting . General practice s in Denmark . Subjects . Of 1821 individuals identified with IFG or IGT , results from oral glucose tolerance tests after one and three years were available in 1510 individuals . Main outcome measures . Progression rates from IFG and IGT to diabetes and effect of intervention were estimated in a regression model using interval censoring . Results . A total of 442 persons developed diabetes .  There was no significant overall effect of intervention on progression rates . For risk factors , no difference in rate of change was found between r and omization groups , but a difference was found between general practice s within the same r and omization groups . Conclusion . General practitioners identify a high number of incident diabetes cases in individuals with IFG or IGT found by high-risk screening . Intervention at the general practitioner 's level in intensive treatment type 2 diabetes does not have a significant spillover effect reducing the risk of diabetes from pre-diabetic conditions . This could indicate that intervention strategies should be specifically targeted at individuals with IFG or IGT , either by training general practitioners or directly at the individual level Background The prevention of type 2 diabetes is a globally recognised health care priority , but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes , based on the promotion of a healthy lifestyle , into routine primary care . The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation ( a composite of impaired glucose tolerance and /or impaired fasting glucose ) identified through a vali date d risk score screening programme in primary care . Design Cluster r and omised controlled trial undertaken at the level of primary care practice s. Follow-up will be conducted at 12 , 24 and 36 months . The primary outcome is the incidence of type 2 diabetes . Secondary outcomes include changes in HbA1c , blood glucose levels , cardiovascular risk , the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention . Methods The study consists of screening and intervention phases within 44 general practice s coordinated from a single academic research centre . Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test . Those with screen detected impaired glucose regulation will be invited to take part in the trial . Practice s will be r and omised to st and ard care or the intensive arm . Participants from intensive arm practice s will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions . The study will run from 2009–2014 . Discussion This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom . Trial registration Clinical trials.gov OBJECTIVE The Diabetes Prevention Program ( DPP ) and its Outcomes Study ( DPPOS ) demonstrated that either intensive lifestyle intervention or metformin could prevent type 2 diabetes in high-risk adults for at least 10 years after r and omization . We report the 10-year within-trial cost-effectiveness of the interventions . RESEARCH DESIGN AND 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 . RESULTS Over 10 years , the cumulative , undiscounted per capita direct medical costs of the interventions , as implemented during the DPP , were greater for lifestyle ( $ 4,572 ) than metformin ( $ 2,281 ) or placebo ( $ 752 ) . The cumulative direct medical costs of care outside the DPP/DPPOS were least for lifestyle ( $ 26,810 lifestyle vs. $ 27,384 metformin vs. $ 29,007 placebo ) . The cumulative , combined total direct medical costs were greatest for lifestyle and least for metformin ( $ 31,382 lifestyle vs. $ 29,665 metformin vs. $ 29,759 placebo ) . The cumulative quality -adjusted life-years ( QALYs ) accrued over 10 years were greater for lifestyle ( 6.89 ) than metformin ( 6.79 ) or placebo ( 6.74 ) . When costs and outcomes were discounted at 3 % and adjusted for survival , lifestyle cost $ 12,878 per QALY , and metformin had slightly lower costs and nearly the same QALYs as placebo . CONCLUSIONS Over 10 years , from a payer perspective , lifestyle was cost-effective and metformin was marginally cost-saving compared with placebo . Investment in lifestyle and metformin interventions for diabetes prevention in high-risk adults provides good value for the money spent 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 AIM To examine attendance , number of people with T2DM and costs of three different stepwise screening strategies for T2DM in general practice ( GP ) . METHODS Diabetes risk question naires were mailed to individuals aged 40 - 69 years from 45 general practice s in 2001 - 2002 and individuals at high risk for T2DM , were asked to contact their GP to arrange a screening test . In 2005 - 2006 , 26 general practice s were r and omised into two different opportunistic screening programmes ( OP-direct and OP-subsequent ) and risk question naires were distributed to individuals aged 40 - 69 years during GP consultations . In the OP-direct approach , high-risk individuals were offered to start the screening during the actual consultation while high-risk individuals in the OP-subsequent approach , were invited to a screening test at a later date . We report attendance , number of people with T2DM and costs of each screening approach . RESULTS The mail-distributed approach identified 0.8 % of the target population with T2DM , the OP-direct approach and the OP-subsequent approach , 0.9 % and 0.5 % respectively . Cost per person with T2DM was in the mail-distributed approach : € 1058 , OP-direct approach : € 707 and the OP-subsequent approach : € 727 . CONCLUSION This study indicates that opportunistic screening identifies the same level of unknown diabetes as a mail-distributed approach but with lower costs OBJECTIVE The Diabetes Prevention Program ( DPP ) demonstrated that intensive lifestyle and metformin interventions reduced the incidence of type 2 diabetes compared with a placebo intervention . The aim of this study was to assess the cost-effectiveness of the lifestyle and metformin interventions relative to the placebo intervention . RESEARCH DESIGN AND METHODS Analyses were performed from a health system perspective that considered direct medical costs only and a societal perspective that considered direct medical costs , direct nonmedical costs , and indirect costs . Analyses were performed with the interventions as implemented in the DPP and as they might be implemented in clinical practice . RESULTS The lifestyle and metformin interventions required more re sources than the placebo intervention from a health system perspective , and over 3 years they cost approximately US dollars 2250 more per participant . As implemented in the DPP and from a societal perspective , the lifestyle and metformin interventions cost US dollars 24400 and US dollars 34500 , respectively , per case of diabetes delayed or prevented and US dollars 51600 and US dollars 99200 per quality -adjusted life-year ( QALY ) gained . As the interventions might be implemented in routine clinical practice and from a societal perspective , the lifestyle and metformin interventions cost US dollars 13200 and US dollars 14300 , respectively , per case of diabetes delayed or prevented and US dollars 27100 and US dollars 35000 per QALY gained . From a health system perspective , costs per case of diabetes delayed or prevented and costs per QALY gained tended to be lower . CONCLUSIONS Over 3 years , the lifestyle and metformin interventions were effective and were cost-effective from the perspective of a health system and society . Both interventions are likely to be affordable in routine clinical practice , especially if implemented in a group format and with generic medication pricing 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 Aims /hypothesisTrials have not demonstrated benefits to the population of screening for type 2 diabetes . However , there may be cost savings for those found to have diabetes . We therefore aim ed to compare healthcare costs among individuals with incident type 2 diabetes in a screened group with those in an unscreened group . Methods In this register-based , non-r and omised controlled trial , eligible individuals were men and women aged 40–69 years without known diabetes who were registered with a general practice in Denmark ( n = 1,912,392 ) . Between 2001 and 2006 , 153,107 individuals registered with 181 practice s participating in the Anglo – Danish – Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care (ADDITION)-Denmark study were sent a diabetes risk-score question naire . Individuals with a moderate-to-high risk were invited to visit their family doctor for assessment of diabetes status and cardiovascular risk ( screening group ) . The 1,759,285 individuals registered with all other practice s in Denmark constituted the retrospectively constructed no-screening ( control ) group . In this post hoc analysis , we identified individuals from the screening and no-screening groups who were diagnosed with diabetes between 2001 and 2009 ( n = 139,075 ) . Using national registry data , we quantified the cost of healthcare services in these two groups between 2001 and 2012 . From a healthcare sector perspective , we estimated the potential healthcare cost savings for individuals with diabetes that were attributable to the screening programme . Results In the screening group , 27,177 of 153,107 individuals ( 18 % of those sent a risk-score question naire ) attended for screening , 1533 of whom were diagnosed with diabetes . Between 2001 and 2009 , 13,992 people were newly diagnosed with diabetes in the screening group ( including those diagnosed by screening ) and 125,083 in the no-screening  group . Healthcare costs were significantly lower in the screening group compared with the no-screening group ( difference in mean total annual healthcare costs −€889 per individual with incident diabetes ; 95 % CI −€1196 , −€581 ) . The screening programme was associated with a cost saving per person with incident diabetes over a 5-year period of € 2688 ( 95 % CI € 1421 , € 3995 ) . Conclusions /interpretationHealthcare costs were lower among individuals with incident type 2 diabetes in the screened group compared with the unscreened group . The relatively modest cost of screening per person discovered to have developed diabetes was offset within 2 years by savings in the healthcare system OBJECTIVE To compare the effect of short-term metformin and fenofibrate treatment , administered alone or in sequence , on glucose and lipid metabolism , cardiovascular risk factors , and monocyte cytokine release in type 2 diabetic patients with mixed dyslipidemia . RESEARCH DESIGN AND METHODS We studied 128 type 2 diabetic patients with mixed dyslipidemia complying throughout the study with lifestyle intervention who were r and omized twice , initially to either  metformin or placebo  , and then to micronized fenofibrate or placebo . RESULTS Fenofibrate alleviated diabetic dyslipidemia – induced changes in plasma high-sensitivity C-reactive protein , fibrinogen , and plasminogen activator inhibitor (PAI)-1 and in monocyte cytokine release , whereas metformin or lifestyle intervention improved mainly glucose and lipid metabolism . The strongest pleiotropic effect was observed when fenofibrate was added to metformin . CONCLUSIONS Fenofibrate , particularly administered together with metformin , is superior to metformin and lifestyle intervention in exhibiting beneficial effects on systemic inflammation , hemostasis , and monocyte secretory function in type 2 diabetic patients with mixed dyslipidemia 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 Cardiovascular disease remains the leading cause of death in women . Both obesity and diabetes mellitus are important independent risk factors for the development of cardiovascular disease . Obesity is the leading risk factor for type 2 diabetes . The Centers for Disease Control and Prevention report that 32 % of white and 53 % of black women are obese . Women with a body mass index ( BMI ) of 30 kg/m2 have a 28 times greater risk of developing diabetes than do women of normal weight . The risk of diabetes is 93 times greater if the BMI is 35 kg/m2.1 The presence of diabetes can increase a woman 's risk of heart disease 2-fold . In addition , the presence of diabetes overshadows the protective effects of the premenopausal state . In 2007 , 11.5 million of all women over the age of 20 ( 10.2 % ) had diabetes , and rates were slightly higher in ethnic minority groups : 10.4 % in Hispanic women and 11.8 % in non-Hispanic black women.2 The national prevalence rates of diabetes have increased in parallel with the rates of obesity ( Fig. 1 ) . Fig. 1 Age-adjusted percentage of U.S. adults who were obese or who had a diagnosis of diabetes mellitus . Screening Screening for obesity and diabetes is the 1st step to treatment and often reveals individuals who are at risk for but do not yet have overt disease . The United States Preventive Services Task Force ( USPSTF ) recommends that all adults be screened for obesity . Obesity signifies excess adipose tissue . The most widely used method for screening is determination of the BMI . The BMI is weight in kilograms divided by height in meters squared ( BMI = kg/m2 ) ( Table I ) . Most electronic medical records automatically calculate BMI if height and weight are entered . There are also many smart-phone applications and online calculators that can calculate BMI ( for example , http://www.nhlbisupport.com/ bmi ) . Other screening tools include  waist circumference and the waist-to-hip ratio . In women , a waist circumference > 35 in ( 88 cm ) or a waist-to-hip ratio > 0.7 indicates excess visceral fat and increased risk for disease . TABLE I. Body Mass Index ( BMI ) Classification Recommendations for screening for diabetes vary by guideline author . The USPSTF recommends screening asymptomatic patients who have  blood pressures > 135/80 mmHg  . The American Diabetes Association ( ADA ) recommends that individuals who are ≥18 years of age and have a BMI ≥25 kg/m2 and 1 additional risk factor for diabetes should be screened annually ( Table II).3 Individuals over the age of 45 without risk factors should be screened every 3 years . In January 2010 , the ADA released new recommendations for the use of hemoglobin A1C as a screening tool . An A1C greater than 6.5 % indicates diabetes . In addition , the results of screening tests for diabetes can identify individuals with “ prediabetes ” who have a markedly increased risk of developing overt disease.3 TABLE II . American Diabetes Association Recommendations on Screening for Type 2 Diabetes3 Non-Pharmaceutical Treatment Lifestyle-treatment options for diabetes mellitus and excess weight are similar , and 2 recent studies 4,5 have demonstrated the critical components for treating pre-diabetes and diabetes through weight loss , using caloric restriction and physical activity . The 1st study was the Diabetes Prevention Program.4 The purpose of the study was to identify individuals who were at risk for developing diabetes because of elevated fasting plasma glucose or impaired glucose tolerance levels that were not yet in the diagnostic range , in order to determine if metformin or an intensive lifestyle intervention could delay or prevent the onset of diabetes . More than 3,000 individuals with prediabetes were r and omized to receive placebo , metformin , or a 16-session lifestyle-modification program . The intensive lifestyle program set a goal of 7 % weight loss and 150 min/wk of moderate physical activity . Fifty percent of the lifestyle-intervention group lost 7 % of their body weight . The 3-year incidence of diabetes in the metformin group was 31 % lower than that in the placebo group . The incidence was 58 % lower in the lifestyle group than in the placebo group.4 The clinical implication s of this study are that we should 1 ) identify individuals with pre-diabetes and 2 ) recommend lifestyle modifications that result in a 7 % weight loss and include 150 min/wk of moderate physical activity . The 2nd study that examined lifestyle treatment of diabetes and obesity is the Look AHEAD Trial . The purpose of the study was to determine the effect of intentional weight loss on cardiovascular risk factors in individuals with diabetes . Approximately 5,100 individuals with type 2 diabetes and an elevated BMI were r and omized . Study conditions specified a 36-session intensive lifestyle intervention with the option of using partial meal replacements for caloric restriction or 4 sessions of st and ard diabetes support and education ( DSE ) . At 1 year , 55 % of the intensive-lifestyle-intervention group achieved 7 % weight loss . Hemoglobin A1C , systolic and diastolic blood pressure , and lipids improved significantly more in the intensive-lifestyle group than in the DSE group.5 The clinical implication of this study is that intentional weight loss of at least 7 % can improve the cardiovascular risk profile of patients with type 2 diabetes . Conclusions Excess weight affects two thirds of the U.S. adult population and increases risk for cardiovascular disease and diabetes . All patients should be screened for obesity and most should be screened for pre-diabetes and diabetes . The best treatment for diabetes is prevention . Prevention of diabetes can be accomplished through a 7 % weight loss through intensive lifestyle interventions that include caloric reduction and approximately 30 min of daily moderate physical activity . Practitioners will have access to these evidence -based programs soon . The Centers for Disease Control and Prevention are promoting community-based diabetes prevention programs throughout the country CONTEXT A past history of gestational diabetes mellitus ( GDM ) confers a very high risk of postpartum development of diabetes , particularly type 2 diabetes . OBJECTIVE The Diabetes Prevention Program ( DPP ) sought to identify individuals with impaired glucose tolerance ( IGT ) and intervene in an effort to prevent or delay their progression to diabetes . This analysis examined the differences between women enrolled in DPP with and without a reported history of GDM . DESIGN The DPP was a r and omized , controlled clinical trial . SETTING The study was a multicenter , National Institutes of Health-sponsored trial carried out at 27 centers including academic and Indian Health Services sites . PATIENTS A total of 2190 women were r and omized into the DPP and provided information for past history of GDM . This analysis addressed the differences between those 350 women providing a past history of GDM and those 1416 women with a previous live birth but no history of GDM . INTERVENTIONS Subjects were r and omized to either st and ard lifestyle and placebo or metformin therapy or to an intensive lifestyle intervention . MAIN OUTCOMES The primary outcome was the time to development of diabetes ascertained by semiannual fasting plasma glucose and annual oral glucose tolerance testing . Assessment s of insulin secretion and insulin sensitivity were also performed . RESULTS Whereas entering the study with similar glucose levels , women with a history of GDM r and omized to placebo had a crude incidence rate of diabetes 71 % higher than that of women without such a history . Among women reporting a history of GDM , both intensive lifestyle and metformin therapy reduced the incidence of diabetes by approximately 50 % compared with the placebo group , whereas this reduction was 49 and 14 % , respectively in parous women without GDM . These data suggest that metformin may be more effective in women with a GDM history as compared with those without . CONCLUSIONS Progression to diabetes is more common in women with a history of GDM compared with those without GDM history despite equivalent degrees of IGT at baseline . Both intensive lifestyle and metformin are highly effective in delaying or preventing diabetes in women with IGT and a history of GDM OBJECTIVE To describe the costs of the Diabetes Prevention Program ( DPP ) interventions to prevent or delay type 2 diabetes . RESEARCH DESIGN AND METHODS We describe the direct medical costs , direct nonmedical costs , and indirect costs of the placebo , metformin , and intensive lifestyle interventions over the 3-year study period of the DPP . Re source use and cost are summarized from the perspective of a large health system and society . Research costs are excluded . RESULTS The direct medical cost of laboratory tests to identify one subject with impaired glucose tolerance ( IGT ) was $ 139 . Over 3 years , the direct medical costs of the interventions were $ 79 per participant in the placebo group , $ 2,542 in the metformin group , and $ 2,780 in the lifestyle group . The direct medical costs of care outside the DPP were $ 272 less per participant in the metformin group and $ 432 less in the lifestyle group compared with the placebo group . Direct nonmedical costs were $ 9 less per participant in the metformin group and $ 1,445 greater in the lifestyle group compared with the placebo group . Indirect costs were $ 230 greater per participant in the metformin group and $ 174 less in the lifestyle group compared with the placebo group . From the perspective of a health system , the cost of the metformin intervention relative to the placebo intervention was $ 2,191 per participant and the cost of the lifestyle intervention was $ 2,269 per participant over 3 years . From the perspective of society , the cost of the metformin intervention relative to the placebo intervention was $ 2,412 per participant and the cost of the lifestyle intervention was $ 3,540 per participant over 3 years . CONCLUSIONS The metformin and lifestyle interventions are associated with modest incremental costs compared with the placebo intervention . The evaluation of costs relative to health benefits will determine the value of these interventions to health systems and society 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 OBJECTIVE Glycated hemoglobin ( HbA1c ) , a st and ard measure of chronic glycemia for managing diabetes , has been proposed to diagnose diabetes and identify people at risk . The Diabetes Prevention Program ( DPP ) was a 3.2-year r and omized clinical trial of preventing type 2 diabetes with a 10-year follow-up study , the DPP Outcomes Study ( DPPOS ) . We evaluated baseline HbA1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA1c ≥6.5 % ( 48 mmol/mol ) . RESEARCH DESIGN AND METHODS We r and omized 3,234 nondiabetic adults at high risk of diabetes to placebo , metformin , or intensive lifestyle intervention  and followed them for the development of diabetes as diagnosed by fasting plasma glucose ( FPG ) and 2-h postload glucose ( 2hPG ) concentrations ( 1997 American Diabetes Association [ ADA ] criteria ) . HbA1c was measured but not used for study eligibility or outcomes . We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG , 2hPG , or HbA1c ( 2010 ADA criteria ) .  RESULTS Baseline HbA1c predicted incident diabetes in all treatment groups . Diabetes incidence defined by HbA1c ≥6.5 % was reduced by 44 % by metformin and 49 % by lifestyle during the DPP and by 38 % by metformin and 29 % by lifestyle throughout follow-up . Unlike the primary DPP and DPPOS findings based on glucose criteria , metformin and lifestyle were similarly effective in preventing diabetes defined by HbA1c . CONCLUSIONS HbA1c predicted incident diabetes . In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes , metformin and lifestyle interventions had similar effects in preventing HbA1c-defined diabetes . The long-term implication s for other health outcomes remain to be determined OBJECTIVE Educational attainment is inversely associated with type 2 diabetes risk , but it is unknown whether education impacts individuals ' diabetes prevention efforts . We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program ( DPP ) , an ongoing U.S. multi-site trial beginning in 1996 . METHODS We studied 2,910 DPP participants r and omized to receive lifestyle intervention , metformin , or placebo .  Stratifying by educational attainment , diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression . RESULTS 47 % of participants had completed college and 53 % had not . Compared to placebo , lifestyle participants who had completed college demonstrated a 68 % reduction in diabetes incidence ( 95 % CI=56 , 77 ) , whereas those with less education experienced a 47 % risk reduction ( 95 % CI=29 , 61 ) . For metformin participants , college graduates experienced a 49 % relative risk reduction ( 95 % CI=33 , 62 ) , compared to 23 % ( 95 % CI=1 , 41 ) among those with lower educational attainment . There was a statistically significant education-by-treatment interaction with incident diabetes ( p=0.03 ) . CONCLUSIONS Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals . Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals ' educational background OBJECTIVE To test whether information about benefits and harms of screening for type 2 diabetes increases intentions to make lifestyle changes amongst attenders , predominantly among the socially advantaged and those with a strong future time orientation . STUDY DESIGN Planned subgroup analysis of attenders for screening participating in a r and omized controlled trial of an informed choice invitation vs a st and ard invitation to attend for type 2 diabetes screening . METHODS Potentially eligible participants were identified from practice registers using routine data which were used to calculate risk scores for diabetes for all aged 40 - 69 years without known type 2 diabetes and area deprivation based on post code . In total , 1272 individuals in the top 25 % risk category were r and omized to receive one of two  invitations to attend their practice s for screening : an informed choice invitation or a st and ard invitation . The subsequent attenders completed self-report measures of future time orientation and deprivation immediately before undergoing a screening test . RESULTS Individual-level deprivation demonstrated a significant moderator effect [ F ( 4,635 ) = 4.32 , P = 0.002 ] : individuals who were high in deprivation had lower intentions to engage in lifestyle change following receipt of the informed choice invitation . However , intentions were not patterned by deprivation when it was assessed at the area-level using the Index of Multiple Deprivation 2007 . The hypothesized moderating effect of future time orientation on invitation type was also supported [ F(14,613 ) = 2.46 , P = 0.002 ) : individuals low in future time orientation had markedly lower intentions to engage in lifestyle change following receipt of an informed choice invitation compared with a st and ard invitation for screening . CONCLUSION Efforts to enhance informed choice where the implication s of diagnosis are a requirement for lifestyle change may require that the immediate benefits are communicated , and efforts to address the apparent barriers to diabetes self-care are made , if the potential for inequity is to be avoided Type 2 diabetes affects over 150 million adults worldwide and this figure is expected to double over the next 25 yr . This increase will be accompanied by a marked increase in the number of patients with ESRD due to diabetes . We hypothesized that a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes We r and omly assigned 3234 nondiabetic persons with elevated fasting and postload plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 % weight loss and at least 150 min of physical activity per week . The mean age of the participants was 51 yr , and the mean body mass index was 34.0 kg/m(2 ) ; 68 % were women , and 45 % were members of non-Caucasian racial/ethnic groups . The average follow-up was 2.8 yr . 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 of diabetes by 58 % ( 95 % CI : 48 to 66 % ) and metformin by 31 % ( 95 % CI : 17 to 43 % ) , compared with placebo ; the lifestyle intervention was significantly more effective than metformin . In conclusion , lifestyle changes and treatment with  metformin  both reduced the incidence of diabetes in persons at high risk and the lifestyle intervention was more effective than metformin . Because the lifestyle changes worked equally in all racial/ethnic groups in the Diabetes Prevention Program , they should be applicable to high-risk population s worldwide and may be able to reduce the projected progressive rise in the incidence of diabetes and the expected increase in ESRD OBJECTIVE The Diabetes Prevention Program demonstrated the ability to delay or prevent type 2 diabetes in participants with impaired glucose tolerance ( IGT ) . Participants with IGT are at high risk for cardiovascular disease ( CVD ) , with a marked increase in the number and severity of CVD risk factors . We prospect ively assessed the impact of our interventions on hypertension , dyslipidemia , and CVD events . RESEARCH DESIGN AND METHODS The study group consisted of 3,234 individuals with IGT r and omly assigned to receive intensive lifestyle intervention , metformin , or placebo . Annual assessment of blood pressure , lipids , electrocardiogram , and CVD events was undertaken . RESULTS Hypertension was present in 30 % of participants at study entry and then increased in the placebo and metformin groups , although it significantly decreased with intensive lifestyle intervention . Triglyceride levels fell in all treatment groups , but fell significantly more with intensive lifestyle intervention . Total cholesterol and LDL cholesterol levels were similar among treatment groups . Intensive lifestyle intervention significantly increased the HDL cholesterol level and reduced the cumulative incidence of the proatherogenic LDL phenotype B. At 3 years of follow-up , the use for pharmacologic therapy to achieve established goals in the intensive lifestyle group was 27 - 28 % less for hypertension and 25 % less for hyperlipidemia compared with placebo and metformin groups . Over an average of 3 years , 89 CVD events from 64 participants were positively adjudicated study wide , with no differences among treatment groups . CONCLUSIONS Lifestyle intervention improves CVD risk factor status compared with placebo and metformin therapy . Although no differences in CVD events were noted after 3 years , achieved risk factor modifications suggest that longer intervention may reduce CVD event rates Background As in clinical practice re sources may be limited compared to experimental setting s , translation of evidence -based lifestyle interventions into daily life setting s is challenging . In this study we therefore evaluated the implementation of the APHRODITE lifestyle intervention for the prevention of type 2 diabetes in Dutch primary care . Based on this evaluation we discuss opportunities for refining intervention delivery . Methods A 2.5-year intervention was performed in 14 general practice s in the Netherl and s among individuals at high risk for type 2 diabetes ( FINDRISC-score ≥ 13 ) ( n = 479 ) and was compared to usual care ( n = 446 ) . Intervention consisted of individual lifestyle counselling by nurse practitioners ( n = 24 ) and GPs ( n = 48 ) and group-consultations .  Drop-out and attendance were registered during the programme . After the intervention , satisfaction with the programme and perceived implementation barriers were assessed with question naires . Results Drop-out was modest ( intervention : 14.6 % ; usual care : 13.2 % ) and attendance at individual consultations was high ( intervention : 80 - 97 % ; usual care : 86 - 94 % ) . Providers were confident about diabetes prevention by lifestyle intervention in primary care . Participants were more satisfied with counselling from nurse practitioners than from GPs . A major part of the GPs reported low self-efficacy regarding dietary guidance . Lack of counselling time ( 60 % ) , participant motivation ( 12 % ) , and financial reimbursement ( 11 % ) were regarded by providers as important barriers for intervention implementation . Conclusions High participant compliance and a positive attitude of providers make primary care a suitable setting for diabetes prevention by lifestyle counselling . Results support a role for the nurse practitioner as the key player in guiding lifestyle modification . Further research is needed on strategies that could increase cost-effectiveness , such as more stringent criteria for participant inclusion , group-counselling , more tailor-made counselling and integration of screening and / or interventions for different disorders Diabetes is an “ old disease ” . The first description of diabetes written on papyrus about 3500 years ago is found in the Ebers papyrus  , which was discovered in Egypt in 1873 by the German archeologist Georg Ebers . Humans , like most mammals , may develop diabetes , if sufficient environmental exposure to physical inactivity , unhealthy diet and obesity are present . Genetic effects are important for the individual risk of type 2 diabetes ( T2D ) but twin studies have shown that the genetic effects combined explain less than 50 % of the risk of T2D ( 1 ) . Today we know almost 100 susceptibility genes associated with T2D but the relative importance of each of these genes is low ( 2 ) , and together they explain only a small part of the disease risk . Thus , genetic screening can not be used for the prediction of T2D for individuals . On the other h and , healthy lifestyle can also prevent T2D in people who are genetically at high risk , e.g. those with positive family history ( 3 ) . Thus , the importance of lifestyle factors for the development and prevention of T2D is overwhelming . The strongest evidence in medicine is considered to come from r and omized controlled trials ( RCTs ) . They are also important in providing the link to causal inference that in most observational studies can not be derived . At the same time , observational studies are necessary for the identification of factors associated with an increased or decreased risk of a disease , and for generation of hypotheses on potential means for prevention based on modifiable risk factors . Observational studies have by now identified a large number of factors that are associated with the development of T2D or with the protection against it . Most of them are related to physical activity , diet and obesity . It has also been shown unequivocally that exposures ( poor nutrition , infections , smoking , etc . ) during fetal life and early infancy result ing in insufficient development ( often shown as low birth weight ) also predict T2D later in life ( 4 ) . Traditionally , T2D has been considered to be a disease of the elderly . However , with increasing obesity and sedentary lifestyle in children , there are increasing numbers of cases of T2D already occurring at a young age in many population s ( 5 ) . In the past two decades several innovative RCTs have repeatedly shown that interventions on modifiable risk factors can reduce the incidence of diabetes in high-risk groups . The evidence has been summarized in several systematic review s and meta-analyses ( 6,7 ) . There is compelling scientific evidence from RCTs that T2D can be prevented or its onset delayed . The key for prevention is a multimodal package of lifestyle changes that is a sum outcome of dietary and physical activity behaviours . The power of lifestyle was dramatically illustrated by the Finnish Diabetes Prevention Study ( DPS ) that explicitly showed that when the study participants with impaired glucose tolerance reached all five modest lifestyle intervention targets , none of them progressed to T2D ( 8) . Importantly , lifestyle intervention lasting for 3–6 years has been shown to have a carry-over effect on T2D incidence that lasts for several years ; up to 15 in the Finnish Diabetes Prevention Study ( 9 ) and 20 years in the China Da Qing Diabetes Prevention Study ( 10 ) . The observed sustained risk reduction seems to be a result of sustained lifestyle changes , but the legacy effect of improved glycaemia during the early intervention may also have contributed to the long-term effect . The follow-up data from the Chinese study indicate moreover that vascular risks are also reduced by lifestyle management . Several prognostic question naires exist for detecting people at risk of T2D ( 11 ) . One of the screening tools with an adequately high sensitivity and specificity is the Finnish Diabetes Risk Score ( FINDRISC ) developed in Finl and ( 12 ) . The FINDRISC has been successfully implemented in the Finnish primary health care system and used also in many other countries . The FINDRISC was also tested in the Omani population and as a result a slightly modified Omani Diabetes Risk Score was developed ( 13 ) which may be a suitable screening tool for the Arab population s in the Middle East . Lifestyle interventions aim ing at translating evidence from efficacy RCTs on T2D prevention into “ real world ” intervention programmes have also been carried out in various population s. Such data were recently combined in a meta- analysis considering the relationship between intervention effectiveness and adherence to guidelines ( 14 ) . The primary meta- analysis included 22 studies with outcome data for weight loss at 12 months . The pooled result of the direct pairwise meta- analysis shows that AIM To compare the effectiveness and cost of two lifestyle-modification programmes in individuals at high risk of developing type 2 diabetes . METHODS Forty-eight men and women with a body mass index ≥27 kg/m(2 ) and prediabetes were r and omly assigned to either a 1-year interdisciplinary intervention including individual counseling every 6 weeks and 25 group seminars ( group I ; n=22 ) or a group intervention comprising seminars only ( group G ; n=26 ) . These interventions were compared in terms of weight loss and improvement of anthropometric measures , metabolic variables and costs . RESULTS Participants in group I lost an average of 4.9 kg ( 95 % CI : -7.3 , -2.4 ; P<0.01 ) and 5 cm in waist circumference ( 95 % CI : -7.0 , -3.0 ; P<0.01 ) , whereas no significant change was noted in those assigned to group G. Among the participants in group I , 50 and 27 % lost at least 5 and 10 % of their initial weight , respectively , compared with only 12 and 4 % , respectively , in group G. Fasting glucose , 2-hour glucose and lipid profiles improved significantly in group I , and no participant ( zero on 22 ) developed diabetes compared with 11.5 % ( 3/26 ) in group G. Most participants ( nine on 11 ) with impaired fasting glucose in group I returned to normal . The direct cost of the individual intervention was estimated to be $ 733.06/year per subject compared with $ 81.36/year per subject for the group intervention . CONCLUSION This study demonstrates that a low-cost , moderate-intensity , individual interdisciplinary approach combined with group seminars leads to clinical ly significant weight loss and metabolic improvement in people with prediabetes . Group seminars alone were not effective in this population ( www . Clinical Trial.gov , Identifier : NCT00991549 ) Several studies have demonstrated that type 2 diabetes mellitus ( DM ) can be prevented/delayed in subjects with impaired glucose tolerance ( IGT ) by using pharmacologic agents and /or lifestyle interventions . However , a number of challenges remain , including the translation of lifestyle programmes to the general population and the need to achieve greater risk reductions by using pharmacologic approaches . IGT , like DM , is characterized by insulin resistance , β‐cell dysfunction and increased hepatic glucose production . We believe that the use of combination diabetes therapy would be a particularly effective diabetes prevention strategy . In this context , we initiated the Canadian Normoglycemia Outcomes Evaluation ( CANOE ) study , a moderately sized , r and omized , double‐blind , controlled trial . The primary objective of CANOE is to determine whether treatment with metformin plus rosiglitazone , in addition to a healthy living lifestyle programme , will prevent the development of DM . The secondary objective of CANOE is to determine whether this treatment approach will improve cardiovascular risk factors associated with IGT . A total of 200 patients will be recruited in Toronto and London , Ontario , and followed for an average of 4 years ( range 3–5 years ) . Active treatment with metformin ( 500 mg ) plus rosiglitazone ( 2 mg ) , administered as one capsule twice daily , will be compared to matched placebo .  Subjects will be eligible for r and omization if they have IGT and are between the ages of 30–75 years . The primary outcome will be the development of new‐onset DM , diagnosed by either two fasting plasma glucose values of ≥7 mmol/l or one positive oral glucose tolerance test with a 2‐h plasma glucose value of > 11.0 mmol/l during the active drug phase of the trial . With a sample size of 100 participants per group , we will be able to detect a relative risk reduction of 45 % , with a two‐sided log‐rank test with a significance level of 0.05 and 80 % power , assuming that the median time to progression is 8 years in the control group and that participants will be recruited over 2 years and followed for an average of 4 years . In conclusion , the CANOE study will determine whether combination pharmacological therapy combined with a lifestyle intervention programme can significantly modify the development of diabetes in high‐risk Canadians Background The worldwide epidemic of type 2 diabetes requires effective prevention . We determined the long-term extent of beneficial effects of lifestyle intervention and metformin on diabetes prevention , originally demonstrated during the 3-year Diabetes Prevention Program ( DPP ) , and whether diabetes-associated microvascular complications are reduced . Methods The DPP ( 1996–2001 ) was a r and omized trial comparing an intensive lifestyle intervention or masked metformin with placebo in a cohort selected to be at very high risk to develop diabetes . All participants were offered lifestyle training at DPP-end . 2776 ( 88 % ) of the surviving DPP cohort were followed in the DPP Outcome Study ( DPPOS 2002–2013 ) and analyzed by intention-to-treat based on original DPP assignment . During DPPOS , the lifestyle group was offered lifestyle reinforcement semi-annually and the metformin group received unmasked metformin . Findings During 15 years of average follow-up , lifestyle intervention and metformin  reduced diabetes incidence rates by 27 % ( p<0.0001 ) and 18 % ( p=0.001 ) , respectively , compared with the placebo group , with declining between group differences over time . At year 15 , the cumulative incidences of diabetes were 55 , 56 and 62 % , respectively . The prevalences at study -end of the aggregate microvascular outcome , composed of nephropathy , neuropathy , and retinopathy , were not significantly different among the treatment groups ( 11–13 % ) in the total cohort . However , in women ( n=1887 ) lifestyle intervention was associated with a lower prevalence ( 8.7 % ) than in the placebo ( 11 % ) and metformin ( 11.2 % ) groups , with 21 % ( p=0.03 ) and 22 % ( p=0.02 ) reductions with lifestyle compared with placebo and metformin , respectively . Compared with participants who progressed to diabetes , those who did n’t progress had a 28 % lower prevalence of microvascular complications ( p<0.0001 ) . Interpretation Lifestyle intervention or metformin significantly reduce diabetes development over 15 years . There were no overall differences in the aggregate microvascular outcome among treatment groups ; however , those who did not progress to diabetes had a lower prevalence of microvascular complications than those who progressed . Funding National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK 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 BACKGROUND Despite the increasing prevalence of type 2 diabetes in youth , there are few data to guide treatment . We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes . METHODS Eligible patients 10 to 17 years of age were treated with metformin ( at a dose of 1000 mg twice daily ) to attain a glycated hemoglobin level of less than 8 % and were r and omly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone ( 4 mg twice a day ) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors . The primary outcome was loss of glycemic control , defined as a glycated hemoglobin level of at least 8 % for 6 months or sustained metabolic decompensation requiring insulin . RESULTS Of the 699 r and omly assigned participants ( mean duration of diagnosed type 2 diabetes , 7.8 months ) , 319 ( 45.6 % ) reached the primary outcome over an average follow-up of 3.86 years . Rates of failure were 51.7 % ( 120 of 232 participants ) , 38.6 % ( 90 of 233 ) , and 46.6 % ( 109 of 234 ) for metformin alone , metformin plus rosiglitazone , and metformin plus lifestyle intervention , respectively . Metformin plus rosiglitazone was superior to metformin alone ( P=0.006 ) ; metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone . Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness , with metformin alone least effective in non-Hispanic black participants and metformin plus rosiglitazone most effective in girls . Serious adverse events were reported in 19.2 % of participants . CONCLUSIONS Monotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes . The addition of rosiglitazone , but not an intensive lifestyle intervention , was superior to metformin alone . ( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; TODAY Clinical Trials.gov number , NCT00081328 . )
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 .
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 .