Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes. Effectiveness and cost-effectiveness of diabetes prevention among adherent participants. 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 Costs associated with the primary prevention of type 2 diabetes mellitus in the diabetes prevention program. The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study The comparative efficacy of lifestyle intervention and metformin by educational attainment in the Diabetes Prevention Program. Cost-effectiveness analysis of intensive blood-glucose control with metformin in overweight patients with Type II diabetes (UKPDS No. 51) Cost-Effectiveness of the Interventions in the Primary Prevention of Diabetes Among Asian Indians Cost-effectiveness of a lifestyle intervention in preventing Type 2 diabetes. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. Lifestyle intervention to prevent diabetes in men and women with impaired glucose tolerance is cost-effective. Cost-utility analyses of intensive blood glucose and tight blood pressure control in type 2 diabetes (UKPDS 72) Impact of intensive lifestyle and metformin therapy on cardiovascular disease risk factors in the diabetes prevention program. Economic evaluation of a lifestyle intervention in primary care to prevent type 2 diabetes mellitus and cardiovascular diseases: a randomized controlled trial Lifestyle and Metformin Interventions Have a Durable Effect to Lower CRP and tPA Levels in the Diabetes Prevention Program Except in Those Who Develop Diabetes Cost-effectiveness of a pragmatic structured education intervention for the prevention of type 2 diabetes: economic evaluation of data from the Let's Prevent Diabetes cluster-randomised controlled trial
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 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 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 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 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 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 Aims /hypothesis . To estimate the economic efficiency of intensive blood-glucose control with metformin compared with conventional therapy primarily with diet in overweight patients with Type II ( non-insulin-dependent ) diabetes mellitus . Methods . Cost-effectiveness analysis based on patient level data from a r and omised clinical controlled trial involving 753 overweight ( > 120 % ideal body weight ) patients with newly diagnosed Type II diabetes conducted in 15 hospital-based clinics in Engl and , Scotl and and Northern Irel and as part of the UK Prospect i ve Diabetes Study . Subjects were allocated at r and om to an intensive blood-glucose control policy with metformin ( n = 342 ) or a conventional policy primarily with diet ( n = 411 ) . The analysis was based on the cost of health care re sources associated with metformin and conventional therapy and the estimated effectiveness in terms of life expectancy gained from within-trial effects . Results . Intensive blood-glucose control with metformin produced a net saving of £ 258 per patient ( 1997 United Kingdom prices ) over the trial period ( median duration of 10.7 years ) due to lower complication costs , and increased life expectancy by 0.4 years ( costs and benefits discounted at 6 % ) . Conclusions /interpretation . As metformin is both cost-saving in the United Kingdom and extends life expectancy when used as first line pharmacological therapy in overweight Type II diabetic patients , its use should be attractive to clinicians and health care managers alike . [ Diabetologia ( 2001 ) 44 : 298–304 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 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 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 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 Aims /hypothesisThis study estimated the economic efficiency ( 1 ) of intensive blood glucose control and tight blood pressure control in patients with type 2 diabetes who also had hypertension , and ( 2 ) of metformin therapy in type 2 diabetic patients who were overweight . Methods We conducted cost-utility analysis based on patient-level data from a r and omised clinical controlled trial involving 4,209 patients with newly diagnosed type 2 diabetes conducted in 23 hospital-based clinics in Engl and , Scotl and and Northern Irel and as part of the UK Prospect i ve Diabetes Study ( UKPDS ) . Three different policies were evaluated : intensive blood glucose control with sulphonylurea/insulin ; intensive blood glucose control with metformin for overweight patients ; and tight blood pressure control of hypertensive patients . Incremental cost : effectiveness ratios were calculated based on the net cost of healthcare re sources associated with these policies and on effectiveness in terms of quality -adjusted life years gained , estimated over a lifetime from within-trial effects using the UKPDS Outcomes Model . Results The incremental cost per quality -adjusted life years gained ( in year 2004 UK prices ) for intensive blood glucose control was £ 6,028 , and for blood pressure control was £ 369 . Metformin  therapy was cost-saving and increased quality -adjusted life expectancy . Conclusions /interpretationEach of the three policies evaluated has a lower cost per quality -adjusted life year gained than that of many other accepted uses of healthcare re sources . The results provide an economic rationale for ensuring that care of patients with type 2 diabetes corresponds at least to the levels of these interventions 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 Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases , addressing ‘ real-world ’ implementation , are needed . This study examines the cost-effectiveness of a primary care intervention from a societal perspective , compared with provision of health brochures , alongside a r and omized controlled trial . Methods Adults aged 30 - 50 years , at risk of type 2 diabetes ( T2DM ) and /or cardiovascular disease ( CVD ) , were recruited from twelve general practice s in The Netherl and s. They were r and omized to the intervention ( n = 314 ) or control group ( n = 308 ) . The intervention consisted of up to six face-to-face counseling sessions with a trained practice nurse , followed by three-monthly sessions by phone . Costs were collected using three-monthly retrospective question naires . Quality of life was measured with the EuroQol-5D-3L , at baseline , 6 , 12 and 24 months . Nine-year risk of developing T2DM and ten-year risk of CVD mortality were estimated using the ARIC and SCORE formulae , respectively , based on measurements at baseline and 24 months while applying a fixed age of 60 years at both time points . Results Small , statistically non-significant differences in effects were found between the intervention and control group with regard to risk scores and Quality Adjusted Life Years ( QALYs ) gained . The mean difference in costs between the intervention and control group was € -866 ( 95 % confidence interval -2372 ; 370 ) . The probability that the intervention was cost-effective varied from 93 % at € 8000/QALY to 88 % at € 80,000/QALY . Conclusion A primary care lifestyle intervention aim ed at adults at increased risk of T2DM and /or CVD  could result in cost savings over a two-year period . However , due to method ological uncertainty no advice can be given regarding the implementation of the intervention in Dutch general practice s . Trial registration Current Controlled Trials IS RCT N59358434 OBJECTIVE We evaluate whether lifestyle and metformin interventions used to prevent diabetes have durable effects on markers of inflammation and coagulation and whether the effects are influenced by the development of diabetes . RESEARCH DESIGN AND METHODS The Diabetes Prevention Program was a controlled clinical trial of 3,234 subjects at high risk for diabetes who were r and omized to lifestyle , metformin , or placebo interventions for 3.4 years . Diabetes was diagnosed semiannually by fasting glucose and annually by oral glucose tolerance testing . In addition to baseline testing , anthropometry was performed every 6 months ; fasting insulin yearly ; and hs-CRP , tissue plasminogen activator ( tPA ) , and fibrinogen at 1 year and end of study ( EOS ) . RESULTS CRP and tPA levels were unchanged in the placebo group but fell in the lifestyle and metformin groups at 1 year and remained lower at EOS . These reductions were not seen in those who developed diabetes over the course of the study despite intervention . Fibrinogen was lower at 1 year in the lifestyle group . Differences in weight and weight change explained most of the influence of diabetes on the CRP response in the lifestyle group , but only partly in the placebo and metformin groups . Weight , insulin sensitivity , and hyperglycemia differences each accounted for the influence of diabetes on the tPA response . CONCLUSIONS Lifestyle and metformin interventions have durable effects to lower hs-CRP and tPA . Incident diabetes prevented these improvements , and this was accounted for by differences in weight , insulin resistance , and glucose levels Objectives Prevention of type 2 diabetes mellitus ( TD2 M ) is a priority for healthcare systems . We estimated the cost-effectiveness compared with st and ard care of a structured education programme ( Let 's Prevent ) targeting lifestyle and behaviour change to prevent progression to T2DM in people with prediabetes . Design Cost-effectiveness analysis alongside r and omised controlled trial . Setting 44 general practice s in Leicestershire , Engl and . Participants 880 participants with prediabetes r and omised to receive either st and ard care or a 6-hour group structured education programme with follow-up sessions in a primary care setting . Main outcome measure Incremental cost utility from the UK National Health Service ( NHS ) perspective . Quality of life and re source use measured from baseline and during the 36 months follow-up using the EuroQoL EQ-5D and 15D instruments and an economic question naire . Outcomes measured using quality -adjusted life years ( QALYs ) and healthcare costs calculated in 2012–2013 prices . Results After accounting for clustering and missing data , the intervention group was found to have a net gain of 0.046 ( 95 % CI −0.0171 to 0.109 ) QALYs over 3 years , adjusted for baseline utility , at an additional cost of £ 168 ( 95 % CI −395 to 732 ) per patient compared with the st and ard care group . The incremental cost-effectiveness ratio is £ 3643/QALY with an 86 % probability of being cost-effective at a willingness to pay threshold of £ 20 000/QALY . Conclusions The education programme had higher costs and higher quality of life compared with the st and ard care group . The Let 's Prevent programme is very likely to be cost-effective at a willingness to pay threshold of £ 20 000/QALY gained . Trial registration number IS RCT N80605705
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 .