***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE Insulin pump therapy ( continuous subcutaneous insulin infusion [ CSII ] ) and multiple daily injections ( MDIs ) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospect ively compared in people naïve to either regimen in a multicenter study . We aim ed to help close that deficiency . RESEARCH DESIGN AND METHODS People with type 1 diabetes on NPH-based insulin therapy  were r and omized to CSII or glargine-based MDI ( both otherwise using lispro ) and followed for 24 weeks in an equivalence design . Fifty people were correctly r and omized , and 43 completed the study .  RESULTS Total insulin requirement ( mean ± SD ) at end point was 36.2 ± 11.5 units/day on CSII and 42.6 ± 15.5 units/day on MDI . Mean A1C fell similarly in the two groups ( CSII −0.7 ± 0.7 % ; MDI −0.6 ± 0.8 % ) with a baseline-adjusted difference of −0.1 % ( 95 % CI −0.5 to 0.3 ) . Similarly , fasting blood glucose and other prepr and ial , postpr and ial , and nighttime self-monitored plasma glucose levels did not differ between the regimens , nor did measures of plasma glucose variability . On CSII , 1,152 hypoglycemia events were recorded by 23 of 28 participants ( 82 % ) and 1,022 in the MDI group by 27 of 29 patients ( 93 % ) ( all hypoglycemia differences were nonsignificant ) . Treatment satisfaction score increased more with CSII ; however , the change in score was similar for the groups . Costs were ∼3.9 times higher for CSII . CONCLUSIONS In unselected people with type 1 diabetes naïve to CSII or insulin glargine , glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy OBJECTIVES We tested how insulin-glucose infusion followed by multidose insulin treatment in diabetic patients with acute myocardial infa rct ion affected mortality during the subsequent 12 months of follow-up . BACKGROUND Despite significant improvements in acute coronary care , diabetic patients with acute myocardial infa rct ion still have a high mortality rate . METHODS A total of 620 patients were studied : 306 r and omized to treatment with insulin-glucose infusion followed by multidose subcutaneous insulin for > or = 3 months and 314 to conventional therapy .  RESULTS The two groups were well matched for baseline characteristics . Blood glucose decreased from 15.4 + /- 4.1 to 9.6 + /- 3.3 mmol/liter ( mean + /- SD ) in the infusion group during the 1st 24 h , and from 15.7 + /- 4.2 to 11.7 + /- 4.1 among control patients ( p < 0.0001 ) . After 1 year 57 subjects ( 18.6 % ) in the infusion group and 82 ( 26.1 % ) in the control group had died ( relative mortality reduction 29 % , p = 0.027 ) . The mortality reduction was particularly evident in patients who had a low cardiovascular risk profile and no previous insulin treatment ( 3-month mortality rate 6.5 % in the infusion group vs. 13.5 % in the control group [ relative reduction 52 % , p = 0.046 ] ; 1-year mortality rate 8.6 % in the infusion group vs. 18.0 % in the control group [ relative reduction 52 % , p = 0.020 ] ) . CONCLUSIONS Insulin-glucose infusion followed by a multidose insulin regimen improved long-term prognosis in diabetic patients with acute myocardial infa rct ion OBJECTIVES This analysis provides an early estimate of the cost-effectiveness of adjunctive exenatide in treating type 2 diabetes mellitus in the United States . Data from pivotal phase III 30-week clinical trials and 52 weeks of their subsequent open-label extension studies ( i.e. , 82 weeks total ) were used to project the effects of 30 years of adjunctive exenatide treatment . METHODS This analysis utilized a published and vali date d Markov model incorporating Monte Carlo simulation with tracker variables to estimate the clinical and cost outcomes of adding exenatide to a background of metformin and /or sulfonylurea treatment , with the effects of 30 years of adjunctive exenatide treatment ( projected from data from 82 weeks of exenatide treatment ) compared with no additional treatment beyond metformin and /or a sulfonylurea . Sensitivity analyses were performed on key clinical assumptions , discount rates , and shorter time horizons . RESULTS The base-case scenario ( 30 years of exenatide ) yielded an incremental cost-effectiveness ratio ( ICER ) of $ 35,571 . We found that shortening the time horizons and removing the lipid effects of exenatide had the greatest negative impact on ICERs when performing sensitivity analysis . CONCLUSIONS Our analysis demonstrated that exenatide used for 20 or 30 years compared with no additional treatment beyond metformin and /or a sulfonylurea is cost-effective in the adjunctive treatment of type 2 diabetes with an ICER less than $ 50,000 per life-year gained . Sensitivity analyses suggest that , in addition to sustained reduction in HbA(1c ) , the added clinical effects of improved lipid values , systolic blood pressure , and reduced body mass index all positively contributed to the cost-effectiveness of exenatide BACKGROUND Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals , their efficacy and safety in elderly people is not fully established . Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with , or at high risk of developing , cardiovascular disease and stroke . METHODS We did a r and omised controlled trial in which we assigned 5804 men ( n=2804 ) and women ( n=3000 ) aged 70 - 82 years with a history of , or risk factors for , vascular disease to pravastatin ( 40 mg per day ; n=2891 ) or placebo ( n=2913 ) . Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke . Analysis was by intention-to-treat . FINDINGS Pravastatin lowered LDL cholesterol concentrations by 34 % and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo ( hazard ratio 0.85 , 95 % CI 0.74 - 0.97 , p=0.014 ) . Coronary heart disease death and non-fatal myocardial infa rct ion risk was also reduced ( 0.81 , 0.69 - 0.94 , p=0.006 ) . Stroke risk was unaffected ( 1.03 , 0.81 - 1.31 , p=0.8 ) , but the hazard ratio for transient ischaemic attack was 0.75 ( 0.55 - 1.00 , p=0.051 ) . New cancer diagnoses were more frequent on pravastatin than on placebo ( 1.25 , 1.04 - 1.51 , p=0.020 ) . However , incorporation of this finding in a meta- analysis of all pravastatin and all statin trials showed no overall increase in risk . Mortality from coronary disease fell by 24 % ( p=0.043 ) in the pravastatin group . Pravastatin had no significant effect on cognitive function or disability . INTERPRETATION Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals . PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people Background Continuous glucose monitoring ( CGM ) has been shown to improve glucose control in adults with type 1 diabetes .  Effectiveness of  CGM  is directly linked with CGM adherence , which can be challenging to maintain in children and adolescents . We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months , and that this is related to greater readiness for making behaviour change at the time of pump initiation . Methods / Design The CGM TIME Trial is a multicenter r and omized controlled trial . Eligible children and adolescents ( 5 - 18 years ) with established type 1 diabetes were r and omized to simultaneous initiation of pump ( Medtronic Veo © ) and CGM ( Enlite © ) or to st and ard pump therapy with delayed CGM introduction  . Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation . Secondary outcomes include glycemic variability , stage of readiness , and other patient-reported outcomes with follow-up to 24 months . 144 ( 95 % ) of the 152 eligible patients were enrolled and r and omized . Allowing for 10 % withdrawals , this will provide 93 % power to detect a between group difference in CGM adherence and 86 % power to detect a between group difference in hemoglobin A1C . Baseline characteristics were similar between the treatment groups . Analysis of 12 month primary outcomes will begin in September 2014 . Discussion The CGM TIME Trial is the first study to examine the relationship between timing of  CGM initiation , readiness for behaviour change , and subsequent CGM adherence in pump naïve children and adolescents . Its findings will advance our underst and ing of when and how to initiate CGM in children and adolescents with type 1 diabetes . Trial registration Clinical Trial.gov NCT01295788 . Registered 14 February 2011 Aims /hypothesisThe aim of this study was to develop a simulation model for Type 2 diabetes that can be used to estimate the likely occurrence of major diabetes-related complications over a lifetime , in order to calculate health economic outcomes such as quality -adjusted life expectancy . Methods Equations for forecasting the occurrence of seven diabetes-related complications and death were estimated using data on 3642 patients from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) . After examining the internal validity , the UKPDS Outcomes Model was used to simulate the mean difference in expected quality -adjusted life years between the UKPDS regimens of intensive and conventional blood glucose control . Results The model ’s forecasts fell within the 95 % confidence interval for the occurrence of observed events during the UKPDS follow-up period . When the model was used to simulate event history over patients ’ lifetimes , those treated with a regimen of conventional glucose control could expect 16.35 undiscounted quality -adjusted life years , and those receiving treatment with intensive glucose control could expect 16.62 quality -adjusted life years , a difference of 0.27 ( 95 % CI : −0.48 to 1.03 ) . Conclusions /interpretationsThe UKPDS Outcomes Model is able to simulate event histories that closely match observed outcomes in the UKPDS and that can be extrapolated over patients ’ lifetimes . Its validity in estimating outcomes in other groups of patients , however , remains to be evaluated . The model allows simulation of a range of long-term outcomes , which should assist in informing future economic evaluations of interventions in Type 2 diabetes A definitive model for predicting absolute risk of coronary heart disease ( CHD ) in male and female people with Type II diabetes is not yet available . This paper provides an equation for estimating the risk of new CHD events in people with Type II diabetes , based on data from 4540 U.K. Prospect i ve Diabetes Study male and female patients . Unlike previously published risk equations , the model is diabetes-specific and incorporates  glycaemia , systolic blood pressure and lipid levels  as risk factors , in addition to age , sex , ethnic group , smoking status and time since diagnosis of diabetes . All variables included in the final model were statistically significant ( P<0.001 , except smoking for which P=0.0013 ) in likelihood ratio testing . This model provides the estimates of CHD risk required by current guidelines for the primary prevention of CHD in Type II diabetes OBJECTIVE To evaluate glycemic control , hypoglycemic events , and quality of life in patients treated with continuous subcutaneous insulin infusion ( CSII ) and multiple daily insulin injection ( MDI ) , with insulin lispro as the principal insulin . RESEARCH DESIGN AND METHODS This clinical trial enrolled 27 patients with type 1 diabetes . They were r and omly assigned to CSII ( n = 13 ) or MDI ( n = 14 ) treatment regimens . Glycemic control ( HbA(1c ) level ) was the primary outcome and was measured monthly for 9 months . Secondary outcomes were patient reports of hypoglycemic events ( recorded monthly for 9 months ) and quality of life assessed at 9 months using the Diabetes Quality of Life ( DQOL ) 
    Output:
    
We also found significant results in favour of the integrated CSII + CGM system over MDIs with SMBG with regard to HbA1c levels and quality of life .
Cost-effectiveness analyses indicated that MDI + SMBG is the option most likely to be cost-effective , given the current threshold of £ 30,000 per quality -adjusted life-year gained , whereas integrated CSII + CGM systems and Veo are dominated and extendedly dominated , respectively , by st and -alone , non-integrated CSII with CGM .
The Veo system does appear to be better than the other systems considered at reducing hypoglycaemic events .
However , in adults , it is unlikely to be cost-effective .
Integrated systems are also generally unlikely to be cost-effective given that st and -alone systems are cheaper and , possibly , no less effective .
However , evidence in this regard is generally lacking , in particular for children .