Re: Considerations for the USPSTF s Future Update to the Diabetes Screening Recommendations, Screening for Type 2 Diabetes Mellitus in Adults

Transcription

1 January 29, 2013 Dr. Virginia A. Moyer Agency for Healthcare Research & Quality US Preventive Services Task Force Program Office 540 Gaither Road Rockville, MD Re: Considerations for the USPSTF s Future Update to the Diabetes Screening Recommendations, Screening for Type 2 Diabetes Mellitus in Adults Dear Dr. Moyer: This letter, along with the enclosed supporting documentation, represents formal comments submitted on behalf of the Diabetes Advocacy Alliance TM (DAA) for the U.S. Preventive Services Task Force (USPSTF) to consider in its review of the recommendation, Screening for Type 2 Diabetes Mellitus in Adults. The DAA was grateful to have had the opportunity to meet with representatives from the Agency for Healthcare Research and Quality (AHRQ) on May 10, We were pleased to learn that the USPSTF plans to reconsider diabetes screening in spring In advance of USPSTF formally opening a review of the topic, the DAA offers the following comments and evidence for AHRQ to consider in conducting this important review. We urge USPSTF to take into account the most recent data and expand its current diabetes screening recommendation, so that more people with undiagnosed diabetes can be identified. The DAA is comprised of 19 member groups representing patient, professional, and trade associations, other nonprofit organizations, and corporations. The DAA strives to influence change in the US healthcare system to improve diabetes prevention, detection and care, and to speed the development of pathways to cures for diabetes. In this pursuit, the DAA seeks to unite and align key diabetes stakeholders and the larger diabetes community around key diabetes-related policy and legislative efforts in order to elevate diabetes on the national agenda. The Diabetes Epidemic and Need for Action There are currently 26 million Americans with diabetes 7 million of them who are undiagnosed and 95 percent of cases are type 2 diabetes. An additional 79 million people are estimated to have prediabetes, a condition in which individuals have blood glucose or A1c levels higher than normal but low enough to not classify as diabetes. Prediabetes often progresses to type 2 diabetes within 10 years. 1 Over the past 30 years, the percentage of Americans diagnosed with diabetes has more than doubled and by 2050, 1 in 3 Americans will be living with diabetes. 2,3 Additionally, diabetes is intrinsically linked with an increased risk of other chronic diseases and is the leading cause of kidney failure, blindness, and lower-limb amputations. 4 In an effort to begin to combat this growing problem, the Healthy People 2020 Diabetes Objectives call for a 10 percent increase in the proportion of people with diabetes whose condition has been 1 Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Boyle JP, Thompson TJ, Gregg EW, et al. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Population Health Metrics. 2010;8:29. 4 Franco OH, Steyerberg EW, Hu FB, et al. Associations of diabetes mellitus with total life expectancy and life expectancy with and without cardiovascular disease. Arch Int Med 2007;167:

2 diagnosed, and a 10 percent increase in the proportion of people with prediabetes who engage in lifestyle behaviors to reduce their risk of diabetes. Both of these objectives could be furthered through an expanded screening and diagnostic process targeting individuals with a known risk for diabetes and prediabetes. 5 There are known risk factors for prediabetes and type 2 diabetes that are easy to assess, including overweight and obesity, family history of diabetes, age, history of gestational diabetes, and certain racial/ethnic populations. 6 For this reason, the American Diabetes Association (ADA) recommends that adults who are overweight (BMI >25) with two or more risk factors (e.g., physical inactivity, high-risk race/ethnicity, hypertension, etc.) undergo screening as part of regular medical care, and for those without these risk factors, testing should begin at age 45. There is consensus among numerous organizations worldwide for targeted screening of high-risk individuals. 7 Additionally, this past year, both the Canadian Task Force on Preventive Health Care (Canadian Task Force) and the National Institute for Health and Clinical Excellence (NICE) released updated guidelines for type 2 diabetes screening. Both guidelines are similar in nature and hold implications for updating the USPSTF guidelines in ,9 Both organizations suggest using a validated diabetes risk calculator to evaluate adult patient risk (adult specifically defined by NICE as at least 40 years of age, or aged and of South Asian/Chinese/African-Caribbean/black African/other high-risk ethnic groups excluding pregnant women), which then informs the clinician of whether a screening blood test would be of benefit. Despite the various well-known risk factors mentioned above, 10 the USPSTF currently recommends screening for type 2 diabetes only in asymptomatic adults with high systolic blood pressure (SBP > 135mmHg). Given the magnitude of the diabetes epidemic and the evidence published since the USPSTF reviewed the topic in 2008, there is an urgent need for an update to the current recommendation. The USPSTF has the opportunity to revise their recommendations to reflect new evidence since 2004, and evidence that the Canadian Task Force and NICE both incorporated into their recommendations. We respectfully ask USPSTF to expand the current recommendation and, as such, offer our comments and accompanying evidence below. The Importance of Early Detection in Type 2 Diabetes Years of basic, clinical, and translational research have resulted in numerous evidence-based and costeffective interventions that improve outcomes in patients with diabetes. Diabetes-related blindness, end-stage renal disease, and myocardial infarction rates have decreased due to the focus on controlling cardiovascular risk factors (e.g., blood pressure), complications, secondary prevention efforts such as screening. However, patients with undiagnosed diabetes cannot benefit from evidence-based diabetes care interventions until they are screened (in a clinical setting using an accepted test, e.g., FPG, OGTT, A1C) and found to be at high risk for diabetes, and are subsequently tracked into care where they can be diagnosed with the disease. Early detection of type 2 diabetes is paramount. Many people with risk factors for diabetes (e.g., overweight/obesity, ethnicity, age) can be found upon screening to possibly have diabetes, or prediabetes. With heightened assurance of earlier diagnosis of diabetes, patients can begin employing effective interventions sooner to reduce the risk of complications in prevalent type 2 diabetes cases. For patients 5 U.S. Department of Health and Human Services. Diabetes Objectives in Healthy People Department of Health and Human Services American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care 2013;36(Suppl 1):S11-S66 7 Ryden L, Standl E, Van den Berghe G, et al.; Task Force on Diabetes and Cardiovascular Disease of the European Society of Cardiology (ESC); European Association for the Study of Diabetes (EASD). Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Disease of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007;28: NICE Guideline: Accessed on December 3, Canadian Task Force Guideline: Accessed on December 3, American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care 2013;36(Suppl 1):S11-S66 2

3 screened and found to have prediabetes, they can access interventions and care, and initiate steps to delay the progression of prediabetes to type 2 diabetes. Consequently, some organizations provide official statements supporting targeted screening of high-risk patients (Appendix C). The evidence concerning the importance of early detection for secondary prevention among patients with type 2 diabetes, and the value of early intervention for primary prevention among people with prediabetes is discussed briefly below. 1. Early Detection of Type 2 Diabetes Leads to Positive Short- and Long-Term Outcomes The United Kingdom Prospective Diabetes Study and its 10-year follow-up study analysis (Appendix B: Holman et al., 2008) provide conclusive evidence that early treatment of type 2 diabetes can lead to lower incidence and progression of microvascular complications in the short-term, while reducing rates of cardiovascular events and mortality in the long-term. Post hoc analyses of several more recent trials provide evidence indicating treatment benefits are associated with a shorter duration of type 2 diabetes or lower baseline HbA1c indicating that earlier detection is of critical importance (Appendix A: Skyler et al., 2009). 2. Detection of Prediabetes Can Inform Effective Treatments Which Provide Good Value The evidence base for the effectiveness of intervening in prediabetes to delay the onset of type 2 diabetes is growing. The Diabetes Prevention Program Study (DPP) found that at 2.8 years, incidence of type 2 diabetes in high-risk adults was reduced by 58% with intensive lifestyle intervention and by 31% with metformin compared to placebo (Appendix B: Diabetes Prevention Program Research Group, 2009). Additionally, a cost-effectiveness analysis of the DPP and the follow-up study demonstrated that at 10 years, lifestyle intervention and metformin were both cost-effective when compared to placebo in patients with screen-detected prediabetes (Appendix A: Herman et al., 2012). Another modeling study suggests that lower cost community implementation of the DPP intervention for people with prediabetes will become cost-saving by year 14 (Appendix A: Zhuo et al., 2012). The literature base outlining the benefits of early detection and intervention has expanded significantly since the 2008 USPSTF review. A comprehensive list of seminal articles illustrating the impact of early versus late intervention to treat type 2 diabetes, as well as the value of intervening in prediabetes to halt or delay the progression to type 2 diabetes can be found in Appendix A. Expansion of USPSTF s clinical framework would facilitate a complete assessment of the expanding literature base. New evidence addresses several data needs from the 2008 recommendation: (1) outcomes of screen-detected or newly diagnosed patients with type 2 diabetes; (2) benefits of early treatment of type 2 diabetes; (3) evidence on primary prevention of type 2 diabetes; and (4) addressing gaps in long-term data with a modeling study. An expanded clinical framework for diabetes screening and secondary prevention would help to put new evidence into context, and provide a more efficient vehicle from which to illustrate the impact of screening on final outcomes. The suggested broader framework relies on updating the 2008 framework to illustrate an expanded indirect chain of evidence. New and existing evidence supports two opportunities to expand the clinical framework for screening high-risk patients: 1. Expanding the use of intermediate outcomes 3

4 Though direct evidence from randomized clinical trials (RCTs) would be the gold standard to demonstrate the impact of diabetes screening on long-term health outcomes, these trials are exceedingly challenging to design and conduct. Such a trial would be quite expensive and require comparisons between patients randomized to be screened or not then followed for decades to allow investigators to ascertain the impact of screening on micro/macrovascular outcomes including mortality. A recently published RCT (ADDITION-Cambridge) succeeded in evaluating the impact of diabetes screening on mortality; however, the trial captured fewer than 10 years of follow-up data, which may not be long enough to depict the full impact of screening on mortality. 11 In lieu of direct evidence from randomized clinical trials comparing screening to no-screening, an indirect chain of evidence (Figure 1) establishing the effect of screening on health outcomes can be deduced through relationships between intermediate outcomes and final outcomes. The indirect chain of evidence uses a step-wise approach to evaluate the impact of screening on long-term outcomes, by using the published literature to establish the links between: (1) screening tests and correctly identifying diabetes or prediabetes, (2) diabetes or prediabetes diagnosis and treatment choice, (3) treatment choice and intermediate outcomes, and (4) intermediate outcomes on longterm (final) outcomes or intermediate (short-term) outcomes. For instance, if diabetes screening identifies high-risk patients with diabetes, pharmacologic interventions can address clinical biomarkers, such as high blood pressure or cholesterol (intermediate outcomes not an actual event), which in turn may help prevent future myocardial infarction (final outcome an actual event). In sum, early detection triggers evidence-based interventions that eventually improve final outcomes. The clinical framework selected to establish the key questions for the 2008 USPSTF review only included one intermediate outcome the incidence of type 2 diabetes. Introducing a broader set of intermediate outcomes (oftentimes measured with surrogate markers such as BP) into the clinical framework would strengthen the structure of an indirect chain of evidence, enabling the USPSTF to better establish the net benefit of screening. For instance, reviewers should utilize cardiovascular disease (CVD) risk as an intermediate outcome, tying to CVD events (e.g., heart attack, mortality) as final outcomes. Most RCTs do not evaluate long-term outcomes directly, failing to capture events that may take decades to emerge (e.g., CVD events and mortality). However, many studies measure CVD biomarkers (e.g., BP, cholesterol), which can be used to estimate long-term outcomes as a vast literature establishes that these biomarkers are predictors of CVD events that may occur in the future. Figure 1. Indirect and Direct Chains of Evidence 2. Moving primary prevention of diabetes from an intermediate to a final outcome 11 Simmons RK, Echouffo-Tcheufui JB et al. Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a clusterrandomised controlled trial. The Lancet. 4 October

5 Large randomized controlled trials (RCTs) and meta-analyses have established that type 2 diabetes can be delayed or prevented by intensive lifestyle interventions and medication therapy, implying that primary prevention could be a valuable approach to slowing the increasing prevalence of diabetes. The DAA encourages AHRQ and USPSTF to expand the current diabetes screening recommendation and is ready to be a resource. Since the 2008 review, new evidence from clinical trials has produced indirect support for the positive impacts of screening (summarized in Appendix B) and the expansion of the USPSTF s recommendation. The positive impacts of screening and early treatment are likely to outweigh any possible harms of diabetes screening. Furthermore, harms such as emotional distress (e.g., anxiety, depression) resulting from receiving a likely diagnosis of diabetes from screening in a clinical setting have not been verified. 12,13 The growing prevalence of those with diagnosed diabetes, undiagnosed diabetes, and prediabetes demonstrates a critical public health need to address this epidemic. The Healthy People 2020 Diabetes Objectives further highlight the importance of this issue. Reassessing existing data and adding new data from high-quality clinical trials can contribute to the indirect chain of evidence and provide a clearer picture of the benefits of more widespread screening of asymptomatic, high-risk patients. An expanded screening and diagnostic process targeting individuals with a known risk for prediabetes and diabetes would result in an increase in the number of individuals who, once aware they have prediabetes, could engage in evidence-based prevention activities. Additionally, detecting type 2 diabetes earlier would trigger evidence-based treatment that has been shown to reduce complications. This could ultimately reduce the economic burden of these patients by reducing the number of cases that progress to diabetes or result in complications. DAA appreciates the USPSTF s consideration of these comments as it updates the diabetes screening recommendations, and we look forward to continuing to collaborate with AHRQ and USPSTF. We are dedicated to being partners and hope to be a resource throughout the USPSTF update process. We appreciate your consideration and are available to provide further information or assist with any additional questions; please feel free to contact Tekisha Everette, PhD, Managing Director-Federal Government Affairs, American Diabetes Association, at teverette@diabetes.org. Sincerely, Academy of Nutrition and Dietetics American Association of Clinical Endocrinologists American Association of Diabetes Educators American Clinical Laboratory Association American Diabetes Association American Optometric Association 12 Norris SL, Kansagara D, Bougatsos C, et al. Screening adults for type 2 diabetes: a review of the evidence for the U.S. Preventive Services Task Force. Annals of Internal Medicine. 2008;148: Edelman D, Olsen MK, Dudley TK, et al. Impact of diabetes screening on quality of life. Diabetes Care. 2002;25:

6 Healthcare Leadership Council Medicare Diabetes Screening Project National Kidney Foundation Novo Nordisk Inc. Results for Life The Endocrine Society VSP Vision Care YMCA of the USA CC: Michael LeFevre, M.D., M.S.P.H., Co-Chair, USPSTF; Albert Siu, M.D., M.S.P.H., Co-Chair, USPSTF; Barbara Bartman, M.D., M.P.H., Medical Officer, Center for Outcomes & Evidence, AHRQ; Therese Miller, Dr.P.H., Director, Prevention & Care Management Portfolio, Center for Primary Care Prevention & Clinical Partnerships, AHRQ; Tracy Wolff, M.D., M.P.H., Medical Officer & Senior Service Fellow, USPSTF 6

7 Appendix A: Comprehensive List of Seminal Studies Published Since the 2008 USPSTF Diabetes Screening Guidelines Research Domain Studies Published Since 2008 That Meet Research Need 14 Organizational statements regarding targeted screening patients at high risk for type 2 diabetes American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care. 2013;36(Suppl 1):S11-S66. Ryden L, Standl E, Van den Berghe G, et al.; Task Force on Diabetes and Cardiovascular Disease of the European Society of Cardiology (ESC); European Association for the Study of Diabetes (EASD). Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. European Heart Journal. 2007;28: Impact of early versus late intervention to treat diabetes ACCORD. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. New England Journal of Medicine. 2008;358: ADVANCE. The ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. New England Journal of Medicine. 2008;358: Bloomgarden ZT. Glycemic Control in Diabetes: A Tale of Three Studies. Diabetes Care.2008;31(9): Skyler JS, Bergenstal R, Bonow RO, et al.; American Diabetes Association; American College of Cardiology Foundation. American Heart Association. Intensive glycemic control and prevention of cardiovascular events: implication of the ACCORD, ADVANCE and VA Diabetes Trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and American Heart Association. Diabetes Care. 2009;32: Duckworth W, Abraira C, Moritz T, et al. The duration of diabetes affects the response to intensive glucose control in type 2 subjects: the VA Diabetes Trial. Journal of Diabetes and its Complications. 25: , 2011 Griffin SJ, Borch-Johnsen K, Davies MJ, et al. Effects of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 3 diabetes detected by screening (ADDITION-Europe): a cluster-randomized trial. Lancet. 2011;378: Herman W. Oral presentation at European Association of the Study of 14 Additional study information can be found in Appendices B and C 7

8 Diabetes annual meeting, Kahn R, Alperin P, Eddy D, et al. Age at initiation and frequency of screening to detect type 2 diabetes: a cost-effectiveness analysis. Lancet. 2010;375(9723): Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. New England Journal of Medicine. 2008;359: Li R, Zhang P, Barker LE, Chowdhury FM, Zhang X. Cost-effectiveness of interventions to prevent and control diabetes mellitus: a systematic review. Diabetes Care. 2010;33: The value of intervening in prediabetes to halt or delay the progression to type 2 diabetes Herman WH, Edelstein SL, Ratner RE, et al.; The Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care In press Zhuo X, Zhang P, Gregg EW, et al. A nationwide community-based lifestyle program could delay or prevent type 2 diabetes cases and save $5.7 billion in 25 years. Health Affairs. 2012;31: Geiss LS, James C, Gregg EW, Albright A, Williamson DF, Cowie CC. Diabetes risk reduction behaviors among U.S. adults with prediabetes. American Journal of Preventive Medicine. 2010;38: Gregg EW, Chen H, Wagenknecht LE, et al. Association of an Intensive Lifestyle Intervention With Remission of Type 2 Diabetes. Journal of the American Medical Association. 2012;308: Eriksson MK, Hagberg L, Lindholm L, et al. Quality of Life and Costeffectiveness of a 3-Year Trial of Lifestyle Intervention in Primary Health Care. Archives of Internal Medicine. 2010;170:

9 Appendix B: Summary of Relevant Evidence Related to Clinical Trials Published Since the 2008 USPSTF Diabetes Screening Guidelines 1. Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care Study (ADDITION) Trial designed as two phases: screening phase which employed a population-based stepwise screening strategy among people aged in three European countries to identify those at high risk for type 2 diabetes and those with undiagnosed type 2 diabetes. Individuals with diagnosed type 2 diabetes entered the treatment phase which compared the effects of standard treatment (according to national guidelines) to intensive multi-factorial therapy focused on a broad set of outcomes over a follow-up period of 5 years. Screening Phase Sandbaek A, Griffin SJ, Rutten G, et al. Stepwise screening for diabetes identifies people with high but modifiable coronary heart disease risk. The ADDITION study. Diabetologia. 2008;51(7): Treatment Phase Rasmussen SS, Glumer C, Sandbaek A, et al. Determinants of progression from impaired fasting glucose and impaired glucose tolerance to diabetes in a high-risk screened population: 3 year follow-up in the ADDITION study, Denmark. Diabetologia. 2008;51(2): Bek T, Lund-Andersen H, Hansen AB, et al. The prevalence of diabetic retinopathy in patients with screen-detected type 2 diabetes in Denmark: the ADDITION study. Acta Ophthalmologia. 2009;87(3): Skriver MV, Borch-Johnsen K, Lauritzen T, et al. HbA1c as predictor of all-cause mortality in individuals at high risk of diabetes with normal glucose tolerance, identified by screening: a followup study of the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION), Denmark. Diabetologia. 2010;53(11): Griffin SJ, Borch-Johnsen K, Davies MJ, et al. Effects of early intensive multifactorial therapy on 5- year cardiovascular outcomes in individuals with type 3 diabetes detected by screening (ADDITION-Europe): a cluster-randomized trial. Lancet. 2011;378: United Kingdom Prospective Diabetes Study (UKPDS) Ten-year follow-up data from the UKPDS were published in During the trial, patients with newly diagnosed type 2 diabetes were randomly assigned to receive either conventional therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin, or in overweight patients, metformin) for glucose control. Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. New England Journal of Medicine. 2008;359: Diabetes Prevention Program Study (DPP) The DPP trial is one of the largest and longest RCTs assessing outcomes from screen-detected IFG, IGT, or type 2 diabetes. Patients were randomized into one of three interventions: (1) intensive 9

10 lifestyle intervention, metformin, or placebo. Results of the 10-year follow-up of the DPP Outcomes Study were published in 2009, a long-term follow-up of the DPP to investigate whether the delay in development of diabetes seen during the DPP could be sustained and to assess long-term effects of the interventions on health were published in Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702): Herman WH, Edelstein SL, Ratner RE, et al. The Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care In press McBride PE, Einerson JA, Grant H, et al. Putting the Diabetes Prevention Program into Practice: A Program for Weight Loss and Cardiovascular Risk Reduction for Patients with Metabolic Syndrome or Type 2 Diabetes Mellitus. The Journal of Nutrition, Health & Aging. 2008;12:745S-749S. 5. Action to Control Cardiovascular Risk in Diabetes Study (ACCORD) The ACCORD study aimed to determine whether cardiovascular events could be reduced with intensive therapy to achieve normal glycated hemoglobin levels in diabetics who had established CVD or cardiovascular risk factors. ACCORD is of indirect relevance to the ultimate benefits and risks of screening in that it provides rigorous evidence about the effectiveness and safety of alternative treatment approaches for diagnosed diabetics. The Action to Control Cardiovascular Risk in Diabetics Study Group. Effects of intensive glucose lowering in type 2 diabetes. New England Journal of Medicine. 2008;358: Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Trial The ADVANCE trial randomized patients with type 2 diabetes to standard or intensive glucose control treatment arms. The trial evaluated the impact of treatment and time to attainment of glycemic control on major macro- and microvascular events and mortality, among other endpoints. The ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. New England Journal of Medicine. 2008;358: , 7. European Potsdam Study The European Potsdam Study evaluated the association between weight changes during two different periods of adulthood and risk of diabetes. A recent report from the Potsdam cohort evaluated the impact of a risk score predictive of type 2 diabetes on incidence and mortality of CVD and cancer. Heidemann C, Boeing, Pishon T, et al. Association of a diabetes risk score with the risk of myocardial infarction, stroke, specific types of cancer, and mortality: a prospective study in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam cohort. European Journal of Epidemiology. 2009;24: Study of Finnish Men and Women 10

11 The aims of this study were to investigate the current prevalence of obesity, central obesity and abnormal glucose tolerance as well as the associations between body mass index, waist circumference and abnormal glucose tolerance among year-old Finnish men and women. Additionally, the study assessed whether the prevalence of abnormal glucose tolerance is associated with increased central obesity among people who are normal weight, overweight or obese. Saaristo TE, Barengo NC, Korpi-Hyovalti E, et al. High prevalence of obesity, central obesity and abnormal glucose tolerance in the middle-aged Finnish population. BMC Public Health. 2008;8(423). 9. The Outcome Reduction With Initial Glargine Intervention (ORIGIN) Trial The aim of the study was to evaluate the hypothesis that the provision of sufficient basal insulin to normalize fasting plasma glucose levels may reduce cardiovascular events. Among patients with prediabetes, the use of basal insulin was associated with a delay in the onset of type 2 diabetes. The ORIGIN Trial Investigators. Basal Insulin and Cardiovascular and Other Outcomes in Dysglycemia. New England Journal of Medicine. 2012;367:

12 Appendix C: Bibliography of Additional New Evidence to Support an Updated Revision of the 2008 USPSTF Diabetes Screening Guidelines 1. Demonstration of the cost-effectiveness of screening and/or treatment for type 2 diabetes. Kahn R, Alperin P, Eddy D, et al. Age at initiation and frequency of screening to detect type 2 diabetes: a cost-effectiveness analysis. Lancet. 2010;375(9723): Waugh N, Scotland G, McNamee P, et al. Screening for type 2 diabetes: literature review and economic modelling. Health Technol Assess 2007;17: iii-iv, ix-xi, Li R, Zhang P, Barker LE, Chowdhury FM, Zhang X. Cost-effectiveness of interventions to prevent and control diabetes mellitus: a systematic review. Diabetes Care. 2010;33: Impact of disease duration on response to glycemia-control interventions. Bloomgarden ZT. Glycemic Control in Diabetes: A Tale of Three Studies. Diabetes Care.2008;31(9): Skyler JS, Bergenstal R, Bonow RO, et al.; American Diabetes Association; American College of Cardiology Foundation. American Heart Association. Intensive glycemic control and prevention of cardiovascular events: implication of the ACCORD, ADVANCE and VA Diabetes Trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and American Heart Association. Diabetes Care. 2009;32: Duckworth W, Abraira C, Moritz T, et al. The duration of diabetes affects the response to intensive glucose control in type 2 subjects: the VA Diabetes Trial. Journal of Diabetes and its Complications. 25: , Impact of primary prevention treatment efforts Zhuo X, Zhang P, Gregg EW, et al. A nationwide community-based lifestyle program could delay or prevent type 2 diabetes cases and save $5.7 billion in 25 years. Health Affairs. 2012;31: Geiss LS, James C, Gregg EW, Albright A, Williamson DF, Cowie CC. Diabetes risk reduction behaviors among U.S. adults with prediabetes. American Journal of Preventive Medicine. 2010;38: Boyle JP, Thompson TJ, Gregg EW, et al. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Population Health Metrics. 2010;8: Recent Organizational Statements Regarding Targeted Screening for Patients at High Risk for Type 2 Diabetes 12

13 American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care. 2013;36(Suppl 1):S11-S66. Ryden L, Standl E, Van den Berghe G, et al.; Task Force on Diabetes and Cardiovascular Disease of the European Society of Cardiology (ESC); European Association for the Study of Diabetes (EASD). Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. European Heart Journal. 2007;28: