Increasing prevalence of cirrhosis among insured adults in the United States, 2012-2018.

BACKGROUND: Liver cirrhosis is a chronic disease that is known as a "silent killer" and its true prevalence is difficult to describe. It is imperative to accurately characterize the prevalence of cirrhosis because of its increasing healthcare burden. METHODS: In this retrospective cohort study, trends in cirrhosis prevalence were evaluated using administrative data from one of the largest national health insurance providers in the US. (2011-2018). Enrolled adult (≥18-years-old) patients with cirrhosis defined by ICD-9 and ICD-10 were included in the study. The primary outcome measured in the study was the prevalence of cirrhosis 2011-2018. RESULTS: Among the 371,482 patients with cirrhosis, the mean age was 62.2 (±13.7) years; 53.3% had commercial insurance and 46.4% had Medicare Advantage. The most frequent cirrhosis etiologies were alcohol-related (26.0%), NASH (20.9%) and HCV (20.0%). Mean time of follow-up was 725 (±732.3) days. The observed cirrhosis prevalence was 0.71% in 2018, a 2-fold increase from 2012 (0.34%). The highest prevalence observed was among patients with Medicare Advantage insurance (1.67%) in 2018. Prevalence increased in each US. state, with Southern states having the most rapid rise (2.3-fold). The most significant increases were observed in patients with NASH (3.9-fold) and alcohol-related (2-fold) cirrhosis. CONCLUSION: Between 2012-2018, the prevalence of liver cirrhosis doubled among insured patients. Alcohol-related and NASH cirrhosis were the most significant contributors to this increase. Patients living in the South, and those insured by Medicare Advantage also have disproportionately higher prevalence of cirrhosis. Public health interventions are important to mitigate this concerning trajectory of strain to the health system.

Clinical performance and health equity implications of the American Diabetes Association's 2023 screening recommendation for prediabetes and diabetes.

Introduction: The American Diabetes Association (ADA) recommends screening for prediabetes and diabetes (dysglycemia) starting at age 35, or younger than 35 years among adults with overweight or obesity and other risk factors. Diabetes risk differs by sex, race, and ethnicity, but performance of the recommendation in these sociodemographic subgroups is unknown. Methods: Nationally representative data from the National Health and Nutrition Examination Surveys (2015-March 2020) were analyzed from 5,287 nonpregnant US adults without diagnosed diabetes. Screening eligibility was based on age, measured body mass index, and the presence of diabetes risk factors. Dysglycemia was defined by fasting plasma glucose ≥100mg/dL (≥5.6 mmol/L) or haemoglobin A1c ≥5.7% (≥39mmol/mol). The sensitivity, specificity, and predictive values of the ADA screening criteria were examined by sex, race, and ethnicity. Results: An estimated 83.1% (95% CI=81.2-84.7) of US adults were eligible for screening according to the 2023 ADA recommendation. Overall, ADA's screening criteria exhibited high sensitivity [95.0% (95% CI=92.7-96.6)] and low specificity [27.1% (95% CI=24.5-29.9)], which did not differ by race or ethnicity. Sensitivity was higher among women [97.8% (95% CI=96.6-98.6)] than men [92.4% (95% CI=88.3-95.1)]. Racial and ethnic differences in sensitivity and specificity among men were statistically significant (P=0.04 and P=0.02, respectively). Among women, guideline performance did not differ by race and ethnicity. Discussion: The ADA screening criteria exhibited high sensitivity for all groups and was marginally higher in women than men. Racial and ethnic differences in guideline performance among men were small and unlikely to have a significant impact on health equity. Future research could examine adoption of this recommendation in practice and examine its effects on treatment and clinical outcomes by sex, race, and ethnicity.

Screening for Prediabetes and Diabetes: Clinical Performance and Implications for Health Equity.

INTRODUCTION: In 2021, the U.S. Preventive Services Task Force (USPSTF) recommended prediabetes and diabetes screening for asymptomatic adults aged 35-70 years with overweight/obesity, lowering the age from 40 years in its 2015 recommendation. The USPSTF suggested considering earlier screening in racial and ethnic groups with high diabetes risk at younger ages or lower BMI. This study examined the clinical performance of these USPSTF screening recommendations as well as alternative age and BMI cutoffs in the U.S. adult population overall, and separately by race and ethnicity. METHODS: Nationally representative data were collected from 3,243 nonpregnant adults without diagnosed diabetes in January 2017-March 2020 and analyzed from 2021 to 2022. Screening eligibility was based on age and measured BMI. Collectively, prediabetes and undiagnosed diabetes were defined by fasting plasma glucose ≥100 mg/dL or hemoglobin A1c ≥5.7%. The sensitivity, specificity, and predictive values of alternate screening criteria were examined overall, and by race and ethnicity. RESULTS: The 2021 criteria exhibited marginally higher sensitivity (58.6%, 95% CI=55.5, 61.6 vs 52.9%, 95% CI=49.7, 56.0) and lower specificity (69.3%, 95% CI=65.7, 72.2 vs 76.4%, 95% CI=73.3, 79.2) than the 2015 criteria overall, and within each racial and ethnic group. Screening at lower age and BMI thresholds resulted in even greater sensitivity and lower specificity, especially among Hispanic, non-Hispanic Black, and Asian adults. Screening all adults aged 35-70 years regardless of BMI yielded the most equitable performance across all racial and ethnic groups. CONCLUSIONS: The 2021 USPSTF screening criteria will identify more adults with prediabetes and diabetes in all racial and ethnic groups than the 2015 criteria. Screening all adults aged 35-70 years exhibited even higher sensitivity and performed most similarly by race and ethnicity, which may further improve early detection of prediabetes and diabetes in diverse populations.

Evaluating Natural Experiments that Impact the Diabetes Epidemic: an Introduction to the NEXT-D3 Network.

PURPOSE OF REVIEW: Diabetes is an ongoing public health issue in the USA, and, despite progress, recent reports suggest acute and chronic diabetes complications are increasing. RECENT FINDINGS: The Natural Experiments for Translation in Diabetes 3.0 (NEXT-D3) Network is a 5-year research collaboration involving six academic centers (Harvard University, Northwestern University, Oregon Health & Science University, Tulane University, University of California Los Angeles, and University of California San Francisco) and two funding agencies (Centers for Disease Control and Prevention and National Institutes of Health) to address the gaps leading to persisting diabetes burdens. The network builds on previously funded networks, expanding to include type 2 diabetes (T2D) prevention and an emphasis on health equity. NEXT-D3 researchers use rigorous natural experiment study designs to evaluate impacts of naturally occurring programs and policies, with a focus on diabetes-related outcomes. NEXT-D3 projects address whether and to what extent federal or state legislative policies and health plan innovations affect T2D risk and diabetes treatment and outcomes in the USA; real-world effects of increased access to health insurance under the Affordable Care Act; and the effectiveness of interventions that reduce barriers to medication access (e.g., decreased or eliminated cost sharing for cardiometabolic medications and new medications such as SGLT-2 inhibitors for Medicaid patients). Overarching goals include (1) expanding generalizable knowledge about policies and programs to manage or prevent T2D and educate decision-makers and organizations and (2) generating evidence to guide the development of health equity goals to reduce disparities in T2D-related risk factors, treatment, and complications.

Randomized Trial Evaluating Health System Expenditures with Transitional Care Services for Adults with No Usual Source of Care at Discharge.

BACKGROUND: Multidisciplinary transitional care services reduce readmissions for high-risk patients, but it is unclear if health system costs to offer these intensive services are offset by avoidance of higher downstream expenditures. OBJECTIVE: To evaluate net costs for a health system offering transitional care services DESIGN: One-year pragmatic, randomized trial PARTICIPANTS: Adults aged ≥ 18 without a usual source of follow-up care at the time of hospital discharge were enrolled through a high-volume, urban academic medical center in Chicago, IL, USA, from September 2015 through February 2016. INTERVENTIONS: Eligible patients were silently randomized before discharge by an automated electronic health record algorithm allocating them in a 1:3 ratio to receive routine coordination of post-discharge care (RC) versus being offered intensive, multidisciplinary transitional care (TC) services. MAIN MEASUREMENTS: Health system costs were collected from facility administrative systems and transformed to standardized costs using Medicare reference files. Multivariable generalized linear models estimated proportional differences in net costs over one year. KEY RESULTS: Study patients (489 TC; 164 RC) had a mean age of 44 years; 34% were uninsured, 55% had public insurance, and 49% self-identified as Black or Latinx. Over 90 days, cost differences between groups were not statistically significant. Over 180 days, the TC group had 41% lower ED/observation costs (adjusted cost ratio [aCR], 0.59; 95% CI, 0.36-0.97), 50% lower inpatient costs (aCR, 0.50; 95% CI, 0.27-0.95), and 41% lower total healthcare costs (aCR, 0.59; 95% CI, 0.36-0.99) than the RC group. Over 365 days, total cost differences remained of similar magnitude but no longer were statistically significant. CONCLUSIONS: Offering TC services for vulnerable adults at discharge reduced net health system expenditures over 180 days. The promising economic case for multidisciplinary transitional care interventions warrants further research. TRIAL REGISTRATION: National Clinical Trials Registry (NCT03066492).

Initiating second-line antidiabetic medication among older adults with type 2 diabetes on Metformin.

BACKGROUND: Antidiabetic medications (ADM), especially sulfonylureas (SFU) and basal insulin (BI), are associated with increased risk of hypoglycemia, which is especially concerning among older adults in poor health. The objective of this study was to investigate prescribing patterns of ADM in older adults according to their health status. METHODS: This case control study analyzed administrative claims between 2013 and 2017 from a large national payer. The study population was derived from a nationwide database of 84,720 U.S. adults aged ≥65, who were enrolled in Medicare Advantage health insurance plans. Participants had type 2 diabetes on metformin monotherapy, and started a second-line ADM during the study period. The exposure was a binary variable for health status, with poor health defined by end-stage medical conditions, dementia, or residence in a long-term nursing facility. The outcome was a variable identifying which second-line ADM class was started, categorized as SFU, BI, or other (i.e. all other ADM classes combined). RESULTS: Over half of participants (54%) received SFU as initial second-line ADM, 14% received BI, and 32% received another ADM. In multivariable models, the odds of filling SFU or BI was higher for participants in poor health than those in good or intermediate health [OR 1.13 (95% CI 1.05-1.21) and OR 2.34 (95% CI 2.14-2.55), respectively]. SFU and BI were also more commonly filled by older adults with poor glycemic control. CONCLUSIONS: Despite clinical consensus to use caution prescribing SFU and BI among older adults in poor health, these medications remain frequently used in this particularly vulnerable population.

Costs for commercially insured adults prescribed second-line diabetes medications.

OBJECTIVES: To examine differences in health care costs associated with choice of second-line antidiabetes medication (ADM) for commercially insured adults with type 2 diabetes. STUDY DESIGN: Retrospective cohort study with multiple pretests and posttests. METHODS: Included patients initiated second-line ADM therapy between 2011 and 2015, with variable follow-up through 2017. The 6 index medication classes were sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), basal insulin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and thiazolidinediones (TZDs). Multivariable regression models compared between-class changes in adjusted quarterly costs after second-line ADM initiation. RESULTS: The study cohort included 34,963 adults. Most were prescribed a sulfonylurea (46.0%) or DPP-4 inhibitor (30.4%). Adjusted quarterly index medication costs were significantly higher for all patients receiving nonsulfonylurea medications, ranging from $108 (95% CI, $99-$118) for TZDs to $742 (95% CI, $720-$765) for GLP-1 RAs. Changes in quarterly total health care costs were significantly higher for all nonsulfonylurea classes. Conversely, changes in quarterly nonpharmacy medical costs were significantly lower for patients receiving DPP-4 inhibitors (-$67; 95% CI, -$92 to -$43), GLP-1 RAs (-$43; 95% CI, -$85 to -$1), and SGLT-2 inhibitors (-$46; 95% CI, -$87 to -$6); changes in all other quarterly costs besides the index medication were significantly lower for patients receiving DPP-4 inhibitors (-$60; 95% CI, -$94 to -$26) and SGLT-2 inhibitors (-$113; 95% CI, -$169 to -$57). CONCLUSIONS: The higher cost of nonsulfonylurea medications was the main driver of relative increases in total costs. Relative decreases in nonpharmacy medical costs among patients receiving newer ADM classes reflect these medications' potential value.

Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program.

PURPOSE OF REVIEW: Type 2 diabetes is common, burdensome, and preventable. Landmark trials such as the Diabetes Prevention Program (DPP) demonstrated that resource-intensive lifestyle support interventions resulting in modest weight loss via healthy diet changes and physical activity can lower the rate of diabetes development by 58%. We performed a review of efforts to translate and implement DPP-like programs throughout the USA to identify challenges and opportunities for improvement. RECENT FINDINGS: For more than a decade, multiple stakeholders have worked to translate evidence-based principles of diabetes prevention to reach 84 million Americans with prediabetes. DPP-like programs have been delivered by over 1500 organizations, reaching almost 300,000 people, but this number represents less than 1% of the target population. Research has uncovered large gaps in efforts to diagnose, raise awareness, and provide access to DPP-like programs for adults with prediabetes, requiring further stakeholder engagement and coordination to resolve. Efforts to address prevailing gaps in diabetes prevention must address distinct and sometimes conflicting priorities and concerns of stakeholders. Our review recommends several areas of further research and action to improve type 2 diabetes prevention on a population scale.

Effect on Health Care Expenditures During Nationwide Implementation of the Diabetes Prevention Program as a Health Insurance Benefit.

OBJECTIVE: Lifestyle interventions slow development of type 2 diabetes by half, but the impact of health payer reimbursement for delivery of intervention programs is not well known. We evaluated net commercial health payer expenditures when offering reimbursement for access to YMCA's Diabetes Prevention Program (YDPP) in 42 states. RESEARCH DESIGN AND METHODS: We used a nonequivalent comparison group design to evaluate net health care expenditures for adults with prediabetes who attended one or more YDPP visit between 1 July 2009 and 31 May 2013 ("YDPP users"). Rolling, 1:1 nearest neighbor propensity score (PS) matching was used to identify a comparison group of nonusers. Administrative data provided measures of YDPP attendance, body weight at YDPP visits, and health care expenditures. Random effects, difference-in-difference regression was used to estimate quarterly health care expenditures before and after participants' first visit to YDPP. RESULTS: Worksite screening identified 9.7% of the target population; 39.1% of those identified (19,933 participants through June 2015) became YDPP users. Mean weight loss for YDPP users enrolled before June 2013 (n = 1,725) was 7.5 lb (3.4%); 29% achieved ≥5% weight loss. Inclusive of added costs to offer YDPP, there were no statistically significant differences in mean per-person net health care expenditures between YDPP users and PS-matched nonusers over 2 years ($0.2 lower [95% CI $56 lower to $56 higher]). Mean reimbursement to the YMCA was $212 per YDPP user, with 92.8% of all expenditures made for those who attended at a high rate (≥9 completed YDPP visits). CONCLUSIONS: Worksite screening was inefficient for identifying the population with prediabetes, but those identified achieved modest YDPP attendance and clinically meaningful weight loss. Over 2 years, added costs to offer the intervention were modest, with neutral effects on net health care costs.

Advancing Health Policy and Program Research in Diabetes: Findings from the Natural Experiments for Translation in Diabetes (NEXT-D) Network.

PURPOSE OF REVIEW: To advance our understanding of the impacts of policies and programs aimed at improving detection, engagement, prevention, and clinical diabetes management in the USA, we synthesized findings from a network of studies that used natural experiments to evaluate diabetes health policies and programs. FINDINGS: Studies from the Natural EXperiments for Translation in Diabetes (NEXT-D) network used rigorous longitudinal quasi-experimental study designs (e.g., interrupted time series) and analytical methods (e.g., difference-in-differences) to augment causal inference. Investigators partnered with health system stakeholders to evaluate whether glucose testing rates changed from before-to-after clinic interventions (e.g., integrating electronic screening decision prompts in New York City) or employer programs (e.g., targeted messaging and waiving copayments for at-risk employees). Other studies examined participation and behavior change in low- (e.g., wellness coaching) or high-intensity lifestyle modification programs (e.g., diabetes prevention program-like interventions) offered by payers or employers. Lastly, studies assessed how employer health insurance benefits impacted healthcare utilization, adherence, and outcomes among people with diabetes. NEXT-D demonstrated that low-intensity interventions to facilitate glucose testing and enhance engagement in lifestyle modification were associated with small improvements in weight but large improvements in screening and testing when supported by electronic health record-based decision-support. Regarding high-intensity diabetes prevention program-like lifestyle programs offered by payers or employers, enrollment was modest and led to weight loss and marginally lower short-term health expenditures. Health plans that incentivize patient behaviors were associated with increases in medication adherence. Meanwhile, shifting patients to high-deductible health plans was associated with no change in medication use and preventive screenings, but patients with diabetes delayed accessing healthcare for acute complications (e.g., cellulitis). Findings were more pronounced among lower-income patients, who experienced increased rates and acuity of emergency department visits for diabetes complications and other high-severity conditions. Findings from NEXT-D studies provide informative data that can guide programs and policies to facilitate detection, prevention, and treatment of diabetes in practice.

Optimization of a technology-supported physical activity intervention for breast cancer survivors: Fit2Thrive study protocol.

Fit2Thrive is a theory-guided physical activity promotion trial using the Multiphase Optimization Strategy (MOST) to test efficacy for improving physical activity of five technology-supported physical activity promotion intervention components among breast cancer survivors. This trial will recruit 256 inactive breast cancer survivors nationwide. All participants will receive the core intervention which includes a Fitbit and standard self-monitoring Fit2Thrive smartphone application which will be downloaded to their personal phone. Women will be randomized to one of 32 conditions in a factorial design involving five factors with two levels: support calls (No vs. Yes), app type (standard vs. deluxe), text messaging (No vs. Yes), online gym (No vs. Yes) and Fitbit Buddy (No vs. Yes). The proposed trial examines the effects of the components on physical activity at 12 and 24weeks. Results will support the selection of a final package of intervention components that has been optimized to maximize physical activity and is subject to an upper limit of cost. The optimized intervention will be tested in a future trial. Fit2Thrive is the first trial to use the MOST framework to develop and test a physical activity promotion intervention in breast cancer survivors and will lead to an improved understanding of how to effectively change survivors' physical activity. These findings could result in more scalable, effective physical activity interventions for breast cancer survivors, and, ultimately, improve health and disease outcomes.

Comparative effectiveness and costs of insulin pump therapy for diabetes.

OBJECTIVES: Continuous subcutaneous insulin infusion (CSII), or "insulin pump" therapy, is an alternative to multiple daily insulin injections (MDII) for management of diabetes. This study evaluates patterns of healthcare utilization, costs, and blood glucose control for patients with diabetes who initiate CSII. STUDY DESIGN: Pre-post with propensity-matched comparison design involving commercially insured US adults (aged 18-64 years) with insulin-requiring diabetes who transitioned from MDII to CSII between July 1, 2009, and June 30, 2012 ("CSII initiators"; n = 2539), or who continued using MDI (n = 2539). METHODS: Medical claims and laboratory results files obtained from a large US-wide health payer were used to construct direct medical expenditures, hospital use, healthcare encounters for hypoglycemia, and mean concentration of glycated hemoglobin (A1C). We fit difference-in-differences regression models to compare healthcare expenditures for 3 years following the switch to CSII. Stratified analyses were performed for prespecified patient subgroups. RESULTS: Over 3 years, mean per-person total healthcare expenditures were $1714 (95% confidence interval [CI], $1184-$2244) higher per quarter for CSII initiators compared with matched MDII patients (total mean 3-year difference of $20,565). Compared with matched controls, mean A1C concentrations became lower for CSII initiators by 0.46% in year 2 (P = .0003) and by 0.32% in year 3 (P = .047). CSII initiators also had a higher rate of hypoglycemia encounters in year 1 (P = .002). CONCLUSIONS: For adults with insulin-requiring diabetes, transitioning from MDII to CSII was associated with modest improvements in A1C but more hypoglycemia encounters and increased healthcare expenditures, without significant improvement in other potentially offsetting areas of healthcare consumption.

A System-Level Approach to Overweight and Obesity in the Veterans Health Administration.

Healthcare systems are challenged by steady increases in the number of patients who are overweight and obese. Large-scale, evidence-based behavioral approaches for addressing overweight and obesity have been successfully implemented in systems such as the Veterans Health Administration (VHA). These population-based interventions target reduction in risk for obesity-associated conditions through lifestyle change and weight loss, and are associated with modest weight loss. Despite the fact that VHA has increased the overall reach of these behavioral interventions, the number of high-risk overweight and obese patients continues to rise. Recommendations for weight loss medications and bariatric surgery are included in clinical practice guidelines for the management of overweight and obesity, but these interventions are underutilized. During a recent state of the art conference on weight management held by VHA, subject matter experts identified challenges and gaps, as well as potential solutions and overarching policy recommendations, for implementing an integrated system-wide approach for improving population-based weight management.

The State of Diabetes Prevention Policy in the USA Following the Affordable Care Act.

Type 2 diabetes is a major public health problem in the USA, affecting over 12 % of American adults and imposing considerable health and economic burden on individuals and society. There is a strong evidence base demonstrating that lifestyle behavioral changes and some medications can prevent or delay the onset of type 2 diabetes in high risk adults, and several policy and healthcare system changes motivated by the Patient Protection and Affordable Care Act (ACA) have the potential to accelerate diabetes prevention. In this narrative review, we (1) offer a conceptual framework for organizing how the ACA may influence diabetes prevention efforts at the level of individuals, healthcare providers, and health systems; (2) highlight ACA provisions at each of these levels that could accelerate type 2 diabetes prevention nationwide; and (3) explore possible policy gaps and opportunity areas for future research and action.

The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ≥ 20 years, fluent Spanish-speaking status, BMI ≥ 23 kg/m(2), and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3 lbs, BMI of 33.3 ± 6.5 kg/m(2), HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a "real-world" setting.

Rationale, design, and baseline characteristics of a community-based comparative effectiveness trial to prevent type 2 diabetes in economically disadvantaged adults: the RAPID Study.

Reaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m(2) or higher and abnormal glucose metabolism (HbA1c 5.7-6.9% or fasting plasma glucose 100-125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m(2). 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥130 mmHg, 33.1% had a total blood cholesterol exceeding 200mg/dL, and 74% reported a household income of <$25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.

Medical costs associated with type 2 diabetes complications and comorbidities.

OBJECTIVES: To estimate the direct medical costs associated with type 2 diabetes, its complications, and its comorbidities among U.S. managed care patients. STUDY DESIGN: Data were from patient surveys, chart reviews, and health insurance claims for 7109 people with type 2 diabetes from 8 health plans participating in the Translating Research Into Action for Diabetes (TRIAD) study between 1999 and 2002. METHODS: A generalized linear regression model was developed to estimate the association of patients' demographic characteristics, tobacco use status, treatments, related complications, and comorbidities with medical costs. RESULTS: The mean annualized direct medical cost was $2465 for a white man with type 2 diabetes who had been diagnosed fewer than 15 years earlier, was treated with oral medication or diet alone, and had no complications or comorbidities. We found annualized medical costs to be 10% to 50% higher for women and for patients whose diabetes had been diagnosed 15 or more years earlier, who used tobacco, who were being treated with insulin, or who had several other complications. Coronary heart disease, congestive heart failure, hemiplegia, and amputation were each associated with 70% to 150% higher costs. Costs were approximately 300% higher for end-stage renal disease treated with dialysis and approximately 500% higher for end-stage renal disease with kidney transplantation. CONCLUSIONS: Most medical costs incurred by patients with type 2 diabetes are related to complications and comorbidities. Our cost estimates can help when determining the most cost-effective interventions to prevent complications and comorbidities.