Clinical and Public Health Implications of 2019 Endocrine Society Guidelines for Diagnosis of Diabetes in Older Adults.

OBJECTIVE: Screening for diabetes is typically done using hemoglobin A1c (HbA1c) or fasting plasma glucose (FPG). The 2019 Endocrine Society guidelines recommend further testing using an oral glucose tolerance test (OGTT) in older adults with prediabetic HbA1c or FPG. We evaluated the impact of this recommendation on diabetes prevalence, eligibility for glucose-lowering treatment, and estimated cost of implementation in a nationally representative sample. RESEARCH DESIGN AND METHODS: We included 2,236 adults aged ≥65 years without known diabetes from the 2005-2016 National Health and Nutrition Examination Survey. Diabetes was defined using: 1) the Endocrine Society approach (HbA1c ≥6.5%, FPG ≥126 mg/dL, or 2-h plasma glucose ≥200 mg/dL among those with HbA1c 5.7-6.4% or FPG 100-125 mg/dL); and 2) a standard approach (HbA1c ≥6.5% or FPG ≥126 mg/dL). Treatment eligibility was defined using HbA1c cut points (≥7% to ≥9%). OGTT screening costs were estimated using Medicare fee schedules. RESULTS: Diabetes prevalence was 15.7% (∼5.0 million) using the Endocrine Society's approach and 7.3% (∼2.3 million) using the standard approach. Treatment eligibility ranged from 5.4% to 0.06% and 11.8% to 1.3% for diabetes cases identified through the Endocrine Society or standard approach, respectively. By definition, diabetes identified exclusively through the Endocrine Society approach had HbA11c <6.5% and would not be recommended for glucose-lowering treatment. Screening all older adults with prediabetic HbA1c/FPG (∼18.3 million) with OGTT could cost between $737 million and $1.7 billion. CONCLUSIONS: Adopting the 2019 Endocrine Society guidelines would substantially increase the number of older adults classified as having diabetes, require significant financial resources, but likely offer limited benefits.

Natural selection? The evolution of diagnostic criteria for gestational diabetes.

Gestational diabetes is a common pregnancy disorder which is generally managed with diet, exercise, metformin or insulin treatment and which usually resolves after delivery of the infant. Identifying and treating gestational diabetes improves maternal and fetal outcomes and allows for health promotion to reduce the mother's risk of type 2 diabetes in later life. However, there remains considerable controversy about the optimal method of identification and diagnosis of women with gestational diabetes. The NICE-2015 diagnostic criteria (75 g oral glucose tolerance test (OGTT) 0 h ≥5.6 mmol/L; 2 h ≥7.8 mmol/L) are based upon cost-effectiveness estimates using observational data, while the WHO-2013 criteria (75 g OGTT 0 h ≥5.1 mmol/L; 1 h ≥10.0 mmol/L; 2 h ≥8.5 mmol/L) identify women and infants at risk of adverse outcomes according to prospective data. There is also considerable controversy about testing for gestational diabetes using universal or risk factor-based screening, and when and how testing should be performed. The aim of this review is to provide a summary of the clinical biochemistry aspects to these debates and to highlight the importance of appropriate identification of gestational diabetes and subsequent type 2 diabetes in this population.

Glucose challenge test screening for prediabetes and early diabetes.

AIMS: To test the hypothesis that a 50-g oral glucose challenge test with 1-h glucose measurement would have superior performance compared with other opportunistic screening methods. METHODS: In this prospective study in a Veterans Health Administration primary care clinic, the following test performances, measured by area under receiver-operating characteristic curves, were compared: 50-g oral glucose challenge test; random glucose; and HbA1c level, using a 75-g oral glucose tolerance test as the 'gold standard'. RESULTS: The study population was comprised of 1535 people (mean age 56 years, BMI 30.3 kg/m2 , 94% men, 74% black). By oral glucose tolerance test criteria, diabetes was present in 10% and high-risk prediabetes was present in 22% of participants. The plasma glucose challenge test provided area under receiver-operating characteristic curves of 0.85 (95% CI 0.78-0.91) to detect diabetes and 0.76 (95% CI 0.72-0.80) to detect high-risk dysglycaemia (diabetes or high-risk prediabetes), while area under receiver-operating characteristic curves for the capillary glucose challenge test were 0.82 (95% CI 0.75-0.89) and 0.73 (95% CI 0.69-0.77) for diabetes and high-risk dysglycaemia, respectively. Random glucose performed less well [plasma: 0.76 (95% CI 0.69-0.82) and 0.66 (95% CI 0.62-0.71), respectively; capillary: 0.72 (95% CI 0.65-0.80) and 0.64 (95% CI 0.59-0.68), respectively], and HbA1c performed even less well [0.67 (95% CI 0.57-0.76) and 0.63 (95% CI 0.58-0.68), respectively]. The cost of identifying one case of high-risk dysglycaemia with a plasma glucose challenge test would be $42 from a Veterans Health Administration perspective, and $55 from a US Medicare perspective. CONCLUSIONS: Glucose challenge test screening, followed, if abnormal, by an oral glucose tolerance test, would be convenient and more accurate than other opportunistic tests. Use of glucose challenge test screening could improve management by permitting earlier therapy.

A new predictive tool for the early risk assessment of gestational diabetes mellitus.

AIMS: The Italian National Institute of Health has recently introduced a selective screening based on the risk profile of pregnant women, which while recommending against screening of women at low risk (LR) for GDM, it recommends an early test for women at high risk (HR) for GDM. Herein, we assessed the accuracy and cost-effectiveness of this screening and developed a new index that improves these requirements. METHODS: We retrospectively enrolled 3974 pregnant women. GDM was diagnosed with a 2h 75-g OGTT at 16-18 weeks (early test) or 24-28 weeks of gestation, according to the IADPSG guidelines. RESULTS: 55.6% of HR women had GDM, although only 38.4% underwent early screening. Among 2654 women at medium risk, 20.9% had GDM; paradoxically, among 770 LR women, that would not have been screened, 26.6% received a GDM diagnosis. Based on these unsatisfactory results, we elaborated the Capula's index, that reduced both screening tests (p<0.001) and potentially undetected GDM cases (p<0.001), and corrected the paradoxical prevalence estimates of GDM obtained with the current Italian guidelines. Also, Capula's index improved correlation of GDM risk profile with obstetric and neonatal adverse events. CONCLUSIONS: Capula's index improves accuracy of selective screening for GDM.

Use of capillary blood glucose for screening for gestational diabetes mellitus in resource-constrained settings.

AIMS: The aim of the study was to evaluate usefulness of capillary blood glucose (CBG) for diagnosis of gestational diabetes mellitus (GDM) in resource-constrained settings where venous plasma glucose (VPG) estimations may be impossible. METHODS: Consecutive pregnant women (n = 1031) attending antenatal clinics in southern India underwent 75-g oral glucose tolerance test (OGTT). Fasting, 1- and 2-h VPG (AU2700 Beckman, Fullerton, CA) and CBG (One Touch Ultra-II, LifeScan) were simultaneously measured. Sensitivity and specificity were estimated for different CBG cut points using the International Association of Diabetes in Pregnancy Study Groups (IADPSG) criteria for the diagnosis of GDM as gold standard. Bland-Altman plots were drawn to look at the agreement between CBG and VPG. Correlation and regression equation analysis were also derived for CBG values. RESULTS: Pearson's correlation between VPG and CBG for fasting was r = 0.433 [intraclass correlation coefficient (ICC) = 0.596, p < 0.001], for 1H, it was r = 0.653 (ICC = 0.776, p < 0.001), and for 2H, r = 0.784 (ICC = 0.834, p < 0.001). Comparing a single CBG 2-h cut point of 140 mg/dl (7.8 mmol/l) with the IADPSG criteria, the sensitivity and specificity were 62.3 and 80.7 %, respectively. If CBG cut points of 120 mg/dl (6.6 mmol/l) or 110 mg/dl (6.1 mmol/l) were used, the sensitivity improves to 78.3 and 92.5 %, respectively. CONCLUSIONS: In settings where VPG estimations are not possible, CBG can be used as an initial screening test for GDM, using lower 2H CBG cut points to maximize the sensitivity. Those who screen positive can be referred to higher centers for definitive testing, using VPG.

Cost-effectiveness of the New Zealand diabetes in pregnancy guideline screening recommendations.

OBJECTIVE: To compare the cost-effectiveness of 2 possible screening strategies for gestational diabetes mellitus (GDM) from the perspective of the New Zealand health system, developed as part of a gestational diabetes guideline. DESIGN: A decision analytic model was built comparing 2-step screening (glycated haemoglobin (HbA1c) test at first booking and a 2 h 75 g oral glucose tolerance test (OGTT) as a single test at 24-28 weeks) with 3-step screening (HbA1c test at first booking and a 1 h glucose challenge test (GCT) followed by a 2 h 75 g OGTT when indicated from 24-28 weeks) using a 9-month time horizon. SETTING: A hypothetical cohort of 62,000 pregnant women in New Zealand. METHODS: Probabilities, costs and benefits were derived from the literature, and supplementary data was obtained from National Women's Annual Clinical Reports. Main outcome measures, screening and treatment costs (NZ$2013) and effect on health outcomes (incidence of complications). RESULTS: The total cost for both strategies under baseline assumptions shows that the 2-step screening strategy would cost NZ$1.38 m more than the 3-step screening strategy overall. The additional cost per case detected was NZ$12,460 per case. The model found that the 2-step screening strategy identifies 12 more women with diabetes and 111 more women with GDM when compared against the 3-step screening strategy. We assessed the effect of changing the sensitivity and specificity of the OGTT. The baseline model assumed that the 2 h 75 g OGTT has a sensitivity and specificity of 95%. The 2-step strategy becomes more cost-effective when the diagnostic accuracy measures are improved. CONCLUSIONS: Adopting a 2-step strategy would moderately increase the number of GDM cases detected at the same time as moderately increasing the number of women with false negatives at a significant cost to the health system. Further evidence on the benefits of the 2 different approaches would be welcome.

Optimal cut-off points of fasting plasma glucose for two-step strategy in estimating prevalence and screening undiagnosed diabetes and pre-diabetes in Harbin, China.

To identify optimal cut-off points of fasting plasma glucose (FPG) for two-step strategy in screening abnormal glucose metabolism and estimating prevalence in general Chinese population. A population-based cross-sectional study was conducted on 7913 people aged 20 to 74 years in Harbin. Diabetes and pre-diabetes were determined by fasting and 2 hour post-load glucose from the oral glucose tolerance test in all participants. Screening potential of FPG, cost per case identified by two-step strategy, and optimal FPG cut-off points were described. The prevalence of diabetes was 12.7%, of which 65.2% was undiagnosed. Twelve percent or 9.0% of participants were diagnosed with pre-diabetes using 2003 ADA criteria or 1999 WHO criteria, respectively. The optimal FPG cut-off points for two-step strategy were 5.6 mmol/l for previously undiagnosed diabetes (area under the receiver-operating characteristic curve of FPG 0.93; sensitivity 82.0%; cost per case identified by two-step strategy ¥261), 5.3 mmol/l for both diabetes and pre-diabetes or pre-diabetes alone using 2003 ADA criteria (0.89 or 0.85; 72.4% or 62.9%; ¥110 or ¥258), 5.0 mmol/l for pre-diabetes using 1999 WHO criteria (0.78; 66.8%; ¥399), and 4.9 mmol/l for IGT alone (0.74; 62.2%; ¥502). Using the two-step strategy, the underestimates of prevalence reduced to nearly 38% for pre-diabetes or 18.7% for undiagnosed diabetes, respectively. Approximately a quarter of the general population in Harbin was in hyperglycemic condition. Using optimal FPG cut-off points for two-step strategy in Chinese population may be more effective and less costly for reducing the missed diagnosis of hyperglycemic condition.

Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.

BACKGROUND: The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. METHODS/DESIGN: This will be an unblinded, two-group, parallel randomised controlled trial (RCT). The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland: Galway University Hospital and Mayo General Hospital. Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care (n=392) or secondary care (n=392) locations. The primary outcome variable is the uptake rate of screening. Secondary outcomes include indicators of clinical effectiveness of screening at each screening site (primary and secondary) including gestational week at time of screening, time to access antenatal diabetes services for women diagnosed with GDM, and pregnancy and neonatal outcomes for women with GDM. In addition, parallel economic and qualitative evaluations will be conducted. The trial will cover the period from the woman's first hospital antenatal visit at 12 to 18 weeks gestation, until the completion of the pregnancy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN02232125.

Medication costs by glucose tolerance stage in younger and older women and men: results from the population-based KORA survey in Germany.

To estimate medication costs in individuals with diagnosed diabetes, undetected diabetes, impaired glucose regulation and normal blood glucose values in a population-based sample by age and sex.Using the KORA F4 follow-up survey, conducted in 2006-2008 (n=2611, age 40-82 years), we identified individuals' glucose tolerance status by means of an oral glucose tolerance test. We assessed all medications taken regularly, calculated age-sex specific medication costs and estimated cost ratios for total, total without antihyperglycemic drugs, and cardiovascular medication, using multiple 2-part regression models.Compared to individuals with normal glucose values, costs were increased in known diabetes, undetected diabetes and impaired glucose regulation, which was more pronounced in participants aged 40-59 years than in those aged 60-82 years (cost ratios for all medications: 40-59 years: 2.85; 95%-confidence interval: 1.78-4.54, 2.00; 1.22-3.29 and 1.53; 1.12-2.09; 60-82 years: 2.04; 1.71-2.43, 1.17; 0.90-1.51 and 1.09; 0.94-1.28). Compared to individuals with diagnosed diabetes, costs were significantly lower among individuals with impaired glucose regulation across all age and sex strata, also when antihyperglycemic medication was excluded (40-59 years: 0.60; 0.36-0.98, 60-82 years: 0.74; 0.60-0.90; men: 0.72; 0.56-0.93; women: 0.72; 0.54-0.96).We could quantify age- and sex-specific medication costs and cost ratios in individuals with diagnosed diabetes, undetected diabetes and impaired glucose regulation compared to those with normal glucose values, using data of a population-based sample, with oral glucose tolerance test-based identification of diabetes states. These results may help to validly estimate cost-effectiveness of screening and early treatment or prevention of diabetes.

Screening for type 2 diabetes: a short report for the National Screening Committee.

BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) has been increasing, owing to increases in overweight and obesity, decreasing physical activity and the changing demographic structure of the population. People can develop T2DM without symptoms and up to 20% may be undiagnosed. They may have diabetic complications, such as retinopathy, by the time they are diagnosed, or may suffer a heart attack, without warning. Undiagnosed diabetes can be detected by raised blood glucose levels. AIM: The aim of this review was to provide an update for the UK National Screening Committee (NSC) on screening for T2DM. METHODS: As this review was undertaken to update a previous Health Technology Assessment review published in 2007, and a more recent Scottish Public Health Network review, searches for evidence were restricted from 2009 to end of January 2012, with selected later studies added. The databases searched were MEDLINE, EMBASE, MEDLINE-in-Process & Other Non-Indexed Citations, Science Citation Index and Conference Proceedings Citation Index. The case for screening was considered against the criteria used by the NSC to assess proposed population screening programmes. RESULTS: Population screening for T2DM does not meet all of the NSC criteria. Criterion 12, on optimisation of existing management, has not been met. A report by the National Audit Office (NAO) gives details of shortcomings. Criterion 13 requires evidence from high-quality randomised controlled trials that screening is beneficial. This has not been met. The Ely trial of screening showed no benefit. The ADDITION trial was not a trial of screening, but showed no benefit in cardiovascular outcomes from intensive management in people with screen-detected T2DM. Criterion 18 on staffing and facilities does not appear to have been met, according to the NAO report. Criterion 19 requires that all other options, including prevention, should have been considered. A large proportion of cases of T2DM could be prevented if people avoided becoming overweight or obese. The first stage of selection would use risk factors, using data held on general practitioner computer systems, using the QDiabetes Risk Score, or by sending out questionnaires, using the Finnish Diabetes Risk Score (FINDRISC). Those at high risk would have a measure of blood glucose. There is no perfect screening test. Glycated haemoglobin (HbA1c) testing has advantages in not requiring a fasting sample, and because it is a predictor of vascular disease across a wider range than just the diabetic one. However, it lacks sensitivity and would miss some people with diabetes. Absolute values of HbA1c may be more useful as part of overall risk assessment than a dichotomous 'diabetes or not diabetes' diagnosis. The oral glucose tolerance test is more sensitive, but inconvenient, more costly, has imperfect reproducibility and is less popular, meaning that uptake would be lower. CONCLUSIONS: When considered against the NSC criteria, the case for screening is less strong than it was in the 2007 review. The main reason is the absence of cardiovascular benefit in the two trials published since the previous review. There is a case for selective screening as part of overall vascular risk assessment. Population screening for T2DM does not meet all of the NSC criteria. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

[Diagnostic accuracy of a standardized carbohydrate-rich breakfast compared to an oral glucose tolerance test in occupational medicine]. / Diagnostische Genauigkeit eines standardisierten kohlenhydrathaltigen Frühstücks im Vergleich zum oralen Glukosetoleranztest in der betriebsmedizinischen Praxis.

BACKGROUND: Increasing prevalence of type 2 diabetes mellitus is not only a problem for the health care system but also impairs working environment. In order to reduce costs by illness and early retirement and the development of diabetic complications occupational medicine is important for early diabetes detection. However, the diagnostic gold standard, oral glucose tolerance test (oGTT), is rarely accepted. Aim of our investigation was to evaluate diagnostic accuracy of a standardizable and cost-effective test-breakfast in comparison to oGTT which might be accepted in workplace. METHODS: During a workplace health promotion program diagnostic accuracy (sensitivity and specificity) of a test-breakfast (index test) was analyzed in a random-cross-over-design with healthy volunteers in comparison to an oGTT (reference test). RESULTS: 278 subjects participated and rated the health promotion program to be useful (99%). 74% stated that they preferred the test-breakfast in contrast to the oGTT. Both screening methods showed comparable plasma glucose and insulin curves. The plasma glucose levels measured capillary and venously during test-breakfast and oGTT were very consistent. Differences were only seen for the 2 h plasma glucose values in the fully adjusted model. The test-breakfast demonstrated high sensitivity and specificity for diabetes diagnosis compared to the reference test with highly comparable results, i. e. 8 persons (2,9%) newly diagnosed with diabetes by the test-breakfast vs. 7 (2,5%) by oGTT. CONCLUSION: A test-breakfast seems to be a useful first screening instrument to increase the compliance of occupational health promotions and might improve early diabetes diagnosis.

NIH consensus development conference: diagnosing gestational diabetes mellitus.

OBJECTIVE: To provide healthcare providers, patients, and the general public with a responsible assessment of currently available data on diagnosing gestational diabetes mellitus (GDM). PARTICIPANTS: A non-U.S. Department of Health and Human Services, nonadvocate 15-member panel representing the fields of obstetrics and gynecology, maternal-fetal medicine, pediatrics, diabetic research, biostatistics, women's health issues, health services research, decision analysis, health management and policy, health economics, epidemiology, and community engagement. In addition, 16 experts from pertinent fields presented data to the panel and conference audience. EVIDENCE: Presentations by experts and a systematic review of the literature prepared by the University of Alberta Evidence-based Practice Centre, through the Agency for Healthcare Research and Quality (AHRQ). Scientific evidence was given precedence over anecdotal experience. CONFERENCE PROCESS: The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was posted at http://prevention.nih.gov/ for public comment and the panel released a final statement approximately 10 weeks later. The final statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. CONCLUSIONS: At present, GDM is commonly diagnosed in the United States using a 1-hour screening test with a 50-gram glucose load followed by a 3-hour 100-gram glucose tolerance test (a two-step approach) for those found to be abnormal on the screen. This approach identifies approximately 5% to 6% of the population as having GDM. In contrast, newly proposed diagnostic strategies rely on the administration of a 2-hour glucose tolerance test (a one-step approach) with a fasting component and a 75-gram glucose load. These strategies differ on whether a 1-hour sample is included, whether two abnormal values are required, and the diagnostic cutoffs that are used. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) has proposed diagnostic thresholds based on demonstrated associations between glycemic levels and an increased risk of obstetric and perinatal morbidities. The panel considered whether a one-step approach to the diagnosis of GDM should be adopted in place of the two-step approach. The one-step approach offers certain operational advantages. The current two-step approach is used only during pregnancy and is largely restricted to the United States. There would be value in a consistent, international diagnostic standard across one's lifespan. This unification would allow better standardization of best practices in patient care and comparability of research outcomes. The one-step approach also holds potential advantages for women and their health care providers, as it would allow a diagnosis to be achieved within the context of one visit as opposed to two. However, the one-step approach, as proposed by the IADPSG, is anticipated to increase the frequency of the diagnosis of GDM by twofold to threefold, to a prevalence of approximately 15% to 20%. There are several concerns regarding the diagnosis of GDM in these additional women. It is not well understood whether the additional women identified by this approach will benefit from treatment, and if so, to what extent. Moreover, the care of these women will generate additional direct and indirect health care costs. There is also evidence that the labeling of these women may have unintended consequences, such as an increase in cesarean delivery and more intensive newborn assessments. In addition, increased patient costs, life disruptions, and psychosocial burdens have been identified. Available studies do not provide clear evidence that a one-step approach is cost-effective in comparison with the current two-step approach. After much deliberation, the panel believes that there are clear benefits to international standardization with regard to the one-step approach. Nevertheless, at present, the panel believes that there is not sufficient evidence to adopt a one-step approach. The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes. Thus, the panel recommends that the two-step approach be continued. However, given the potential benefits of a one-step approach, resolution of the uncertainties associated with its use would warrant revision of this conclusion.

Use of glycosylated hemoglobin increases diabetes screening for at-risk adolescents in primary care settings.

OBJECTIVE: To examine rates of diabetes screening in obese adolescents in an ethnically diverse primary care health care system before and after an internal recommendation to use HbA1c-based screening. RESEARCH DESIGN AND METHODS: Adolescents 12-18-years old with BMI > 95% were identified through electronic medical record review during two 18-month periods in 8 community health clinics and 13 school-based health centers: period 1 (P1, 19 April 2008 to 19 October 2009) and period 2 (P2, 3 May 2010 to 3 November 2011). Testing for diabetes in the 2 yr preceding the most recently elevated BMI was reviewed. RESULTS: A total of 2870 obese adolescents were identified in P1 and 3940 in P2. Ethnicity was primarily Hispanic, with smaller populations of Black and White youth. The percent of obese teens screened for diabetes increased from 40% in P1 to 47% in P2. Use of HbA1c increased 493% during P2. Older teens (>15 yr), those seen during P2, and those with BMI ≥ 30 kg/m2 were more likely to be screened. Record review confirmed equal rates of type 2 diabetes in the two periods: 8 incident (0.7%) cases in P1 and 13 (0.7%) in P2. CONCLUSIONS: The use of HbA1c, a non-fasting and logistically simpler test, was associated with increased diabetes screening in primary care. The percentage of screened patients with confirmed type 2 diabetes remained unchanged. Thus, despite potential pitfalls, the use of HbA1c for screening appears to be as successful as previous approaches in identifying adolescents with diabetes.

Cost-effectiveness of screening strategies for identifying pediatric diabetes mellitus and dysglycemia.

OBJECTIVE: To conduct a cost-effectiveness analysis of screening strategies for identifying children with type 2 diabetes mellitus and dysglycemia (prediabetes/diabetes). DESIGN: Cost simulation study. SETTING: A one-time US screening program. STUDY PARTICIPANTS: A total of 2.5 million children aged 10 to 17 years. INTERVENTION: Screening strategies for identifying diabetes and dysglycemia. MAIN OUTCOME MEASURES: Effectiveness (proportion of cases identified), total costs (direct and indirect), and efficiency (cost per case identified) of each screening strategy based on test performance data from a pediatric cohort and cost data from Medicare and the US Bureau of Labor Statistics. RESULTS: In the base-case model, 500 and 400 000 US adolescents had diabetes and dysglycemia, respectively. For diabetes, the cost per case was extremely high ($312 000-$831 000 per case identified) because of the low prevalence of disease. For dysglycemia, the cost per case was in a more reasonable range. For dysglycemia, preferred strategies were the 2-hour oral glucose tolerance test (100% effectiveness; $390 per case), 1-hour glucose challenge test (63% effectiveness; $571), random glucose test (55% effectiveness; $498), or a hemoglobin A1c threshold of 5.5% (45% effectiveness; $763). Hemoglobin A1c thresholds of 5.7% and 6.5% were the least effective and least efficient (ranges, 7%-32% and $938-$3370) of all strategies evaluated. Sensitivity analyses for diabetes revealed that disease prevalence was a major driver of cost-effectiveness. Sensitivity analyses for dysglycemia did not lead to appreciable changes in overall rankings among tests. CONCLUSIONS: For diabetes, the cost per case is extremely high because of the low prevalence of the disease in the pediatric population. Screening for diabetes could become more cost-effective if dysglycemia is explicitly considered as a screening outcome.

HbA1c for screening and diagnosis of diabetes mellitus.

HbA1c has become the gold standard for monitoring glycemic control in patients with diabetes mellitus. The use of this test has been expanded to diagnose and screen for diabetes mellitus with the endorsement of influential diabetes societies and the World Health Organization. The literature on the use of HbA1c for the diagnosis and screening of diabetes mellitus was critically examined. There is substantial recent literature on this topic with strong advocates for the use of HbA1c to diagnose and screen for diabetes and equally strong detractors for its use. Advocates of the use of HbA1c cite challenges in respect of patient compliance and the analysis of glucose and inconsistency of diagnosis with glucose-based diabetes diagnosis with the elimination or reduction in these challenges in HbA1c-based diagnosis. Detractors of its use cite increased cost, concerns about the availability of HbA1c testing, and the influence of demographic and clinical factors on HbA1c results that make the use of a single-threshold values questionable for different ethnic and age groups. Despite the recommendation of many international diabetes societies that HbA1c be used for screening and diagnosis of diabetes mellitus, there is a wide divergence of opinion on this use.

Diagnostic performance of using one- or two-HbA1c cut-point strategies to detect undiagnosed type 2 diabetes and impaired glucose regulation within a multi-ethnic population.

INTRODUCTION: We compared test performance and cost per case for strategies detecting diabetes on the oral glucose tolerance test (OGTT) using either (a) glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) or (b) two HbA1c thresholds where the first cut-point 'rules out' and the second 'rules in' diabetes. HbA1c values in between the thresholds require confirmatory glucose testing for diagnosis. MATERIALS AND METHODS: We conducted an analysis of adults aged 40-75 years from the Leicester Ethnic Atherosclerosis and Diabetes Risk (LEADER) cohort (Leicester, UK), from 2002 to 2008, who underwent oral glucose tolerance testing (OGTT) and HbA1c testing. RESULTS: From 8696 individuals (mean age 57.3 years, 73% white Europeans (WE) and 27% South Asians (SA)), HbA1c ≥ 6.5% produced sensitivity of 62.1% for detecting diabetes in WE and 78.9% in SA. Using two selected thresholds, HbA1c ≤ 5.8% (rule-in, 40 mmol/mol) and HbA1c ≥ 6.8% (rule-out, 51 mmol/mol) produced high sensitivity/specificity (> 91.0%) for detecting diabetes, however, 28.8% of the cohort with HbA1c 5.9%-6.7% required a subsequent glucose test. The two cut-point threshold produced a lower cost per case of diabetes detected in WE, compared to HbA1c ≥ 6.5% of £38.53 (1.89 to 86.81) per case, but was more expensive in SA by £84.50 (69.72 to 100.92) per case. Using a risk score to determine HbA1c testing, the same costs per case became £63.33 (23.33 to 113.26) in WE and £69.21 (55.60 to 82.41) in SA. CONCLUSION: Using a two-threshold strategy may have some benefits over a single cut-point; however, 28.8% of individuals required two blood tests.

Gestational diabetes screening with the new IADPSG guidelines: a cost-effectiveness analysis.

OBJECTIVE: This study investigates the cost effectiveness of gestational diabetes mellitus screening using the new International Association of Diabetes in Pregnancy Study Group (IADPSG) guidelines. STUDY DESIGN: A decision analytic model was built comparing routine screening with the 2-hour (2h) oral glucose tolerance test (OGTT) vs the 1-hour glucose challenge test. All probabilities, costs, and benefits were derived from the literature. Base case, sensitivity analyses, and a Monte Carlo simulation were performed. RESULTS: Screening with the 2h OGTT was more expensive, more effective, and cost effective at $61,503/quality-adjusted life year. In a 1-way sensitivity analysis, the more inclusive IADPSG diagnostic approach remained cost effective as long as an additional 2.0% or more of patients were diagnosed and treated for gestational diabetes mellitus. CONCLUSION: Screening at 24-28 weeks' gestational age under the new IADPSG guidelines with the 2h OGTT is expensive but cost effective in improving maternal and neonatal outcomes. How the health care system will provide expanded care to this group of women will need to be examined.