The category of "prediabetes" defined by the American Diabetes Association comprises a range of intermediate hyperglycemia based on fasting or 2-h postload glucose or on HbA1c Over the recent past, ...the "cut points" identifying this stage have changed, i.e., a lower fasting glucose level is used. On one hand, it can be argued that the change to a lower cut point identifies a group of individuals still at higher risk and provides heightened awareness for a condition associated with higher risk for cardiovascular disease. In addition, identification of individuals at this stage may represent a chance of earlier intervention in the disease. However, the argument against this definition of "prediabetes" is that it disguises the differences in the three subcategories and creates problems in interpreting observations on interventions and outcomes. In addition, it can be argued that the enormous numbers of people identified with the criteria far exceeds the capacity of health care systems to respond through individual care, particularly without evidence that interventions benefit any category other than impaired glucose tolerance. Thus, there does not appear to be consensus on the definition using the cut points identified. Controversy also remains as to whether there are glycemic metrics beyond HbA1c that can be used in addition to HbA1c to help assess risk of an individual developing diabetes complications. Given the current controversy, a Point-Counterpoint debate on this issue is provided herein. In the point narrative below, Dr. Yudkin provides his argument that there are significant problems with this label. In the counterpoint narrative that follows Dr. Yudkin's contribution, Dr. Cefalu argues that the cut points are appropriate and do provide useful and important information in trying to reduce the future burden of diabetes.-William T. CefaluEditor in Chief, Diabetes Care.
The idolatry of the surrogate Yudkin, John S; Lipska, Kasia J; Montori, Victor M
BMJ,
12/2011, Letnik:
343, Številka:
7839
Journal Article
Recenzirano
Easier to measure surrogate outcomes are often used instead of patient important outcomes such as death, quality of life, or functional capacity when assessing treatments. John Yudkin, Kasia Lipska, ...and Victor Montori argue that our obsession with surrogates is damaging patient care
Type 2 diabetes mellitus is common, and treatment to correct blood glucose levels is standard. However, treatment burden starts years before treatment benefits accrue. Because guidelines often ignore ...treatment burden, many patients with diabetes may be overtreated.
To examine how treatment burden affects the benefits of intensive vs moderate glycemic control in patients with type 2 diabetes.
We estimated the effects of hemoglobin A1c (HbA1c) reduction on diabetes outcomes and overall quality-adjusted life years (QALYs) using a Markov simulation model. Model probabilities were based on estimates from randomized trials and observational studies. Simulated patients were based on adult patients with type 2 diabetes drawn from the National Health and Nutrition Examination Study.
Glucose lowering with oral agents or insulin in type 2 diabetes.
Main outcomes were QALYs and reduction in risk of microvascular and cardiovascular diabetes complications.
Assuming a low treatment burden (0.001, or 0.4 lost days per year), treatment that lowered HbA1c level by 1 percentage point provided benefits ranging from 0.77 to 0.91 QALYs for simulated patients who received a diagnosis at age 45 years to 0.08 to 0.10 QALYs for those who received a diagnosis at age 75 years. An increase in treatment burden (0.01, or 3.7 days lost per year) resulted in HbA1c level lowering being associated with more harm than benefit in those aged 75 years. Across all ages, patients who viewed treatment as more burdensome (0.025-0.05 disutility) experienced a net loss in QALYs from treatments to lower HbA1c level.
Improving glycemic control can provide substantial benefits, especially for younger patients; however, for most patients older than 50 years with an HbA1c level less than 9% receiving metformin therapy, additional glycemic treatment usually offers at most modest benefits. Furthermore, the magnitude of benefit is sensitive to patients' views of the treatment burden, and even small treatment adverse effects result in net harm in older patients. The current approach of broadly advocating intensive glycemic control should be reconsidered; instead, treating patients with HbA1c levels less than 9% should be individualized on the basis of estimates of benefit weighed against the patient's views of the burdens of treatment.
Type 2 diabetes mellitus and cardiovascular disease and have become leading causes of morbidity and mortality among Palestinian refugees in the Middle East, many of whom live in long-term settlements ...and receive grain-based food aid. The objective of this study was to estimate changes in type 2 diabetes and cardiovascular disease morbidity and mortality attributable to a transition from traditional food aid to either (i) a debit card restricted to food purchases, (ii) cash, or (iii) an alternative food parcel with less grain and more fruits and vegetables, each valued at $30/person/month.
An individual-level microsimulation was created to estimate relationships between food aid delivery method, food consumption, type 2 diabetes, and cardiovascular disease morbidity and mortality using demographic data from the United Nations (UN; 2017) on 5,340,443 registered Palestinian refugees in Syria, Jordan, Lebanon, Gaza, and the West Bank, food consumption data (2011-2017) from households receiving traditional food parcel delivery of food aid (n = 1,507 households) and electronic debit card delivery of food aid (n = 1,047 households), and health data from a random 10% sample of refugees receiving medical care through the UN (2012-2015; n = 516,386). Outcome metrics included incidence per 1,000 person-years of hypertension, type 2 diabetes, atherosclerotic cardiovascular disease events, microvascular events (end-stage renal disease, diabetic neuropathy, and proliferative diabetic retinopathy), and all-cause mortality. The model estimated changes in total calories, sodium and potassium intake, fatty acid intake, and overall dietary quality (Mediterranean Dietary Score MDS) as mediators to each outcome metric. We did not observe that a change from food parcel to electronic debit card delivery of food aid or to cash aid led to a meaningful change in consumption, biomarkers, or disease outcomes. By contrast, a shift to an alternative food parcel with less grain and more fruits and vegetables was estimated to produce a 0.08 per 1,000 person-years decrease in the incidence of hypertension (95% confidence interval CI 0.05-0.11), 0.18 per 1,000 person-years decrease in the incidence of type 2 diabetes (95% CI 0.14-0.22), 0.18 per 1,000 person-years decrease in the incidence of atherosclerotic cardiovascular disease events (95% CI 0.17-0.19), and 0.02 decrease per 1,000 person-years all-cause mortality (95% CI 0.01 decrease to 0.04 increase) among those receiving aid. The benefits of this shift, however, could be neutralized by a small (2%) increase in compensatory (out-of-pocket) increases in consumption of refined grains, fats and oils, or confectionaries. A larger alternative parcel requiring an increase in total food aid expenditure by 27% would be more likely to have a clinically meaningful improvement on type 2 diabetes and cardiovascular disease incidence.
Contrary to the supposition in the literature, our findings do not robustly support the theory that transitioning from traditional food aid to either debit card or cash delivery alone would necessarily reduce chronic disease outcomes. Rather, an alternative food parcel would be more effective, even after matching current budget ceilings. But compensatory increases in consumption of less healthy foods may neutralize the improvements from an alternative food parcel unless total aid funding were increased substantially. Our analysis is limited by uncertainty in estimates of modeling long-term outcomes from shorter-term trials, focusing on diabetes and cardiovascular outcomes for which validated equations are available instead of all nutrition-associated health outcomes, and using data from food frequency questionnaires in the absence of 24-hour dietary recall data.
Early life stunting may have long-term effects on body composition, resulting in obesity-related comorbidities. We tested the hypothesis that individuals stunted in early childhood may be at higher ...cardiometabolic risk later in adulthood. 1753 men and 1781 women participating in the 1982 Pelotas (Brazil) birth cohort study had measurements of anthropometry, body composition, lipids, glucose, blood pressure, and other cardiometabolic traits at age 30 years. Early stunting was defined as height-for-age Z-score at age 2 years below -2 against the World Health Organization growth standards. Linear regression models were performed controlling for sex, maternal race/ethnicity, family income at birth, and birthweight. Analyses were stratified by sex when p-interaction<0.05. Stunted individuals were shorter (β = -0.71 s.d.; 95% CI: -0.78 to -0.64), had lower BMI (β = -0.14 s.d.; 95%CI: -0.25 to -0.03), fat mass (β = -0.28 s.d.; 95%CI: -0.38 to -0.17), SAFT (β = -0.16 s.d.; 95%CI: -0.26 to -0.06), systolic (β = -0.12 s.d.; 95%CI: -0.21 to -0.02) and diastolic blood pressure (β = -0.11 s.d.; 95%CI: -0.22 to -0.01), and higher VFT/SAFT ratio (β = 0.15 s.d.; 95%CI: 0.06 to 0.24), in comparison with non-stunted individuals. In addition, early stunting was associated with lower fat free mass in both men (β = -0.39 s.d.; 95%CI: -0.47 to -0.31) and women (β = -0.37 s.d.; 95%CI: -0.46 to -0.29) after adjustment for potential confounders. Our results suggest that early stunting has implications on attained height, body composition and blood pressure. The apparent tendency of stunted individuals to accumulate less fat-free mass and subcutaneous fat might predispose them towards increased metabolic risks in later life.
Muhsen and colleagues1 might have better interrogated available data to explore the contributions of poverty, education, diet, and other behaviours, and of health care and other services, to these ...ethnic differences in life expectancy.On a more general point relating to the Health in Israel Series, although the word “settlement” appears four times in the Series, none of these mentions relates to the Israeli settlements in the West Bank.
In view of substantial mis-estimation of risks of diabetes complications using existing equations, we sought to develop updated Risk Equations for Complications Of type 2 Diabetes (RECODe).
To ...develop and validate these risk equations, we used data from the Action to Control Cardiovascular Risk in Diabetes study (ACCORD, n=9635; 2001-09) and validated the equations for microvascular events using data from the Diabetes Prevention Program Outcomes Study (DPPOS, n=1018; 1996-2001), and for cardiovascular events using data from the Action for Health in Diabetes (Look AHEAD, n=4760; 2001-12). Microvascular outcomes were nephropathy, retinopathy, and neuropathy. Cardiovascular outcomes were myocardial infarction, stroke, congestive heart failure, and cardiovascular mortality. We also included all-cause mortality as an outcome. We used a cross-validating machine learning method to select predictor variables from demographic characteristics, clinical variables, comorbidities, medications, and biomarkers into Cox proportional hazards models for each outcome. The new equations were compared to older risk equations by assessing model discrimination, calibration, and the net reclassification index.
All equations had moderate internal and external discrimination (C-statistics 0·55-0·84 internally, 0·57-0·79 externally) and high internal and external calibration (slopes 0·71-1·31 between observed and estimated risk). Our equations had better discrimination and calibration than the UK Prospective Diabetes Study Outcomes Model 2 (for microvascular and cardiovascular outcomes, C-statistics 0·54-0·62, slopes 0·06-1·12) and the American College of Cardiology/American Heart Association Pooled Cohort Equations (for fatal or non-fatal myocardial infarction or stroke, C-statistics 0·61-0·66, slopes 0·30-0·39).
RECODe might improve estimation of risk of complications for patients with type 2 diabetes.
National Institute for Diabetes and Digestive and Kidney Disease, National Heart, Lung and Blood Institute, and National Institute on Minority Health and Health Disparities, National Institutes of Health, and US Department of Veterans Affairs.
The amount of insulin needed to effectively treat type 2 diabetes worldwide is unknown. It also remains unclear how alternative treatment algorithms would affect insulin use and disability-adjusted ...life-years (DALYs) averted by insulin use, given that current access to insulin (availability and affordability) in many areas is low. The aim of this study was to compare alternative projections for and consequences of insulin use worldwide under varying treatment algorithms and degrees of insulin access.
We developed a microsimulation of type 2 diabetes burden from 2018 to 2030 across 221 countries using data from the International Diabetes Federation for prevalence projections and from 14 cohort studies representing more than 60% of the global type 2 diabetes population for HbA
, treatment, and bodyweight data. We estimated the number of people with type 2 diabetes expected to use insulin, international units (IU) required, and DALYs averted per year under alternative treatment algorithms targeting HbA
from 6·5% to 8%, lower microvascular risk, or higher HbA
for those aged 75 years and older.
The number of people with type 2 diabetes worldwide was estimated to increase from 405·6 million (95% CI 315·3 million-533·7 million) in 2018 to 510·8 million (395·9 million-674·3 million) in 2030. On this basis, insulin use is estimated to increase from 516·1 million 1000 IU vials (95% CI 409·0 million-658·6 million) per year in 2018 to 633·7 million (500·5 million-806·7 million) per year in 2030. Without improved insulin access, 7·4% (95% CI 5·8-9·4) of people with type 2 diabetes in 2030 would use insulin, increasing to 15·5% (12·0-20·3) if insulin were widely accessible and prescribed to achieve an HbA
of 7% (53 mmol/mol) or lower. If HbA
of 7% or lower was universally achieved, insulin would avert 331 101 DALYs per year by 2030 (95% CI 256 601-437 053). DALYs averted would increase by 14·9% with access to newer oral antihyperglycaemic drugs. DALYs averted would increase by 44·2% if an HbA
of 8% (64 mmol/mol) were used as a target among people aged 75 years and older because of reduced hypoglycaemia.
The insulin required to treat type 2 diabetes is expected to increase by more than 20% from 2018 to 2030. More DALYs might be averted if HbA
targets are higher for older adults.
The Leona M and Harry B Helmsley Charitable Trust.
Diabetes care in sub-Saharan Africa Beran, David; Yudkin, John S
The Lancet (British edition),
11/2006, Letnik:
368, Številka:
9548
Journal Article
Recenzirano
The increasing numbers of people with type 2 diabetes is a worldwide concern. It presents an added challenge in sub-Saharan Africa, where diabetes must compete for resources with communicable ...diseases. A scarcity of financial resources and appropriate staff mean that many people with type 2 diabetes have complications and that those with type 1 diabetes have an extremely short life-expectancy, whether or not they have been diagnosed with the disorder. We review the current evidence on diabetes care in sub-Saharan Africa and propose an 11-point action plan to address this problem in the region.