Utility of HbA1c and fasting plasma glucose for screening of Type 2 diabetes: a meta-analysis of full ROC curves.
TL;DR: A meta‐analysis is performed that includes the complete information reported in the individual studies of two existing systematic reviews of diabetes screening using tests like HbA1c or fasting plasma glucose.
Abstract: Aims
There is still debate on the optimal threshold for population-based screening of diabetes (diagnosed by the oral glucose tolerance test) using tests like HbA1c or fasting plasma glucose. Meta-analyses provide meaningful input in such situations. The aim of this article is to perform a meta-analysis that includes the complete information reported in the individual studies of two existing systematic reviews.
Methods
We screened the individual studies from two systematic reviews and reconstructed the full four-fold tables for every reported threshold. Using a recently proposed meta-analysis model for the comparison of two diagnostic tests, we compared HbA1c with fasting plasma glucose, and estimated meta-analytic receiver operating characteristic curves for both tests using the 11.1 mmol/l threshold of the 2-h post-challenge glucose level (2 h-PG) as the gold standard.
Results
We included nine studies from two existing systematic reviews in our analysis.
Based on our data set, the optimal threshold lies between 42 and 44 mmol/mol (6.0–6.2%) for HbA1c, and 6.2–6.4 mmol/l for fasting plasma glucose choosing the Youden index as the technical criterion. In addition, we found that there is no relevant difference in the performance of HbA1c and fasting plasma glucose.
Conclusions
In our meta-analysis, we found that the optimal threshold with reference to the 2 h-PG should be chosen between 42 and 44 mmol/mol (6.0–6.2%) for HbA1c, and 6.2–6.4 mmol/l for fasting plasma glucose on the basis of maximal sensitivity and specificity.
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TL;DR: A diagnosis of gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that is not clearly overt diabetes) or chemical-induced diabetes (such as in the treatment of HIV/AIDS or after organ transplantation)
Abstract: 1. Type 1 diabetes (due to b-cell destruction, usually leading to absolute insulin deficiency) 2. Type 2 diabetes (due to a progressive insulin secretory defect on the background of insulin resistance) 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that is not clearly overt diabetes) 4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young [MODY]), diseases of the exocrine pancreas (such as cystic fibrosis), and drugor chemical-induced diabetes (such as in the treatment of HIV/AIDS or after organ transplantation)
2,339 citations
TL;DR: The findings suggest that at present recommended threshold of 6.5%, HbA1c is more specific and less sensitive in diagnosing the newly detected diabetes in undiagnosed population from community settings.
Abstract: Aim This systematic review aimed to ascertain the diagnostic accuracy (sensitivity and specificity) of screening tests for early detection of type 2 diabetes and prediabetes in previously undiagnosed adults. Methods This systematic review included published studies that included one or more index tests (random and fasting tests, HbA1c) for glucose detection, with 75-gram Oral Glucose Tolerance Test (or 2-hour post load glucose) as a reference standard (PROSPERO ID CRD42018102477). Seven databases were searched electronically (from their inception up to March 9, 2020) accompanied with bibliographic and website searches. Records were manually screened and full text were selected based on inclusion and exclusion criteria. Subsequently, data extraction was done using standardized form and quality assessment of studies using QUADAS-2 tool. Meta-analysis was done using bivariate model using Stata 14.0. Optimal cut offs in terms of sensitivity and specificity for the tests were analysed using R software. Results Of 7,151 records assessed by title and abstract, a total of 37 peer reviewed articles were included in this systematic review. The pooled sensitivity, specificity, positive (LR+) and negative likelihood ratio (LR-) for diagnosing diabetes with HbA1c (6.5%; venous sample; n = 17 studies) were 50% (95% CI: 42-59%), 97.3% (95% CI: 95.3-98.4), 18.32 (95% CI: 11.06-30.53) and 0.51 (95% CI: 0.43-0.60), respectively. However, the optimal cut-off for diagnosing diabetes in previously undiagnosed adults with HbA1c was estimated as 6.03% with pooled sensitivity of 73.9% (95% CI: 68-79.1%) and specificity of 87.2% (95% CI: 82-91%). The optimal cut-off for Fasting Plasma Glucose (FPG) was estimated as 104 milligram/dL (mg/dL) with a sensitivity of 82.3% (95% CI: 74.6-88.1%) and specificity of 89.4% (95% CI: 85.2-92.5%). Conclusion Our findings suggest that at present recommended threshold of 6.5%, HbA1c is more specific and less sensitive in diagnosing the newly detected diabetes in undiagnosed population from community settings. Lowering of thresholds for HbA1c and FPG to 6.03% and 104 mg/dL for early detection in previously undiagnosed persons for screening purposes may be considered.
24 citations
TL;DR: The diagnostic effort (FG and/or oGTT+HbA1c) with serious consequences is minimal invasive, reasonable and cheap, and prevents over- and underdiagnosis.
Abstract: Die Diabetesdiagnose zeigt viele praanalytische und analytische Probleme Nuchtern-Glukose (NG), orale Glukosetoleranztest (oGTT) und HbA1c haben Vor- und Nachteile und sind nicht gleichwertig in ihrer diagnostischen Aussagekraft Der oGTT ist der empfindlichste Test, die Reproduzierbarkeit ist relativ niedrig (VK ± 15 %) Die NG entdeckt maximal 70 – 80 % der Patienten mit einem manifesten Diabetes Die Glukose-Messung wird durch unsachgemase Blutabnahme, intraindividuelle Glukose-Schwankungen, Fastendauer und Fehler beim oGTT verfalscht HbA1c ist trotz IFCC-Standardisierung bei erlaubter Abweichung von ± 18 % in Ringversuchen und dem Einsatz von nicht kommutablem Ringversuchsmaterial schlecht uberprufbar HbA1c-Analyse zeigt viele Interferenzen und ist nur begrenzt zur Diabetesdiagnose geeignet Der Schwellenwert von HbA1c von ≥ 6,5 % (≥ 48 mmol/mol Hb) beruht nicht auf harter Evidenz Der Aufwand bei der Diagnose (NG und/oder oGTT+HbA1c) ist bei den sich daraus ergebenden klinischen Konsequenzen minimal invasiv, zumutbar, preiswert und verhindert eine Uber- und Unterdiagnostik
13 citations
Cites background from "Utility of HbA1c and fasting plasma..."
...[39] fand sich ein sinnvoller Schwellenwert für die Diagnose eines Diabetes auf der Basis eines 2-Std....
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TL;DR: The most rigorous extant recommendations are those of the American Diabetes Association and US Preventive Services Task Force, which advise opportunistic 3-yearly screening as discussed by the authors, and simulations suggest that clinic-based opportunistic screening of high-risk individuals is cost effective.
12 citations
TL;DR: The serum irisin level in T2DM group was significantly lower than that in control group, suggesting that irisin may be a protective factor for type 2 diabetes.
Abstract: Background: The aim of this study is to evaluate the level and role of serum irisin in elderly patients with type 2 diabetes mellitus (T2DM) using case-control study. Methods: A total of 71 patients with T2DM were selected as the case group according to the inclusion criteria and exclusion criteria; and the ratio of 1:1 was calculated according to the inclusion rate of the residents. The cohort established in Guankou Town, Jimei District, Xiamen City, Fujian Province, China and the residents of this cohort were selected at the age of 60 and above. A total of 71 healthy subjects were included as the control group with the same gender and the age with a difference of ± 5 years old. The clinical data of the subjects were collected to determine their previous history, blood pressure, body mass index (BMI), hemoglobin (HB), liver function test, renal function test, fasting blood glucose and serum lipid. The irisin level in serum was measured by enzyme-linked immunosorbent assay (ELISA). The data were analyzed by using SPSS17.0 software. Single factor analysis using Chi-square test or t -test was performed to compare the differences between T2DM patients with the control group of the general data, clinical indicators and irisin level in serum. Logistic regression was used to analyze the protective factors and risk factors of diabetes mellitus. Results: The results of single factor analysis showed that the level of irisin in T2DM group was significantly lower than that in the control group (703.37 ± 241.51 ng/mL and 800.22 ± 275.59 ng/mL, respectively). The levels of BMI, systolic blood pressure (SBP), diastolic blood pressure (DBP), triglyceride (TG) and fasting plasma glucose (FPG) in T2DM group were higher than those in control group, and differences were statistically significant. Logistic regression analysis indicated that irisin may be a protective factor for type 2 diabetes (odds ratio (OR) = 0.997, 95% confidence interval (CI): 0.994 - 0.999). Conclusions: The serum irisin level in T2DM group was significantly lower than that in control group, suggesting that irisin may be a protective factor for type 2 diabetes. J Clin Med Res. 2020;12(9):612-617 doi: https://doi.org/10.14740/jocmr4261
11 citations
Cites background from "Utility of HbA1c and fasting plasma..."
...It also plays a role in ongoing monitoring of blood glucose control for patients with T2DM [29]....
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References
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8,687 citations
TL;DR: Kilpatrick et al. as mentioned in this paper discussed the limitations of the A1C assay for populations in which it is not available or is currently too expensive, as well as for individuals in whom the assay may be misleading.
Abstract: We appreciate the comment by Kilpatrick et al (1) regarding the International Expert Committee report on the diagnosis of diabetes with the A1C assay (2) The Committee considered all of the limitations of the A1C assay for populations in which it is not available or is currently too expensive, as well as for individuals in whom the assay may be misleading On the basis of these recognized limitations, the Committee emphasized the use of the currently recommended glucose tests and criteria in such populations or individuals We did not “breeze over” any of the relative advantages or disadvantages of the A1C assay as a means of diagnosis; rather, the …
2,601 citations
TL;DR: The bivariate model can be seen as an improvement and extension of the traditional sROC approach by reanalyzing the data of a published meta-analysis of diagnostic studies reporting pairs of sensitivity and specificity.
2,582 citations
Journal Article•
TL;DR: A diagnosis of gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that is not clearly overt diabetes) or chemical-induced diabetes (such as in the treatment of HIV/AIDS or after organ transplantation)
Abstract: 1. Type 1 diabetes (due to b-cell destruction, usually leading to absolute insulin deficiency) 2. Type 2 diabetes (due to a progressive insulin secretory defect on the background of insulin resistance) 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that is not clearly overt diabetes) 4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young [MODY]), diseases of the exocrine pancreas (such as cystic fibrosis), and drugor chemical-induced diabetes (such as in the treatment of HIV/AIDS or after organ transplantation)
2,339 citations
13 Apr 2010
TL;DR: Members of the International Expert Committee have recommended that diabetes should be diagnosed if A1C is ≤6.5%, without need to measure the plasma glucose concentration, but there are concerns that practical limitations will lead to false positives and negatives with this approach.
Abstract: We appreciate the comment by Kilpatrick et al. (1) regarding the International Expert Committee report on the diagnosis of diabetes with the A1C assay (2). The Committee considered all of the limitations of the A1C assay for populations in which it is not available or is currently too expensive, as well as for individuals in whom the assay may be misleading. On the basis of these recognized limitations, the Committee emphasized the use of the currently recommended glucose tests and criteria in such populations or individuals. We did not “breeze over” any of the relative advantages or disadvantages of the A1C assay as a means of diagnosis; rather, the …
2,104 citations