HbA1c 5·7–6·4% and impaired fasting plasma glucose for diagnosis of prediabetes and risk of progression to diabetes in Japan (TOPICS 3): a longitudinal cohort study
Summary Background The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A1c (HbA1c ) 5·7–6·4% criterion or by impaired fastin...
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Published in | The Lancet (British edition) Vol. 378; no. 9786; pp. 147 - 155 |
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Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Kidlington
Elsevier Ltd
2011
Elsevier |
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Abstract | Summary Background The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A1c (HbA1c ) 5·7–6·4% criterion or by impaired fasting glucose, and assessed differences in progression rate to diabetes between these two criteria for prediabetes in a Japanese population. Methods Our longitudinal cohort study included 4670 men and 1571 women aged 24–82 years without diabetes at baseline (diabetes was defined as fasting plasma glucose ≥7·0 mmol/L, self-reported clinician-diagnosed diabetes, or HbA1c ≥6·5%) who attended Toranomon Hospital (Tokyo, Japan) for a routine health check between 1997 and 2003. Participants with a baseline diagnosis of prediabetes according to impaired fasting glucose (fasting plasma glucose 5·6–6·9 mmol/L) or HbA1c 5·7–6·4%, or both, were divided into four groups on the basis of baseline diagnosis of prediabetes. Rate of progression to diabetes was assessed annually. Findings Mean follow-up was 4·7 (SD 0·7) years. 412 (7%) of 6241 participants were diagnosed with prediabetes on the basis of the HbA1c 5·7–6·4% criterion. Screening by HbA1c alone missed 1270 (61%) of the 2092 prediabetic individuals diagnosed by a combination of impaired fasting glucose and HbA1c 5·7–6·4%. Overall cumulative probability of progression to diabetes did not differ significantly between participants with prediabetes discordantly diagnosed by either HbA1c or impaired fasting glucose alone (incidence was 7% for HbA1c alone [n=412 individuals and 30 incident cases] and 9% for impaired fasting glucose alone [n=1270, 108 cases]; log-rank test, p=0·3317). Multivariate-adjusted hazard ratios for incident diabetes were 6·16 (95% CI 4·33–8·77) for those diagnosed with prediabetes by impaired fasting glucose alone and 6·00 (3·76–9·56) for diagnosis by HbA1c alone, and were substantially increased to 31·9 (22·6–45·0) for diagnosis by both impaired fasting glucose and HbA1c compared with normoglycaemic individuals. Interpretation Diagnosis of prediabetes by both the new HbA1c criterion and impaired fasting glucose identified individuals with an increased risk of progression to diabetes. Although the new HbA1c criterion identified fewer individuals at high risk than did impaired fasting glucose, the predictive value for progression to diabetes assessed by HbA1c 5·7–6·4% was similar to that assessed by impaired fasting glucose alone. The two tests used together could efficiently target people who are most likely to develop diabetes and allow for early intervention. Funding Japan Society for the Promotion of Science; Ministry of Health Labor and Welfare, Japan. |
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AbstractList | BACKGROUNDThe clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A(1c) (HbA(1c)) 5·7-6·4% criterion or by impaired fasting glucose, and assessed differences in progression rate to diabetes between these two criteria for prediabetes in a Japanese population.METHODSOur longitudinal cohort study included 4670 men and 1571 women aged 24-82 years without diabetes at baseline (diabetes was defined as fasting plasma glucose ≥7·0 mmol/L, self-reported clinician-diagnosed diabetes, or HbA(1c) ≥6·5%) who attended Toranomon Hospital (Tokyo, Japan) for a routine health check between 1997 and 2003. Participants with a baseline diagnosis of prediabetes according to impaired fasting glucose (fasting plasma glucose 5·6-6·9 mmol/L) or HbA(1c) 5·7-6·4%, or both, were divided into four groups on the basis of baseline diagnosis of prediabetes. Rate of progression to diabetes was assessed annually.FINDINGSMean follow-up was 4·7 (SD 0·7) years. 412 (7%) of 6241 participants were diagnosed with prediabetes on the basis of the HbA(1c) 5·7-6·4% criterion. Screening by HbA(1c) alone missed 1270 (61%) of the 2092 prediabetic individuals diagnosed by a combination of impaired fasting glucose and HbA(1c) 5·7-6·4%. Overall cumulative probability of progression to diabetes did not differ significantly between participants with prediabetes discordantly diagnosed by either HbA(1c) or impaired fasting glucose alone (incidence was 7% for HbA(1c) alone [n=412 individuals and 30 incident cases] and 9% for impaired fasting glucose alone [n=1270, 108 cases]; log-rank test, p=0·3317). Multivariate-adjusted hazard ratios for incident diabetes were 6·16 (95% CI 4·33-8·77) for those diagnosed with prediabetes by impaired fasting glucose alone and 6·00 (3·76-9·56) for diagnosis by HbA(1c) alone, and were substantially increased to 31·9 (22·6-45·0) for diagnosis by both impaired fasting glucose and HbA(1c) compared with normoglycaemic individuals.INTERPRETATIONDiagnosis of prediabetes by both the new HbA(1c) criterion and impaired fasting glucose identified individuals with an increased risk of progression to diabetes. Although the new HbA(1c) criterion identified fewer individuals at high risk than did impaired fasting glucose, the predictive value for progression to diabetes assessed by HbA(1c) 5·7-6·4% was similar to that assessed by impaired fasting glucose alone. The two tests used together could efficiently target people who are most likely to develop diabetes and allow for early intervention.FUNDINGJapan Society for the Promotion of Science; Ministry of Health Labor and Welfare, Japan. BACKGROUND: The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A₁c (HbA₁c) 5·7–6·4% criterion or by impaired fasting glucose, and assessed differences in progression rate to diabetes between these two criteria for prediabetes in a Japanese population. METHODS: Our longitudinal cohort study included 4670 men and 1571 women aged 24–82 years without diabetes at baseline (diabetes was defined as fasting plasma glucose ≥7·0 mmol/L, self-reported clinician-diagnosed diabetes, or HbA₁c ≥6·5%) who attended Toranomon Hospital (Tokyo, Japan) for a routine health check between 1997 and 2003. Participants with a baseline diagnosis of prediabetes according to impaired fasting glucose (fasting plasma glucose 5·6–6·9 mmol/L) or HbA₁c 5·7–6·4%, or both, were divided into four groups on the basis of baseline diagnosis of prediabetes. Rate of progression to diabetes was assessed annually. FINDINGS: Mean follow-up was 4·7 (SD 0·7) years. 412 (7%) of 6241 participants were diagnosed with prediabetes on the basis of the HbA₁c 5·7–6·4% criterion. Screening by HbA₁c alone missed 1270 (61%) of the 2092 prediabetic individuals diagnosed by a combination of impaired fasting glucose and HbA₁c 5·7–6·4%. Overall cumulative probability of progression to diabetes did not differ significantly between participants with prediabetes discordantly diagnosed by either HbA₁c or impaired fasting glucose alone (incidence was 7% for HbA₁c alone [n=412 individuals and 30 incident cases] and 9% for impaired fasting glucose alone [n=1270, 108 cases]; log-rank test, p=0·3317). Multivariate-adjusted hazard ratios for incident diabetes were 6·16 (95% CI 4·33–8·77) for those diagnosed with prediabetes by impaired fasting glucose alone and 6·00 (3·76–9·56) for diagnosis by HbA₁c alone, and were substantially increased to 31·9 (22·6–45·0) for diagnosis by both impaired fasting glucose and HbA₁c compared with normoglycaemic individuals. INTERPRETATION: Diagnosis of prediabetes by both the new HbA₁c criterion and impaired fasting glucose identified individuals with an increased risk of progression to diabetes. Although the new HbA₁c criterion identified fewer individuals at high risk than did impaired fasting glucose, the predictive value for progression to diabetes assessed by HbA₁c 5·7–6·4% was similar to that assessed by impaired fasting glucose alone. The two tests used together could efficiently target people who are most likely to develop diabetes and allow for early intervention. FUNDING: Japan Society for the Promotion of Science; Ministry of Health Labor and Welfare, Japan. Summary Background The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A1c (HbA1c ) 5·7–6·4% criterion or by impaired fasting glucose, and assessed differences in progression rate to diabetes between these two criteria for prediabetes in a Japanese population. Methods Our longitudinal cohort study included 4670 men and 1571 women aged 24–82 years without diabetes at baseline (diabetes was defined as fasting plasma glucose ≥7·0 mmol/L, self-reported clinician-diagnosed diabetes, or HbA1c ≥6·5%) who attended Toranomon Hospital (Tokyo, Japan) for a routine health check between 1997 and 2003. Participants with a baseline diagnosis of prediabetes according to impaired fasting glucose (fasting plasma glucose 5·6–6·9 mmol/L) or HbA1c 5·7–6·4%, or both, were divided into four groups on the basis of baseline diagnosis of prediabetes. Rate of progression to diabetes was assessed annually. Findings Mean follow-up was 4·7 (SD 0·7) years. 412 (7%) of 6241 participants were diagnosed with prediabetes on the basis of the HbA1c 5·7–6·4% criterion. Screening by HbA1c alone missed 1270 (61%) of the 2092 prediabetic individuals diagnosed by a combination of impaired fasting glucose and HbA1c 5·7–6·4%. Overall cumulative probability of progression to diabetes did not differ significantly between participants with prediabetes discordantly diagnosed by either HbA1c or impaired fasting glucose alone (incidence was 7% for HbA1c alone [n=412 individuals and 30 incident cases] and 9% for impaired fasting glucose alone [n=1270, 108 cases]; log-rank test, p=0·3317). Multivariate-adjusted hazard ratios for incident diabetes were 6·16 (95% CI 4·33–8·77) for those diagnosed with prediabetes by impaired fasting glucose alone and 6·00 (3·76–9·56) for diagnosis by HbA1c alone, and were substantially increased to 31·9 (22·6–45·0) for diagnosis by both impaired fasting glucose and HbA1c compared with normoglycaemic individuals. Interpretation Diagnosis of prediabetes by both the new HbA1c criterion and impaired fasting glucose identified individuals with an increased risk of progression to diabetes. Although the new HbA1c criterion identified fewer individuals at high risk than did impaired fasting glucose, the predictive value for progression to diabetes assessed by HbA1c 5·7–6·4% was similar to that assessed by impaired fasting glucose alone. The two tests used together could efficiently target people who are most likely to develop diabetes and allow for early intervention. Funding Japan Society for the Promotion of Science; Ministry of Health Labor and Welfare, Japan. The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A(1c) (HbA(1c)) 5·7-6·4% criterion or by impaired fasting glucose, and assessed differences in progression rate to diabetes between these two criteria for prediabetes in a Japanese population. Our longitudinal cohort study included 4670 men and 1571 women aged 24-82 years without diabetes at baseline (diabetes was defined as fasting plasma glucose ≥7·0 mmol/L, self-reported clinician-diagnosed diabetes, or HbA(1c) ≥6·5%) who attended Toranomon Hospital (Tokyo, Japan) for a routine health check between 1997 and 2003. Participants with a baseline diagnosis of prediabetes according to impaired fasting glucose (fasting plasma glucose 5·6-6·9 mmol/L) or HbA(1c) 5·7-6·4%, or both, were divided into four groups on the basis of baseline diagnosis of prediabetes. Rate of progression to diabetes was assessed annually. Mean follow-up was 4·7 (SD 0·7) years. 412 (7%) of 6241 participants were diagnosed with prediabetes on the basis of the HbA(1c) 5·7-6·4% criterion. Screening by HbA(1c) alone missed 1270 (61%) of the 2092 prediabetic individuals diagnosed by a combination of impaired fasting glucose and HbA(1c) 5·7-6·4%. Overall cumulative probability of progression to diabetes did not differ significantly between participants with prediabetes discordantly diagnosed by either HbA(1c) or impaired fasting glucose alone (incidence was 7% for HbA(1c) alone [n=412 individuals and 30 incident cases] and 9% for impaired fasting glucose alone [n=1270, 108 cases]; log-rank test, p=0·3317). Multivariate-adjusted hazard ratios for incident diabetes were 6·16 (95% CI 4·33-8·77) for those diagnosed with prediabetes by impaired fasting glucose alone and 6·00 (3·76-9·56) for diagnosis by HbA(1c) alone, and were substantially increased to 31·9 (22·6-45·0) for diagnosis by both impaired fasting glucose and HbA(1c) compared with normoglycaemic individuals. Diagnosis of prediabetes by both the new HbA(1c) criterion and impaired fasting glucose identified individuals with an increased risk of progression to diabetes. Although the new HbA(1c) criterion identified fewer individuals at high risk than did impaired fasting glucose, the predictive value for progression to diabetes assessed by HbA(1c) 5·7-6·4% was similar to that assessed by impaired fasting glucose alone. The two tests used together could efficiently target people who are most likely to develop diabetes and allow for early intervention. Japan Society for the Promotion of Science; Ministry of Health Labor and Welfare, Japan. |
Author | Yamada, Nobuhiro, Prof Hara, Shigeko, MD Tsuji, Hiroshi, MD Kosaka, Kinori, Prof Mori, Yasumichi, MD Heianza, Yoriko, RD Fujiwara, Kazuya, MD Hsieh, Shiun Dong, MD Arase, Yasuji, MD Saito, Kazumi, MD Shimano, Hitoshi, Prof Kodama, Satoru, MD Sone, Hirohito, Prof |
Author_xml | – sequence: 1 fullname: Heianza, Yoriko, RD – sequence: 2 fullname: Hara, Shigeko, MD – sequence: 3 fullname: Arase, Yasuji, MD – sequence: 4 fullname: Saito, Kazumi, MD – sequence: 5 fullname: Fujiwara, Kazuya, MD – sequence: 6 fullname: Tsuji, Hiroshi, MD – sequence: 7 fullname: Kodama, Satoru, MD – sequence: 8 fullname: Hsieh, Shiun Dong, MD – sequence: 9 fullname: Mori, Yasumichi, MD – sequence: 10 fullname: Shimano, Hitoshi, Prof – sequence: 11 fullname: Yamada, Nobuhiro, Prof – sequence: 12 fullname: Kosaka, Kinori, Prof – sequence: 13 fullname: Sone, Hirohito, Prof |
BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24327035$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/21705064$$D View this record in MEDLINE/PubMed |
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ContentType | Journal Article |
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Keywords | Endocrinopathy Medicine Follow up study Hemoglobin A1c Diabetes mellitus Cohort study Evolutivity Diagnosis Hemoglobin A1 Impaired glucose tolerance Public health Blood plasma |
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UK multi-ethnic cohort publication-title: Diabetes Res Clin Pract doi: 10.1016/j.diabres.2010.06.008 contributor: fullname: Mostafa – volume: 362 start-page: 800 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib20 article-title: Glycated hemoglobin, diabetes, and cardiovascular risk in nondiabetic adults publication-title: N Engl J Med doi: 10.1056/NEJMoa0908359 contributor: fullname: Selvin – volume: 29 start-page: 1619 year: 2006 ident: 10.1016/S0140-6736(11)60472-8_bib19 article-title: Use of HbA1c in predicting progression to diabetes in French men and women: data from an Epidemiological Study on the Insulin Resistance Syndrome (DESIR) publication-title: Diabetes Care doi: 10.2337/dc05-2525 contributor: fullname: Droumaguet – volume: 47 start-page: 215 year: 1999 ident: 10.1016/S0140-6736(11)60472-8_bib29 article-title: Hemoglobinopathy in Japan: detection and analysis publication-title: Rinsho Byori contributor: fullname: Harano – volume: 32 start-page: 2288 year: 2009 ident: 10.1016/S0140-6736(11)60472-8_bib28 article-title: Impact of metabolic syndrome compared with impaired fasting glucose on the development of type 2 diabetes in a general Japanese population: the Hisayama study publication-title: Diabetes Care doi: 10.2337/dc09-0896 contributor: fullname: Mukai – volume: 33 start-page: 2077 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib7 article-title: Postchallenge glucose, A1C, and fasting glucose as predictors of type 2 diabetes and cardiovascular disease: a 10-year prospective cohort study publication-title: Diabetes Care doi: 10.2337/dc10-0262 contributor: fullname: Cederberg – volume: 54 start-page: 762 year: 2011 ident: 10.1016/S0140-6736(11)60472-8_bib9 article-title: Low serum potassium levels and risk of type 2 diabetes: the Toranomon Hospital Health Management Center Study 1 (TOPICS 1) publication-title: Diabetologia doi: 10.1007/s00125-010-2029-9 contributor: fullname: Heianza – volume: 30 start-page: 753 year: 2007 ident: 10.1016/S0140-6736(11)60472-8_bib18 article-title: Impaired fasting glucose and impaired glucose tolerance: implications for care publication-title: Diabetes Care doi: 10.2337/dc07-9920 contributor: fullname: Nathan – volume: 34 start-page: 84 year: 2011 ident: 10.1016/S0140-6736(11)60472-8_bib8 article-title: Performance of A1C for the classification and prediction of diabetes publication-title: Diabetes Care doi: 10.2337/dc10-1235 contributor: fullname: Selvin – volume: 34 start-page: 950 year: 2011 ident: 10.1016/S0140-6736(11)60472-8_bib21 article-title: Incidence of type 2 diabetes using proposed HbA1c diagnostic criteria in the EPIC-Norfolk cohort: implications for preventive strategies publication-title: Diabetes Care doi: 10.2337/dc09-2326 contributor: fullname: Chamnan – volume: 53 start-page: 450 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib10 article-title: Report of the Committee on the classification and diagnostic criteria of diabetes mellitus publication-title: J Japan Diab Soc – volume: 30 start-page: 2453 year: 2007 ident: 10.1016/S0140-6736(11)60472-8_bib16 article-title: Differences in A1C by race and ethnicity among patients with impaired glucose tolerance in the Diabetes Prevention Program publication-title: Diabetes Care doi: 10.2337/dc06-2003 contributor: fullname: Herman – volume: 373 start-page: 2215 year: 2009 ident: 10.1016/S0140-6736(11)60472-8_bib22 article-title: Trajectories of glycaemia, insulin sensitivity, and insulin secretion before diagnosis of type 2 diabetes: an analysis from the Whitehall II study publication-title: Lancet doi: 10.1016/S0140-6736(09)60619-X contributor: fullname: Tabák – volume: 33 start-page: S62 issue: suppl 1 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib1 article-title: Diagnosis and classification of diabetes mellitus publication-title: Diabetes Care – volume: 33 start-page: 515 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib6 article-title: A1C cut points to define various glucose intolerance groups in Asian Indians publication-title: Diabetes Care doi: 10.2337/dc09-1694 contributor: fullname: Mohan – volume: 22 start-page: 323 year: 2005 ident: 10.1016/S0140-6736(11)60472-8_bib26 article-title: Alcohol consumption and other risk factors for self-reported diabetes among middle-aged Japanese: a population-based prospective study in the JPHC study cohort I publication-title: Diabet Med doi: 10.1111/j.1464-5491.2004.01403.x contributor: fullname: Waki – volume: 33 start-page: 580 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib15 article-title: Moving to an A1C-based diagnosis of diabetes has a different impact on prevalence in different ethnic groups publication-title: Diabetes Care doi: 10.2337/dc09-1843 contributor: fullname: Christensen – volume: 33 start-page: 2184 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib4 article-title: Screening for diabetes and prediabetes with proposed A1c-based diagnostic criteria publication-title: Diabetes Care doi: 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Dutch population: the new Hoorn study publication-title: Diabetes Care doi: 10.2337/dc09-0677 contributor: fullname: van 't Riet – volume: 87 start-page: 126 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib27 article-title: Hemoglobin A1c in predicting progression to diabetes publication-title: Diabetes Res Clin Pract doi: 10.1016/j.diabres.2009.11.001 contributor: fullname: Nakagami – volume: 33 start-page: 2104 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib3 article-title: A1C between 5·7 and 6·4% as a marker for identifying pre-diabetes, insulin sensitivity and secretion, and cardiovascular risk factors: the Insulin Resistance Atherosclerosis Study (IRAS) publication-title: Diabetes Care doi: 10.2337/dc10-0679 contributor: fullname: Lorenzo – volume: 78 start-page: 305 year: 2007 ident: 10.1016/S0140-6736(11)60472-8_bib12 article-title: Annual incidence and relative risk of diabetes in people with various categories of dysglycemia: a systematic overview and meta-analysis of prospective studies publication-title: Diabetes Res Clin Pract doi: 10.1016/j.diabres.2007.05.004 contributor: fullname: Gerstein – volume: 362 start-page: 1090 year: 2010 ident: 10.1016/S0140-6736(11)60472-8_bib23 article-title: Prevalence of diabetes among men and women in China publication-title: N Engl J Med doi: 10.1056/NEJMoa0908292 contributor: fullname: Yang |
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Snippet | Summary Background The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed... BACKGROUND: The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to... The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the... BACKGROUNDThe clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to... |
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SubjectTerms | Adult Aged Aged, 80 and over Biological and medical sciences blood glucose Blood Glucose - analysis cohort studies diabetes Diabetes. Impaired glucose tolerance Disease Progression Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance fasting Female General aspects glucose Glycated Hemoglobin A - analysis Heart Rate hemoglobin Humans Internal Medicine Japan Male Medical sciences men Middle Aged Miscellaneous Prediabetic State - diagnosis Prediabetic State - epidemiology prediction Prevalence Public health. Hygiene Public health. Hygiene-occupational medicine risk ROC Curve screening Sensitivity and Specificity women |
Title | HbA1c 5·7–6·4% and impaired fasting plasma glucose for diagnosis of prediabetes and risk of progression to diabetes in Japan (TOPICS 3): a longitudinal cohort study |
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