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Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: A pooled analysis of 96 population-based studies with 331 288 participants

Danaei, G and Fahimi, S and Lu, Y and Zhou, B and Hajifathalian, K and Cesare, MD and Lo, W-C and Reis-Santos, B and Cowan, MJ and Shaw, JE and Bentham, J and Lin, JK and Bixby, H and Magliano, D and Bovet, P and Miranda, JJ and Khang, Y-H and Stevens, GA and Riley, LM and Ali, MK and Ezzati, M and Abdeen, ZA and Kadir, KA and Abu-Rmeileh, NM and Acosta-Cazares, B and Aekplakorn, W and Aguilar-Salinas, CA and Ahmadvand, A and Nsour, MA and Alkerwi, A and Amouyel, P and Andersen, LB and Anderssen, SA and Andrade, DS and Anjana, RM and Aounallah-Skhiri, H and Aris, T and Arlappa, N and Arveiler, D and Assah, FK and Avdicová, M and Balakrishna, N and Bandosz, P and Barbagallo, CM and Barceló, Alberto and Batieha, AM and Baur, LA and Romdhane, HB and Bernabe-Ortiz, A and Bhargava, SK and Bi, Y and Bjerregaard, P and Björkelund, C and Blake, M and Blokstra, A and Bo, S and Boehm, BO and Boissonnet, CP and Brajkovich, I and Breckenkamp, J and Brewster, LM and Brian, GR and Bruno, G and Bugge, A and de León, AC and Can, G and Cândido, APC and Capuano, V and Carvalho, MJ and Casanueva, FF and Caserta, CA and Castetbon, K and Chamukuttan, S and Chaturvedi, N and Chen, CJ and Chen, F and Chen, S and Cheng, C-Y and Chetrit, A and Chiou, S-T and Cho, Y and Chudek, J and Cifkova, R and Claessens, F and Concin, H and Cooper, C and Cooper, R and Costanzo, S and Cottel, D and Cowell, C and Crujeiras, AB and D Arrigo, G and Dallongeville, J and Dankner, R and Dauchet, L and de Gaetano, G and de Henauw, S and Deepa, M and Dehghan, A and Dhana, K and Di Castelnuovo, AF and Djalalinia, S and Doua, K and Drygas, W and Du, Y and Egbagbe, EE and Eggertsen, R and Ati, JE and Elosua, R and Erasmus, RT and Erem, C and Ergor, G and Eriksen, L and Escobedo-de la Pe na, J and Fall, CH and Farzadfar, F and Felix-Redondo, FJ and Ferguson, TS and Fernández-Bergés, D and Ferrari, M and Ferreccio, C and Finn, JD and Föger, B and Foo, LH and Fouad, HM and Francis, DK and do Carmo Franco, M and Franco, OH and Frontera, G and Furusawa, T and Gaciong, Z and Galbarczyk, A and Garnett, SP and Gaspoz, J-M and Gasull, M and Gates, L and Geleijnse, JM and Ghasemain, A and Giampaoli, S and Gianfagna, F and Giovannelli, J and Gross, MG and González Rivas, JP and Gorbea, MB and Gottrand, F and Grant, JF and Grodzicki, T and Grøntved, A and Gruden, G and Gu, D and Guan, OP and Guerrero, R and Guessous, I and Guimaraes, AL and Gutierrez, L and Hardy, R and Kumar, RH and He, J and Heidemann, C and Hihtaniemi, IT and Ho, SY and Ho, SC and Hofman, A and Russo Horimoto, ARV and Hormiga, CM and Horta, BL and Houti, L and Hussieni, AS and Huybrechts, I and Hwalla, N and Iacoviello, L and Iannone, AG and Ibrahim, MM and Ikeda, N and Ikram, AM and Irazola, VE and Islam, M and Iwasaki, M and Jacobs, JM and Jafar, T and Jasienska, G and Jiang, CQ and Jonas, JB and Joshi, P and Kafatos, A and Kalter-Leibovici, O and Kasaeian, A and Katz, J and Kaur, P and Kavousi, M and Kelishadi, R and Kengne, AP and Kersting, M and Khader, YS and Kiechl, S and Kim, J and Kiyohara, Y and Kolsteren, P and Korrovits, P and Koskinen, S and Kratzer, W and Kromhout, D and Kula, K and Kurjata, P and Kyobutungi, C and Lachat, C and Laid, Y and Lam, TH and Landrove, O and Lanska, V and Lappas, G and Laxmaiah, A and Leclercq, C and Lee, J and Lee, J and Lehtimäki, T and Lekhraj, R and León-Mu noz, LM and Li, Y and Lim, W-Y and Fernanda Lima-Costa, M and Lin, H-H and Lin, X and Lissner, L and Lorbeer, R and Lozano, JE and Lundqvist, A and Lytsy, P and Ma, G and Machado-Coelho, GLL and Machi, S and Maggi, S and Makdisse, M and Rao, KM and Manios, Y and Manzato, E and Margozzini, P and Marques-Vidal, P and Martorell, R and Masoodi, SR and Matsha, TE and Mbanya, JCN and McFarlane, SR and McGarvey, ST and McLachlan, S and McNulty, BA and Mediene-Benchekor, S and Meirhaeghe, A and Menezes, AMB and Merat, S and Meshram, II and Mi, J and Miquel, JF and Mohamed, MK and Mohammad, K and Mohan, V and Yusoff, MFM and Moller, NC and Molnar, D and Mondo, CK and Moreno, LA and Morgan, K and Moschonis, G and Mossakowska, M and Mostafa, A and Mota, J and Muiesan, ML and Müller-Nurasyid, M and Mursu, J and Nagel, G and Namesna, J and Nang, EEK and Nangia, VB and Navarrete-Mu noz, EM and Ndiaye, NC and Nervi, F and Nguyen, ND and Nieto-Martínez, RE and Ning, G and Ninomiya, T and Noale, M and Noto, D and Ochoa-Avilés, AM and Oh, K and Onat, A and Osmond, C and Otero, JA and Palmieri, L and Panda-Jonas, S and Panza, F and Parsaeian, M and Peixoto, SV and Pereira, AC and Peters, A and Peykari, N and Pilav, A and Pitakaka, F and Piwonska, A and Piwonski, J and Plans-Rubió, P and Porta, M and Portegies, MLP and Poustchi, H and Pradeepa, R and Price, JF and Punab, M and Qasrawi, RF and Qorbani, M and Raitakari, O and Rao, SR and Ramachandran, A and Ramos, R and Rampal, S and Rathmann, W and Redon, J and Reganit, PFM and Rigo, F and Robinson, SM and Robitaille, C and Rodríguez, LA and Rodríguez-Artalejo, F and Rodriguez-Perez, MDC and Rojas-Martinez, R and Romaguera, D and Rosengren, A and Rubinstein, A and Rui, O and Ruiz-Betancourt, BS and Rutkowski, M and Sabanayagam, C and Sachdev, HS and Saidi, O and Sakarya, S and Salanave, B and Salonen, JT and Salvetti, M and Sánchez-Abanto, J and dos Santos, RN and Santos, R and Sardinha, LB and Scazufca, M and Schargrodsky, H and Scheidt-Nave, C and Shibuya, K and Shin, Y and Shiri, R and Siantar, R and Sibai, AM and Simon, M and Simons, J and Simons, LA and Sjostrom, M and Slowikowska-Hilczer, J and Slusarczyk, P and Smeeth, L and Snijder, MB and Solfrizzi, V and Sonestedt, E and Soumare, A and Staessen, JA and Steene-Johannessen, J and Stehle, P and Stein, AD and Stessman, J and Stöckl, D and Stokwiszewski, J and Strufaldi, MW and Sun, C-A and Sundström, J and Suriyawongpaisal, P and Sy, RG and Tai, ES and Tarawneh, M and Tarqui-Mamani, CB and Thijs, L and Tolstrup, JS and Topbas, M and Torrent, M and Traissac, P and Trinh, OTH and Tulloch-Reid, MK and Tuomainen, T-P and Turley, ML and Tzourio, C and Ueda, P and Ukoli, FM and Ulmer, H and Valdivia, G and van Valkengoed, IGM and Vanderschueren, D and Vanuzzo, D and Vega, T and Velasquez-Melendez, G and Veronesi, G and Verschuren, M and Vioque, J and Virtanen, J and Visvikis-Siest, S and Viswanathan, B and Vollenweider, P and Voutilainen, S and Wade, AN and Wagner, A and Walton, J and Mohamud, WNW and Wang, M-D and Wang, YX and Wannamethee, SG and Weerasekera, D and Whincup, PH and Widhalm, K and Wiecek, A and Wilks, RJ and Willeit, J and Wojtyniak, B and Wong, TY and Woo, J and Woodward, M and Wu, AG and Wu, FC and Wu, SL and Xu, H and Yang, X and Ye, X and Yoshihara, A and Younger-Coleman, NO and Zambon, S and Zargar, AH and Zdrojewski, T and Zhao, W and Zheng, Y (2015) Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: A pooled analysis of 96 population-based studies with 331 288 participants. The Lancet Diabetes and Endocrinology, 3 (8). pp. 624-637. ISSN 2213-8587

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Abstract

Background Diabetes has been defined on the basis of different biomarkers, including fasting plasma glucose (FPG), 2-h plasma glucose in an oral glucose tolerance test (2hOGTT), and HbA1c. We assessed the effect of different diagnostic definitions on both the population prevalence of diabetes and the classification of previously undiagnosed individuals as having diabetes versus not having diabetes in a pooled analysis of data from population-based health examination surveys in different regions. Methods We used data from 96 population-based health examination surveys that had measured at least two of the biomarkers used for defining diabetes. Diabetes was defined using HbA1c (HbA1c ≥6·5% or history of diabetes diagnosis or using insulin or oral hypoglycaemic drugs) compared with either FPG only or FPG-or-2hOGTT definitions (FPG ≥7·0 mmol/L or 2hOGTT ≥11·1 mmol/L or history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated diabetes prevalence, taking into account complex survey design and survey sample weights. We compared the prevalences of diabetes using different definitions graphically and by regression analyses. We calculated sensitivity and specificity of diabetes diagnosis based on HbA1c compared with diagnosis based on glucose among previously undiagnosed individuals (ie, excluding those with history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated sensitivity and specificity in each survey, and then pooled results using a random-effects model. We assessed the sources of heterogeneity of sensitivity by meta-regressions for study characteristics selected a priori. Findings Population prevalence of diabetes based on FPG-or-2hOGTT was correlated with prevalence based on FPG alone (r=0·98), but was higher by 2–6 percentage points at different prevalence levels. Prevalence based on HbA1c was lower than prevalence based on FPG in 42·8% of age–sex–survey groups and higher in another 41·6%; in the other 15·6%, the two definitions provided similar prevalence estimates. The variation across studies in the relation between glucose-based and HbA1c-based prevalences was partly related to participants' age, followed by natural logarithm of per person gross domestic product, the year of survey, mean BMI, and whether the survey population was national, subnational, or from specific communities. Diabetes defined as HbA1c 6·5% or more had a pooled sensitivity of 52·8% (95% CI 51·3–54·3%) and a pooled specificity of 99·74% (99·71–99·78%) compared with FPG 7·0 mmol/L or more for diagnosing previously undiagnosed participants; sensitivity compared with diabetes defined based on FPG-or-2hOGTT was 30·5% (28·7–32·3%). None of the preselected study-level characteristics explained the heterogeneity in the sensitivity of HbA1c versus FPG. Interpretation Different biomarkers and definitions for diabetes can provide different estimates of population prevalence of diabetes, and differentially identify people without previous diagnosis as having diabetes. Using an HbA1c-based definition alone in health surveys will not identify a substantial proportion of previously undiagnosed people who would be considered as having diabetes using a glucose-based test.

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