了解与 2 型糖尿病胰岛素治疗进展相关的挑战的观察性研究 (MOSAIc)
2020年2月25日 更新者：Eli Lilly and Company
评估胰岛素使用的多国观察研究：了解与治疗进展相关的挑战 - MOSAIc 2 型糖尿病研究
本研究的目的是确定与 2 型糖尿病患者从初始胰岛素治疗进展到更强化治疗方案相关的特定患者、医生和卫生系统相关因素。
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
4299
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100101
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Changchun City、中国、130041
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Chongqing、中国
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Guang Zhou、中国、510080
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Shijiazhuang、中国、50000
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Xi'An、中国、710061
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Beer Sheva、以色列、84350
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Beer Yaakov、以色列、70300
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Dimona、以色列、68000
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Givataim、以色列、53488
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Netanya、以色列、42470
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Petach Tikwa、以色列、49582
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Rishon Le Zion、以色列、75650
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Safed、以色列、13110
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Moscow、俄罗斯联邦、117997
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Nizhniy Novgorod、俄罗斯联邦、603126
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Rostov-On-Don、俄罗斯联邦、344022
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Saint Petersburg、俄罗斯联邦、194358
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Tomsk、俄罗斯联邦、634050
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Vsevolozhsk、俄罗斯联邦、188640
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Yaroslavl、俄罗斯联邦、150010
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Alberta
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Edmonton、Alberta、加拿大、T5A 4L8
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Spruce Grove、Alberta、加拿大、T7X 2V2
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Manitoba
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Winnipeg、Manitoba、加拿大、R3C 0N2
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Newfoundland and Labrador
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St. John'S、Newfoundland and Labrador、加拿大、A1A3R5
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Ontario
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Burlington、Ontario、加拿大、L7M 4Y1
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London、Ontario、加拿大、N6A 5G6
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Smiths Falls、Ontario、加拿大、K7A 4W8
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Quebec
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Gatineau、Quebec、加拿大、J8V 2P5
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Montreal、Quebec、加拿大、H3N 1S4
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Sherbrooke、Quebec、加拿大、J1G 1B8
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Ahmedabad、印度、380007
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Ahmedabad, Gujarat、印度、380009
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Bangalore、印度、560054
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Belgaum、印度、590001
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Hyderabaad、印度、500033
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Jaipur、印度、302020
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Kormangala、印度、560034
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Mangalore、印度、575001
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Mumbai、印度、400053
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Mysore、印度、570023
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Nagpur、印度、440025
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New Delhi、印度、110070
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Pune、印度、411035
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Aguascalientes、墨西哥、20217
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Durango、墨西哥、34080
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Guadalajara、墨西哥、44680
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Huixquilucan、墨西哥、52763
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Mexico City、墨西哥、11850
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Zapopan、墨西哥、45200
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Daegu、大韩民国、705-717
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Daejeon、大韩民国、301-721
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Gangwon-Do、大韩民国、200-722
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Goyang-Si、大韩民国、412-270
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Jeju Special Self-Governing Pr、大韩民国、690-767
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Sungnam-Si、大韩民国、463-712
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Campina Grande Do Sul、巴西、83430-000
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Caxias Do Sul、巴西、95070560
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Fortaleza、巴西、60430-370
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Santa Maria、巴西、97015-530
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Setor Oeste/Goiania、巴西、74100-120
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São Paulo、巴西、04020-041
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Tatui、巴西、18270-170
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Bosenheim、德国、55545
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Dresden、德国、01307
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Essen、德国、45359
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Hamburg、德国、22415
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Hohenmölsen、德国、06679
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Kamp-Lintfort、德国、47475
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Köln、德国、51069
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Lambrecht、德国、67466
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Schramberg、德国、78713
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Speyer、德国、67346
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Acquaviva Delle Fonti、意大利、70021
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Ancona、意大利、60110
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Foggia、意大利、71100
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Lucca、意大利、55100
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Napoli、意大利、80131
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Parma、意大利、43100
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Pavia、意大利、27100
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Rome、意大利、00168
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San Giovanni Rotondo、意大利、71013
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Siena、意大利、53100
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Kanagawa、日本、242-0004
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Kanagawa-Ken、日本、232-0071
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Dammam、沙特阿拉伯、31412
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Makkah、沙特阿拉伯、21955
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Riyadh、沙特阿拉伯、245
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Taif、沙特阿拉伯、21944
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Bayamon、波多黎各、00956
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Carolina、波多黎各、00983
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Loiza、波多黎各、772
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Rio Grande、波多黎各、00745
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Rio Piedras、波多黎各、00921
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San Juan、波多黎各、00920
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Toa Baja、波多黎各、00949
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Villa Fontana、波多黎各、00983
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Ankara、火鸡、6560
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Canakkale、火鸡、06310
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Diyarbakir、火鸡、21280
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Gaziantep、火鸡、27310
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Istanbul、火鸡、34865
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Izmir、火鸡
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Kahramanmaras、火鸡、46050
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Kirikkale、火鸡、71450
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Arkansas
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Little Rock、Arkansas、美国、72204
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Florida
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Orlando、Florida、美国、32806
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Wellington、Florida、美国、33414
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Georgia
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Canton、Georgia、美国、30114
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Illinois
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Crystal Lake、Illinois、美国、60012
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Nebraska
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North Platte、Nebraska、美国、69101
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Nevada
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Reno、Nevada、美国、89511
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North Carolina
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Burlington、North Carolina、美国、27215
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Greensboro、North Carolina、美国、27408
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Morganton、North Carolina、美国、28655
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Tabor City、North Carolina、美国、28463
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Pennsylvania
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Johnstown、Pennsylvania、美国、15905
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Levittown、Pennsylvania、美国、19056
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South Carolina
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Charleston、South Carolina、美国、29412
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Tennessee
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Kingsport、Tennessee、美国、37660
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Texas
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Dallas、Texas、美国、75235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fort Worth、Texas、美国、76104
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Georgetown、Texas、美国、78626
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Houston、Texas、美国、77074
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Plano、Texas、美国、75023
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Virginia
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Alexandria、Virginia、美国、22304
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Richmond、Virginia、美国、23219
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Cardiff、英国、CF5 4AD
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Chesterfield、英国、S40 4TF
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Avon
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Bath、Avon、英国、BA2 3HT
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Cornwall
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Torpoint、Cornwall、英国、PL11 2JW
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Greater Manchester
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Manchester、Greater Manchester、英国、M20 2RN
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lancashire
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Bolton、Lancashire、英国、BL3 6TL
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South Yorkshire
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Doncaster、South Yorkshire、英国、DN9 1EP
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Warwickshire
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Atherstone、Warwickshire、英国、CV9 1EU
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West Glamorgan
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Swansea、West Glamorgan、英国、SA2 8QA
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Wiltshire
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Bradford On Avon、Wiltshire、英国、BA15 1DQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona、西班牙、8025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gerena、西班牙
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La Roca Del Valles、西班牙、8430
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid、西班牙、28034
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Sevilla、西班牙、41009
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Vic、西班牙、08500
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Abu Dhabi、阿拉伯联合酋长国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Al Ain、阿拉伯联合酋长国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dubai、阿拉伯联合酋长国、9115
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sharjah、阿拉伯联合酋长国
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Buenos Aires、阿根廷、CBA 1419
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Corrientes、阿根廷、3400
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Mendoza、阿根廷、5500
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-
Parana、阿根廷、3100
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Rosario、阿根廷、S2000DSZ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
San Juan、阿根廷、5400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
在初级保健和糖尿病专科诊所就诊的 2 型糖尿病患者。
描述
纳入标准：
- 已被诊断出患有2型糖尿病
- 在正常护理过程中出现
- 已接受初始胰岛素治疗 ≥ 3 个月（有或没有任何经批准的非胰岛素抗糖尿病药物的组合）
- 在进入研究时没有同时参与包括研究药物或程序的研究
- 已充分了解并已书面同意使用其数据
- 对该国的主要语言有足够的了解，以便他们能够完成问卷调查
- 尚未开始基础推注治疗（三餐时间注射胰岛素）
排除标准：
- 没有任何
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：预期
队列和干预
团体/队列 |
|---|
|
马赛克参与者
参加评估胰岛素使用情况的多国观察研究 (MOSAIc) 的参与者在研究期间拥有完整的治疗数据。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
接受胰岛素相关治疗的参与者人数从最初的胰岛素治疗开始发生变化
大体时间：通过 24 个月的基线
|
多变量逻辑回归模型检查了与胰岛素治疗发生任何变化相关的基线参与者、医生和医疗保健系统相关因素。
人际关系过程护理调查 [IPC] 的歧视范围为 1-5，分数越高表示歧视越多，糖尿病痛苦量表的范围为 1-6，分数越高表示痛苦越多。
|
通过 24 个月的基线
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
低血糖和严重低血糖发作的次数
大体时间：通过 24 个月的基线
|
低血糖和严重低血糖事件由所有参与者自行报告，并提供从基线访视前一个月到最后一次访视（24 个月）的完整治疗数据。
每次就诊时要求患者自我报告自上次就诊以来的任何低血糖症。
在基线访问时，参与者被问及基线访问前一个月的低血糖信息。
|
通过 24 个月的基线
|
|
研究期间坚持处方胰岛素治疗的参与者人数（研究坚持者）
大体时间：通过 24 个月的基线
|
MOSAIC 参与者回答了以下问题：“在过去的 7 天内，您多久错过一次胰岛素注射？”。
在每次访问时，如果参与者回答“我没有错过任何镜头”或“我错过了一些镜头”，则参与者被定义为访问依从者。
如果他/她回答以下任何一项，则他们被定义为未就诊依从者：“我错过了大约一半的投篮”、“我错过了我的大部分投篮”或“我错过了我所有的投篮”。
如果参与者至少满足以下条件，则参与者被定义为研究依从者：5 人中有 4 人是依从者。
|
通过 24 个月的基线
|
|
研究结束时达到个性化 HbA1c 目标的参与者人数
大体时间：通过 24 个月的基线
|
由于 MOSAIC 所代表的国家/地区的糖尿病管理实践各不相同，实现目标的更合适的衡量标准是在研究开始时为每位患者设定的个性化目标。
|
通过 24 个月的基线
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Matsuba I, Kawata T, Ajima M, Umezawa S, Kaneshiro M, Asakura T, Machimura H, Sawa T, Tanaka K, Takeda H, Imaoka T, Kanamori A. Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study. Diabetes Ther. 2022 Feb;13(2):265-274. doi: 10.1007/s13300-021-01195-8. Epub 2022 Jan 6.
- Caballero AE, Nordstrom BL, Liao B, Fan L, Zhang N, Fraeman KH, Perez-Nieves M. Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study. J Diabetes Complications. 2021 Nov;35(11):108011. doi: 10.1016/j.jdiacomp.2021.108011. Epub 2021 Jul 30.
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- Matsuba I, Sawa T, Kawata T, Kanamori A, Jiang D, Machimura H, Takeda H, Han JH, Wang K, Tanaka K, Shen L, Ajima M, Kaneshiro M, Kim SW, Umezawa S, Asakura T, Suzuki S, Kim SC. Cross-National Variation in Glycemic Control and Diabetes-Related Distress Among East Asian Patients Using Insulin: Results from the MOSAIc Study. Diabetes Ther. 2016 Jun;7(2):349-60. doi: 10.1007/s13300-016-0178-7. Epub 2016 Jun 2.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年7月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2011年7月21日
首先提交符合 QC 标准的
2011年7月21日
首次发布 (估计)
2011年7月25日
研究记录更新
最后更新发布 (实际的)
2020年3月9日
上次提交的符合 QC 标准的更新
2020年2月25日
最后验证
2020年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.