Um estudo observacional para entender os desafios associados à progressão da terapia com insulina no diabetes tipo 2 (MOSAIc)
25 de fevereiro de 2020 atualizado por: Eli Lilly and Company
Um estudo observacional multinacional avaliando o uso de insulina: compreendendo os desafios associados à progressão da terapia - The MOSAIc Type 2 Diabetes Study
O objetivo deste estudo é identificar fatores específicos relacionados ao paciente, ao médico e ao sistema de saúde associados à progressão para um regime mais intensivo da terapia inicial com insulina para pacientes com diabetes tipo 2.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
4299
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bosenheim, Alemanha, 55545
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Dresden, Alemanha, 01307
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Essen, Alemanha, 45359
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Hamburg, Alemanha, 22415
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Hohenmölsen, Alemanha, 06679
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Kamp-Lintfort, Alemanha, 47475
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Köln, Alemanha, 51069
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Lambrecht, Alemanha, 67466
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Schramberg, Alemanha, 78713
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Speyer, Alemanha, 67346
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Buenos Aires, Argentina, CBA 1419
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Corrientes, Argentina, 3400
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Mendoza, Argentina, 5500
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Parana, Argentina, 3100
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Rosario, Argentina, S2000DSZ
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San Juan, Argentina, 5400
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Dammam, Arábia Saudita, 31412
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Makkah, Arábia Saudita, 21955
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Riyadh, Arábia Saudita, 245
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Taif, Arábia Saudita, 21944
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Campina Grande Do Sul, Brasil, 83430-000
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Caxias Do Sul, Brasil, 95070560
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Fortaleza, Brasil, 60430-370
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Santa Maria, Brasil, 97015-530
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Setor Oeste/Goiania, Brasil, 74100-120
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São Paulo, Brasil, 04020-041
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Tatui, Brasil, 18270-170
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Alberta
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Edmonton, Alberta, Canadá, T5A 4L8
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Spruce Grove, Alberta, Canadá, T7X 2V2
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Manitoba
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Winnipeg, Manitoba, Canadá, R3C 0N2
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canadá, A1A3R5
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Ontario
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Burlington, Ontario, Canadá, L7M 4Y1
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London, Ontario, Canadá, N6A 5G6
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Smiths Falls, Ontario, Canadá, K7A 4W8
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Quebec
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Gatineau, Quebec, Canadá, J8V 2P5
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Montreal, Quebec, Canadá, H3N 1S4
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Sherbrooke, Quebec, Canadá, J1G 1B8
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Beijing, China, 100101
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Changchun City, China, 130041
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Chongqing, China
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Guang Zhou, China, 510080
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Shijiazhuang, China, 50000
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Xi'An, China, 710061
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Abu Dhabi, Emirados Árabes Unidos
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Al Ain, Emirados Árabes Unidos
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Dubai, Emirados Árabes Unidos, 9115
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Sharjah, Emirados Árabes Unidos
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Barcelona, Espanha, 8025
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Gerena, Espanha
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La Roca Del Valles, Espanha, 8430
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Madrid, Espanha, 28034
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Sevilla, Espanha, 41009
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Vic, Espanha, 08500
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72204
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Florida
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Orlando, Florida, Estados Unidos, 32806
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Wellington, Florida, Estados Unidos, 33414
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Georgia
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Canton, Georgia, Estados Unidos, 30114
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Illinois
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Crystal Lake, Illinois, Estados Unidos, 60012
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Nebraska
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North Platte, Nebraska, Estados Unidos, 69101
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Nevada
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Reno, Nevada, Estados Unidos, 89511
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North Carolina
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Burlington, North Carolina, Estados Unidos, 27215
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Greensboro, North Carolina, Estados Unidos, 27408
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Morganton, North Carolina, Estados Unidos, 28655
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Tabor City, North Carolina, Estados Unidos, 28463
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Pennsylvania
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Johnstown, Pennsylvania, Estados Unidos, 15905
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Levittown, Pennsylvania, Estados Unidos, 19056
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29412
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
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Texas
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Dallas, Texas, Estados Unidos, 75235
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Fort Worth, Texas, Estados Unidos, 76104
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Georgetown, Texas, Estados Unidos, 78626
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Houston, Texas, Estados Unidos, 77074
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Plano, Texas, Estados Unidos, 75023
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Virginia
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Alexandria, Virginia, Estados Unidos, 22304
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Richmond, Virginia, Estados Unidos, 23219
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Moscow, Federação Russa, 117997
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Nizhniy Novgorod, Federação Russa, 603126
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Rostov-On-Don, Federação Russa, 344022
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Saint Petersburg, Federação Russa, 194358
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Tomsk, Federação Russa, 634050
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Vsevolozhsk, Federação Russa, 188640
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Yaroslavl, Federação Russa, 150010
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Beer Sheva, Israel, 84350
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Beer Yaakov, Israel, 70300
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Dimona, Israel, 68000
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Givataim, Israel, 53488
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Netanya, Israel, 42470
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Petach Tikwa, Israel, 49582
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Rishon Le Zion, Israel, 75650
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Safed, Israel, 13110
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Acquaviva Delle Fonti, Itália, 70021
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Ancona, Itália, 60110
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Foggia, Itália, 71100
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Lucca, Itália, 55100
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Napoli, Itália, 80131
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Parma, Itália, 43100
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Pavia, Itália, 27100
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Rome, Itália, 00168
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San Giovanni Rotondo, Itália, 71013
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Siena, Itália, 53100
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Kanagawa, Japão, 242-0004
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Kanagawa-Ken, Japão, 232-0071
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Aguascalientes, México, 20217
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Durango, México, 34080
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Guadalajara, México, 44680
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Huixquilucan, México, 52763
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Mexico City, México, 11850
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Zapopan, México, 45200
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Ankara, Peru, 6560
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Canakkale, Peru, 06310
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Diyarbakir, Peru, 21280
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Gaziantep, Peru, 27310
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Istanbul, Peru, 34865
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Izmir, Peru
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Kahramanmaras, Peru, 46050
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Kirikkale, Peru, 71450
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Bayamon, Porto Rico, 00956
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Carolina, Porto Rico, 00983
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Loiza, Porto Rico, 772
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Rio Grande, Porto Rico, 00745
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Rio Piedras, Porto Rico, 00921
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San Juan, Porto Rico, 00920
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Toa Baja, Porto Rico, 00949
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Villa Fontana, Porto Rico, 00983
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Cardiff, Reino Unido, CF5 4AD
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Chesterfield, Reino Unido, S40 4TF
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Avon
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Bath, Avon, Reino Unido, BA2 3HT
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Cornwall
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Torpoint, Cornwall, Reino Unido, PL11 2JW
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M20 2RN
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Lancashire
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Bolton, Lancashire, Reino Unido, BL3 6TL
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South Yorkshire
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Doncaster, South Yorkshire, Reino Unido, DN9 1EP
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Warwickshire
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Atherstone, Warwickshire, Reino Unido, CV9 1EU
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West Glamorgan
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Swansea, West Glamorgan, Reino Unido, SA2 8QA
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Wiltshire
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Bradford On Avon, Wiltshire, Reino Unido, BA15 1DQ
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Daegu, Republica da Coréia, 705-717
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Daejeon, Republica da Coréia, 301-721
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Gangwon-Do, Republica da Coréia, 200-722
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Goyang-Si, Republica da Coréia, 412-270
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Jeju Special Self-Governing Pr, Republica da Coréia, 690-767
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Sungnam-Si, Republica da Coréia, 463-712
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Ahmedabad, Índia, 380007
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Ahmedabad, Gujarat, Índia, 380009
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Bangalore, Índia, 560054
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Belgaum, Índia, 590001
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Hyderabaad, Índia, 500033
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Jaipur, Índia, 302020
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Kormangala, Índia, 560034
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Mangalore, Índia, 575001
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Mumbai, Índia, 400053
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Mysore, Índia, 570023
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Nagpur, Índia, 440025
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New Delhi, Índia, 110070
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Pune, Índia, 411035
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Pacientes com diabetes tipo 2 atendidos em cuidados primários e clínicas especializadas em diabetes.
Descrição
Critério de inclusão:
- Foi diagnosticado com diabetes tipo 2
- Apresentaram-se no decurso normal dos cuidados
- Estiveram em terapia inicial com insulina por ≥3 meses (com ou sem qualquer combinação de medicamentos antidiabéticos não insulínicos aprovados)
- Não estão participando simultaneamente de um estudo que inclui um medicamento ou procedimento experimental no início do estudo
- Ter sido totalmente informado e ter dado consentimento por escrito para o uso de seus dados
- Ter uma compreensão suficiente do idioma principal do país para que possam preencher os questionários
- Não iniciou terapia basal em bolus (três injeções de insulina na hora das refeições)
Critério de exclusão:
- Nenhum
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Outro
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Participantes do MOSAIc
Participantes inscritos no Estudo Observacional Multinacional de Avaliação do Uso de Insulina (MOSAIc) que tiveram dados de tratamento completos durante o estudo.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Número de participantes com alteração no tratamento relacionado à insulina desde a terapia inicial com insulina
Prazo: Linha de base até 24 meses
|
O modelo de regressão logística multivariada examinou os fatores basais do participante, do médico e do sistema de saúde associados à ocorrência de qualquer alteração na terapia com insulina.
O domínio de discriminação da Pesquisa Interpessoal de Processos de Cuidados [IPC] varia de 1 a 5, com pontuações mais altas indicando mais discriminação, e a Diabetes Distress Scale varia de 1 a 6, com pontuações mais altas indicando mais sofrimento.
|
Linha de base até 24 meses
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Número de episódios de hipoglicemia e hipoglicemia grave
Prazo: Linha de base até 24 meses
|
Hipoglicemia e episódios graves de hipoglicemia são autorrelatados por todos os participantes com dados de tratamento completos de um mês antes da visita inicial até a última visita (24 meses).
Os pacientes foram solicitados em cada visita a relatar qualquer hipoglicemia desde a última visita.
Na visita inicial, os participantes foram questionados sobre suas informações sobre hipoglicemia no mês anterior à visita inicial.
|
Linha de base até 24 meses
|
|
Número de participantes aderentes à terapia com insulina prescrita durante o estudo (adepto do estudo)
Prazo: Linha de base até 24 meses
|
Os participantes do MOSAIC responderam à pergunta: "Com que frequência você perdeu suas injeções de insulina nos últimos 7 dias?".
Em cada visita, os participantes foram definidos como adeptos da visita se o participante respondesse "não errei nenhuma tacada" ou "errei algumas das minhas tacadas".
Eles foram definidos como não aderentes à visita se respondessem a qualquer uma das seguintes perguntas: "Errei cerca de metade das minhas tacadas", "Errei a maioria das minhas tacadas" ou "Errei todas as minhas tacadas".
Um participante é definido como aderente ao estudo se pelo menos: 4 de 5 aderem à visita.
|
Linha de base até 24 meses
|
|
Número de participantes que atingiram sua meta personalizada de HbA1c até o final do estudo
Prazo: Linha de base até 24 meses
|
Como as práticas de controle do diabetes variam entre os países representados no MOSAIC, uma medida mais adequada para atingir a meta é a meta personalizada definida para cada paciente no início do estudo.
|
Linha de base até 24 meses
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- Linetzky B, Curtis B, Frechtel G, Montenegro R Jr, Escalante Pulido M, Stempa O, de Lana JM, Gagliardino JJ. Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data. Diabetol Metab Syndr. 2016 Jul 22;8:41. doi: 10.1186/s13098-016-0157-1. eCollection 2016.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2011
Conclusão Primária (Real)
1 de setembro de 2015
Conclusão do estudo (Real)
1 de setembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2011
Primeira postagem (Estimativa)
25 de julho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de março de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de fevereiro de 2020
Última verificação
1 de fevereiro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14056
- F3Z-MC-B010 (Outro identificador: Eli Lilly and Company)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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