Uno studio osservazionale per comprendere le sfide associate alla progressione della terapia insulinica nel diabete di tipo 2 (MOSAIc)
25 febbraio 2020 aggiornato da: Eli Lilly and Company
Uno studio osservazionale multinazionale che valuta l'uso di insulina: comprendere le sfide associate alla progressione della terapia - Lo studio MOSAic sul diabete di tipo 2
Lo scopo di questo studio è identificare specifici fattori correlati al paziente, al medico e al sistema sanitario associati alla progressione verso un regime più intensivo dalla terapia insulinica iniziale per i pazienti con diabete di tipo 2.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
4299
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Dammam, Arabia Saudita, 31412
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Makkah, Arabia Saudita, 21955
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Riyadh, Arabia Saudita, 245
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Taif, Arabia Saudita, 21944
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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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Campina Grande Do Sul, Brasile, 83430-000
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Caxias Do Sul, Brasile, 95070560
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Fortaleza, Brasile, 60430-370
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Santa Maria, Brasile, 97015-530
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Setor Oeste/Goiania, Brasile, 74100-120
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São Paulo, Brasile, 04020-041
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Tatui, Brasile, 18270-170
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
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Spruce Grove, Alberta, Canada, T7X 2V2
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canada, A1A3R5
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Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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London, Ontario, Canada, N6A 5G6
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Smiths Falls, Ontario, Canada, K7A 4W8
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Quebec
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Gatineau, Quebec, Canada, J8V 2P5
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Montreal, Quebec, Canada, H3N 1S4
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Sherbrooke, Quebec, Canada, J1G 1B8
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Beijing, Cina, 100101
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Changchun City, Cina, 130041
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Chongqing, Cina
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Guang Zhou, Cina, 510080
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Shijiazhuang, Cina, 50000
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Xi'An, Cina, 710061
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Daegu, Corea, Repubblica di, 705-717
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Daejeon, Corea, Repubblica di, 301-721
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Gangwon-Do, Corea, Repubblica di, 200-722
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Goyang-Si, Corea, Repubblica di, 412-270
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Jeju Special Self-Governing Pr, Corea, Repubblica di, 690-767
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Sungnam-Si, Corea, Repubblica di, 463-712
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Abu Dhabi, Emirati Arabi Uniti
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Al Ain, Emirati Arabi Uniti
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Dubai, Emirati Arabi Uniti, 9115
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Sharjah, Emirati Arabi Uniti
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Moscow, Federazione Russa, 117997
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Nizhniy Novgorod, Federazione Russa, 603126
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Rostov-On-Don, Federazione Russa, 344022
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Saint Petersburg, Federazione Russa, 194358
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Tomsk, Federazione Russa, 634050
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Vsevolozhsk, Federazione Russa, 188640
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Yaroslavl, Federazione Russa, 150010
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Bosenheim, Germania, 55545
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Dresden, Germania, 01307
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Essen, Germania, 45359
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Hamburg, Germania, 22415
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Hohenmölsen, Germania, 06679
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Kamp-Lintfort, Germania, 47475
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Köln, Germania, 51069
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Lambrecht, Germania, 67466
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Schramberg, Germania, 78713
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Speyer, Germania, 67346
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Kanagawa, Giappone, 242-0004
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Kanagawa-Ken, Giappone, 232-0071
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Ahmedabad, India, 380007
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Ahmedabad, Gujarat, India, 380009
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Bangalore, India, 560054
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Belgaum, India, 590001
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Hyderabaad, India, 500033
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Jaipur, India, 302020
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Kormangala, India, 560034
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Mangalore, India, 575001
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Mumbai, India, 400053
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Mysore, India, 570023
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Nagpur, India, 440025
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New Delhi, India, 110070
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Pune, India, 411035
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Beer Sheva, Israele, 84350
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Beer Yaakov, Israele, 70300
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Dimona, Israele, 68000
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Givataim, Israele, 53488
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Netanya, Israele, 42470
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Petach Tikwa, Israele, 49582
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Rishon Le Zion, Israele, 75650
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Safed, Israele, 13110
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Acquaviva Delle Fonti, Italia, 70021
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Ancona, Italia, 60110
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Foggia, Italia, 71100
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Lucca, Italia, 55100
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Napoli, Italia, 80131
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Parma, Italia, 43100
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Pavia, Italia, 27100
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Rome, Italia, 00168
- 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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San Giovanni Rotondo, Italia, 71013
- 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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Siena, Italia, 53100
- 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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Aguascalientes, Messico, 20217
- 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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Durango, Messico, 34080
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Guadalajara, Messico, 44680
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Huixquilucan, Messico, 52763
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Mexico City, Messico, 11850
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Zapopan, Messico, 45200
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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, Regno Unito, CF5 4AD
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Chesterfield, Regno Unito, S40 4TF
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Avon
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Bath, Avon, Regno Unito, BA2 3HT
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Cornwall
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Torpoint, Cornwall, Regno Unito, PL11 2JW
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Greater Manchester
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Manchester, Greater Manchester, Regno Unito, M20 2RN
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Lancashire
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Bolton, Lancashire, Regno Unito, BL3 6TL
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South Yorkshire
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Doncaster, South Yorkshire, Regno Unito, DN9 1EP
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Warwickshire
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Atherstone, Warwickshire, Regno Unito, CV9 1EU
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West Glamorgan
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Swansea, West Glamorgan, Regno Unito, SA2 8QA
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Wiltshire
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Bradford On Avon, Wiltshire, Regno Unito, BA15 1DQ
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Barcelona, Spagna, 8025
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Gerena, Spagna
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La Roca Del Valles, Spagna, 8430
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Madrid, Spagna, 28034
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Sevilla, Spagna, 41009
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Vic, Spagna, 08500
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72204
- 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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Florida
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Orlando, Florida, Stati Uniti, 32806
- 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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Wellington, Florida, Stati Uniti, 33414
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Georgia
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Canton, Georgia, Stati Uniti, 30114
- 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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Illinois
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Crystal Lake, Illinois, Stati Uniti, 60012
- 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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Nebraska
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North Platte, Nebraska, Stati Uniti, 69101
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Nevada
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Reno, Nevada, Stati Uniti, 89511
- 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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North Carolina
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Burlington, North Carolina, Stati Uniti, 27215
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Greensboro, North Carolina, Stati Uniti, 27408
- 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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Morganton, North Carolina, Stati Uniti, 28655
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Tabor City, North Carolina, Stati Uniti, 28463
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Pennsylvania
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Johnstown, Pennsylvania, Stati Uniti, 15905
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Levittown, Pennsylvania, Stati Uniti, 19056
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29412
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Tennessee
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Kingsport, Tennessee, Stati Uniti, 37660
- 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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Texas
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Dallas, Texas, Stati Uniti, 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, Stati Uniti, 76104
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Georgetown, Texas, Stati Uniti, 78626
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Houston, Texas, Stati Uniti, 77074
- 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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Plano, Texas, Stati Uniti, 75023
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Virginia
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Alexandria, Virginia, Stati Uniti, 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, Stati Uniti, 23219
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Ankara, Tacchino, 6560
- 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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Canakkale, Tacchino, 06310
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Diyarbakir, Tacchino, 21280
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Gaziantep, Tacchino, 27310
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Istanbul, Tacchino, 34865
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Izmir, Tacchino
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Kahramanmaras, Tacchino, 46050
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Kirikkale, Tacchino, 71450
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Pazienti con diabete di tipo 2 che frequentano le cure primarie e le cliniche specialistiche per il diabete.
Descrizione
Criterio di inclusione:
- Le è stato diagnosticato il diabete di tipo 2
- Si sono presentati nell'ambito del normale corso di cura
- Sono stati in terapia insulinica iniziale per ≥3 mesi (con o senza alcuna combinazione di farmaci antidiabetici non insulinici approvati)
- Non stanno partecipando contemporaneamente a uno studio che include un farmaco sperimentale o una procedura all'ingresso nello studio
- Sono stati pienamente informati e hanno dato il consenso scritto per l'utilizzo dei loro dati
- Avere una conoscenza sufficiente della lingua principale del paese in modo tale da essere in grado di completare i questionari
- Non hanno iniziato la terapia in bolo basale (tre iniezioni di insulina durante i pasti)
Criteri di esclusione:
- Nessuno
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Altro
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
|---|
|
Partecipanti MOSAIC
Partecipanti iscritti al Multinational Observational Study Assessing Insulin use (MOSAIc) che disponevano di dati completi sul trattamento durante lo studio.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Numero di partecipanti con modifica del trattamento correlato all'insulina rispetto alla terapia insulinica iniziale
Lasso di tempo: Basale per 24 mesi
|
Il modello di regressione logistica multivariata ha esaminato i fattori basali relativi ai partecipanti, al medico e al sistema sanitario associati al verificarsi di qualsiasi cambiamento nella terapia insulinica.
Il dominio di discriminazione dell'Interpersonal Processes of Care Survey [IPC] varia da 1 a 5 con punteggi più alti che indicano una maggiore discriminazione e la Diabetes Distress Scale varia da 1 a 6 con punteggi più alti che indicano più disagio.
|
Basale per 24 mesi
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Numero di episodi ipoglicemici e gravi
Lasso di tempo: Basale per 24 mesi
|
Gli episodi di ipoglicemia e ipoglicemia grave sono auto-riportati da tutti i partecipanti con dati completi sul trattamento da un mese prima della visita di base fino all'ultima visita (24 mesi).
Ai pazienti è stato chiesto ad ogni visita di auto-riferire qualsiasi ipoglicemia dalla loro ultima visita.
Alla visita di riferimento ai partecipanti sono state chieste le informazioni sull'ipoglicemia per il mese precedente la visita di riferimento.
|
Basale per 24 mesi
|
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Numero di partecipanti aderenti alla terapia insulinica prescritta durante lo studio (aderenti allo studio)
Lasso di tempo: Basale per 24 mesi
|
I partecipanti al MOSAIC hanno risposto alla domanda: "Quante volte hai saltato le iniezioni di insulina negli ultimi 7 giorni?".
Ad ogni visita, i partecipanti sono stati definiti aderenti alla visita se il partecipante ha risposto "Non ho perso nessuno scatto" o "Ho perso alcuni dei miei scatti".
Sono stati definiti non aderenti alla visita se rispondevano a una delle seguenti domande: "Ho perso circa la metà dei miei colpi", "Ho perso la maggior parte dei miei colpi" o "Ho perso tutti i miei colpi".
Un partecipante è definito aderente allo studio se almeno: 4 su 5 visita aderenti.
|
Basale per 24 mesi
|
|
Numero di partecipanti che hanno raggiunto il loro obiettivo HbA1c personalizzato entro la fine dello studio
Lasso di tempo: Basale per 24 mesi
|
Poiché le pratiche di gestione del diabete variano tra i paesi rappresentati in MOSAIC, una misura più appropriata per raggiungere l'obiettivo è l'obiettivo personalizzato che è stato fissato per ciascun paziente all'inizio dello studio.
|
Basale per 24 mesi
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2011
Completamento primario (Effettivo)
1 settembre 2015
Completamento dello studio (Effettivo)
1 settembre 2015
Date di iscrizione allo studio
Primo inviato
21 luglio 2011
Primo inviato che soddisfa i criteri di controllo qualità
21 luglio 2011
Primo Inserito (Stima)
25 luglio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 febbraio 2020
Ultimo verificato
1 febbraio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14056
- F3Z-MC-B010 (Altro identificatore: Eli Lilly and Company)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .