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Badanie obserwacyjne mające na celu zrozumienie wyzwań związanych z postępem insulinoterapii w cukrzycy typu 2 (MOSAIc)

25 lutego 2020 zaktualizowane przez: Eli Lilly and Company

Międzynarodowe badanie obserwacyjne oceniające stosowanie insuliny: zrozumienie wyzwań związanych z postępem terapii — badanie MOSAIc typu 2 Diabetes

Celem tego badania jest identyfikacja specyficznych czynników związanych z pacjentem, lekarzem i systemem opieki zdrowotnej, związanych z przejściem od początkowej insulinoterapii do bardziej intensywnego schematu u pacjentów z cukrzycą typu 2.

Przegląd badań

Status

Zakończony

Warunki

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

4299

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Dammam, Arabia Saudyjska, 31412
        • 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.
      • Makkah, Arabia Saudyjska, 21955
        • 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.
      • Riyadh, Arabia Saudyjska, 245
        • 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.
      • Taif, Arabia Saudyjska, 21944
        • 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.
      • Buenos Aires, Argentyna, CBA 1419
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      • Corrientes, Argentyna, 3400
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      • Mendoza, Argentyna, 5500
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      • Parana, Argentyna, 3100
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      • Rosario, Argentyna, S2000DSZ
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      • San Juan, Argentyna, 5400
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      • Campina Grande Do Sul, Brazylia, 83430-000
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      • Caxias Do Sul, Brazylia, 95070560
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      • Fortaleza, Brazylia, 60430-370
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      • Santa Maria, Brazylia, 97015-530
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      • Setor Oeste/Goiania, Brazylia, 74100-120
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      • São Paulo, Brazylia, 04020-041
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      • Tatui, Brazylia, 18270-170
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      • Beijing, Chiny, 100101
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      • Changchun City, Chiny, 130041
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      • Chongqing, Chiny
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      • Guang Zhou, Chiny, 510080
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      • Shijiazhuang, Chiny, 50000
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      • Xi'An, Chiny, 710061
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      • Moscow, Federacja Rosyjska, 117997
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      • Nizhniy Novgorod, Federacja Rosyjska, 603126
        • 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.
      • Rostov-On-Don, Federacja Rosyjska, 344022
        • 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.
      • Saint Petersburg, Federacja Rosyjska, 194358
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      • Tomsk, Federacja Rosyjska, 634050
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      • Vsevolozhsk, Federacja Rosyjska, 188640
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      • Yaroslavl, Federacja Rosyjska, 150010
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      • Barcelona, Hiszpania, 8025
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      • Gerena, Hiszpania
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      • La Roca Del Valles, Hiszpania, 8430
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      • Madrid, Hiszpania, 28034
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      • Sevilla, Hiszpania, 41009
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      • Vic, Hiszpania, 08500
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      • Ahmedabad, Indie, 380007
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      • Ahmedabad, Gujarat, Indie, 380009
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      • Bangalore, Indie, 560054
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      • Belgaum, Indie, 590001
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      • Hyderabaad, Indie, 500033
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      • Jaipur, Indie, 302020
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      • Kormangala, Indie, 560034
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      • Mangalore, Indie, 575001
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      • Mumbai, Indie, 400053
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      • Mysore, Indie, 570023
        • 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.
      • Nagpur, Indie, 440025
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      • New Delhi, Indie, 110070
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      • Pune, Indie, 411035
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      • Ankara, Indyk, 6560
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      • Canakkale, Indyk, 06310
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      • Diyarbakir, Indyk, 21280
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      • Gaziantep, Indyk, 27310
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      • Istanbul, Indyk, 34865
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      • Izmir, Indyk
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      • Kahramanmaras, Indyk, 46050
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      • Kirikkale, Indyk, 71450
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      • Beer Sheva, Izrael, 84350
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      • Beer Yaakov, Izrael, 70300
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      • Dimona, Izrael, 68000
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      • Givataim, Izrael, 53488
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      • Netanya, Izrael, 42470
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      • Petach Tikwa, Izrael, 49582
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      • Rishon Le Zion, Izrael, 75650
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      • Safed, Izrael, 13110
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      • Kanagawa, Japonia, 242-0004
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      • Kanagawa-Ken, Japonia, 232-0071
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    • Alberta
      • Edmonton, Alberta, Kanada, T5A 4L8
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      • Spruce Grove, Alberta, Kanada, T7X 2V2
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    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3C 0N2
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    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Kanada, A1A3R5
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    • Ontario
      • Burlington, Ontario, Kanada, L7M 4Y1
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      • London, Ontario, Kanada, N6A 5G6
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      • Smiths Falls, Ontario, Kanada, K7A 4W8
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    • Quebec
      • Gatineau, Quebec, Kanada, J8V 2P5
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      • Montreal, Quebec, Kanada, H3N 1S4
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      • Sherbrooke, Quebec, Kanada, J1G 1B8
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      • Aguascalientes, Meksyk, 20217
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      • Durango, Meksyk, 34080
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      • Guadalajara, Meksyk, 44680
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      • Huixquilucan, Meksyk, 52763
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      • Mexico City, Meksyk, 11850
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      • Zapopan, Meksyk, 45200
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      • Bosenheim, Niemcy, 55545
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      • Dresden, Niemcy, 01307
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      • Essen, Niemcy, 45359
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      • Hamburg, Niemcy, 22415
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      • Hohenmölsen, Niemcy, 06679
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      • Kamp-Lintfort, Niemcy, 47475
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      • Köln, Niemcy, 51069
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      • Lambrecht, Niemcy, 67466
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      • Schramberg, Niemcy, 78713
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      • Speyer, Niemcy, 67346
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      • Bayamon, Portoryko, 00956
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      • Carolina, Portoryko, 00983
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      • Loiza, Portoryko, 772
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      • Rio Grande, Portoryko, 00745
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      • Rio Piedras, Portoryko, 00921
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      • San Juan, Portoryko, 00920
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      • Toa Baja, Portoryko, 00949
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      • Villa Fontana, Portoryko, 00983
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      • Daegu, Republika Korei, 705-717
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      • Daejeon, Republika Korei, 301-721
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      • Gangwon-Do, Republika Korei, 200-722
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      • Goyang-Si, Republika Korei, 412-270
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      • Jeju Special Self-Governing Pr, Republika Korei, 690-767
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      • Sungnam-Si, Republika Korei, 463-712
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    • Arkansas
      • Little Rock, Arkansas, Stany Zjednoczone, 72204
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    • Florida
      • Orlando, Florida, Stany Zjednoczone, 32806
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      • Wellington, Florida, Stany Zjednoczone, 33414
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    • Georgia
      • Canton, Georgia, Stany Zjednoczone, 30114
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    • Illinois
      • Crystal Lake, Illinois, Stany Zjednoczone, 60012
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    • Nebraska
      • North Platte, Nebraska, Stany Zjednoczone, 69101
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    • Nevada
      • Reno, Nevada, Stany Zjednoczone, 89511
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    • North Carolina
      • Burlington, North Carolina, Stany Zjednoczone, 27215
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      • Greensboro, North Carolina, Stany Zjednoczone, 27408
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      • Morganton, North Carolina, Stany Zjednoczone, 28655
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      • Tabor City, North Carolina, Stany Zjednoczone, 28463
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    • Pennsylvania
      • Johnstown, Pennsylvania, Stany Zjednoczone, 15905
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      • Levittown, Pennsylvania, Stany Zjednoczone, 19056
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    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29412
        • 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.
    • Tennessee
      • Kingsport, Tennessee, Stany Zjednoczone, 37660
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    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75235
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      • Fort Worth, Texas, Stany Zjednoczone, 76104
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      • Georgetown, Texas, Stany Zjednoczone, 78626
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      • Houston, Texas, Stany Zjednoczone, 77074
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      • Plano, Texas, Stany Zjednoczone, 75023
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    • Virginia
      • Alexandria, Virginia, Stany Zjednoczone, 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.
      • Richmond, Virginia, Stany Zjednoczone, 23219
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      • Acquaviva Delle Fonti, Włochy, 70021
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      • Ancona, Włochy, 60110
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      • Foggia, Włochy, 71100
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      • Lucca, Włochy, 55100
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      • Napoli, Włochy, 80131
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      • Parma, Włochy, 43100
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      • Pavia, Włochy, 27100
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      • Rome, Włochy, 00168
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      • San Giovanni Rotondo, Włochy, 71013
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      • Siena, Włochy, 53100
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      • Abu Dhabi, Zjednoczone Emiraty Arabskie
        • 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.
      • Al Ain, Zjednoczone Emiraty Arabskie
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      • Dubai, Zjednoczone Emiraty Arabskie, 9115
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      • Sharjah, Zjednoczone Emiraty Arabskie
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      • Cardiff, Zjednoczone Królestwo, CF5 4AD
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      • Chesterfield, Zjednoczone Królestwo, S40 4TF
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    • Avon
      • Bath, Avon, Zjednoczone Królestwo, BA2 3HT
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    • Cornwall
      • Torpoint, Cornwall, Zjednoczone Królestwo, PL11 2JW
        • 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.
    • Greater Manchester
      • Manchester, Greater Manchester, Zjednoczone Królestwo, 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.
    • Lancashire
      • Bolton, Lancashire, Zjednoczone Królestwo, BL3 6TL
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    • South Yorkshire
      • Doncaster, South Yorkshire, Zjednoczone Królestwo, DN9 1EP
        • 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.
    • Warwickshire
      • Atherstone, Warwickshire, Zjednoczone Królestwo, CV9 1EU
        • 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.
    • West Glamorgan
      • Swansea, West Glamorgan, Zjednoczone Królestwo, SA2 8QA
        • 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.
    • Wiltshire
      • Bradford On Avon, Wiltshire, Zjednoczone Królestwo, 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.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Pacjenci z cukrzycą typu 2 zgłaszający się do poradni podstawowej opieki zdrowotnej i poradni diabetologicznych.

Opis

Kryteria przyjęcia:

  • Zdiagnozowano cukrzycę typu 2
  • Zgłosili się w ramach normalnego toku opieki
  • Byli na początkowej insulinoterapii przez ≥3 miesiące (z jakąkolwiek kombinacją zatwierdzonych nieinsulinowych leków przeciwcukrzycowych lub bez)
  • Nie biorą jednocześnie udziału w badaniu, które obejmuje badany lek lub procedurę w chwili przystąpienia do badania
  • zostali w pełni poinformowani i wyrazili pisemną zgodę na wykorzystanie swoich danych
  • Mieć wystarczającą znajomość podstawowego języka kraju, aby móc wypełnić kwestionariusze
  • Nie rozpoczęto terapii bolusem podstawowym (trzy wstrzyknięcia insuliny w czasie posiłku)

Kryteria wyłączenia:

  • Nic

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Inny
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / Kohorta
Uczestnicy MOSAIc
Uczestnicy zakwalifikowani do międzynarodowego badania obserwacyjnego oceniającego stosowanie insuliny (MOSAIc), którzy mieli pełne dane dotyczące leczenia podczas badania.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Liczba uczestników ze zmianą leczenia związanego z insuliną od początkowej insulinoterapii
Ramy czasowe: Wartość bazowa przez 24 miesiące
Wielowymiarowy model regresji logistycznej zbadał wyjściowe czynniki związane z uczestnikiem, lekarzem i systemem opieki zdrowotnej związane z wystąpieniem jakiejkolwiek zmiany w insulinoterapii. Dziedzina dyskryminacji kwestionariusza Interpersonal Processes of Care Survey [IPC] mieści się w zakresie od 1 do 5, przy czym wyższe wyniki wskazują na większą dyskryminację, a Skala Dystresu Cukrzycowego obejmuje zakresy od 1 do 6, przy czym wyższe wyniki wskazują na większy niepokój.
Wartość bazowa przez 24 miesiące

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Liczba epizodów hipoglikemii i ciężkiej hipoglikemii
Ramy czasowe: Wartość bazowa przez 24 miesiące
Epizody hipoglikemii i ciężkiej hipoglikemii są zgłaszane przez wszystkich uczestników wraz z pełnymi danymi dotyczącymi leczenia od jednego miesiąca przed wizytą wyjściową do ostatniej wizyty (24 miesiące). Podczas każdej wizyty pacjenci byli proszeni o zgłaszanie hipoglikemii od czasu ostatniej wizyty. Podczas wizyty początkowej uczestnicy zostali poproszeni o informacje dotyczące hipoglikemii za miesiąc poprzedzający wizytę wyjściową.
Wartość bazowa przez 24 miesiące
Liczba uczestników przestrzegających przepisanej insulinoterapii podczas badania (osoby przestrzegające zaleceń dotyczących badania)
Ramy czasowe: Wartość bazowa przez 24 miesiące
Uczestnicy MOSAIC odpowiedzieli na pytanie: „Jak często przegapiłeś zastrzyki z insuliny w ciągu ostatnich 7 dni?”. Podczas każdej wizyty uczestnicy byli definiowani jako przestrzegający wizyty, jeśli uczestnik odpowiedział „Nie przegapiłem żadnych ujęć” lub „Przegapiłem niektóre z moich ujęć”. Zostali oni zdefiniowani jako nie przestrzegający wizyt, jeśli odpowiedział/a na którekolwiek z poniższych pytań: „Przegapiłem mniej więcej połowę moich strzałów”, „Przegapiłem większość moich strzałów” lub „Przegapiłem wszystkie moje strzały”. Uczestnik jest definiowany jako przestrzegający zasad badania, jeśli co najmniej: 4 z 5 osób przestrzega zaleceń.
Wartość bazowa przez 24 miesiące
Liczba uczestników, którzy osiągnęli spersonalizowany docelowy poziom HbA1c do końca badania
Ramy czasowe: Wartość bazowa przez 24 miesiące
Ponieważ praktyki leczenia cukrzycy różnią się w poszczególnych krajach reprezentowanych w badaniu MOSAIC, bardziej trafną miarą osiągnięcia celu jest spersonalizowany cel, który został ustalony dla każdego pacjenta na początku badania.
Wartość bazowa przez 24 miesiące

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2011

Zakończenie podstawowe (Rzeczywisty)

1 września 2015

Ukończenie studiów (Rzeczywisty)

1 września 2015

Daty rejestracji na studia

Pierwszy przesłany

21 lipca 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2011

Pierwszy wysłany (Oszacować)

25 lipca 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 marca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 lutego 2020

Ostatnia weryfikacja

1 lutego 2020

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Cukrzyca typu 2

  • Leiden University Medical Center
    Zakończony
    Gruczolak przysadki | Guz przysadki | Diabetes Insipidus Cranial Type | Dokrewny; Niedobór
    Holandia
  • Centre Hospitalier Universitaire de Liege
    Sanofi; Takeda; University of Liege; Orchard Therapeutics; Centre Hospitalier Régional... i inni współpracownicy
    Rekrutacyjny
    Wrodzony przerost nadnerczy | Hemofilia A | Hemofilia B | Mukopolisacharydoza I | Mukopolisacharydoza II | Mukowiscydoza | Niedobór alfa 1-antytrypsyny | Anemia sierpowata | Anemia Fanconiego | Przewlekła choroba ziarniniakowa | Choroba Wilsona | Ciężka wrodzona neutropenia | Niedobór transkarbamylazy ornityny | Mukopolisacharydoza... i inne warunki
    Belgia
  • UK Kidney Association
    Rekrutacyjny
    Zapalenie naczyń | AL Amyloidoza | Stwardnienie guzowate | Choroba Fabry'ego | Cystynuria | Ogniskowe segmentowe stwardnienie kłębuszków nerkowych | Nefropatia IgA | Syndrom Barttera | Czysta aplazja czerwonokrwinkowa | Nefropatia błoniasta | Atypowy zespół hemolityczno-mocznicowy | Autosomalna dominująca policystyczna... i inne warunki
    Zjednoczone Królestwo
3
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