CONCEPTT : Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol
Feig, Denice S. (Mt Sinai Hospital)
Asztalos, Elizabeth (Sunnybrook Research Institute)
Corcoy i Pla, Rosa (Institut d'Investigació Biomèdica Sant Pau)
De Leiva, Alberto (Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina)
Donovan, Lois (Alberta Health Services)
Hod, Moshe (Helen Schneider Hospital for Women)
Jovanovic, Lois
Keely, Erin (The Ottawa Hospital)
Kollman, Craig (Jaeb Center For Health Research)
McManus, Ruth (St. Joseph's Health Centre)
Murphy, Kellie (Lunenfeld-Tanenbaum Research Institute)
Ruedy, Katrina (Jaeb Center For Health Research)
Sanchez, J.Johanna (Sunnybrook Research Institute)
Tomlinson, George (Toronto General Hospital)
Murphy, Helen R. (Norwich Medical School)
Cleave, Barbara (Mt Sinai Hospital)
Donat, Diane (Mt Sinai Hospital)
Gandhi, Shital (Mt Sinai Hospital)
Strom, Michelle (Mt Sinai Hospital)
Chico Ballesteros, Ana (Institut d'Investigació Biomèdica Sant Pau)
José Martínez, Mª (Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina)
Sánchez, Mireia (Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina)
Tundidor, Diana (Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina)
Amiel, Stephanie (King's College Hospital NHS Foundation Trus)
Hunt, Katharine (King's College Hospital NHS Foundation Trust)
Green, Louisa (King's College Hospital NHS Foundation Trust)
Rogers, Helen (King's College Hospital NHS Foundation Trust)
Rossi, Benedetta (King's College Hospital NHS Foundation Trust)
Stodhart, Ben (King's College Hospital NHS Foundation Trust)
Bonomo, Matteo (Niguarda ca' Granda Hospital)
Bertuzzi, Federico (Niguarda ca' Granda Hospital)
Corica, Giuseppina D. (Niguarda ca' Granda Hospital)
Fazio, Silvana (Niguarda ca' Granda Hospital)
Giro, Ropberto (Niguarda ca' Granda Hospital)
Mion, Elena (Niguarda ca' Granda Hospital)
Moletta, Andrea (Niguarda ca' Granda Hospital)
Pintaudi, Basilio (Niguarda ca' Granda Hospital)
Sorrentino, Rosa (Niguarda ca' Granda Hospital)
Booth, John (McMaster University (Canadà))
McInnes, Natalia (McMaster University (Canadà))
Nykamp, Adelle (McMaster University (Canadà))
Otto, Rose (McMaster University (Canadà))
Smith, Ada (McMaster University (Canadà))
Stanton, Irene (McMaster University (Canadà))
Tazzeo, Tracy (McMaster University (Canadà))
Oldford, Carolyn (University of Calgary)
Young, Catherine (University of Calgary)
Gougeon, Claire (University of Calgary)
Houlden, Robyn (Queen's University)
Breen, Adriana (Queen's University)
Castorino, Kristin (Diabetes Center)
Sansum, William (Diabetes Center)
Erin Keely, None (The Ottawa Hospital General Campus)
Clark, Heather (The Ottawa Hospital General Campus)
Gaudet, Laura (The Ottawa Hospital General Campus)
Karovitch, Alan (The Ottawa Hospital General Campus)
Malcolm, Janine (The Ottawa Hospital General Campus)
Lowe, Julia (Sunnybrook Health Sciences Centre (Toronto))
Rogowsky, Anna (Sunnybrook Health Sciences Centre (Toronto))
Kudirka, Anne (St. Joseph's Health Centre)
Watson, Margaret (St. Joseph's Health Centre)
Morris, Damian (Ipswich Hospital NHS Trust)
Farnworth, Frances (Ipswich Hospital NHS Trust)
Fowler, Duncan (Ipswich Hospital NHS Trust)
Mitchell, Sue (Ipswich Hospital NHS Trust)
Rosier, Josephine (Ipswich Hospital NHS Trust)
Murphy, Helen (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Byrne, Caroline (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Davenport, Katy (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Grisoni, Jeannie (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Mulrennan, Sandra (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Neoh, Sandra (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
O'Sullivan, Esther (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Simmons, David (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Stewart, Zoe (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Templin, Heike (Cambridge University Hospitals NHS Foundation Trust (Anglaterra))
Helen Murphy, None (Norfolk and Norwich University Hospital)
Turner, Jeremy (Norfolk and Norwich University Hospital)
Canciani, Gioia (Norfolk and Norwich University Hospital)
Hewapathirana, Niranjala (Nilu) (Norfolk and Norwich University Hospital)
Jones, Louise (Norfolk and Norwich University Hospital)
Piper, Leanne (Norfolk and Norwich University Hospital)
Temple, Rosemary (Norfolk and Norwich University Hospital)
Wallace, Tara (Norfolk and Norwich University Hospital)
Maitland, Rahat (Guys and St Thomas' NHS Foundation Trust)
Banerjee, Anita (Guys and St Thomas' NHS Foundation Trust)
Briley, Anette (Guys and St Thomas' NHS Foundation Trust)
Brackenridge, Anna (Guys and St Thomas' NHS Foundation Trust)
Gilby, Pam (Guys and St Thomas' NHS Foundation Trust)
Gill, Carolyn (Guys and St Thomas' NHS Foundation Trust)
Reid, Anna (Guys and St Thomas' NHS Foundation Trust)
Singh, Claire (Guys and St Thomas' NHS Foundation Trust)
White, Sara (Guys and St Thomas' NHS Foundation Trust)
Wolfs, Maria (St. Michael's Hospital)
Scott, Eleanor (Leeds Teaching Hospitals NHS Trust)
Endersby, Del (Leeds Teaching Hospitals NHS Trust)
Maresh, Michael (Central Manchester University Hospitals NHS Foundation Trust)
Kearney, Gretta (Central Manchester University Hospitals NHS Foundation Trust)
Morris, Juliet (Central Manchester University Hospitals NHS Foundation Trust)
Quinn, Susan (Central Manchester University Hospitals NHS Foundation Trust)
Rao-Balakrishna, Prasanna (Central Manchester University Hospitals NHS Foundation Trust)
MacDougall, Malcolm (Royal Victoria Infirmary)
Bilous, Rudy (South Tees Hospitals. NHS Foundation Trust)
Bilous, Mary (South Tees Hospitals. NHS Foundation Trust)
Mahadissu, Shilpa (South Tees Hospitals. NHS Foundation Trust)
Menini, Deepika (South Tees Hospitals. NHS Foundation Trust)
Mukhtar, Rasha (South Tees Hospitals. NHS Foundation Trust)
Holt, Richard (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Forbes, Jane (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Martin, Nicki (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Walbridge, Fiona (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Mansell, Peter (Queen's Medical Centre)
Babington, Gayna (Queen's Medical Centre)
Bugg, George (Queen's Medical Centre)
Gazis, Tasso (Queen's Medical Centre)
Nia Jones, None (Queen's Medical Centre)
Spick, Dawn (Queen's Medical Centre)
Heller, Simon (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Bustani, Rebbeca (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Gordon, Val (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Madhuvrata, Priya (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Hudson, Sue (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Nisbet, Chloe (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Novodvorsky, Peter (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Solomon, Alexandra (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Towse, Karen (Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield, Regne Unit))
Philip, Sam (Grampian Diabetes Centre)
Booth, Anne (Grampian Diabetes Centre)
Cadzow, Ann (Grampian Diabetes Centre)
Chlost, Martyna (Grampian Diabetes Centre)
Murray, Lynne (Grampian Diabetes Centre)
Karen Norris, None (Grampian Diabetes Centre)
Shearer, K.atrina (Grampian Diabetes Centre)
Dover, Anna (Royal Infirmary of Edinburgh)
Dougherty, Frances (Royal Infirmary of Edinburgh)
Johnston, Susan (Royal Infirmary of Edinburgh)
Little, Jill (Royal Infirmary of Edinburgh)
McKay, Liz (Royal Infirmary of Edinburgh)
Lindsay, Robert (Glasgow Royal Infirmary)
Carty, David (Glasgow Royal Infirmary)
Crawford, Isobel (Glasgow Royal Infirmary)
Mackenzie, Fiona (Glasgow Royal Infirmary)
McSorley, Therese (Glasgow Royal Infirmary)
Dunne, Fidelma (Galway University Hospitals)
Brosnan, Elizabeth (Galway University Hospitals)
Conway, Sharon (Galway University Hospitals)
Byrnes, Michelle Courcy (Galway University Hospitals)
Duane, Linda (Galway University Hospitals)
Duffy, Niamh (Galway University Hospitals)
Egan, Aoife (Galway University Hospitals)
Gaffney, Geraldine (Galway University Hospitals)
Higgins, Grainne (Galway University Hospitals)
Kelly, Caroline (Galway University Hospitals)
Kirwan, Collette (Galway University Hospitals)
Liew, Aaron (Galway University Hospitals)
Normoyle, Kevin (Galway University Hospitals)
Roarty, Christina (Galway University Hospitals)
Waldron, Mairead (Galway University Hospitals)
Weisnagel, John (Centre hospitalier universitaire de Québec)
Allen, Christyne (Centre hospitalier universitaire de Québec)
D'Amours, Martin (Centre hospitalier universitaire de Québec)
Dubé, Marie-Christine (Centre hospitalier universitaire de Québec)
Julien, Valérie-Eve (Centre hospitalier universitaire de Québec)
Godbout, Ariane (Hôpital St. Luc)
Daigle, Sylvie (Hôpital St. Luc)
Ransom, Thomas (Izaak Walton Killam Health Sciences Centre (IWK))
Coolen, Jill (Izaak Walton Killam Health Sciences Centre (IWK))
Baxendale, Darlene (Izaak Walton Killam Health Sciences Centre (IWK))
Newstead-Angel, Jill (Royal University Hospital)
Soloman, Alexandra L. (Russells Hall Hospital)
Gorton, Karen (Russells Hall Hospital)
Jackson, Margaret (Russells Hall Hospital)
Miller, Kirsty (Russells Hall Hospital)
Taylor, Julie (Russells Hall Hospital)
Mergler, Sonya (The Centre for Mother. Infant and Child Research (CMICR))
Qureshi, Asma (The Centre for Mother. Infant and Child Research (CMICR))
Rodriguez, Adriana (The Centre for Mother. Infant and Child Research (CMICR))
Mangoff, Kathryn (The Centre for Mother. Infant and Child Research (CMICR))
Universitat Autònoma de Barcelona

Data:	2016
Resum:	Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7. 0 % to ≤10. 0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6. 5 % to ≤10. 0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0. 5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3. 5-7. 8 mmol/l), glucose variability measures, maternal and neonatal outcomes. This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes. NCT01788527 December 19, 2012.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Continuous glucose monitoring ; Diabetes mellitus type 1 ; Preconception ; Pregnancy ; Randomized controlled trial
Publicat a:	BMC Pregnancy and Childbirth, Vol. 16 Núm. 1 (18 2016) , p. 167, ISSN 1471-2393

Article original: 10.1186/s12884-016-0961-5
Erratum: 10.1186/s12884-016-1036-3
DOI: 10.1186/s12884-016-0961-5
PMID: 27430714

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