Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial

Autor: Kellie E. Murphy, Fidelma Dunne, Alberto de Leiva, Denice S. Feig, Alexandra Lubina, Sam Philip, Gioia Canciani, Matteo Bonomo, Margaret Hadley Jackson, Benedetta Rossi, Nia Jones, Sylvie Daigle, Sapida Adib, Damian Morris, Eileen K. Hutton, Simon Heller, Susan Mitchell, Claire L Meek, Jeannie Grisoni, Janet Baxter, Richard I. G. Holt, Moshe Hod, John Weisnagel, Stephanie A. Amiel, Michelle Perkins, Craig Kollman, Chloe Nisbet, Anna Dover, Michael Maresh, Katharine F. Hunt, Tracy Tazzeo, Helen R. Murphy, Fiona Mackenzie, Jane Forbes, Eleanor Scott, Jill Coolen, Rasha Mukhtar, George Tomlinson, Kristin Castorino, Jeremy Turner, Lois E. Donovan, Annette Briley, Anna Reid, Emma Paul, Lois Jovanovic, Rosa Corcoy, Giuseppina Daniela, Aoife M. Egan, Catherine Young, Jill Newstead-Angel, Basilio Pintaudi, Gerry Rayman, Peter Novodorsky, Diana Tundidor, Julie Taylor, Niranjala M Hewapathirana, Rudy Bilous, Therese McSorley, Sharon Conway, J. D. Booth, Thomas Ransom, Jon Barrett, Collette Kirwin, Dawn Spick, Malcolm MacDougall, Natalia McInnes, Olivia Lou, Carolyn Oldford, Elizabeth Asztalos, Ruth McManus, Donna Frase, Anna Brackenridge, Zoe A. Stewart, Sandra L. Neoh, Juliet Morris, Anna Rogowsky, Robert S. Lindsay, Claire Singh, Carolyn Byrne, Gretta Kearney, Sue Hudson, Claire Gougeon, Barbara Cleave, Katrina J. Ruedy, Michelle Strom, Del Endersby, J. Johanna Sanchez, Katy Davenport, David M. Carty, J. M. Adelantado, Duncan Fowler, Josephine Rosier, Margaret Watson, Anne Kudirka, Irene Stanton, Peter Mansell, Gayna Babington, Leanne Piper, Elena Mion, Robert O'Brien, Darlene Baxendale, Erin Keely, Ilana Halperin, Susan Johnston, Martyna Chlost, Terri Cutts, Tim Wysocki, Louisa Green, Lynne Murray, Kathy Henry, Federico Bertuzzi, Ana Chico, Fiona Walbridge, Susan J. Quinn, Anita Banerjee, Sharon Chilton, Julia Lowe, Ariane Godbout, Adriana Breen, Marlon Pragnell, Isobel Crawford, Robyn L. Houlden, Ada Smith, Frances Dougherty, R. C. Temple, Helen Rogers, Janine Malcolm, Nicki Martin
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: Feig, D S, Donovan, L E, Corcoy, R, Murphy, K E, Amiel, S A, Hunt, K F, Asztalos, E, Barrett, J F R, Sanchez, J J, de Leiva, A, Hod, M, Jovanovic, L, Keely, E, McManus, R, Hutton, E K, Meek, C L, Stewart, Z A, Wysocki, T, O'Brien, R, Ruedy, K, Kollman, C, Tomlinson, G & Murphy, H R 2017, ' Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT) : A multicentre international randomised controlled trial ', Lancet, vol. 390, no. 10110, pp. 2347-2359 . https://doi.org/10.1016/S0140-6736(17)32400-5
Lancet (London, England)
LANCET
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
Universitat Pompeu Fabra
ISSN: 0140-6736
DOI: 10.1016/S0140-6736(17)32400-5
Popis: Background: Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes. Methods: In this multicentre, open-label, randomised controlled trial, we recruited women aged 18-40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527. Findings: Between March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference -0·19%; 95% CI -0·34 to -0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most common adverse events were skin reactions occurring in 49 (48%) of 103 CGM participants and eight (8%) of 104 control participants during pregnancy and in 23 (44%) of 52 CGM participants and five (9%) of 57 control participants in the planning pregnancy trial. The most common serious adverse events were gastrointestinal (nausea and vomiting in four participants during pregnancy and three participants planning pregnancy). Interpretation: Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes, which are likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy. This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use. Funding: Juvenile Diabetes Research Foundation, Canadian Clinical Trials Network, and National Institute for Health Research.
Databáze: OpenAIRE
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