Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial
Authors: Denice S. Feig, Rosa Corcoy, Lois E. Donovan, Kellie E. Murphy, Jon F.R. Barrett, J. Johanna Sanchez, Tim Wysocki, Katrina Ruedy, Craig Kollman, George Tomlinson, Helen R. Murphy, Helen Murphy, Jeannie Grisoni, Carolyn Byrne, Sandra Neoh, Katy Davenport, Lois Donovan, Claire Gougeon, Carolyn Oldford, Catherine Young, Stephanie Amiel, Katharine Hunt, Louisa Green, Helen Rogers, Benedetta Rossi, Denice Feig, Barbara Cleave, Michelle Strom, Rosa Corcoy, Alberto de Leiva, Juan María Adelantado, Ana Isabel Chico, Diana Tundidor, Erin Keely, Janine Malcolm, Kathy Henry, Damian Morris, Gerry Rayman, Duncan Fowler, Susan Mitchell, Josephine Rosier, Rosemary Temple, Jeremy Turner, Gioia Canciani, Niranjala Hewapathirana, Leanne Piper, Ruth McManus, Anne Kudirka, Margaret Watson, Matteo Bonomo, Basilio Pintaudi, Federico Bertuzzi, Giuseppina Daniela Corica, Elena Mion, Julia Lowe, Ilana Halperin, Anna Rogowsky, Sapida Adib, Robert Lindsay, David Carty, Isobel Crawford, Fiona Mackenzie, Therese McSorley, John Booth, Natalia McInnes, Ada Smith, Irene Stanton, Tracy Tazzeo, John Weisnagel, Peter Mansell, Nia Jones, Gayna Babington, Dawn Spick, Malcolm MacDougall, Sharon Chilton, Terri Cutts, Michelle Perkins, Eleanor Scott, Del Endersby, Anna Dover, Frances Dougherty, Susan Johnston, Simon Heller, Peter Novodorsky, Sue Hudson, Chloe Nisbet, Thomas Ransom, Jill Coolen, Darlene Baxendale, Richard Holt, Jane Forbes, Nicki Martin, Fiona Walbridge, Fidelma Dunne, Sharon Conway, Aoife Egan, Collette Kirwin, Michael Maresh, Gretta Kearney, Juliet Morris, Susan Quinn, Rudy Bilous, Rasha Mukhtar, Ariane Godbout, Sylvie Daigle, Alexandra Lubina Solomon, Margaret Jackson, Emma Paul, Julie Taylor, Robyn Houlden, Adriana Breen, Anita Banerjee, Anna Brackenridge, Annette Briley, Anna Reid, Claire Singh, Jill Newstead-Angel, Janet Baxter, Sam Philip, Martyna Chlost, Lynne Murray, Kristin Castorino, Lois Jovanovic, Donna Frase, Olivia Lou, Marlon Pragnell
Journal: Diabetes Care (2018)

OBJECTIVE To compare glycemic control, quality of life, and pregnancy outcomes of women using insulin pumps and multiple daily injection therapy (MDI) during the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT). RESEARCH DESIGN AND METHODS This was a prespecified analysis of CONCEPTT involving 248 pregnant women from 31 centers. Randomization was stratified for pump versus MDI and HbA1c. The primary outcome was change in HbA1c from randomization to 34 weeks’ gestation. Key secondary outcomes were continuous glucose monitoring (CGM) measures, maternal-infant health, and patient-reported outcomes. RESULTS At baseline, pump users were more often in stable relationships (P = 0.003), more likely to take preconception vitamins (P = 0.03), and less likely to smoke (P = 0.02). Pump and MDI users had comparable first-trimester glycemia: HbA1c 6.84 ± 0.71 vs. 6.95 ± 0.58% (51 ± 7.8 vs. 52 ± 6.3 mmol/mol) (P = 0.31) and CGM time in target (51 ± 14 vs. 50 ± 13%) (P = 0.40). At 34 weeks, MDI users had a greater decrease in HbA1c (−0.55 ± 0.59 vs. −0.32 ± 0.65%, P = 0.001). At 24 and 34 weeks, MDI users were more likely to achieve target HbA1c (P = 0.009 and P = 0.001, respectively). Pump users had more hypertensive disorders (P = 0.011), mainly driven by increased gestational hypertension (14.4 vs. 5.2%; P = 0.025), and more neonatal hypoglycemia (31.8 vs. 19.1%, P = 0.05) and neonatal intensive care unit (NICU) admissions &amp;gt;24 h (44.5 vs. 29.6%; P = 0.02). Pump users had a larger reduction in hypoglycemia-related anxiety (P = 0.05) but greater decline in health/well-being (P = 0.02). CONCLUSIONS In CONCEPTT, MDI users were more likely to have better glycemic outcomes and less likely to have gestational hypertension, neonatal hypoglycemia, and NICU admissions than pump users. These data suggest that implementation of insulin pump therapy is potentially suboptimal during pregnancy.