Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial
Author:
Feig Denice S.123ORCID, Corcoy Rosa45ORCID, Donovan Lois E.6, Murphy Kellie E.123, Barrett Jon F.R.7, Sanchez J. Johanna7, Wysocki Tim8, Ruedy Katrina9, Kollman Craig9, Tomlinson George310, Murphy Helen R.111213ORCID, Murphy Helen, Grisoni Jeannie, Byrne Carolyn, Neoh Sandra, Davenport Katy, Donovan Lois, Gougeon Claire, Oldford Carolyn, Young Catherine, Amiel Stephanie, Hunt Katharine, Green Louisa, Rogers Helen, Rossi Benedetta, Feig Denice, Cleave Barbara, Strom Michelle, Corcoy Rosa, de Leiva Alberto, María Adelantado Juan, Isabel Chico Ana, Tundidor Diana, Keely Erin, Malcolm Janine, Henry Kathy, Morris Damian, Rayman Gerry, Fowler Duncan, Mitchell Susan, Rosier Josephine, Temple Rosemary, Turner Jeremy, Canciani Gioia, Hewapathirana Niranjala, Piper Leanne, McManus Ruth, Kudirka Anne, Watson Margaret, Bonomo Matteo, Pintaudi Basilio, Bertuzzi Federico, Daniela Corica Giuseppina, Mion Elena, Lowe Julia, Halperin Ilana, Rogowsky Anna, Adib Sapida, Lindsay Robert, Carty David, Crawford Isobel, Mackenzie Fiona, McSorley Therese, Booth John, McInnes Natalia, Smith Ada, Stanton Irene, Tazzeo Tracy, Weisnagel John, Mansell Peter, Jones Nia, Babington Gayna, Spick Dawn, MacDougall Malcolm, Chilton Sharon, Cutts Terri, Perkins Michelle, Scott Eleanor, Endersby Del, Dover Anna, Dougherty Frances, Johnston Susan, Heller Simon, Novodorsky Peter, Hudson Sue, Nisbet Chloe, Ransom Thomas, Coolen Jill, Baxendale Darlene, Holt Richard, Forbes Jane, Martin Nicki, Walbridge Fiona, Dunne Fidelma, Conway Sharon, Egan Aoife, Kirwin Collette, Maresh Michael, Kearney Gretta, Morris Juliet, Quinn Susan, Bilous Rudy, Mukhtar Rasha, Godbout Ariane, Daigle Sylvie, Lubina Solomon Alexandra, Jackson Margaret, Paul Emma, Taylor Julie, Houlden Robyn, Breen Adriana, Banerjee Anita, Brackenridge Anna, Briley Annette, Reid Anna, Singh Claire, Newstead-Angel Jill, Baxter Janet, Philip Sam, Chlost Martyna, Murray Lynne, Castorino Kristin, Jovanovic Lois, Frase Donna, Lou Olivia, Pragnell Marlon,
Affiliation:
1. Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada 2. Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada 3. Department of Medicine, University of Toronto, Toronto, Ontario, Canada 4. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain 5. CIBER-BBN, Zaragoza, Spain 6. University of Calgary, Calgary, Alberta, Canada 7. Sunnybrook Research Institute, Toronto, Ontario, Canada 8. Nemours Children’s Health System, Jacksonville, FL 9. Jaeb Center for Health Research, Tampa, FL 10. University Health Network, Toronto, Ontario, Canada 11. Cambridge University Hospitals NHS Foundation Trust, Cambridge, U.K. 12. Department of Women and Children’s Health, King’s College London, London, U.K. 13. Department of Medicine, University of East Anglia, Norwich, U.K.
Abstract
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 >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.
Funder
JDRF JDRF and FedDev Ontario
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Reference35 articles.
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