A Real-World Study Comparing Advanced Hybrid Closed-Loop Systems During Pregnancy in Women with Type 1 Diabetes
Year: 2025
Type: article
Study design: Observational Study
Abstract: Objective: To compare maternal glucose metrics and pregnancy outcomes of three advanced hybrid closed-loop (aHCL) systems (MiniMed 780G®, CamAPS® FX, and Tandem Control-IQ) in a real-world, multicenter cohort of pregnant women with type 1 diabetes. Research Design and Methods: Cohort study including 137 pregnant women with type 1 diabetes using aHCL from 27 hospitals in Spain. Participants were grouped according to the aHCL system used: 85 MiniMed 780G (62%), 38 CamAPS FX (27.7%), and 14 Control-IQ (10.2%). Maternal glucose metrics (HbA1c and time spent within [TIRp], below [TBRp], and above [TARp] the pregnancy-specific glucose range 3.5–7.8 mmol/L), as well as pregnancy outcomes, were analyzed. Adjusted models were applied to account for potential confounding factors. Results: No between-group differences in HbA1c levels were observed at baseline. By the third trimester, CamAPS FX and Control-IQ users had significantly lower HbA1c levels compared with the MiniMed 780G group (β adjusted –4.77 mmol/mol, 95% confidence interval [CI] –7.40 to –2.13; and β adjusted –4.79, 95% CI –8.53 to –1.06; respectively). In the second trimester, CamAPS FX was associated with a higher percentage of time in range (β adjusted +5.88%, 95% CI 1.09 to 10.67) and a lower percentage of time above range (β adjusted –6.36%, 95% CI –11.46 to –1.26) compared with MiniMed 780G, with no other significant differences observed in other trimesters. Both CamAPS FX and Control-IQ were associated with lower odds of large-for-gestational-age (LGA) infants (CamAPS FX: OR adjusted 0.25, 95% CI 0.08 to 0.77; Control-IQ: OR adjusted 0.10, 95% CI 0.01 to 0.99) compared with MiniMed 780G. Conclusions: In this multicenter observational study, CamAPS FX and Control-IQ users achieved better glycemic metrics and lower odds of delivering LGA infants compared with those using MiniMed 780G. These findings warrant investigation to confirm associations and inform individualized clinical decision-making in pregnant women with type 1 diabetes.
Authors: Carmen Quirós, Ana M. Wägner, Sharona Azriel, Berta Soldevila, Pilar I. Beato-Vibora, Mayte Herrera Arranz, Lía Nattero, María José Picón-César, Elisenda Climent, Judit Amigó, Natalia Colomo, María Durán-Martínez, Macarena Alpañes Buesa, Ana Megía, Irene Vinagre, Begoña Vega Guedes, Gonzalo Díaz-Soto, Orosia Bandrés, Beatriz Barquiel, Cristina López Tinoco, Rosa Márquez-Pardo, Maria A. Martínez-Brocca, Rosa Corcoy, Mercè Codina, María Piedra, Ángel Rebollo Román, Martín Cuesta, Gema López-Gallardo, Maria M. Goya Canino, Fernando Bugatto, Lilian C. Mendoza, María del Pilar Olvera Márquez, Verónica Perea
Institutions: University Hospital Mútua de Terrassa, Universidad de Las Palmas de Gran Canaria, Hospital Universitario Infanta Sofía, Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Hospital Universitari Germans Trias i Pujol, Hospital Universitario Nuestra Señora de Candelaria, Hospital Universitario Ramón y Cajal, Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition, Andalusian Centre for Nanomedicine and Biotechnology, Hospital Clínico Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Hospital Del Mar, Vall d'Hebron Hospital Universitari, Hospital Regional Universitario de Málaga, Hospital Universitario de Getafe, Hospital Universitario Puerta de Hierro Majadahonda, Institut de Recerca Biomèdica Catalunya Sud, Hospital Universitari Joan XXIII de Tarragona, Universitat Rovira i Virgili, Hospital Clínic de Barcelona, Hospital Clínico Universitario de Valladolid, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario La Paz, Universidad de Cádiz, Biomedical Research and Innovation Institute of Cadiz, Hospital Universitario Puerta del Mar, Hospital Juan Ramón Jiménez, Hospital Universitario Virgen Macarena, Hospital de Sant Pau, Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine, Centro de Investigación Biomédica en Red, Institut de Recerca Sant Pau, Hospital Universitario Son Espases, Marqués de Valdecilla University Hospital, Hospital Universitario Reina Sofía, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Hospital Universitario Virgen del Rocío, Universitat Autònoma de Barcelona
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4414575416