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. 2025 Sep 26.
doi: 10.1177/15209156251379488. Online ahead of print.

A Real-World Study Comparing Advanced Hybrid Closed-Loop Systems During Pregnancy in Women with Type 1 Diabetes

Carmen Quirós  1 , Ana M Wägner  2 , Sharona Azriel  3 , Berta Soldevila  4   5 , Pilar I Beato-Vibora  6 , Mayte Herrera Arranz  7 , Lía Nattero  5   8 , María José Picón-César  9   10   11 , Elisenda Climent  12 , Judit Amigó  13 , Natalia Colomo  5   14   15 , María Durán-Martínez  16 , Macarena Alpañes Buesa  17 , Ana Megía  5   18   19 , Irene Vinagre  2   20 , Begoña Vega Guedes  2 , Gonzalo Díaz-Soto  21 , Orosia Bandrés  22 , Beatriz Barquiel  23 , Cristina López Tinoco  24   25   26 , Rosa Márquez-Pardo  27 , Maria A Martínez-Brocca  28 , Rosa Corcoy  29   30   31 , Mercè Codina  32 , María Piedra  33 , Ángel Rebollo Román  34 , Martín Cuesta  5   35   36 , Gema López-Gallardo  37 , Maria M Goya Canino  38   39 , Fernando Bugatto  24 , Lilian C Mendoza  30   31   40 , María Del Pilar Olvera Márquez  41 , Verónica Perea  1
Affiliations

A Real-World Study Comparing Advanced Hybrid Closed-Loop Systems During Pregnancy in Women with Type 1 Diabetes

Carmen Quirós et al. Diabetes Technol Ther. .

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 (βadjusted -4.77 mmol/mol, 95% confidence interval [CI] -7.40 to -2.13; and βadjusted -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 (βadjusted +5.88%, 95% CI 1.09 to 10.67) and a lower percentage of time above range (βadjusted -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: ORadjusted 0.25, 95% CI 0.08 to 0.77; Control-IQ: ORadjusted 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.

Keywords: HbA1c; advanced hybrid closed-loop; continuous glucose monitoring; maternal–fetal outcomes; pregnancy; type 1 diabetes.

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