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

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.