BES2025 BES 2025 CLINICAL STUDIES (21 abstracts)
Who benefits most from advanced hybrid closed loop therapy in pregnancy based on baseline characteristics? a secondary analysis of the CRISTAL trial
Ina Geerts 1 , Kaat Beunen 1 , Nancy Van Wilder 2 , Dominique Ballaux 3 , Gerd Vanhaverbeke 4 , Youri Taes 5 , Xavier-Philippe Aers 6 , Frank Nobels 7 , Liesbeth Van Huffel 7 , Joke Marlier 8 , Dahae Lee 9 , Joke Cuypers 10 , Vanessa Preumont 11 , Sarah E. Siegelaar 12,13 , Rebecca C. Painter 14,15 , Annouschka Laenen 16 , Pieter Gillard 1,17 , Chantal Mathieu 1,17 & Katrien Benhalima 1,17
1Clinical and Experimental Endocrinology, KU Leuven; 2University Hospital Brussels; 3Vitaz Sint-Niklaas Moerland; 4AZ Groeninge Kortrijk; 5AZ Sint-Jan Brugge; 6AZ Delta Campus Rumbeke; 7AZORG Hospital Aalst; 8University Hospital Ghent; 9Imelda Hospital Bonheiden; 10AZ Turnhout Campus Sint-Jozef; 11University Hospital Saint-Luc; 12Endocrinology and Metabolism, Amsterdam UMC; 13Gastroenterology Endocrinology and Metabolism, Amsterdam UMC; 14Obstetrics & Gynecology, Amsterdam UMC; 15Amsterdam Reproduction and Development, Amsterdam UMC; 16Center of Biostatics and Statistical Bioinformatics, KU Leuven; 17University Hospitals Leuven
Introduction: The CRISTAL trial showed that advanced hybrid closed-loop (AHCL) therapy with the MiniMed™ 780G system in type 1 diabetes (T1D) pregnancy did not improve the pregnancy-specific time in range (TIRp) overall compared to standard insulin therapy (SoC), but improved TIRp overnight and reduced time below range (TBRp) (1). Identifying subgroups that may benefit most from AHCL use is crucial for optimizing treatment strategies. We aimed to identify subgroups that may benefit most from AHCL therapy in pregnancy based on baseline characteristics.
Methods: This is a secondary analysis of the CRISTAL study, a multicenter randomized controlled trial comparing MiniMed™ 780G AHCL with SoC in 95 pregnant women with T1D. The primary outcome (TIRp) and key secondary outcomes (TIRp overnight, TBRp overall and overnight) were evaluated according to various baseline characteristics.
Results: AHCL users with baseline HbA1c <7.0% (n = 35) had a significantly higher TIRp than SoC (n = 37), with a mean difference of 5.64% (95% CI: 1.32-9.96), corresponding to 1h21min more TIRp per day and 11.89% (95% CI: 7.01-16.76) higher TIRp overnight. In women without prior AHCL use, TIRp was 6.29% (95% CI:0.90-11.68) higher in the AHCL group (n = 24) with an 11.91% (95% CI: 5.65-18.16) higher overnight TIRp compared to SoC (n = 28). TIRp was significantly higher in AHCL users (n = 14) compared to SoC (n = 14) in women without higher education (7.33%, 95% CI: 0.88-13.78). TBRp was significantly lower in AHCL users with baseline HbA1c <7.0% and in women without prior AHCL use compared to SoC.
Conclusion: AHCL use with the MiniMed™ 780G system improved glycemic control in pregnant women with baseline HbA1c<7.0%, women without prior AHCL use, and women without higher education, indicating that AHCL use might particularly benefit these subgroups.
Reference: 1. Benhalima K, Beunen K, Van Wilder N, et al. Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, openlabel, randomised controlled trial.12(6),390–403 (2024).
Keywords: Diabetes in pregnancy, Technology and diabetes, Artificial pancreas
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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