Advanced Hybrid Closed-Loop Therapy Compared With Standard Insulin Therapy Intrapartum and Early Postpartum in Women With Type 1 Diabetes: A Secondary Observational Analysis From the CRISTAL Randomized Controlled Trial.

Autor:	Beunen K; Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium., Gillard P; Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium.; Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium., Van Wilder N; Department of Endocrinology, University Hospital Brussels, Jette, Belgium., Ballaux D; Department of Endocrinology, Vitaz Campus Sint-Niklaas Moerland, Sint-Niklaas, Belgium., Vanhaverbeke G; Department of Endocrinology, General Hospital Groeninge Kortrijk, Kortrijk, Belgium., Taes Y; Department of Endocrinology, General Hospital Sint-Jan Brugge, Brugge, Belgium., Aers XP; Department of Endocrinology, General Hospital Delta Campus Rumbeke, Roeselare, Belgium., Nobels F; Department of Endocrinology, OLV Hospital Aalst, Aalst, Belgium., Van Huffel L; Department of Endocrinology, OLV Hospital Aalst, Aalst, Belgium., Marlier J; Department of Endocrinology, Ghent University Hospital, Gent, Belgium., Lee D; Department of Endocrinology, Imelda Hospital Bonheiden, Bonheiden, Belgium., Cuypers J; Department of Endocrinology, General Hospital Turnhout Campus Sint-Jozef, Turnhout, Belgium., Preumont V; Department of Endocrinology, University Hospital Saint-Luc, Brussel, Belgium., Siegelaar SE; Department of Endocrinology and Metabolism, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands.; Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, Amsterdam, the Netherlands., Painter RC; Department of Obstetrics & Gynecology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.; Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, the Netherlands., Laenen A; Center of Biostatics and Statistical bioinformatics, KU Leuven, Leuven, Belgium., Mathieu C; Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium.; Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium., Benhalima K; Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium.; Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium.
Jazyk:	angličtina
Zdroj:	Diabetes care [Diabetes Care] 2024 Sep 27. Date of Electronic Publication: 2024 Sep 27.
DOI:	10.2337/dc24-1320
Abstrakt:	Objective: To determine efficacy and safety of intrapartum and early postpartum advanced hybrid closed-loop (AHCL) therapy compared with standard insulin therapy in pregnant women with type 1 diabetes (T1D). Research Design and Methods: CRISTAL was a double-arm, open-label, randomized controlled trial performed in Belgium and the Netherlands that assigned 95 pregnant participants with T1D 1:1 to a MiniMed 780G AHCL system (n = 46) or standard insulin therapy (n = 49). This prespecified, secondary observational analysis focused on differences in glycemic control and safety outcomes between participants from the original AHCL group who continued AHCL intrapartum (n = 27) and/or early postpartum (n = 37, until hospital discharge) and those from the original standard insulin therapy group using standard insulin therapy intrapartum (n = 45) and/or early postpartum (n = 34). Results: Of the 43 and 46 participants in the AHCL and standard insulin therapy groups, respectively, completing the trial, 27 (62.8%) in the AHCL group continued AHCL and 45 in the standard insulin therapy group (97.8%) continued standard insulin therapy intrapartum. Compared with standard insulin therapy, intrapartum AHCL was associated with more time in range 3.5-7.8 mmol/L (71.5 ± 17.7% vs. 63.1 ± 17.0%, P = 0.030) and numerically lower time above range >7.8 mmol/L (27.3 ± 17.4% vs. 35.3 ± 17.5%, P = 0.054), without increases in time below range <3.5 mmol/L (1.1 ± 2.4% vs. 1.5 ± 2.3%, P = 0.146). Early postpartum, 37 (86.0%) participants randomized to AHCL continued AHCL, with a median increase in insulin-to-carbohydrate ratios of 67% (interquartile range -14 to 126). Similar tight glycemic control (3.9-10.0 mmol/L: 86.8 ± 6.7% vs. 83.8 ± 8.1%, P = 0.124) was observed with AHCL versus standard insulin therapy. No severe hypoglycemia or diabetic ketoacidosis was reported in either group. Conclusions: AHCL is effective in maintaining tight glycemic control intrapartum and early postpartum and can be safely continued during periods of rapidly changing insulin requirements. (© 2024 by the American Diabetes Association.)
Databáze:	MEDLINE
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