Glycemic Control Across the Menstrual Cycle in Women with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System: The 780MENS Prospective Study.

Abstract

Objective: To evaluate whether the MiniMed™ 780G advanced hybrid closed-loop (AHCL) system maintains similar glycemic control across two different phases of the menstrual cycle in women with type 1 diabetes (T1D) and to analyze the system's performance in these situations. Methods: Continuous glucose monitoring (CGM) and insulin delivery metrics from 12 participants with T1D using the MiniMed™ 780G AHCL were analyzed throughout 3 prospectively recorded, consecutive menstrual cycles (36 cycles in total). Mixed models were used to compare the different variables between the early follicular phase and late luteal phase. Results: A higher average glucose was found throughout the late luteal phase compared with the early follicular phase (139.5 [133.5, 145.2] vs. 131.5 [126.8, 140.2] mg/dl, respectively, P = 0.002), together with an increase in total daily insulin dose (37.2 ± 11.9 vs. 33.6 ± 12.2 IU, P < 0.001). However, similar values between phases were observed for most of the remaining CGM metrics, including time in range (83.0 [76.0, 87.5] vs. 85.0 [79.8, 89.0] %, P = 0.101). Conclusion: Our results suggest that differences in glycemic control may be found across the menstrual cycle in women with T1D using the MiniMed™ 780G AHCL. Although higher average glucose levels may be expected in the late luteal phase, the deterioration of glycemic control during this phase may be mild with the MiniMed™ 780G AHCL, given the similarities for most of the CGM metrics with respect to the early follicular phase.