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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 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.
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Recent cohort data have indicated that menstrual cycle-related metabolic variability may persist despite advanced hybrid closed-loop therapy.
“Conversely, recent cohort data have indicated that menstrual cycle‐related metabolic variability may persist despite AHCL therapy.”
In that cohort study of advanced hybrid closed-loop users, mean glucose levels increased during the late-luteal phase.
“A cohort study of AHCL users reported that although TIR was maintained with an increase in total daily insulin dose (TDD) during the late‐luteal phase, the mean glucose levels increased 10 .”
In a cohort study of advanced hybrid closed-loop users, Time in Range was maintained with an increase in total daily insulin dose during the late-luteal phase.
“A cohort study of AHCL users reported that although TIR was maintained with an increase in total daily insulin dose (TDD) during the late‐luteal phase, the mean glucose levels increased 10 .”
Monroy et al. examined individuals with relatively high baseline glycemic control (TIR in the 80% range).
“Elhenawy et al. 9 investigated an adolescent and young adult cohort (14–21 years), whereas Monroy et al. 10 examined individuals with relatively high baseline glycemic control (TIR in the 80% range).”
Monroy et al. restricted enrollment to users with auto-mode utilization >95%.
“Monroy et al. 10 restricted enrollment to users with auto‐mode utilization >95%, reflecting near‐continuous algorithm support.”
Recorded carbohydrate amount and carbohydrate entry frequency increased during the late-luteal phase.
“From a behavioral perspective, both the recorded carbohydrate amount and carbohydrate entry frequency increased during the late‐luteal phase, consistent with prior observations of increased carbohydrate intake during this phase 10 .”
Monroy et al. reported increased mean glucose levels and TAR during the luteal phase.
“Elhenawy et al. observed that menstrual phase‐related differences in TIR disappeared after AHCL initiation 9 , whereas Monroy et al. reported increased mean glucose levels and TAR during the luteal phase 10 .”
Body weight-adjusted TDD was higher in this cohort than in prior reports.
“Body weight‐adjusted TDD was higher in this cohort than in prior reports 10 .”
Our results are broadly aligned with prior investigations using the MiniMed 780G system.
“Furthermore, our results are broadly aligned with those of prior investigations using the MiniMed 780G system 9 , 10 .”
The observed increase in insulin demand during the luteal phase corresponds to reports of algorithm-driven increases in insulin delivery during AHCL therapy and increased TDD during the luteal phase.
“The observed increase in insulin demand during the luteal phase corresponds to reports demonstrating algorithm‐driven increases in insulin delivery during AHCL therapy 9 and increased TDD during the luteal phase 10 .”
Citations
Cites
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Brown, S. A., Kovatchev, B. P., Raghinaru, D., Lum, J. W., Buckingham, B. A., Kudva, Y. C., Laffel, L. M., Levy, C. J., Pinsker, J. E., Wadwa, R. P., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1907863 · Cited by 1,030
Brown, S. A., Jiang, B., McElwee-Malloy, M., Wakeman, C., & Breton, M. D. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815608400 · Cited by 81
Menstrual Cycle Effects on Insulin Sensitivity in Women with Type 1 Diabetes: A Pilot Study
Trout, K. K., Rickels, M. R., Schutta, M. H., Petrova, M., Freeman, E. W., Tkacs, N. C., & Teff, K. L. (2007) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2006.0004 · Cited by 75
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Brain insulin action on peripheral insulin sensitivity in women depends on menstrual cycle phase
Hummel, J., Benkendorff, C., Fritsche, L., Prystupa, K., Vosseler, A., Gancheva, S., Trenkamp, S., Birkenfeld, A. L., Preissl, H., Roden, M., et al. (2023) · Nature Metabolism · doi:10.1038/s42255-023-00869-w · Cited by 48 · cited 1×
“19 The performance of AHCL systems across the menstrual cycle in women with T1D remains poorly explored.”
Diaz C., J. L., Fabris, C., Breton, M. D., & Cengiz, E. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2022.0154 · Cited by 19
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Takagi, E., Kaga, H., Mori, R., Fujikawa, S., Nagashima, H., Kogai, T., Koshibu, M., Sato, J., Nishida, Y., Ikeda, F., et al. (2026) · Journal of Diabetes Investigation · doi:10.1111/jdi.70463
Metadata
- Authors
- Monroy, G., Picón-César, M. J., García-Alemán, J., Tinahones, F. J., & Martínez-Montoro, J. I.
- Affiliations
- Sant Joan de Déu Research Foundation (ES)
- Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Málaga, Spain.
- Instituto de Salud Carlos III (ES)
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2025-05
- Volume
- 27
- Issue
- 5
- Pages
- 395-401
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- OpenAlex
- W4407102726
- Cited by
- 17
- References
- 6
- Citations by year
- 2026: 10 · 2025: 7
- FWCI
- 11.67
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- type 1 diabetes, menstrual cycle, glycemic control, advanced hybrid closed-loop system, MiniMed 780G, continuous glucose monitoring, luteal phase, follicular phase, insulin dose, time in range, women with diabetes
- MeSH terms
- Glycemic Control, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Follicular Phase, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Luteal Phase, Menstrual Cycle, Prospective Studies, Blood Glucose Self-Monitoring, Young Adult
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