Variability of Glycemic Outcomes and Insulin Requirements Throughout the Menstrual Cycle: A Qualitative Study on Women With Type 1 Diabetes Using an Open-Source Automated Insulin Delivery System

Abstract

Background: The impact of hormone dynamics throughout the menstrual cycle on insulin sensitivity represents a currently under-researched area. Despite therapeutic and technological advances, self-managing insulin therapy remains challenging for women with type 1 diabetes (T1D). Methods: To investigate perceived changes in glycemic levels and insulin requirements throughout the menstrual cycle and different phases of life, we performed semi-structured interviews with 12 women with T1D who are using personalized open-source automated insulin delivery (AID) systems. Transcripts were analyzed using thematic analysis with an inductive, hypothesis-generating approach. Results: Participants reported significant differences between the follicular phase, ovulation, and luteal phase of the menstrual cycle and also during puberty, pregnancy, and menopause. All participants reported increased comfort and safety since using AID, but were still required to manually adjust their therapy according to their cycle. A lack of information and awareness and limited guidance by health care providers were frequently mentioned. Although individual adjustment strategies exist, achieving optimum outcomes was still perceived as challenging. Conclusions: This study highlights that scientific evidence, therapeutic options, and professional guidance on female health-related aspects in T1D are insufficient to date. Further efforts are required to better inform people with T1D, as well as for health care professionals, researchers, medical device manufacturers, and regulatory bodies to better address female health needs in therapeutic advances.

The effect of menstrual hormonal fluctuations on the glycaemic control in women with type 1 diabetes mellitus

“…Women with T1DM themselves frequently report an awareness of higher tendency toward high blood sugar and a need for increased insulin dosage in the latter half of their cycle. 22,23 Therefore, cyclical hormonal changes should be taken into consideration when treating premenopausal women with T1DM. The utilisation of information about interphase variability in glucose tolerance to fine-tune insulin doses in these subjects could assist in improving glycaemic control by reducing hyperglycaemic excursions (especially in the luteal phase) without increasing hypoglycaemic events.…”

“…Unfortunately, this vulnerability is oftentimes not properly addressed in therapeutic instructions, leading thereby to increased exposure to hyperglycaemia. Women with T1DM themselves frequently report an awareness of higher tendency toward high blood sugar and a need for increased insulin dosage in the latter half of their cycle 22,23 . Therefore, cyclical hormonal changes should be taken into consideration when treating premenopausal women with T1DM.…”

Patient‐led innovation and global health justice: Open‐source digital health technology for type 1 diabetes care

“…), Routledge handbook of feminist bioethics (pp. [151][152][153][154][155][156][157][158][159][160][161][162][163][164][165][166]. Routledge.…”

“…151 Unlike citizen science in this project, people withT1D are not only invited to participate, but they are at the center of all steps of the research project. The project also advances research on so far neglected aspects of T1D, such as the relationship between automated insulin delivery systems and users' menstrual cycle, exploring how digital technologies might work differently for women and fellow people with uteruses in terms of menstruation, 158 which is an understudied area of diabetology 159 and medicine in general. 160 Notably, the OPEN project also enables the collection and analysis of data about the users of open-source automated insulin delivery systems.…”