Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery (NCT07478211) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery
Switzerland40 participantsStarted 2025-05-09
Plain-language summary
The hypothesis is that menstrual cyclicity affects glucose and energy metabolism in women with type 1 diabetes. The rationale of the hypothesis on cycle effects builds on the assumption that fluctuations of female sex hormones across the menstrual cycle cause changes in physiological parameters of glucose metabolism and energy homeostasis and/or lifestyle aspects involved in the regulation of blood glucose and body weight. It is expected that hormone fluctuations affect insulin sensitivity, gastric emptying, eating behaviour and energy expenditure. It is anticipated that insulin sensitivity is highest in the pre-ovulatory phase and lowest in the mid-luteal phase. It is further expected that gastric emptying peaks in the follicular phase, and highest energy expenditure and dietary intake are expected during the mid-luteal phase.
The primary objective of this study is to characterize glucose and energy metabolism throughout the menstrual cycle in natural cycling women with type 1 diabetes. Further objectives are to assess the impact of the menstrual cycle on glucose control and insulin requirements, investigate how fluctuations in sex hormone levels influence glucose and energy metabolism, and quantify both inter- and intra-individual variability in metabolic changes related to the menstrual cycle. Additionally, the study will evaluate whether changes in key physiological components of glucose metabolism and behavioural factors mediate menstrual cycle-related variations in glucose control and insulin requirements.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female sex assigned at birth
* Type 1 diabetes for at least 12 months
* Aged 18-45 years
* Natural menstrual cycle (occurring without medical or hormonal interventions)
* Functional insulin therapy delivered via injection or insulin pump
* Willingness to follow study-related procedures
* Willingness to use mechanical contraception during the time of study participation
Exclusion Criteria:
* Use of contraceptives or medical interventions that interfere with natural hormonal fluctuations of the menstrual cycle or cyclical bleeding
* Interventions interfering with glucose or energy metabolism (other than insulin, thyroid hormone replacement or statins), as judged by the investigator, will be paused for the duration of the study, with an adequate washout duration prior to the start of data collection
* Presence of any physical or psychological condition, or any medical intervention likely to interfere with the conduct of the procedures and/or their evaluation, as judged by the investigator
* Pregnant or breast-feeding
* Participation in another clinical study that interferes with the interpretation of the study results as judged by the investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying how the menstrual cycle affects blood sugar control with a closed-loop insulin delivery system — does my own cycle pattern or hormonal situation make me a good or poor fit for what they're trying to measure?
2Since this trial is no longer recruiting new participants, are there similar ongoing studies looking at how hormonal fluctuations interact with automated insulin delivery that I might still be able to join?
3The trial is measuring 'time in target glucose range' — can you help me understand what my current time in range looks like, and whether that baseline might be relevant to how I think about studies like this one?
4This is listed as 'Phase NA,' which often means it's observational or device-based rather than testing a new drug — does that change the risk profile compared to a standard drug trial, and what would participation actually involve day-to-day?
5Given that this study focuses on energy metabolism and the menstrual cycle alongside Type 1 diabetes, are there any findings already published from this kind of research that might inform how we manage my insulin settings around my cycle right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time in target glucose range
Timeframe: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).