Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes (NCT06282055) | Clinical Trial Compass
RecruitingNot Applicable
Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
Switzerland350 participantsStarted 2025-11-20
Plain-language summary
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
Who can participate
Age range
18 Years – 40 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
* Between 18 and 40 years at inclusion
* Menarche at least one year prior to study inclusion
* Regular menstrual cycle (at least one menstrual cycle in the last 40 days)
* Average menstrual cycle length between 21 and 38 days
* Difference in length between consecutive menstrual cycles of at most 7 days
* Living with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year
* Actively using an AID system for their diabetes management at least six months prior to study inclusion
Exclusion criteria:
* Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception
* Pregnancy until two months postpartum (ongoing or planned)
* Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping
* Known Polycystic Ovary Syndrome (PCOS)
* Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs
* Individuals with work patterns involving frequent shifts between night and day work (e.g., alternating night and day shifts on a weekly or similar basis).
* Participation in an interventional study within two months preceding and during the present study
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Identify clusters in trajectories across the menstrual cycle