Map how the menstrual cycle affects blood sugar and energy while using closed-loop insulin
Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery
This study will test if normal menstrual hormone changes alter blood sugar control, insulin needs, and energy use in women aged 18–45 with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern, Canton of Bern) |
| Trial ID | NCT07478211 on ClinicalTrials.gov |
What this trial studies
This observational study follows natural-cycling women with type 1 diabetes across their menstrual cycles while they use their usual insulin therapy, including closed-loop systems when applicable. Researchers will characterize changes in glucose metabolism and energy balance that may be driven by hormone fluctuations, focusing on insulin sensitivity, gastric emptying, eating behavior, and energy expenditure. The study aims to map timing and magnitude of metabolic variation across follicular, ovulatory, and luteal phases to provide a detailed picture of cycle-related effects on glucose control. Data are intended to inform more precise timing of insulin adjustments and lifestyle advice.
Who should consider this trial
Good fit: Women aged 18–45 with type 1 diabetes, a natural menstrual cycle, and willingness to follow study procedures (including using mechanical contraception during participation) are ideal candidates.
Not a fit: People using hormonal contraceptives, other interventions that alter cyclical bleeding, or with conditions likely to interfere with glucose or energy metabolism are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could help personalize insulin dosing and meal planning across the menstrual cycle to improve glucose control and reduce hypoglycemia.
How similar studies have performed: Previous research suggests menstrual hormones can affect glucose and energy metabolism, but detailed natural-cycle metabolic data specifically in women with type 1 diabetes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern, Canton of Bern
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital — Bern, Canton of Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Prof. Dr. med. et Dr. phil. Lia Bally
- Email: lia.bally@insel.ch
- Phone: +41 31 632 36 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.