RecruitingNCT07478211

Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery


Sponsor

Lia Bally

Enrollment

40 participants

Start Date

May 9, 2025

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is mapping how the menstrual cycle affects blood sugar levels in women with type 1 diabetes who use an automated insulin delivery system (also called a closed-loop or artificial pancreas system). Hormonal changes across the cycle can shift insulin needs, and this study aims to track those patterns. **You may be eligible if...** - You were assigned female at birth - You have had type 1 diabetes for at least 12 months - You are between 18 and 45 years old - You have a natural menstrual cycle not controlled by hormones or medications - You use insulin therapy (via injections or an insulin pump) - You are willing to use barrier contraception (like condoms) during the study **You may NOT be eligible if...** - You use hormonal contraceptives (birth control pills, IUD with hormones, implant, patch, ring, etc.) or any medication that affects your natural cycle - You are pregnant or breastfeeding - You have a condition that affects glucose metabolism (other than diabetes, thyroid conditions, or statins) - You are participating in another study that could interfere with results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital

Bern, Canton of Bern, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07478211


Related Trials