Actively Recruiting
Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery
Led by Lia Bally · Updated on 2026-03-17
40
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
Sponsors
L
Lia Bally
Lead Sponsor
G
Gertrud and Walter Siegenthaler Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex assigned at birth
- Type 1 diabetes for at least 12 months
- Aged 18-45 years
- Natural menstrual cycle 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 study participation
You will not qualify if you...
- Use of contraceptives or medical treatments that affect natural hormonal fluctuations or menstrual bleeding
- Use of interventions affecting glucose or energy metabolism (except insulin, thyroid hormone replacement, or statins) unless paused with washout before study
- Any physical or psychological condition or medical intervention interfering with study procedures or evaluation
- Pregnant or breast-feeding
- Participation in another clinical study that affects interpretation of results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
Research Team
P
Prof. Dr. med. et Dr. phil. Lia Bally
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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