Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery

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.

Conditions

• Diabetes Mellitus, Type 1
• Energy Metabolism

Sponsors & Collaborators

• Gertrud and Walter Siegenthaler Foundation

  collaborator UNKNOWN

• Burgergemeinde

  collaborator UNKNOWN

• Bangerter Foundation and Swiss Academy of Medical Science

  collaborator UNKNOWN

• mylife Diabetes Care AG

  collaborator INDUSTRY

• Innosuisse - Swiss Innovation Agency

  collaborator OTHER

• CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

  collaborator INDUSTRY

• University of Bern

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• DexCom, Inc.

  collaborator INDUSTRY

• Fresenius Kabi (Schweiz) AG

  collaborator UNKNOWN

• Bern Medtech Collaboration Call

  collaborator UNKNOWN

• Lia Bally

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-09

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Switzerland

Study Locations