Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control.
• Women presenting spontaneous regular menstrual cycles with a duration of 24 to 35 days, during the last year.
• Men under 50 years old.
• Acceptance of participation in the study and signing of the informed consent
Locations
Other Locations
Spain
Lía Nattero-Chávez
RECRUITING
Madrid
Contact Information
Primary
Lía Nattero-Chávez, MD.PhD
marialia.nattero@salud.madrid.org
Backup
Esther De la calle, MD.
esther.delacalle@salud.madrid.org
Time Frame
Start Date:2024-03-03
Estimated Completion Date:2026-12-01
Participants
Target number of participants:119
Treatments
Adult women of childbearing age using a loop system.
Adult women of childbearing age using the Minimed 780G loop system. Sixty-nine women of reproductive age will be recruited to assess variations in glycemic control across different stages of the menstrual cycle. Additionally, a subset of these women (n = 50) will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data.
Adult men under 50 years old using a closed loop system.
A control group of 50 men will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data.