Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Mar 23, 2024

Keywords

ClinConnect Summary

This clinical trial, called DIABETEXX/1, is looking at how women's menstrual cycles affect their ability to manage type 1 diabetes while using an advanced insulin delivery system. Specifically, the study will observe how changes in insulin sensitivity throughout the menstrual cycle influence the effectiveness of an automatic insulin infusion system. The goal is to understand these effects better, which may help improve diabetes management for women, who often face unique challenges in controlling their blood sugar levels.

To participate, individuals must be either women with regular menstrual cycles lasting between 24 to 35 days or men under 50 years old, and they must be using the Medtronic Minimed 780G closed-loop system for their diabetes treatment. Participants will need to agree to take part in the study and sign a consent form. Those who are pregnant, using hormonal birth control, or have serious health issues will not be eligible. If you join the trial, you'll be helping researchers learn how to enhance diabetes care for women, which could make a significant difference in their lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnostic criteria for DM1 according to ADA
• • Women and men treated with the Medtronic© MinimedTM 780G advanced closed loop system.
• • 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
• Exclusion Criteria:
• • Gestation
• • Use of hormonal contraceptives (including intrauterine devices)
• • Institutionalization, serious or terminal illness or renal replacement therapy.
• • Refusal to participate in the study or to sign the informed consent