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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Enrolling

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06338072

DIABETEXX/1

Details and patient eligibility

About

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.

Enrollment: 119 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

119 participants in 2 patient groups

Adult women of childbearing age using a loop system.

Description:

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.

Description:

A control group of 50 men will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data.