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

NCT06338072 · tracked via the Priya Life Science Spain tracker

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Phase

Observational

Started

2024-03-03

Last updated

2025-08-07

Condition(s) studied

Type 1 Diabetes

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

50 Years

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

Primary outcome measure(s)

Time in range — 1 month
To assess the influence of menstrual cycle phases on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).

Trial sites (1)

Facility	City	Region	Status
Lía Nattero-Chávez	Madrid	Madrid	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06338072 on ClinicalTrials.gov ↗ ← All trials in Spain