Clinical Trial

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

Study acronym: DIABETEXX/1
Recruiting
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-03-23; most recent amendment 2025-08-05.
Status change: Active, Not Recruiting → Recruiting 2025-01-30
Trial Details
NCT Number NCT06338072
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators: Universitat Politècnica de València
Conditions Type 1 Diabetes
Enrollment 119 participants
Start Date 2024-03-03
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-07