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

Recruitingn/aAges 18 Years - 50 YearsAllFundacion para la Investigacion Biomedica del Hos…
NCT06338072 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Lía Nattero-Chávez
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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