Actively Recruiting

Age: 18Years - 50Years
All Genders
NCT06338072

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

Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-08-07

119

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

Sponsors

F

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Lead Sponsor

U

Universitat Politècnica de València

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of type 1 diabetes according to ADA criteria
  • Use of the Medtronic Minimed 780G advanced closed-loop system
  • Women with spontaneous regular menstrual cycles lasting 24 to 35 days in the past year
  • Men under 50 years old
  • Agreement to participate and signing of informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Use of hormonal contraceptives, including intrauterine devices
  • Institutionalization, serious or terminal illness, or renal replacement therapy
  • Refusal to participate or to sign informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Lía Nattero-Chávez

Madrid, Madrid, Spain, 28034

Actively Recruiting

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Research Team

L

Lía Nattero-Chávez, MD.PhD

CONTACT

E

Esther De la calle, MD.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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