Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
NCT ID: NCT06338072
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
119 participants
OBSERVATIONAL
2024-03-03
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Adult women of childbearing age using a loop system.
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.
No interventions assigned to this group
Adult men under 50 years old using a closed loop system.
A control group of 50 men will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Universitat Politècnica de València
OTHER
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Principal Investigators
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Lía Nattero, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
Locations
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Lía Nattero-Chávez
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DIABETEXX/1
Identifier Type: -
Identifier Source: org_study_id
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