NCT06338072 Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
| NCT ID | NCT06338072 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 119 participants |
| Start Date | 2024-03-03 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 119 participants in total. It began in 2024-03-03 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Lía Nattero-Chávez, MD.PhD
✉ marialia.nattero@salud.madrid.orgLía Nattero, MD.PhD
PRINCIPAL INVESTIGATOR
Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
Frequently Asked Questions
Who can join the NCT06338072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06338072 currently recruiting?
Yes, NCT06338072 is actively recruiting participants. Contact the research team at marialia.nattero@salud.madrid.org for enrollment information.
Where is the NCT06338072 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06338072 clinical trial?
NCT06338072 is sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. The principal investigator is Lía Nattero, MD.PhD at Diabetes, Obesity and Human Reproduction Research Group (IRYCIS). The trial plans to enroll 119 participants.
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