NCT06338072Recruiting
Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 119 (estimated)
- First submitted
- 23 Mar 2024
- Start date
- 3 Mar 2024
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Type 1 diabetes
- NCT number
- NCT06338072
What you commit to
- Study type: Observational
- Planned participants: 119
- From 3 Mar 2024 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Institutionalization, serious or terminal illness or renal replacement therapy.
Other
- Gestation
- Use of hormonal contraceptives (including intrauterine devices)
- Refusal to participate in the study or to sign the informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lía Nattero-Chávez Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.