RecruitingRecruiting
Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
NCT06338072 · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
About this study
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
Study design
Enrollment target: 119 participants
Age groups: adult
Timeline
Starts: 2024-03-03
Estimated completion: 2026-12-01
Last updated: 2025-08-07
Primary outcomes
- • Time in range (1 month)
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · other
With: Universitat Politècnica de València
Contacts & investigators
ContactLía Nattero-Chávez, MD.PhD · contact · marialia.nattero@salud.madrid.org
ContactEsther De la calle, MD. · contact · esther.delacalle@salud.madrid.org
InvestigatorLía Nattero, MD.PhD · principal_investigator, Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
All locations (1)
Lía Nattero-ChávezRecruiting
Madrid, Madrid, Spain