Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
Overview
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.
Primary outcome measures
- Time in range [Time frame: 1 month]
Secondary outcome measures (6)
- Time below range [Time frame: 1 month]
- Time above range [Time frame: 1 month]
- Caloric intake [Time frame: 1 month]
- Temperature [Time frame: 1 month]
- Photoplethysmography [Time frame: 1 month]
- Accelerometry [Time frame: 1 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Lía Nattero-Chávez — Madrid
Identifiers
NCT: NCT06338072 · DIABETEXX/1