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.
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.
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
Patients of both genders, aged 18 or older, with type 1 diabetes and in their reproductive years, receiving care at the Endocrinology and Nutrition Department of Ramón y Cajal University Hospital in Madrid, and undergoing treatment with the Medtronic© MinimedTM 780G closed loop advanced system.
Cohort
Cross-sectional
Not listed
Time in range
To assess the influence of menstrual cycle phases on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
Time below range
To assess the influence of menstrual cycle phases on the glycemic control expressed as time in below range (% of time \< 70 mg/dl of interstitial glucose).
Time above range
To assess the influence of menstrual cycle phases on time in above range (% of time \>180 mg/dl of interstitial glucose).
Caloric intake
To assess the influence of changes in intake throughout the menstrual cycle
Temperature
To collect temperature using a wearable.
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Universitat Politècnica de València
Collaborator
