Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time in range
时间窗: 1 month
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).
次要结局
- Caloric intake(1 month)
- Temperature(1 month)
- Photoplethysmography(1 month)
- Accelerometry(1 month)
- Time below range(1 month)
- Time above range(1 month)