Menstrual Cycle Mapping While Using Closed-Loop Insulin Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time in target glucose range
研究概览
简要总结
The hypothesis is that menstrual cyclicity affects glucose and energy metabolism in women with type 1 diabetes. The rationale of the hypothesis on cycle effects builds on the assumption that fluctuations of female sex hormones across the menstrual cycle cause changes in physiological parameters of glucose metabolism and energy homeostasis and/or lifestyle aspects involved in the regulation of blood glucose and body weight. It is expected that hormone fluctuations affect insulin sensitivity, gastric emptying, eating behaviour and energy expenditure. It is anticipated that insulin sensitivity is highest in the pre-ovulatory phase and lowest in the mid-luteal phase. It is further expected that gastric emptying peaks in the follicular phase, and highest energy expenditure and dietary intake are expected during the mid-luteal phase.
The primary objective of this study is to characterize glucose and energy metabolism throughout the menstrual cycle in natural cycling women with type 1 diabetes. Further objectives are to assess the impact of the menstrual cycle on glucose control and insulin requirements, investigate how fluctuations in sex hormone levels influence glucose and energy metabolism, and quantify both inter- and intra-individual variability in metabolic changes related to the menstrual cycle. Additionally, the study will evaluate whether changes in key physiological components of glucose metabolism and behavioural factors mediate menstrual cycle-related variations in glucose control and insulin requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex assigned at birth
- •Type 1 diabetes for at least 12 months
- •Aged 18-45 years
- •Natural menstrual cycle (occurring without medical or hormonal interventions)
- •Functional insulin therapy delivered via injection or insulin pump
- •Willingness to follow study-related procedures
- •Willingness to use mechanical contraception during the time of study participation
排除标准
- •Use of contraceptives or medical interventions that interfere with natural hormonal fluctuations of the menstrual cycle or cyclical bleeding
- •Interventions interfering with glucose or energy metabolism (other than insulin, thyroid hormone replacement or statins), as judged by the investigator, will be paused for the duration of the study, with an adequate washout duration prior to the start of data collection
- •Presence of any physical or psychological condition, or any medical intervention likely to interfere with the conduct of the procedures and/or their evaluation, as judged by the investigator
- •Pregnant or breast-feeding
- •Participation in another clinical study that interferes with the interpretation of the study results as judged by the investigator
研究组 & 干预措施
Women with Type 1 Diabetes
Participants with type 1 diabetes from age 18 to 45 years and a natural menstrual cycle will be followed for 3 consecutive menstrual cycles.
结局指标
主要结局
Time in target glucose range
时间窗: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 78 days (26-day cycles) to 120 days (40-day cycles).
The primary metric for glucose control is the proportion of time with sensor glucose levels in the target range (3.9-10mmol/L, %). Glucose levels will be measured using a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor).
次要结局
- Gastric emptying(The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.)
- Algorithm-directed insulin delivery following a standardized meal(The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal), across three menstrual cycles, resulting in a total of nine 3-hour assessment time)
- Insulin sensitivity(Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 78 days (26-day cycles) to 120 days (40-day cycles).)
- Total energy expenditure(Continuoulsy over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 26 days to 40 days.)
- Substrate oxidation(Assessed once at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle)
- Dietary intake(Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 9 assessements.)
- Physical activity(Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 78 days (26-day cycles) to 120 days (40-day cycles).)
研究者
Lia Bally
Prof. Dr. med. et phil.
Insel Gruppe AG, University Hospital Bern