Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics.
研究概览
简要总结
This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.
详细描述
Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 12 months
- •Use of glucose sensor in the last 6 months
- •Use of insulin pump in the last 6 months
- •Age ≥18 to ≤40 years
- •HbA1c ≤8.5% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately 200 mg/dL or less
- •Absence of perimenopausal/menopausal symptoms
- •Willingness to keep track of beginning of menstrual cycle
- •Willingness to keep track of ingested carbohydrates
- •Willingness to not become pregnant during study participation
- •Regularly menstruating (at least every month with no missed cycles)
- •Only free-cycling participants: willingness to use ovulation kits to confirm ovulation
- •Only participants under oral contraceptive therapy: use of monophasic pill, with 3 weeks of active pill and 1 week of placebo
- •Willingness to use the study Dexcom G6 during the study
- •Participants must have Internet access and a computer system that meets the requirements for uploading the study equipment
排除标准
- •Pregnancy
- •Hormonal birth control therapy except monophasic pill contraceptive
- •Polycystic ovary syndrome (PCOS) diagnosis
- •Current use of steroids
- •Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas, metformin)
- •Uncontrolled thyroid disease
- •Active fertility treatment
- •Concomitant disease or condition that may compromise patient safety or ability to follow the protocol including: planned or current dialysis treatment; moderate to advanced nephropathy; known or suspected allergy to medical grade adhesives.
- •Severe hypoglycemia or diabetes ketoacidosis (DKA) in the previous 6 months
结局指标
主要结局
Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics.
时间窗: 3 months
Primary Variable
次要结局
未报告次要终点
研究者
Chiara Fabris, PhD
Primary Investigator
University of Virginia