NCT05258292招募中不适用
Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study
Institut de Recherches Cliniques de Montreal1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年5月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Mean glucose levels during the mid-late follicular phase
研究概览
简要总结
In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase).
Overall, despite an important proportion of women reporting glycemic and/or insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 to 50 living in Canada.
- •Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year.
- •Using insulin pump therapy, multiple daily injections or automated insulin delivery systems for at least 3 months.
- •Using a continuous glucose monitoring (CGM) system.
- •Having at least one menses in the last 40 days.
- •Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period.
- •Having a smartphone or tablet to follow menstrual cycles.
- •Stable weight (less than 5% variation in the last 3 months).
排除标准
- •Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill)
- •Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).
- •Clinically significant nephropathy (eGFR < 30 ml/min/1.73m2, planned or on dialysis) or neuropathy (e.g., known uncontrolled gastroparesis) as judged by the investigator.
- •Recent (< 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).
- •Anticipated therapeutic change (including change of insulin type and/or type of CGM sensor, insulin pump or AID (automated insulin device) system) between admission and end of the study.
- •Anticipated change in contraception method or plan to begin or stop a contraceptive method.
- •Anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours.
- •Pregnancy (ongoing or current attempt to become pregnant)
- •Breastfeeding
- •Uncontrolled thyroid disease (TSH should be in target range and treatment stable for at least 6 weeks).
- •Severe hypoglycemic episode within two weeks of screening
- •Severe hyperglycemic episodes requiring hospitalization in the last 3 months.
- •Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
- •Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study.
- •Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed.
- •Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.
- •Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change).
- •Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).
- •In the opinion of the investigator, a participant who is unable or unwilling to complete the study.
- •If taking medication for hypothyroidism, no change of dose (Levothyroxin) in the last 6 weeks.
研究组 & 干预措施
Women with type 1 diabetes
干预措施: Continuous glucose monitoring (Device)
Women with type 1 diabetes
干预措施: Insulin (Drug)
Women with type 1 diabetes
干预措施: Premenstrual symptoms (Other)
Women with type 1 diabetes
干预措施: Ovulation kits (Other)
Women with type 1 diabetes
干预措施: Fitbit Inspire 2 (Device)
Women with type 1 diabetes
干预措施: Keenoa (Other)
Women with type 1 diabetes
干预措施: Menstrual cycle (Other)
结局指标
主要结局
Mean glucose levels during the mid-late follicular phase
时间窗: Day 6 until 2 days prior to ovulation
Mean glucose levels during the early follicular phase
时间窗: Day 1 to 5 of the menstrual cycle
Mean glucose levels during the periovulation phase
时间窗: Ovulation plus/minus 1 day
Mean glucose levels during the early luteal phase
时间窗: Day 2 to 4 after ovulation
Mean glucose levels during the late luteal phase
时间窗: Day 10 after ovulation until the first day of the next menstrual cycle
Mean glucose levels during the mid-luteal phase
时间窗: Day 5 to 9 after ovulation
次要结局
- Percentage of time of glucose levels between 3.9 and 7.8 mmol/L(Day 10 after ovulation until the first day of the next menstrual cycle)
- Percentage of time of glucose levels between 3.9 and 10.0 mmol/L(Day 10 after ovulation until the first day of the next menstrual cycle)
- Percentage of time of glucose levels below 3.0 mmol/L(Day 10 after ovulation until the first day of the next menstrual cycle)
- Percentage of time of glucose levels above 10.0 mmol/L(Day 10 after ovulation until the first day of the next menstrual cycle)
- Percentage of time of glucose levels above 13.9 mmol/L(Day 10 after ovulation until the first day of the next menstrual cycle)
- High blood glucose index(Day 10 after ovulation until the first day of the next menstrual cycle)
- Percentage of time of glucose levels below 3.9 mmol/L(Day 10 after ovulation until the first day of the next menstrual cycle)
- Standard deviation of glucose levels(Day 10 after ovulation until the first day of the next menstrual cycle)
- Coefficient of variance of glucose levels(Day 10 after ovulation until the first day of the next menstrual cycle)
- Low blood glucose index(Day 10 after ovulation until the first day of the next menstrual cycle)
- Standard deviation of insulin delivery(Day 10 after ovulation until the first day of the next menstrual cycle)
- Coefficient of variance of insulin delivery(Day 10 after ovulation until the first day of the next menstrual cycle)
- Total insulin delivery(Day 10 after ovulation until the first day of the next menstrual cycle)
- Percentage of time of glucose levels below 3.0 mmol/L(Day 6 until 2 days prior to ovulation)
- Percentage of time of glucose levels below 3.0 mmol/L(Ovulation plus/minus 1 day)
- Percentage of time of glucose levels below 3.0 mmol/L(Day 2 to 4 after ovulation)
- Percentage of time of glucose levels below 3.0 mmol/L(Day 5 to 9 after ovulation)
- Percentage of time of glucose levels above 10.0 mmol/L(Day 1 to 5 of the menstrual cycle)
- Percentage of time of glucose levels above 10.0 mmol/L(Day 6 until 2 days prior to ovulation)
- Percentage of time of glucose levels above 10.0 mmol/L(Ovulation plus/minus 1 day)
- Percentage of time of glucose levels above 10.0 mmol/L(Day 2 to 4 after ovulation)
- Percentage of time of glucose levels above 10.0 mmol/L(Day 5 to 9 after ovulation)
- Percentage of time of glucose levels above 13.9 mmol/L(Day 1 to 5 of the menstrual cycle)
- Percentage of time of glucose levels above 13.9 mmol/L(Day 6 until 2 days prior to ovulation)
- Percentage of time of glucose levels above 13.9 mmol/L(Ovulation plus/minus 1 day)
- Percentage of time of glucose levels above 13.9 mmol/L(Day 2 to 4 after ovulation)
- Percentage of time of glucose levels above 13.9 mmol/L(Day 5 to 9 after ovulation)
- Standard deviation of glucose levels(Day 1 to 5 of the menstrual cycle)
- Standard deviation of glucose levels(Day 6 until 2 days prior to ovulation)
- Standard deviation of glucose levels(Ovulation plus/minus 1 day)
- Standard deviation of glucose levels(Day 2 to 4 after ovulation)
- Standard deviation of glucose levels(Day 5 to 9 after ovulation)
- Coefficient of variance of glucose levels(Day 1 to 5 of the menstrual cycle)
- Coefficient of variance of glucose levels(Day 6 until 2 days prior to ovulation)
- Coefficient of variance of glucose levels(Ovulation plus/minus 1 day)
- Coefficient of variance of glucose levels(Day 2 to 4 after ovulation)
- Coefficient of variance of glucose levels(Day 5 to 9 after ovulation)
- Low blood glucose index(Day 1 to 5 of the menstrual cycle)
- Low blood glucose index(Day 6 until 2 days prior to ovulation)
- Low blood glucose index(Ovulation plus/minus 1 day)
- Low blood glucose index(Day 2 to 4 after ovulation)
- Low blood glucose index(Day 5 to 9 after ovulation)
- High blood glucose index(Day 1 to 5 of the menstrual cycle)
- High blood glucose index(Day 6 until 2 days prior to ovulation)
- High blood glucose index(Ovulation plus/minus 1 day)
- High blood glucose index(Day 2 to 4 after ovulation)
- High blood glucose index(Day 5 to 9 after ovulation)
- Standard deviation of insulin delivery(Day 1 to 5 of the menstrual cycle)
- Standard deviation of insulin delivery(Day 6 until 2 days prior to ovulation)
- Standard deviation of insulin delivery(Ovulation plus/minus 1 day)
- Standard deviation of insulin delivery(Day 2 to 4 after ovulation)
- Standard deviation of insulin delivery(Day 5 to 9 after ovulation)
- Coefficient of variance of insulin delivery(Day 1 to 5 of the menstrual cycle)
- Coefficient of variance of insulin delivery(Day 6 until 2 days prior to ovulation)
- Coefficient of variance of insulin delivery(Ovulation plus/minus 1 day)
- Coefficient of variance of insulin delivery(Day 2 to 4 after ovulation)
- Coefficient of variance of insulin delivery(Day 5 to 9 after ovulation)
- Total insulin delivery(Day 1 to 5 of the menstrual cycle)
- Total insulin delivery(Day 6 until 2 days prior to ovulation)
- Total insulin delivery(Ovulation plus/minus 1 day)
- Total insulin delivery(Day 2 to 4 after ovulation)
- Total insulin delivery(Day 5 to 9 after ovulation)
- Percentage of time of glucose levels below 3.9 mmol/L(Day 2 to 4 after ovulation)
- Percentage of time of glucose levels below 3.9 mmol/L(Day 5 to 9 after ovulation)
- Percentage of time of glucose levels below 3.0 mmol/L(Day 1 to 5 of the menstrual cycle)
- Percentage of time of glucose levels between 3.9 and 7.8 mmol/L(Day 2 to 4 after ovulation)
- Percentage of time of glucose levels between 3.9 and 7.8 mmol/L(Day 5 to 9 after ovulation)
- Percentage of time of glucose levels between 3.9 and 10.0 mmol/L(Day 1 to 5 of the menstrual cycle)
- Percentage of time of glucose levels between 3.9 and 10.0 mmol/L(Day 6 until 2 days prior to ovulation)
- Percentage of time of glucose levels between 3.9 and 10.0 mmol/L(Ovulation plus/minus 1 day)
- Percentage of time of glucose levels between 3.9 and 10.0 mmol/L(Day 2 to 4 after ovulation)
- Percentage of time of glucose levels between 3.9 and 10.0 mmol/L(Day 5 to 9 after ovulation)
- Percentage of time of glucose levels below 3.9 mmol/L(Day 1 to 5 of the menstrual cycle)
- Percentage of time of glucose levels below 3.9 mmol/L(Day 6 until 2 days prior to ovulation)
- Percentage of time of glucose levels below 3.9 mmol/L(Ovulation plus/minus 1 day)
- Percentage of time of glucose levels between 3.9 and 7.8 mmol/L(Day 1 to 5 of the menstrual cycle)
- Percentage of time of glucose levels between 3.9 and 7.8 mmol/L(Day 6 until 2 days prior to ovulation)
- Percentage of time of glucose levels between 3.9 and 7.8 mmol/L(Ovulation plus/minus 1 day)
研究者
Rémi Rabasa-Lhoret
Full professor
Institut de Recherches Cliniques de Montreal
研究点 (1)
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