NCT06147466招募中不适用
Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time in target range
研究概览
简要总结
Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of >6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.
- •≤14 weeks gestation,
- •age ≥18 years
- •Willingness to use the study devices a minimum of 10 days per trimester
- •Able to provide informed consent
- •Have access to email
排除标准
- •Non-type 2 diabetes
- •Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- •Known or suspected allergy against insulin
- •Women with nephropathy (eGFR<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results
- •Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
- •Unable to communicate effectively in English as judged by the investigator
- •Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
结局指标
主要结局
Time in target range
时间窗: 7-9 months
To determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis
次要结局
- Maternal outcome(7-9 months)
- Maternal outcome (HTN)(7-9 months)
- Delivery outcome(7-9 months)
- Neonatal weight at birth(7-9 months (Delivery of neonate))
- Neonatal outcomes (hypoglycemia)(7-9 months (Delivery of neonate))
- Neonatal outcomes (chromosomal abnormality)(7-9 months (Delivery of neonate))
- Neonatal outcomes (congenital anomaly)(7-9 months (Delivery of neonate))
- Neonatal outcomes (hyperbilirubinemia)(7-9 months (Delivery of neonate))
- Neonatal outcomes (neonatal intensive care admission)(Delivery of neonate to 6 weeks postpartum)
- Covariates (maternal obesity)(16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum)
- Covariates (maternal ethnicity)(Enrollment (16-24 weeks gestation))
- Covariates (Mother's total household income)(enrollment 16-24 weeks gestation)
- Measures of insulin resistance (HOMA-IR )(at 16-24 weeks gestation)
- Blood Insulin(at 16-24 weeks gestation)
- Neonatal outcomes (birth injury)(7-9 months (Delivery of neonate))
- Adverse events(7-9 months)
- Mean blood glucose measurement(at 16-24 weeks gestation)
- Diabetes distress(at 16-24 weeks gestation and at 34 weeks gestation)
- Sleep quality(at 16-24 weeks gestation and at 34 weeks gestation)
- Perceived social support(16-24 weeks gestation)
- Sleep apnea(at 16-24 weeks gestation and at 34 weeks gestation)
研究者
研究点 (1)
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