Predictive Role of Non-Invasive Glucose Assessment During Pregnancy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Diastolic Blood Pressure
研究概览
简要总结
The purpose of this research is to examine the beneficial effects of regular, non-invasive, glucose (sugar) assessment on glucose (sugar) and blood pressure regulation during pregnancy to help in predicting gestational diabetes and preeclampsia.
详细描述
This is an open-label pilot trial for the LabClasp combined with standard clinical care compared to standard clinical on [glucose] and blood pressure during pregnancy. Potential study participants will be pre-screened using questionnaires and review of their clinical records. Once the consent has been obtained, participants will undergo screening to confirm eligibility. Subjects who meet all criteria will be randomized to either LC+SC or SC cohorts for 24-39wks depending upon their gestational duration at enrollment. Study measures including anthropometrics, surveys/questionnaires, 24hr ABPM, accelerometry, and an oral glucose tolerance test (OGTT). Furthermore, the investigators will obtain repeated (annual) subject information including vitals, labs, medications, and development of cardiometabolic disorders for up to 10yrs in follow-up by reviewing Mayo Clinic medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Age range: 18-45 years (inclusive)
- •Body mass index (BMI) ≤40kg/m2
- •>1 risk factor for GDM
- •<16wks gestation
- •Gender: only females will be recruited into this study
- •Ability to provide written informed consent
排除标准
- •Presence of chronic kidney disease (creatinine >2.5mg/dL) and/or active cancer
- •Multiple pregnancies
- •Congenital abnormalities
- •Use of chronic medications which influence blood [glucose] or [insulin]
- •Subsequent diagnosis of GDM or preeclampsia
研究组 & 干预措施
LabClasp+Standard of care
干预措施: LabClasp (Device)
Standard of care
结局指标
主要结局
Diastolic Blood Pressure
时间窗: Baseline
Diastolic Blood Pressure will be measured in mmHg
Blood Glucose
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
Blood Glucose will be measured in Mmol/L
Systolic Blood Pressure
时间窗: Baseline
Systolic Blood Pressure will be measured in mmHg
次要结局
- Pittsburgh sleep study quality index(Baseline)
研究者
Virend Somers, MD, PhD
Professor of Medicine
Mayo Clinic