Correlation of CGM Metrics With OGTT and Pregnancy Outcomes in Pregnant Women With or Without a High Risk for GDM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Obtain CGM data concomitant with OGTT to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches)
研究概览
简要总结
the aim of the study is to obtain CGM data concomitant with OGTT and to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches).
详细描述
Study Objectives
Primary Objective:
- Obtain CGM data concomitant with OGTT to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches)
Secondary Objectives: 2. Compare GDM diagnosis using the 1-step and 2-step OGTT 3. Obtain CGM data concomitant with OGTT while comparing reproducibility of the 1-step and 2-step methods 4. Determine what CGM metrics obtained concomitant with OGTT correlate best with maternal and fetal outcomes in pregnant women with and without diagnosed GDM 5. Determine how dysglycemia evolves over the third trimester in women with or without diagnosed GDM 6. Compare hyperglycemia determined with CGM to hyperglycemia determined by SMBG in participants diagnosed with GDM 7. Determine what CGM metrics obtained during the third trimester correlate best with maternal and fetal outcomes in pregnant women with and without diagnosed GDM 8. Determine what CGM metrics obtained in pregnant women correlate best with the need for pharmacologic management of GDM Study Devices Dexcom G6 Pro CGM systems blinded to participants. Sample Size Observational. Not powered. The total sample size is up to 280 participants.
the invastigators anticipate enrollment of 280 participants with up to 50 low risk participants and 230 high risk participants. Risk assessment is based on the glucose challenge test results. This should result in 50-80 participants with GDM out of the 230 high risk participants, and allow for 25% dropout for observation throughout the third trimester in the subset of participants Patient Population Pregnant women undergoing screening for GDM Inclusion Criteria To enroll subjects across the glycemic spectrum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All are blinded to the CGM results.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women at high risk for GDM based on GCT results
- •Pregnant women at low risk for GDM based on GCT results.
- •Had an ultrasound earlier before 12 weeks to confirm gestational age
- •Singleton pregnancy
排除标准
- •Pregestational diabetes or overt diabetes diagnosed during enrollment
- •Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long-term medical condition at the investigator's discretion
- •Known (or suspected) allergy to medical grade adhesives
- •Use of hydroxyurea (a known interferent of CGM)
结局指标
主要结局
Obtain CGM data concomitant with OGTT to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches)
时间窗: 2 years
blood level will be measured of CGM versus self monitoring blood glucose
次要结局
- Compare hyperglycemia determined with CGM to hyperglycemia determined by SMBG in participants diagnosed with GDM(2 years)
- Obtain CGM data concomitant with OGTT while comparing reproducibility of the 1-step and 2-step methods(2 years)
- Determine what CGM metrics obtained in pregnant women correlate best with the need for pharmacologic management of GDM(2 years)
- Determine how dysglycemia evolves over the third trimester in women with or without diagnosed GDM(2 years)
- Determine what CGM metrics obtained during the third trimester correlate best with maternal and fetal outcomes in pregnant women with and without diagnosed GDM(2 years)
- Compare GDM diagnosis using the 1-step and 2-step OGTT(2 years)
- Determine what CGM metrics obtained concomitant with OGTT correlate best with maternal and fetal outcomes in pregnant women with and without diagnosed GDM(2 years)
研究者
Eli Sprecher, MD
Director, Head of Clinical Trails Department, Principal Investigator, Clinical Professor
Tel-Aviv Sourasky Medical Center