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临床试验/NCT06184373
NCT06184373招募中不适用

Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus

Ohio State University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Comparative experience of OGTT and CGM

研究概览

简要总结

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

详细描述

Gestational diabetes (GDM) is associated with a significantly increased risk of type 2 diabetes, with 1/3 of individuals with GDM developing glucose intolerance in the first 3 years postpartum. The American Diabetes Association recommends a follow up oral glucose tolerance test (OGTT) 4-12 weeks after delivery for all patients with GDM, but rates of follow up screening are as low as 19%. OGTT presents many challenges to postpartum patients, including lengthy visits and the need to fast for at least 8 hours, that likely impact these follow up rates. There is also evidence that many individuals with normal OGTT develop dysglycemia within the first year postpartum, leading to concerns about the diagnostic yield of OGTT. Continuous glucose monitors (CGM) have revolutionized the care of type 1 and 2 diabetes, but its utility in GDM is poorly studied. There are many potential benefits of CGM as a possible GDM postpartum screening, including the ability to transmit data remotely and increased glycemic data, but the impact CGMs have on quality of life postpartum and if they would be acceptable screening methods for patients after delivery has yet to be studied. Our research aims to understand the acceptability and feasibility of CGM for detection of ongoing dysglycemia in the postpartum period in GDM. A sample of 20 postpartum individuals with a history of GDM will have CGMs placed at 6-8 weeks postpartum . Participants will have surveys after the CGM period about CGM impact on quality of life as well as complete a validated glucose monitoring satisfaction survey. They will then complete the standard of care OGTT at 10-12 weeks postpartum and be asked to compare their experience with CGM versus OGTT and which screening method they found preferable. Wear times and study dropout rates will be analyzed for intervention fidelity as a marker of feasibility. The investigators will begin to characterize postpartum glycemia by mean serum glucose, time in range (TIR) and coefficient of variation (CV) as measured by CGM. Glycemic data will be compared to a 12-week OGTT to determine relative sensitivity. This study could determine if CGM may provide a novel screening method for postpartum GDM that is acceptable to patients.

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 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women with a viable singleton intrauterine pregnancy
  • •Able to understand the study, and having understood, provide written informed consent in English
  • •Recent pregnancy affected by gestational diabetes

排除标准

  • •Pregestational Diabetes (Type I or Type II)
  • •Continued use of diabetes medications (including metformin and insulin) immediately after delivery
  • •Preterm delivery (< 37 weeks gestation)
  • •Twin or higher order gestation
  • •No access to a smartphone
  • •Unable or unwilling to wear CGM or return for follow up at postpartum mother-infant dyad clinic
  • •Participation in this trial in a prior pregnancy
  • •History of skin allergy to adhesive products or CGM

结局指标

主要结局

Comparative experience of OGTT and CGM

时间窗: 15 weeks from enrollment

As determined by survey

Acceptability of CGM

时间窗: 15 weeks from enrollment

As determined by survey

次要结局

  • Prevalence and characteristics of dysglycemia in GDM postpartum(15 weeks from enrollment)
  • Lifestyle changes survey(15 weeks from enrollment)
  • Medical care(15 weeks from enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel D'Amico

Assistant Professor

Ohio State University

研究点 (1)

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