Self-Administered 2-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Completion of 75-gram oral glucose tolerance test
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate whether self-administered postpartum diabetes screening tests in patients with gestational diabetes improves screening completion rates. The primary question it aims to answer is:
- Does a self-administered 75-gram oral glucose tolerance test with virtual follow-up visit increase the rate of postpartum diabetes screening within 12 weeks of delivery?
详细描述
Gestational diabetes affects up to 10% of pregnancies, with increasing prevalence. Due to the risk of developing overt type 2 diabetes mellitus, patients are recommended to complete postpartum diabetes screening within 4-12 weeks of delivery. Despite these recommendations, screening rates remain low. Research evaluating reasons for low screening have identified social barriers like lack of transportation or childcare, as well as health literacy barriers. The consequences of missed screening include delay in diagnosis, delay in care, and ultimately higher health burden for the patient and the healthcare system.
This study seeks to evaluate a novel approach to increase uptake of recommended postpartum diabetes screening. The primary objective of this study is to determine if a self-administered postpartum diabetes screen (75-gram oral glucose tolerance test) increases screening completion rates. Our hypothesis is that the ability to perform the 75-gram oral glucose tolerance test at home will improve compliance with screening.
Additionally, we will evaluate the level of patient satisfaction with virtual follow-up in the intervention arm as a pre-specified additional outcome.
Eligible, consenting participants will be enrolled and randomized in a 1:1 ratio to the control arm (routine postpartum care with office-based diabetes screen) or intervention arm (self-administered diabetes screen). The randomization sequence will be generated by the study statistician using a block design. Investigators will remain masked to the randomization sequence.
All participants will be asked to complete a brief survey containing patient characteristics and two questions about perceived risk. Additional patient and neonatal data will be abstracted from the electronic medical record. All information will be stored in a secure password protected database.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age 18 years or older
- •English or Spanish speaking
- •Diagnosis of gestational diabetes with recommendation for postpartum screening, by any of the following criteria (1) HgbA1c 5.9-6.4% at ≤ 14 6/7 weeks, (2) HgbA1c ≥ 5.9% at 15-23 6/7 weeks, (3) 50-gram oral glucose tolerance test plasma glucose value ≥ 200 mg/dL, (4) 2 or more abnormal plasma glucose values on a 100-gram oral glucose tolerance test with the following thresholds: fasting ≥ 95 mg/dL, 1 hour ≥ 180 mg/dL, 2 hour ≥155 mg/dL, 3 hour ≥140 mg/dL or (5) fasting blood glucose ≥ 126
- •No personal history of Type 1 or Type 2 diabetes defined by self-reported or documented history, or HgbA1c >/=6.5% at ≤ 14 6/7 weeks gestation
- •Antepartum care with Prisma Health affiliated obstetric practices
- •Delivery at Greenville Memorial Hospital
- •Active Epic MyChart access at time of enrollment
- •Capable of providing informed consent
排除标准
- •Pre-pregnancy diagnosis of diabetes (Type 1, 2, or other form of diabetes)
- •No glucometer or supplies for fingerstick glucose monitoring, or inability to perform fingerstick glucose monitoring
- •Unable to provide informed consent
- •Inability to follow up for routine postpartum care
结局指标
主要结局
Completion of 75-gram oral glucose tolerance test
时间窗: within 12 weeks of delivery
A comparison of the proportion of patients in each arm (intervention vs control) who complete recommended postpartum diabetes screening within 12 weeks of delivery. For the intervention arm, this will be completion of the self-administered 75-gram oral glucose tolerance test. For the control arm, this will be completion of the in-office 75-gram glucose tolerance test. The test will be considered completed in either arm if the patient has a fasting blood glucose \>/=126 mg/dL (diagnostic of type 2 diabetes and does not require a post glucose load value), or both fasting and 2-hour post 75-gram glucose load blood glucose levels are documented.
次要结局
未报告次要终点