Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of adherence
研究概览
简要总结
The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.
The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
详细描述
Consented patients who are diagnosed with gestational diabetes will be randomized to either 1-hour or 2-hour postprandial blood glucose monitoring. A retrospective chart review from July 2020 until study commencement for patients from the same clinic will be used as a historical control group. This study will assess differences in adherence to testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Pregnant patients with singleton gestation who are ≥ 18 years of age.
- •Diagnosis of GDM after 24 0/7 weeks.
- •For diagnosing GDM, a two-step screening algorithm will be performed according to the American College of Obstetrics and Gynecologists.4 Specifically, a 1-hour 50-g glucose-loading test is given first. Plasma glucose levels between 140 and 200 mg/dL will be considered elevated. Confirmatory testing will then be performed using a 3-hour 100-g glucose tolerance test. Diagnosis was made when two of the four values were elevated. Abnormal glucose value thresholds are established via the criteria suggested by Carpenter and Coustan: fasting value ≥ 95 mg/dL, 1-hour ≥ 180 mg/dL, 2-hour ≥ 155 mg/dL, and 3-hour ≥ 140 mg/dL.9 Patients with a blood glucose level greater than 200 mg/dL after 1-hour 50-g glucose-loading test will be diagnosed with GDM without requirement for the 3-hour 100-g glucose tolerance test.
排除标准
- •Type 1 pre-gestational diabetes
- •Type 2 pre-gestational diabetes
- •GDM diagnosed prior to 24 0/7 weeks gestation.
结局指标
主要结局
Rate of adherence
时间窗: During the intervention
Evaluate rate of adherence (binary outcome defined as \<80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
次要结局
- Percentage of postprandial glucose log complete, averaged over the duration of the study period(During the intervention)
- Neonatal birthweight(At time of delivery)
- Percentage of elevated blood glucose values per week, averaged over the duration of the study period(During the intervention)
- Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period(During the intervention)
- Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy(During the intervention)
- Number of patients with 3rd or 4th degree perineal lacerations(At time of delivery)
- Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.(During the intervention)
- Number of subjects with a vaginal delivery(At time of delivery)
- Number of subjects with shoulder dystocia(At time of delivery)
- Number of patients requiring supplemental oxygen support(At time of delivery)
- Number of patients with brachial plexus palsy(At time of delivery)
- Gestational age at medication therapy initiation(During the intervention)
- Number of subjects with a caesarean section delivery(At time of delivery)
- Number of patients with diagnosis of hypoglycemia(At time of delivery)
- Number of subjects with an operative delivery(At time of delivery)
- Number of subjects with a preeclampsia diagnosis(During intervention)
- Number of patients with postpartum hemorrhage.(At time of delivery)
- Number of NICU admissions(At time of delivery)
- Number of patients with clavicular fracture(At time of delivery)
- Number of stillbirths(At time of delivery)
- Number of patients with diagnosis of hyperbilirubinemia(At time of delivery)
- Number of patients with humeral fracture(At time of delivery)