Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics
- Conditions
- Gestational Diabetes
- Interventions
- Other: 2 hour blood glucose monitoringOther: 1 hour Blood glucose monitoring
- Registration Number
- NCT05062460
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 140
- 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.
- Type 1 pre-gestational diabetes
- Type 2 pre-gestational diabetes
- GDM diagnosed prior to 24 0/7 weeks gestation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2-hour post-prandial blood glucose monitoring Arm 2 hour blood glucose monitoring Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating. 1-hour post-prandial blood glucose monitoring Arm 1 hour Blood glucose monitoring Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating.
- Primary Outcome Measures
Name Time Method Rate of adherence 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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
New York Prebyterian Hospital Weill Cornell
🇺🇸New York, New York, United States