Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics
NCT ID: NCT05062460
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2021-07-15
2025-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1-hour post-prandial blood glucose monitoring Arm
Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating.
1 hour Blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
2-hour post-prandial blood glucose monitoring Arm
Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating.
2 hour blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring
Interventions
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1 hour Blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
2 hour blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Type 2 pre-gestational diabetes
* GDM diagnosed prior to 24 0/7 weeks gestation.
18 Years
FEMALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Stephen Chasen, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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New York Prebyterian Hospital Weill Cornell
New York, New York, United States
Countries
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Other Identifiers
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20-10022829
Identifier Type: -
Identifier Source: org_study_id
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