Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
Thomas Jefferson University
430 participants
Sep 1, 2024
INTERVENTIONAL
Conditions
Summary
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
Eligibility
Inclusion Criteria3
- Live, non-anomalous fetus
- Literacy in English, Spanish, Mandarin, or Arabic
- Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
Exclusion Criteria9
- <18 years at EDD
- pre-existing diabetes or diagnosis of GDM before 24 weeks
- multi-fetal gestation
- known major fetal anomaly
- known allergy to insulin
- chronic maternal corticosteroid use
- diagnosis of GDM based on finger sticks alone
- patients who have contraindication to oral glucose tolerance test
- a primary language other than English, Spanish, Mandarin, or Arabic
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Interventions
Insulin will be used in gestational diabetics to control blood glucose levels
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06419777