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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)
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * \<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
About the study
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).
What is being tested
- Insulin (drug)
Sponsor: Thomas Jefferson University · Participants: 430 · Started: Sep 1, 2024
Contact the study team
- Kavisha Khanuja, MD · Phone: 215-955-5000
- Rodney McLaren Jr, MD · Phone: 215-955-5000
Official record on ClinicalTrials.gov — NCT06419777
Locations in the U.S.
| New York | University of Rochester Medical Center, Rochester (Not yet recruiting) |
| Pennsylvania | Thomas Jefferson University, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.