Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)

Recruiting now · Not applicable

Conditions studied: Gestational Diabetes, Pregnancy Related

In brief

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 study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Key facts

Study ID

NCT06419803

Run by

Thomas Jefferson University

People needed

430

Starts

2024-09-01

Expected to finish

2026-05-01

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• <18 years at EDD
• pre-existing diabetes or diagnosis of GDM prior to 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

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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