NCT06419803 Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
| NCT ID | NCT06419803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Jefferson University |
| Condition | Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 430 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 430 participants in total. It began in 2024-09-01 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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%.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06419803 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06419803 currently recruiting?
Yes, NCT06419803 is actively recruiting participants. Contact the research team at kxk334@jefferson.edu for enrollment information.
Where is the NCT06419803 trial being conducted?
This trial is being conducted at Rochester, United States, Philadelphia, United States.
Who is sponsoring the NCT06419803 clinical trial?
NCT06419803 is sponsored by Thomas Jefferson University. The trial plans to enroll 430 participants.
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