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

RECRUITINGN/ASponsored by Thomas Jefferson University
Actively Recruiting
PhaseN/A
SponsorThomas Jefferson University
Started2024-09-01
Est. completion2026-05
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

DiabetesGestational DiabetesPregnancy Related

Locations2 sites

New York

1 site
University of Rochester Medical Center
Rochester, New York, 14642
Sarah Crimmins, Do

Pennsylvania

1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kavisha Khanuja, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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