Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University
About this trial
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
Qualifiers
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.
Disqualifiers
<18 years at EDD
pre-existing diabetes or diagnosis of GDM prior to 24 weeks
multi-fetal gestation
known major fetal anomaly
Trial design
Treatments tested in this trial
- Insulin
Treatment groups
430 Participants
are divided into 2 treatment groupsSponsors and collaborators
Thomas Jefferson University
Lead sponsor
University of Rochester
Collaborator
Source ClinicalTrials.gov