Actively Recruiting
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
Led by Thomas Jefferson University · Updated on 2024-11-22
430
Participants Needed
2
Research Sites
86 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
U
University of Rochester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Live, non-anomalous fetus
- Literacy in English, Spanish, Mandarin, or Arabic
- Provide consent, understand study purpose, and agree to study protocol
You will not qualify if you...
- Under 18 years old at estimated delivery date
- Pre-existing diabetes or gestational diabetes diagnosed before 24 weeks
- Multiple fetus pregnancy
- Known major fetal anomaly
- Known allergy to insulin
- Chronic maternal corticosteroid use
- Diagnosis of gestational diabetes based only on finger stick tests
- Contraindication to oral glucose tolerance test
- Primary language other than English, Spanish, Mandarin, or Arabic
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
Not Yet Recruiting
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
K
Kavisha Khanuja, MD
CONTACT
R
Rodney McLaren Jr, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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