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Anti-diabetic agent

Insulin Therapy for Gestational Diabetes (START2 Trial)

N/A
Waitlist Available
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
<18 years at EDD
Patients who have contraindication to oral glucose tolerance test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of delivery
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to compare the outcomes for babies and mothers when using different levels of medication for gestational diabetes. One group will have strict blood sugar targets, while the other group will have more lenient

Who is the study for?
This trial is for pregnant individuals diagnosed with gestational diabetes. Participants should be those who are being considered for pharmacotherapy to manage their blood sugar levels. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.
What is being tested?
The START 2 trial is testing two different blood sugar level targets for managing gestational diabetes with insulin therapy. One group will follow a 'Strict' target range of 65-120 mg/dL, while the other group will have a 'Permissive' range of 65-140 mg/dL. Both aim for a time in range goal of 70%.
What are the potential side effects?
While specific side effects are not listed, insulin use can commonly lead to low blood sugar (hypoglycemia), which might cause shaking, sweating, fast heartbeat, dizziness or hunger.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I will be younger than 18 years old at my expected due date.
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I cannot undergo an oral glucose tolerance test due to health reasons.
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My primary language is not English, Spanish, Mandarin, or Arabic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 28 days of birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 28 days of birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neonatal Composite Outcome
Secondary study objectives
Maternal Outcomes: Cesarean Delivery
Maternal Outcomes: Hypertensive Disorders of Pregnancy
Maternal Outcomes: Maternal hypoglycemia
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Strict ArmActive Control1 Intervention
The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%.
Group II: PermissiveActive Control1 Intervention
The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
462 Previous Clinical Trials
175,108 Total Patients Enrolled
University of RochesterOTHER
867 Previous Clinical Trials
548,452 Total Patients Enrolled
~287 spots leftby May 2026
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