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Anti-diabetic agent

Insulin Thresholds for Gestational Diabetes (START 1 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
Patients who have contraindication to oral glucose tolerance test
<18 years at EDD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from gestational age of 20 weeks during pregnancy to 6 weeks postpartum
Awards & highlights

Summary

"This trial aims to compare the outcomes for newborns and mothers when using different approaches to treating gestational diabetes. They will compare a strict approach, where two or more abnormal blood sugar values over a week

Who is the study for?
This trial is for pregnant individuals with gestational diabetes diagnosed after 24 weeks, carrying a single fetus without anomalies. Participants must be literate in English, Spanish, Mandarin, or Arabic and give informed consent. It excludes those under 18 at expected delivery date (EDD), with pre-existing diabetes or multiple fetuses.
What is being tested?
The study compares maternal and neonatal outcomes using strict versus permissive thresholds for starting insulin treatment in gestational diabetes. Strict threshold means two abnormal blood sugar readings in a week; permissive allows up to half the weekly readings to be high before starting insulin.
What are the potential side effects?
Insulin use may cause low blood sugar levels (hypoglycemia), injection site reactions, weight gain, swelling of arms and legs (edema), and potential allergic reactions for those not known to have an allergy.

Eligibility Criteria

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery 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
+10 more

Trial Design

2Treatment groups
Active Control
Group I: Strict ArmActive Control1 Intervention
The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated)
Group II: PermissiveActive Control1 Intervention
The permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).

Find a Location

Who is running the clinical trial?

University of RochesterOTHER
859 Previous Clinical Trials
538,273 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
456 Previous Clinical Trials
148,966 Total Patients Enrolled
~287 spots leftby May 2026
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