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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

No Placebo-Only Group

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.

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I am under 18 years old.

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My primary language is not English, Spanish, Mandarin, or Arabic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

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

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 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).

0 / 3Eligibility criteria met