← Back to Search

Insulin

Insulin Therapy for Gestational Diabetes (GAP Trial)

Phase 4

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years old

Be between 18 and 65 years old

Must not have

Significantly abnormal GDM testing, suggestive of the presence of pre-gestational diabetes, either with fasting values >=126 mg/dL or 2-hour post-prandial levels >=200 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the data will be collected up to 6 weeks of life

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is comparing two different thresholds for when to start medical treatment for gestational diabetes mellitus (GDM). Pregnant women with GDM will be randomly assigned to start treatment when they reach at least 20% or 40% above the target goal for capillary blood glucose (CBG) levels. The investigators think that a lower threshold of 20% will lead to fewer obstetric and medical complications.

Who is the study for?

This trial is for pregnant women over 18 with gestational diabetes who can communicate in English and check their blood sugar at least twice a day. It's not for those with pre-gestational diabetes, fasting blood sugar >=126 mg/dL, post-meal levels >=200 mg/dL, or already on pharmacotherapy.

What is being tested?

The GAP study is testing when to start insulin treatment for gestational diabetes by comparing two groups: one starts treatment if at least 20% of their blood glucose readings are high, the other waits until at least 40% are high.

What are the potential side effects?

Insulin use may cause low blood sugar (hypoglycemia), which can lead to symptoms like dizziness, sweating, confusion and in severe cases unconsciousness. Some might experience injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood sugar tests indicate I might have had diabetes before pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the data will be collected up to 6 weeks of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the data will be collected up to 6 weeks of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and the data will be collected up to 6 weeks of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Neonatal Outcome

Secondary study objectives

Cesarean Delivery Rate

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: 20% cutoff groupActive Control1 Intervention

Treatment intervention will be initiated with insulin if 20% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.

Group II: 40% cutoff groupActive Control1 Intervention

Treatment intervention will be initiated with insulin if 40% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.

0 / 2Eligibility criteria met