Insulin Therapy for Gestational Diabetes
(GAP Trial)
Trial Summary
What is the purpose of this trial?
The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications. However, if you have already started medication for gestational diabetes before joining the study, you cannot participate.
Is insulin therapy safe for use during pregnancy and in people with diabetes?
How does insulin therapy differ from other treatments for gestational diabetes?
Insulin therapy for gestational diabetes is unique because it involves direct administration of insulin to manage blood sugar levels, which can be more effective for some women compared to oral medications like metformin. Insulin can be tailored in terms of dosage and timing to achieve precise blood sugar control, especially in cases where other treatments are insufficient.678910
What data supports the effectiveness of insulin therapy for gestational diabetes?
Research shows that insulin analogs like Humalog and insulin detemir are effective in managing blood sugar levels during pregnancy, which is crucial for reducing complications in diabetic women. Studies indicate that these insulins help achieve good metabolic control without adverse effects on mothers or babies.1112131415
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Pregnant women with GDM are randomized to start pharmacotherapy at either 20% or 40% of elevated CBG values
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neonatal outcomes
Treatment Details
Interventions
- Insulin
Insulin is already approved in European Union, United States, Canada for the following indications:
- Diabetes mellitus
- Diabetes mellitus
- Diabetes mellitus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator