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Insulin Therapy for Gestational Diabetes (GAP Trial)
GAP Trial 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.
GAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGAP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.GAP Trial Design
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Who is running the clinical trial?
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- You have already started taking medication before being referred to the study.You have diabetes before getting pregnant.I am 18 years old or older.You do not regularly check your blood sugar levels at least two times a day, even after getting proper advice.You have been diagnosed with gestational diabetes.My blood sugar tests indicate I might have had diabetes before pregnancy.You are pregnant with only one baby.
- Group 1: 20% cutoff group
- Group 2: 40% cutoff group
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there vacancies in this medical experiment for participants?
"Indeed, records on clinicaltrials.gov confirm that this research project is actively enrolling. It was initially posted on May 1st 2021 and has been modified most recently on August 12th 2022; it seeks 416 volunteers at a single trial site."
What research findings have been gained from the 40% cutoff group?
"Presently, there are 72 trials studying the effects of 40% cutoff group. Out of these studies, 13 have advanced to Phase 3. While many tests for this medication are based in Cincinnati, Ohio, an additional 248 locations across the globe offer access to clinical trials regarding this treatment."
How many individuals are involved in the current clinical investigation?
"Affirmative. Documentation hosted on clinicaltrials.gov verifies that recruitment for this medical trial is currently underway. It was initially posted May 1, 2021 and last modified August 12, 2022; 416 patients are being sought from a single site."
Is the current research open to participants of advanced age?
"This trial is offering participation to individuals between the ages of 18 and 45. For those under 18 or above 65, there are 196 studies available for minors and 938 trials suitable for seniors respectivelly."
Is the 40% cutoff a safe threshold for individuals?
"After a thorough review, the safety of 40% cutoff group was rated 3 on our organization's scale due to its Phase 4 status which indicates that it has been approved."
Do I satisfy the criteria to qualify for this research initiative?
"Participants aged between 18 and 45 with Gestational Diabetes Mellitus (GDM) are invited to join this study, for a total of 416 enrollees. Additionally, participants must be carrying viable singleton pregnancies in order to qualify."
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