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RECRUITING Phase 4

Gestational Diabetes and Pharmacotherapy (GAP)

NCT03527537 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Insulin

Study Locations (1)

Wisconsin

  • Medical College of Wisconsin — Milwaukee

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2021-05-04
Est. Completion 2026-10-01
Phase Phase 4

Sponsor

Medical College of Wisconsin

614 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03527537

The ClinicalTrials.gov registry entry for NCT03527537 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Gestational Diabetes appearing as the primary indexed condition, and to 1 intervention — of which Insulin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03527537 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03527537 about?

NCT03527537 is a clinical study titled "Gestational Diabetes and Pharmacotherapy (GAP)". 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...

What is the current status of trial NCT03527537?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 416 participants. The study started on 2021-05-04. Estimated completion is 2026-10-01.

What conditions does trial NCT03527537 study?

This clinical trial studies the following conditions: Gestational Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03527537?

The interventions under investigation include: Insulin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03527537?

This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03527537 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial