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Gestational Diabetes and Pharmacotherapy (GAP)

RECRUITINGPhase 4Sponsored by Medical College of Wisconsin
Actively Recruiting
PhasePhase 4
SponsorMedical College of Wisconsin
Started2021-05-04
Est. completion2026-03-31
Eligibility
Age18 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Viable singleton pregnancy
* Age \>= 18 years old
* Diagnosed with gestational diabetes mellitus
* Able to communicate in English

Exclusion Criteria:

* Pre-gestational diabetes
* 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
* Patients who check blood sugars on average less than 2 times per day after appropriate counseling
* Already started pharmacotherapy prior to referral to the study

Conditions2

DiabetesGestational Diabetes

Locations1 site

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226

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