RECRUITING

Gestational Diabetes and Pharmacotherapy (GAP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gestational Diabetes and Pharmacotherapy (GAP) - A Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients With Gestational Diabetes

Quick Facts

Study Start:2021-05-04
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03527537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Viable singleton pregnancy
  2. * Age \>= 18 years old
  3. * Diagnosed with gestational diabetes mellitus
  4. * Able to communicate in English
  1. * Pre-gestational diabetes
  2. * 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
  3. * Patients who check blood sugars on average less than 2 times per day after appropriate counseling
  4. * Already started pharmacotherapy prior to referral to the study

Contacts and Locations

Study Contact

Anna Palatnik, MD
CONTACT
414-805-6627
apalatnik@mcw.edu
Eleanor Saffian
CONTACT
414-805-6605
esaffian@mcw.edu

Study Locations (Sites)

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-04
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2021-05-04
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Gestational Diabetes