RECRUITING

Glycemic Targets for Pregnant Women With GDM and T2DM

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 purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.

Official Title

Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes

Quick Facts

Study Start:2021-07-08
Study Completion:2023-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04672031

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
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women with a singleton gestation
  2. * 18 years or older
  3. * Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes
  1. * Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
  2. * Type 1 diabetes
  3. * Diabetic retinopathy
  4. * Diabetic nephropathy
  5. * Diabetic vasculopathy

Contacts and Locations

Study Contact

Brendan H Grubbs, MD
CONTACT
323-409-3306
brendan.grubbs@med.usc.edu

Study Locations (Sites)

Los Angeles County + University of Southern California Medical Center (LAC+USC)
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

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 Date2021-07-08
Study Completion Date2023-07

Study Record Updates

Study Start Date2021-07-08
Study Completion Date2023-07

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus in Pregnancy
  • Diabetes, Gestational
  • Diabetes Mellitus, Type 2