Glycemic Targets for Pregnant Women With GDM and T2DM
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.
Conditions:
🦠 Diabetes Mellitus in Pregnancy 🦠 Diabetes, Gestational 🦠 Diabetes Mellitus, Type 2
🗓️ Study Start (Actual) 8 July 2021
🗓️ Primary Completion (Estimated) July 2023
✅ Study Completion (Estimated) July 2023
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pregnant women with a singleton gestation
    • * 18 years or older
    • * Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes

    Exclusion Criteria:

    • * Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
    • * Type 1 diabetes
    • * Diabetic retinopathy
    • * Diabetic nephropathy
    • * Diabetic vasculopathy
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 8 December 2020
  • First Submitted that Met QC Criteria 10 December 2020
  • First Posted 17 December 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2023
  • Last Update Posted 11 May 2023
  • Last Verified May 2023