Recruiting

Glycemic Targets

Sponsor:

University of Southern California

Code:

NCT04672031

Conditions

Diabetes Mellitus in Pregnancy

Diabetes, Gestational

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Glycemic Targets

Study Details

Brief summary:

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 ID

NCT04672031

Start date

Jul 8, 2021

Status verified date

May, 2023

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Arm

Patients in the control arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. 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 (i.e. conventional targets). Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist.

experimental: Interventional Arm

Patients in the experimental arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. 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. Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist.

Interventions

Glycemic Targets

The intervention is glycemic targets that are lower than those currently recommended by ADA and ACOG: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL instead of fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL.

Primary outcome measure

  • Difference in birth weight [ Time Frame: 41 weeks gestation ]

Central Contacts and Locations

Central contacts

Brendan H Grubbs, MD

323-409-3306brendan.grubbs@med.usc.edu

Locations

Los Angeles County + University of Southern California Medical Center (LAC+USC)

Recruiting

Los Angeles, California, United States, 90033

Contacts

Michelle T Nguyen, MD

323-409-4084michelle.nguyen3@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

May 11, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-05-11.