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Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus

Clinical Trial Details

This behavioral intervention trial is intended for women newly diagnosed with gestational diabetes mellitus (GDM). If left untreated, GDM can lead to an increased risk for complications during delivery, neonatal hypoglycemia/seizures, stillbirth, and postpartum development of type-2 diabetes. The current front-line treatment for GDM is medical nutrition therapy, i.e. personalized diets which may or may not include mild carbohydrate restriction. Use of carbohydrate restriction increases the risk of the mother developing starvation ketoacidosis, a harmful condition for both the mother and fetus. If MNT is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. 

In patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. Given this combination of potential benefits, the addition of this behavior in patients with GDM may be helpful in achieving controlled blood sugar levels without increasing the risk of ketoacidosis. 


This study will include two randomized groups newly diagnosed with GDM. Patients in the control group will be prescribed standard medical nutrition counseling. Patients in the intervention group will have identical medical nutrition counseling but with additional food order instruction/therapy. All patients will be followed up with at 1-2 week intervals. At each follow-up the physician and dietician will analyze the patient’s blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. Treatment will continue through delivery or at the initiation of pharmacotherapy, whichever comes first. 

Key Eligibility: 
  • Women 18 years of age or older
  • Newly diagnosed with gestational diabetes mellitus between 24-28 weeks of gestation
  • Detailed eligibility reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Wanda Truong, MS
(646) 962-2424
wat7003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1802018956

ClinicalTrials.gov:

NCT03592784

Status

Open to Enrollment

Age Group

Adult