Recruiting

Gestational Diabetes

Sponsor:

Thomas Jefferson University

Code:

NCT06419803

Conditions

Gestational Diabetes

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Insulin

Study Details

Brief summary:

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Conditions

Gestational Diabetes

Pregnancy Related

Study ID

NCT06419803

Start date

Sep 1, 2024

Status verified date

Nov, 2024

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Live, non-anomalous fetus
  • Literacy in English, Spanish, Mandarin, or Arabic
  • Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

Exclusion Criteria:

  • <18 years at EDD
  • pre-existing diabetes or diagnosis of GDM prior to 24 weeks
  • multi-fetal gestation
  • known major fetal anomaly
  • known allergy to insulin
  • chronic maternal corticosteroid use
  • diagnosis of GDM based on finger sticks alone
  • patients who have contraindication to oral glucose tolerance test
  • a primary language other than English, Spanish, Mandarin, or Arabic

Study Design

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Strict Arm

The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%.

active comparator: Permissive

The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Interventions

Insulin

Insulin will be used in gestational diabetics to control blood glucose levels

Primary outcome measure

  • Neonatal Composite Outcome [ Time Frame: First 28 days of birth ]

Central Contacts and Locations

Central contacts

Kavisha Khanuja, MD

2159555000kxk334@jefferson.edu

Rodney McLaren Jr, MD

2159555000rodney.mclaren@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

Thomas Jefferson University

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • gestational diabetes
  • pregnancy
  • insulin
  • Initiation of medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2024-11-22.