Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)

Description

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

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Study Overview

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Study Details

Study overview

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%.

Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Continuous Glucose Monitoring Use - A Randomized Control Trial (START 2 Trial)

Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)

Condition
Gestational Diabetes
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester Medical Center, Rochester, New York, United States, 14642

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * \<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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Thomas Jefferson University,

Study Record Dates

2026-05