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

ConditionsGestational DiabetesPregnancy Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University

About this trial

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%.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

<18 years at EDD

pre-existing diabetes or diagnosis of GDM prior to 24 weeks

multi-fetal gestation

known major fetal anomaly

Trial design

Design model

Parallel

Treatments tested in this trial

  • Insulin

    Drug

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

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Strict ArmActive comparator 1 intervention
Group B: PermissiveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neonatal Composite Outcome

Neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma

Time frame
First 28 days of birth

Secondary outcomes

1

Neonatal Outcome: Gestational Age of Birth

Gestational age at delivery in weeks and days

Time frame
Delivery Time
2

Neonatal Outcome: APGAR Score

Scoring system provided a standardized assessment for infants after delivery from 0-10

Time frame
At 1 minute of life and at 5 min of life
3

Neonatal Outcome: Birthweight

Birthweight in grams, Macrosomia (birthweight \>4000g, Small for gestational age (\<10th percentile based on Fenton Growth Charts)

Time frame
Delivery Time
4

Neonatal Outcome: Respiratory distress

Breathing difficulties after birth requiring supplemental oxygen, mask, intubation, and/or surfactant

Time frame
Within first 24 hours after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

University of Rochester

Collaborator

Source ClinicalTrials.gov
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