Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

Part of paid clinical trials in Rochester, New York.

Sponsor
Thomas Jefferson University
Study ID
NCT06419777
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).

Key Dates

Start date
Sep 1, 2024
Status verified
Nov 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Strict Arm
    The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated)
  • Active Comparator: Permissive
    The permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Sarah Crimmins, DO
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Kavisha Khanuja, MD
Rodney McLaren, MD

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By research site
University of Rochester Medical Center· Rochester, NYThomas Jefferson University· Philadelphia, PA

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