RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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%.

Official Title

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)

Quick Facts

Study Start:2024-09-01
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06419803

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Live, non-anomalous fetus
  2. * Literacy in English, Spanish, Mandarin, or Arabic
  3. * Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
  1. * \<18 years at EDD
  2. * pre-existing diabetes or diagnosis of GDM prior to 24 weeks
  3. * multi-fetal gestation
  4. * known major fetal anomaly
  5. * known allergy to insulin
  6. * chronic maternal corticosteroid use
  7. * diagnosis of GDM based on finger sticks alone
  8. * patients who have contraindication to oral glucose tolerance test
  9. * a primary language other than English, Spanish, Mandarin, or Arabic

Contacts and Locations

Study Contact

Kavisha Khanuja, MD
CONTACT
2159555000
kxk334@jefferson.edu
Rodney McLaren Jr, MD
CONTACT
2159555000
rodney.mclaren@jefferson.edu

Study Locations (Sites)

University of Rochester Medical Center
Rochester, New York, 14642
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • gestational diabetes
  • pregnancy
  • insulin
  • Initiation of medication

Additional Relevant MeSH Terms

  • Gestational Diabetes
  • Pregnancy Related