|
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
RECRUITINGN/ASponsored by Thomas Jefferson University
Actively Recruiting
PhaseN/A
SponsorThomas Jefferson University
Started2024-09-01
Est. completion2026-05
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06419803
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%.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy 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
Conditions3
DiabetesGestational DiabetesPregnancy Related
Interventions1
Locations2 sites
New York
1 sitePennsylvania
1 siteFind trials near these locations
Related trials
- Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes — Mostafa Bahaa
- Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes — Institut de Recherches Cliniques de Montreal
- Insulin Sensitivity After Breast Cancer — University of Copenhagen
- Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes — Nanjing Medical University
- DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes — Ohio State University
- FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) — Sanofi
- Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes — Thomas Jefferson University
- Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D) — Ohio State University
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhaseN/A
SponsorThomas Jefferson University
Started2024-09-01
Est. completion2026-05
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06419803