Comparing strict and permissive thresholds for treating gestational diabetes
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)
Run by Thomas Jefferson University · NCT06419803 · Data updated 2026-11-12
This study is testing whether treating gestational diabetes with stricter or more relaxed blood sugar targets leads to better health outcomes for mothers and their babies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 430 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 2 sites (Rochester, New York and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | May 2026 |
| Study ends | May 2026 |
| Registry record updated | November 22, 2024 |
| Trial ID | NCT06419803 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant individuals diagnosed with gestational diabetes who are literate in English, Spanish, Mandarin, or Arabic.
✕Probably not a fit
Patients under 18 years old, those with pre-existing diabetes, or those with certain medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effects of different thresholds for initiating and adjusting pharmacotherapy in patients with gestational diabetes (GDM). Participants will be assigned to either a strict threshold group, targeting blood glucose levels between 65-120 mg/dL, or a permissive threshold group, targeting levels between 65-140 mg/dL. The study will assess maternal and neonatal outcomes to determine the most effective approach for managing GDM. By addressing the lack of consensus on treatment thresholds, this research seeks to provide clearer guidelines for clinical practice.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal and neonatal health outcomes by establishing optimal treatment thresholds for gestational diabetes.
How similar studies have gone: Previous studies have shown benefits from treating gestational diabetes, but this specific head-to-head comparison of treatment thresholds is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Thomas Jefferson University
Philadelphia, Pennsylvania, United States Recruiting -
University of Rochester Medical Center
Rochester, New York, United States Not yet recruiting
Study contacts
- Study coordinator: Kavisha Khanuja, MD
- Email: kxk334@jefferson.edu
- Phone: 2159555000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding Gestational Diabetes in Asian Pregnant Women
This study is trying to learn more about gestational diabetes in Asian pregnant women to see how different types of the condition affect their health and treatment options.
-
Comparing strict and permissive thresholds for treating gestational diabetes
This study tests whether starting treatment for gestational diabetes with stricter or more relaxed rules leads to better health outcomes for moms and their babies.
-
Early Glucose Patterns in Pregnant Women at Risk for GDM
This study tests whether continuous glucose monitoring in early pregnancy can detect dysglycemia before GDM is diagnosed, in women with and without known risk factors.
-
Prenatal education to reduce environmental exposures during pregnancy
Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.
-
Interprofessional Training to Improve Care for Peri-Delivery Patients with Substance Use Disorder
This program tests INSPIRE, a set of online and in-person trainings for healthcare teams to reduce stigma and improve care for people with substance use disorder around labor, delivery, and postpartum at the University of Utah.
-
Lower-extremity blood pressure monitoring during cesarean under spinal anesthesia
This study tests whether noninvasive blood pressure monitoring from the toe is better than the arm at predicting neonatal outcomes during cesarean delivery with spinal anesthesia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.