Comparing strict and permissive thresholds for treating gestational diabetes
Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 2 sites (Rochester, New York and 1 other locations) |
| Trial ID | NCT06419777 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of different thresholds for initiating pharmacotherapy in patients with gestational diabetes (GDM). It compares a strict threshold, requiring two abnormal glucose values over a week, to a permissive threshold, where treatment is initiated if 50% of values are elevated. 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 initiation criteria, this research seeks to standardize care for pregnant patients with GDM.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals diagnosed with gestational diabetes who meet the inclusion criteria and are literate in English, Spanish, Mandarin, or Arabic.
Not a fit: Patients under 18 years, those with pre-existing diabetes, or those with contraindications to the study protocols may not benefit from this study.
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 performed: Previous studies have shown benefits from treating gestational diabetes, but this is the first randomized controlled trial comparing different treatment initiation thresholds.
Eligibility criteria
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 before 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 this trial is running
Rochester, New York and 1 other locations
- University of Rochester Medical Center — Rochester, New York, United States (Not_yet_recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Kavisha Khanuja, MD
- Email: kxk334@jefferson.edu
- Phone: 215-955-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.