Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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 Glucometer Use - A Randomized Control Trial (START1)

Run by Thomas Jefferson University · NCT06419777 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment430 (estimated)
SponsorThomas Jefferson University
Academic / other
Locations2 sites (Rochester, New York and 1 other locations)
StatusRecruiting
StartedSeptember 1, 2024
Main results expectedMay 2026
Study endsMay 2026
Registry record updatedNovember 21, 2024
Trial IDNCT06419777 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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 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.

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 is the first randomized controlled trial comparing different treatment initiation thresholds.

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 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 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.