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

Launched by THOMAS JEFFERSON UNIVERSITY · May 14, 2024

Keywords

ClinConnect Summary

The START 2 clinical trial is studying how different blood sugar targets affect the health of mothers and their babies during pregnancy in women diagnosed with gestational diabetes. The researchers want to find out if having a stricter blood sugar target (keeping levels between 65-120 mg/dL) is better compared to a more flexible target (keeping levels between 65-140 mg/dL). Both groups aim to keep their blood sugar levels within the target range 70% of the time.

To be eligible for the study, participants must be pregnant women over 18 years old with a single, healthy fetus and must be able to read and understand English, Spanish, Mandarin, or Arabic. Participants will need to provide consent and understand the study's purpose. If you join the trial, you will be monitored closely for your blood sugar levels, and you may receive medication to help manage your condition. This study is currently recruiting participants, so it’s a great opportunity to contribute to important research that could improve care for women with gestational diabetes.

Gender

FEMALE

Eligibility 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