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Compares treatment options for Gestational Diabetes
Official title Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
ClinicalTrials.gov ID: NCT06419803
What this study is testing
What is Insulin?
Insulin is an investigational medicine, being studied as a potential treatment for gestational diabetes.
Also referred to as Lantus, Lispro.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- \<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
See the full eligibility 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.
- \<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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.