Plain-English translation of NCT06619301 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing whether or works better for managing diabetes during pregnancy. Both are long-acting insulins that help control blood sugar. The main goal is to see which one causes fewer episodes of dangerously low blood sugar while keeping your baby safe.
Pregnant people with diabetes need careful insulin management to protect both their health and their baby's development. Doctors want to know which of these two insulins is safer and more effective during pregnancy, especially when it comes to avoiding low blood sugar episodes.
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You will be randomly assigned to receive either or , given as 1–2 injections daily throughout your pregnancy. You'll check your blood sugar 4 times a day (fasting and after meals), log your results in a chart, attend regular prenatal care visits, and have routine ultrasounds. You'll also receive teaching on insulin use and nutrition guidance. Your care and number of visits will be the same whether or not you join the study.
AI-generated summary from trial data · Jul 22, 2026 · Not medical advice
United States
Phase
Large-scale testing
Sponsor
Loyola University
Enrollment target
~160 participants
Started
April 2024
Primary completion
April 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years and older
Sex
Female only
Last updated on clinicaltrials.gov in October 2024.
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Central contact
Joana Lopes Perdigao, MD
Loyola University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.