Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
Recruiting
Phase 2
Phase 3
Interventional Study
Diabetes, Gestational
Pregnancy Complications
Glucose Metabolism Disorders
Glucose Intolerance During Pregnancy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 40
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Jaeb Center for Health Research · Other
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About This Trial
Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly d…
Trial Locations
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Eligibility Criteria
Inclusion Criteria
1. Ability to provide informed consent for study participation
2. Age ≥18 years and \<41 years old
3. Singleton pregnancy at 24-34 weeks gestation
4. Diagnosis of GDM via standard 1-step or 2-step criteria
5. Treated with an insulin regimen that includes a RAA bolus of any type f…
Contacts