Inhaled Insulin vs Injections for Gestational Diabetes

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for pregnant women aged 18-40 who have gestational diabetes. Participants will try two types of insulin to see which one works better for controlling blood sugar after meals.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesType 2 diabetes

You may be able to join if

  • I am between 18 and 40 years old.
  • I am pregnant and between 24 and 34 weeks along.
  • I have been diagnosed with gestational diabetes.
  • I use a rapid-acting insulin for breakfast.
  • My body mass index (BMI) is between 25 and 45.
  • I can read and speak English.
  • I can give informed consent for the study.
  • My doctor believes I can participate safely.

You may not be able to join if

  • I have type 1 or type 2 diabetes.
  • My blood sugar levels indicate pre-existing diabetes.
  • I use any non-insulin medications to lower my blood sugar.
  • I have a recent history of asthma or serious lung disease.
  • I have smoked in the last 90 days.
  • I have a history of lung cancer.
  • I am using glucocorticoids like steroids.
  • I have significant kidney or liver problems.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
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
Loading…

Loading trial locations…

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

Katrina Ruedy, MSPH

813-975-8690

kruedy@jaeb.org

CONTACT

Jennifer Gurley

jgurley@jaeb.org

CONTACT