RecruitingPhase 2Phase 3NCT06535789

Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes

The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes


Sponsor

Jaeb Center for Health Research

Enrollment

30 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Inhaled Technosphere Insulin for people with diabetes, gestational, glucose intolerance during pregnancy, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include women aged 18 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInhaled Technosphere Insulin

Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal


Locations(5)

Sansum Diabetes Research Institute

Santa Barbara, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06535789


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