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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Ability to provide informed consent for study participation

• Age ≥18 years and \<41 years old

• Singleton pregnancy at 24-34 weeks gestation

• Diagnosis of GDM via standard 1-step or 2-step criteria

• Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \<20 units

• Pre-pregnancy or first trimester body mass index (BMI) 25-45

• Investigator believes that the protocol can be safely conducted by the participant

• Able to read and speak English

Locations
United States
California
Sansum Diabetes Research Institute
RECRUITING
Santa Barbara
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Katrina Ruedy, MSPH
kruedy@jaeb.org
813-975-8690
Backup
Jennifer Gurley
jgurley@jaeb.org
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2025-07
Participants
Target number of participants: 30
Treatments
Experimental: technosphere insulin (TI)
All participants will ingest one standardized meal using technosphere insulin to manage their blood glucose
No_intervention: Rapid-acting insulin analog
All participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose
Related Therapeutic Areas
Sponsors
Leads: Jaeb Center for Health Research
Collaborators: Mannkind Corporation

This content was sourced from clinicaltrials.gov