RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06535789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katrina Ruedy, MSPH
CONTACT
813-975-8690
kruedy@jaeb.org
Jennifer Gurley
CONTACT
jgurley@jaeb.org

Principal Investigator

Amy Valent, DO
STUDY_CHAIR
Oregon Health and Science University

Study Locations (Sites)

Sansum Diabetes Research Institute
Santa Barbara, California, 93105
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Icahn School of Medicine at Mount Sinai
New York City, New York, 10029
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

  • Amy Valent, DO, STUDY_CHAIR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2025-07

Study Record Updates

Study Start Date2025-05
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Gestational Diabetes
  • Inhaled Insulin

Additional Relevant MeSH Terms

  • Diabetes, Gestational
  • Pregnancy Complications
  • Glucose Metabolism Disorders
  • Glucose Intolerance During Pregnancy