Actively Recruiting
The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets in Gestational Diabetes
Led by Jaeb Center for Health Research · Updated on 2025-05-15
30
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
M
Mannkind Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how two types of insulin treatments affect blood sugar levels after meals in pregnant women aged 18 to 40 with gestational diabetes (GDM). The study focuses on comparing a rapid-acting insulin analog (RAA) given by injection, which is commonly used before and after meals, with a newer inhaled insulin called technosphere insulin (TI). This study is a randomized crossover trial aiming to assess the effectiveness and safety of these treatments during pregnancy when managing post-meal blood sugar is critical for both mother and baby. Participants will attend the clinic for two meal sessions. In one session, they will use their usual rapid-acting injected insulin, and in the other, they will use the inhaled technosphere insulin. The order of treatments is randomized. Each participant will consume a standardized meal, and their blood sugar will be monitored after each meal to compare the effects of the two insulin types. The study uses the inhaled insulin delivered by a breath-powered inhaler and compares it to the standard injected insulin. During the study, blood sugar levels will be closely monitored after meals using various measurements over three hours, including glucose levels and time spent within target ranges. Participants will have continuous glucose monitoring and other assessments to track their blood sugar responses. Safety and efficacy will be evaluated, focusing on post-meal blood sugar control and the frequency of low blood sugar episodes. The study period includes these two meal visits and follow-up to assess outcomes. Overall participation duration is based on these specific visits around meals.
CONDITIONS
Brief Title
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent for study participation
- Female aged 18 years or older and younger than 41 years
- Pregnant with a single baby at 24 to 34 weeks gestation
- Diagnosed with gestational diabetes by standard criteria
- Treated with a rapid-acting insulin injection for breakfast with a dose less than 20 units
- Pre-pregnancy or first trimester body mass index between 25 and 45
- Investigator believes the study protocol is safe for the participant
- Able to read and speak English
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes
- HbA1c 6.5% or higher, fasting blood glucose 125 mg/dL or higher, or 2-hour glucose 200 mg/dL or higher indicating pre-existing diabetes
- Current use of any non-insulin glucose-lowering medications
- Using technosphere insulin, regular insulin, or 20 or more units of rapid-acting insulin at breakfast
- Peak expiratory flow less than 80% predicted
- Recent asthma, COPD, or other significant lung diseases or serious heart-lung conditions
- Smoking cigarettes, cigars, pipes, or vaping within 90 days before screening
- History or current diagnosis of lung cancer
- Current or planned use of oral, inhaled, or injectable glucocorticoids during the trial (topical use allowed)
- Kidney or liver problems posing safety concerns
- Frequent severe low blood sugar episodes
- Current use of non-cardio-selective beta blockers
- Being part of the study team or having close relatives involved in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short-term, based on single meal interventions during gestational weeks 24 to 34
Participants receive either inhaled Technosphere insulin or their prescribed rapid-acting insulin injections to manage blood glucose after a standardized breakfast meal. They switch between these treatments in a randomized crossover design to compare efficacy and safety.
2 treatment visits with standardized meals
Trial Site Locations
Total: 5 locations
1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Actively Recruiting
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
4
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Katrina Ruedy, MSPH
J
Jennifer Gurley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here