Actively Recruiting
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
Led by Jaeb Center for Health Research · Updated on 2025-05-15
30
Participants Needed
5
Research Sites
8 weeks
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
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.
CONDITIONS
Official 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...
- Ability to provide informed consent for study participation
- Age 18 years or older and younger than 41 years
- Singleton pregnancy at 24 to 34 weeks gestation
- Diagnosed with gestational diabetes mellitus using standard criteria
- Currently treated with a rapid-acting insulin bolus for breakfast with a dose less than 20 units
- Pre-pregnancy or first trimester body mass index (BMI) between 25 and 45
- Investigator believes participation 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, 2-hour glucose 200 mg/dL or higher on 75g oral glucose tolerance test, or random plasma glucose 200 mg/dL or higher indicating pre-existing diabetes
- Current use of any non-insulin glucose lowering medication
- Using technosphere insulin, regular insulin, or 20 or more units of rapid-acting insulin at breakfast (NPH insulin allowed)
- Peak expiratory flow less than 80% predicted
- Recent history of asthma, chronic obstructive pulmonary disease, or other significant lung or heart diseases
- Smoking cigarettes, cigars, pipes, or vaping devices 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 steroids allowed)
- Kidney or liver problems posing safety risks
- Recurrent severe low blood sugar events
- Current use of non-cardio-selective beta blockers
- Being a member of the study team, having a direct supervisor involved in the trial, or having a first-degree relative involved in the trial
AI-Screening
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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
CONTACT
J
Jennifer Gurley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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