NCT06535789 · Jaeb Center for Health Research
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
(INHALE-GDM)
What this study 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.
View original scientific 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.
Interventions
DRUG
Inhaled Technosphere Insulin
Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal
Primary outcome measures
Post-prandial AUC120
Time frame: 3 hours from start of meal
3-hour post-prandial (PP) area under the curve \>120 mg/dL (AUC120)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ability to provide informed consent for study participation 2. Age ≥18 years and \<41 years old 3. Singleton pregnancy at 24-34 weeks gestation 4. Diagnosis of GDM via standard 1-step or 2-step criteria 5. Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \<20 units 6. Pre-pregnancy or first trimester body mass index (BMI) 25-45 7. Investigator believes that the protocol can be safely conducted by the participant 8. Able to read and speak English
Exclusion criteria
- Type 1 diabetes or type 2 diabetes 2. HbA1c ≥ 6.5%, FBG ≥125 mg/dl or 2-hr glucose ≥200 mg/dL on 75g OGTT, or random plasma glucose ≥200 mg/dL (consistent with pre-existing diabetes and not GDM diagnosis) 3. Current use of any non-insulin glucose lowering medication 4. Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible) 5. Peak expiratory flow \<80% predicted as measured by peak flow meter 6. Recent history of asthm
Where
- Santa Barbara, California
- Aurora, Colorado
- New York, New York
- Portland, Oregon
- Philadelphia, Pennsylvania
Collaborators
Mannkind Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2025 · Source of record for eligibility and locations