Status:
RECRUITING
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
Mannkind Corporation
Conditions:
Diabetes, Gestational
Pregnancy Complications
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Gestational diabetes mellitus (GDM) affects up to 25% of births globally, and its rates continue to rise each year. Pregnancy is a dynamic time marked by rapid changes in physiology, anatomy, and meta...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- Type 1 diabetes or type 2 diabetes
- 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)
- Current use of any non-insulin glucose lowering medication
- Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)
- Peak expiratory flow \<80% predicted as measured by peak flow meter
- Recent history of asthma (defined as using any medications to treat asthma within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator
- Smoking (includes cigarettes, cigars, pipes, and/or vaping devices) within 90 days prior to screening
- History or current diagnosis of lung cancer
- Current or anticipated use of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable)
- Renal or hepatic impairment that in the investigator's judgment poses a safety risk for the study participant
- Recurrent Level 2 (blood glucose \<54 mg/dL) or Level 3 severe hypoglycemia events
- Current use of non-cardio-selective beta blockers
- Being a member of the study team, having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06535789
Start Date
May 1 2025
End Date
July 1 2025
Last Update
May 15 2025
Active Locations (5)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Oregon Health and Science University
Portland, Oregon, United States, 97239