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

Recruiting now · Phase 2/Phase 3

Conditions studied: Diabetes, Gestational, Pregnancy Complications, Glucose Metabolism Disorders, Glucose Intolerance During Pregnancy

In brief

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.

Key facts

Study ID: NCT06535789
Run by: Jaeb Center for Health Research
People needed: 30
Starts: 2025-05-01
Expected to finish: 2025-07-01
Last updated by the study team: 2025-05-15

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Sansum Diabetes Research Institute — Santa Barbara, California, United States (enrolling)
University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Oregon Health and Science University — Portland, Oregon, United States (enrolling)
University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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