The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes
Jaeb Center for Health Research
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 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.
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 metabolism that support the growth and development of the fetus. This period can also be vulnerable, as expectant mothers may experience shifts in body perception, food preferences, and physical fitness, which can lead to decreased self-esteem, depression, and anxiety. A diagnosis of GDM often catches women by surprise and may bring feelings of guilt and anxiety about the potential effects on their ba…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria 1. 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 1. Type 1 diabetes or type 2 diabetes 2. HbA1c ≥ 6.5%, FBG…
Interventions
- DrugInhaled Technosphere Insulin
Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal
Locations (5)
- Sansum Diabetes Research InstituteSanta Barbara, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Icahn School of Medicine at Mount SinaiNew York, New York
- Oregon Health and Science UniversityPortland, Oregon
- University of PennsylvaniaPhiladelphia, Pennsylvania