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.
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
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)
Jaeb Center for Health Research
Lead sponsor
Mannkind Corporation
Collaborator