Comparing Inhaled Technosphere Insulin and Rapid-Acting Insulin Injections for Blood Sugar Control After Meals in Pregnant Women with Gestational Diabetes

What this Trial Is About

Researchers are evaluating how two types of insulin treatments affect blood sugar levels after meals in pregnant women aged 18 to 40 with gestational diabetes GDM. The study focuses on comparing a rapid-acting insulin analog RAA given by injection, which is commonly used before and after meals, with a newer inhaled insulin called technosphere insulin TI. This study is a randomized crossover trial aiming to assess the effectiveness and safety of these treatments during pregnancy when managing post-meal blood sugar is critical for both mother and baby. Participants will attend the clinic for two meal sessions. In one session, they will use their usual rapid-acting injected insulin, and in the other, they will use the inhaled technosphere insulin. The order of treatments is randomized. Each participant will consume a standardized meal, and their blood sugar will be monitored after each meal to compare the effects of the two insulin types. The study uses the inhaled insulin delivered by a breath-powered inhaler and compares it to the standard injected insulin. During the study, blood sugar levels will be closely monitored after meals using various measurements over three hours, including glucose levels and time spent within target ranges. Participants will have continuous glucose monitoring and other assessments to track their blood sugar responses. Safety and efficacy will be evaluated, focusing on post-meal blood sugar control and the frequency of low blood sugar episodes. The study period includes these two meal visits and follow-up to assess outcomes. Overall participation duration is based on these specific visits around meals.

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