Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
NCT Number: NCT06535789
Acronym: INHALE-GDM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Diabetes, Gestational|Pregnancy Complications|Glucose Metabolism Disorders|Glucose Intolerance During Pregnancy
Interventions: DRUG: Inhaled Technosphere Insulin
Sponsor: Jaeb Center for Health Research
Collaborators: Mannkind Corporation
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2024-12
Locations: Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States|University of Colorado School of Medicine, Aurora, Colorado, 80045, United States|Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
Pregnant women aged 18-49 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.

Primary Outcome Measures: Post-prandial AUC120, 2-hour post-prandial (PP) area under the curve ≥120 mg/dL (AUC120), 2 hours post-prandial (PP)
Secondary Outcome Measures: AUC >120 mg/dL, AUC \>120 mg/dL over 3 hours PP, 3 hours PP|AUC >140 mg/dL, AUC \>140 mg/dL over 3 hours PP, 3 hours PP|Excursion from baseline glucose to peak glucose, Excursion from baseline glucose to peak glucose during 2 hours PP, 2 hours PP|Maximum peak glucose, Maximum peak glucose during 2 hours PP, 2 hours PP|Time to peak glucose, Time to peak glucose during 2 hours PP, 2 hours PP|Time to nadir glucose, Time to nadir (lowest) glucose during 2 hours PP, 2 hours PP|Mean CGM glucose, Mean CGM glucose during 2 hours PP, 2 hours PP|Time with glucose >120 mg/dL, Time with glucose \>120 mg/dL during 3 hours PP, 3 hours PP|Time with glucose >140 mg/dL, Time with glucose \>140 mg/dL during 3 hours PP, 3 hours PP|Glucose ≤140 mg/dL, Glucose ≤140 mg/dL at 1 hour PP, 1 hours PP|Glucose ≤120 mg/dL, Glucose ≤120 mg/dL at 1 hour PP, 1 hours PP|Glucose in range 70-140 mg/dL, Glucose in range 70-140 mg/dL at 1 hour PP, 1 hours PP|Glucose in range 70-120 mg/dL, Glucose in range 70-120 mg/dL at 2 hour PP, 2 hours PP
Other Outcome Measures: Any blood glucose <54 mg/dL, Any blood glucose \<54 mg/dL during 3 hours PP, 3 hours PP|Any blood glucose <63 mg/dL, Any blood glucose \<63 mg/dL during 3 hours PP, 3 hours PP|Any blood glucose <70 mg/dL, Any blood glucose \<70 mg/dL during 3 hours PP, 3 hours PP|Percent time glucose <63 mg/dL, CGM-measured percent time with glucose \<63 mg/dL during 3 hours PP, 3 hours PP|Hypersensitivity to inhaled technosphere insulin, Hypersensitivity reaction, acute bronchospasm, treatment provided for asthma symptoms, or other symptoms associated with TI dosing, Up to 5 hours PP