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

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Jaeb Center for Health Research
Study ID
NCT06535789
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes, Gestational
  • Glucose Intolerance During Pregnancy
  • Glucose Metabolism Disorders
  • Pregnancy Complications

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Inhaled Technosphere Insulin — DRUG
    Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal

Study Details

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 Dates

Start date
May 31, 2025
Status verified
May 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: technosphere insulin (TI)
    All participants will ingest one standardized meal using technosphere insulin to manage their blood glucose
  • No Intervention: Rapid-acting insulin analog
    All participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose

Primary Outcome Measure

Post-prandial AUC120 [ Time Frame: 3 hours from start of meal ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105
Sarintha Bell
[email protected]
805-682-7640
Kristin Castorino, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Jocelyn Phipers, RN
[email protected]
303-724-7807
Linda A Barbour, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Denisa Tamarez
[email protected]
212-241-9089
Carol Levy, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Monica Rincon
[email protected]
503-494-8748
Amy Valent, DO (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Elizabeth Norton
[email protected]
800-789-7366
Celeste Durnwald, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Barbara, CA

By research site
Sansum Diabetes Research Institute· Santa Barbara, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COIcahn School of Medicine at Mount Sinai· New York, NYOregon Health and Science University· Portland, ORUniversity of Pennsylvania· Philadelphia, PA

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