Clinical Trial

Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery

Study acronym: INHALE-AIDEx
Recruiting
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Summary
This investigator-initiated study will enroll about 30 adults 18 to 65 years of age with type 1 diabetes (T1D) who are using the Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ or Control-IQ+ technology ("Control-IQ" which will refer to either Control-IQ or Control-IQ+). The study is being done to find out if inhaled insulin given for a meal is safer and better to use than a bolus of insulin through your pump when you exercise following a meal. Participants are asked to complete three study exercise visits in the clinic.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-03-12; most recent amendment 2026-07-14.
Status change: Not Yet Recruiting → Recruiting 2025-06-09
Trial Details
NCT Number NCT06880835
Lead Sponsor Jaeb Center for Health Research
Collaborators: Mannkind Corporation, Tandem Diabetes Care, Inc., The Leona M. and Harry B. Helmsley Charitable Trust
Conditions Diabetes Mellitus, Type 1
Enrollment 30 participants
Start Date 2025-06-05
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16