NCT06880835

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

INHALE-AIDEx: A Randomized Crossover Trial Evaluating the Effect of Inhaled Technosphere Insulin (Afrezza®) vs Rapid Acting Analogue Insulin on Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes Using Automated Insulin Delivery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a 3-period randomized crossover trial, each with a structured afternoon exercise session following a standard lunch meal. The 3 sessions are as follows: (1) TI for meal bolus with pump in sleep mode, (2) RAA for meal bolus with pump in sleep mode, and (3) RAA for meal bolus with pump in standard mode with transition to exercise mode one hour before start of exercise. The study is being done to compare the efficacy and safety of TI versus RAA given as bolus for meal prior to initiating aerobic exercise in adults ≥18 to ≤ 65 years of age with T1D using Control-IQ. All participants will complete 3 exercise sessions, with the order determined through randomization.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Control IQ + sleep activity with TI	TI for meal bolus with Control IQ + sleep activity pump setting

Timeline

• Start date: 2025-06-05
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-03-18
• Last updated: 2025-09-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study