RecruitingNot ApplicableNCT06880835

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


Sponsor

Jaeb Center for Health Research

Enrollment

30 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of insulin for covering meals during exercise in adults with type 1 diabetes who use an automated insulin delivery system (closed-loop pump). It compares inhaled Technosphere insulin (a rapid-acting inhaled insulin) with the standard rapid-acting injected insulin used just before exercise, to see which better prevents blood sugar from dropping too low during physical activity. **You may be eligible if:** - You are between 18 and 65 years old with type 1 diabetes - You use a Tandem t:slim X2 or Tandem Mobi pump with Control-IQ technology for at least 90 days - You use insulin aspart or lispro in your pump - Your total daily insulin dose is between 20 and 80 units - You exercise moderately to vigorously at least 3 times per week for 30+ minutes **You may NOT be eligible if:** - You use a different type of insulin pump or insulin - You do not exercise regularly - You have certain heart conditions detected on ECG - You have conditions that make inhaled insulin unsafe (e.g., lung disease) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEControl IQ + sleep activity with TI

TI for meal bolus with Control IQ + sleep activity pump setting


Locations(3)

University of Louisville

Louisville, Kentucky, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

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NCT06880835


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