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
This investigator-initiated study will enroll about 30 adults 18 to 60 years of age with type 1 diabetes (T1D) who are using the Tandem t:slim X2 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.
• Ability to provide informed consent for study participation
• Age ≥18 years to 60 years
• Clinical diagnosis of T1D (per the Investigator)
• Using Tandem t:slim X2 insulin pump with Control-IQ for at least 90 days prior to screening visit
• Using insulin aspart or insulin lispro in Tandem t:slim X2 insulin pump
• Total daily insulin dose 20 to 80 units
• Usual RAA insulin bolus for 50 gram carbohydrate lunch meal is ≤12 units
• Physically active, with at least 3 moderate or vigorous exercise sessions ≥30 minutes per typical week self-reported by participant
• No medical, psychiatric, or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study
⁃ No electrocardiogram (ECG) abnormality that in the judgment of the investigator, which will take into consideration the usual exercise performed by the participant and their overall medical condition, increases the risk of exercise
⁃ Investigator believes that the participant can safely follow the protocol
⁃ Able to read and understand written and spoken English or Spanish