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

First, you will have a visit to review the informed consent form, to check that you are eligible for the study, to answer some questions about your health, and to have a lung function test. You may need to have an electrocardiogram (ECG, a test for your heart) if you have not had one in the last 6 months.
You will be asked to keep a log of your lunch meals and insulin bolus for about one week. You will also be given a lunch meal to try. This will be similar to the lunch meal you will eat during your other study exercise visits.

There will be three study exercise visits in the clinic. Each exercise visit will be about 4-5 hours. When you arrive at the clinic, we will place a needle and plastic tube (called an IV) so that your blood sugar can be checked throughout the visit. Fingerstick blood sugars may also be checked. Your blood pressure and pulse will be measured. During each exercise visit you will be given a lunch meal to eat. Prior to the meal at two visits, you will use your RAA insulin in your pump for the lunch meal bolus. This will be similar to what you are doing at home. At the other exercise visit, you will eat the same meal and inhale the Afrezza insulin for your bolus. At any of the sessions, an additional dose of insulin might be given about an hour after the meal if your blood sugar level is high.

For two of the exercise sessions, your pump will be placed in sleep activity mode prior to the meal. When in sleep activity mode, the 30-minute projected glucose target level is lower than it is when the pump is set to exercise activity mode.  The use of sleep activity  mode during exercise has not been approved by the FDA. For this reason, use of the Control-IQ system in sleep mode during exercise is called “investigational” in this study.

About two hours after your meal, we will have you complete exercise that will last about 45 minutes. The exercise will be a brisk walk or jog on a treadmill. Your heart rate will be measured during exercise. When the exercise is over, you will be observed for at least another 45 minutes. Before you leave the clinic, you will be given a snack.

The clinic staff will contact you the day before your exercise visits to review instructions with you. They will also contact you the day after your exercise visits to see how you are doing. They may contact you at other times with reminders.