RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants are asked to complete three study exercise visits in the clinic."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether inhaled mealtime insulin is safer and works better than insulin given through a pump when adults with type 1 diabetes exercise after a meal. It focuses on low blood sugar during exercise. Adults ages 18–65 who use certain Tandem pumps will complete three exercise visits at the clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–65 years old and have type 1 diabetes.
  • You have used a Tandem t:slim X2 or Tandem Mobi pump with Control-IQ or Control-IQ+ for at least 90 days.
  • You use insulin aspart or insulin lispro in your pump and take 20–80 units of insulin per day.
  • Your usual mealtime insulin dose for a lunch with 50 grams of carbs is no more than 12 units.
  • You usually do moderate or hard exercise at least 3 times a week, for at least 30 minutes each time.
  • The study doctor believes you can safely follow the study plan, with no health conditions or medicines that make it unsafe.
  • Your ECG, a test of your heart’s electrical activity, shows no problem that the study doctor thinks makes exercise riskier.
  • You can agree to take part and can read and understand written and spoken English or Spanish.

Who can't join

  • You used inhaled insulin in the past week, smoked or vaped in the past 90 days, or plan to smoke during the study.
  • You have a history of asthma, COPD or another major lung disease, major heart-and-lung disease, or lung cancer. You also cannot join if a breathing test result called FEV1 is below 70% of the predicted value.
  • You are pregnant, breastfeeding, or planning pregnancy during the study. If you can become pregnant, you must use accepted birth control, which may include not having sex, and take a pregnancy test.
  • You had severe low blood sugar or diabetic ketoacidosis, a dangerous buildup of acids in the blood, in the past 90 days.
  • You have another illness or take a medicine that may greatly affect blood sugar; used a non-insulin blood sugar-lowering medicine in the past 4 weeks; or received an experimental drug in the past 90 days.
  • You take hydroxyurea or need short-term steroid medicine by mouth, inhaler, or injection during the study. Steroids used on the skin or in the nose are allowed.
  • You follow or plan a diet with less than 50 grams of carbs or 800 calories per day, are being treated for diabetes-related eye damage, or have stage 4 or 5 kidney disease or receive dialysis.
  • Your direct supervisor at work, parent, sibling, or child is directly involved in running the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Ability to provide informed consent for study participation 2. Age ≥18 years to 65 years 3. Clinical diagnosis of T1D (per the Investigator) 4. Using Tandem t:slim X2 or Tandem Mobi insulin pump with Control-IQ for at least 90 days prior to screening visit 5. Using insulin aspart or insulin lispro in Tandem insulin pump 6. Total daily insulin dose 20 to 80 units 7. Usual RAA insulin bolus for 50 gram carbohydrate lunch meal is ≤12 units 8. Physically active, with at least 3 moderate or vigorous exercise sessions ≥30 minutes per typical week self-reported by participant 9. 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 10. 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 11. Investigator believes that the participant can safely follow the protocol 12. Able to read and understand written and spoken English or Spanish Exclusion Criteria: 1. Use of inhaled insulin within one week prior to screening visit 2. History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator 3. Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study 4. History or current diagnosis of lung cancer 5. Forced expiratory volume in 1 second (FEV1) measurement of \<70% of predicted Global Lung Function Initiative value 6. Pregnant or lactating, planning to become pregnant during the study, or is of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal) • A pregnancy test is required for any person of childbearing potential. 7. An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit 8. An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit 9. Any disease other than diabetes or current use (or anticipated use during the study) of any medication (e.g., beta blocker) that, in the judgment of the Investigator, may substantially impact glucose metabolism 10. Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit 11. Exposure to any investigational drug in the 90 days prior to the screening visit 12. Current or anticipated acute uses of oral, inhaled, or injectable glucocorticoids during the time period of the study (topical or intranasal glucocorticoid use is acceptable) 13. Current use of Hydroxyurea medication 14. Current or anticipated use of a low carbohydrate diet (\<50 grams/day) or low calorie diet (\<800 kcal/day) during the time period of the study 15. Current treatment for diabetic retinopathy 16. Known stage 4/5 chronic kidney disease or on dialysis 17. Having a direct supervisor at place of employment who is directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the study

Study sites (3)

KY

PA

WA