RECRUITING

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

Conditions

Diabetes Mellitus, Type 1 Exercise Technosphere Insulin Automated Insulin Delivery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-05

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06880835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to provide informed consent for study participation 2. Age ≥18 years to 60 years 3. Clinical diagnosis of T1D (per the Investigator) 4. Using Tandem t:slim X2 insulin pump with Control-IQ for at least 90 days prior to screening visit 5. Using insulin aspart or insulin lispro in Tandem t:slim X2 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	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) 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

Inclusion Criteria

Exclusion Criteria

1. Ability to provide informed consent for study participation
2. Age ≥18 years to 60 years
3. Clinical diagnosis of T1D (per the Investigator)
4. Using Tandem t:slim X2 insulin pump with Control-IQ for at least 90 days prior to screening visit
5. Using insulin aspart or insulin lispro in Tandem t:slim X2 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

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)
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

Contacts and Locations

Study Contact

Robin Gal, MSPH

CONTACT

813-975-8690

rgal@jaeb.org

Principal Investigator

Michael R Rickels, MD, MA

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Michael Ridell, PhD

STUDY_CHAIR

York University

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

Michael R Rickels, MD, MA, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
Michael Ridell, PhD, STUDY_CHAIR, York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-05

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2025-06-05

Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

Diabetes Mellitus, Type 1
Exercise
Technosphere Insulin
Automated Insulin Delivery

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1