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

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID: NCT06880835
Run by: Jaeb Center for Health Research
People needed: 30
Starts: 2025-06-05
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to provide informed consent for study participation
Age ≥18 years to 65 years
Clinical diagnosis of T1D (per the Investigator)
Using Tandem t:slim X2 or Tandem Mobi insulin pump with Control-IQ for at least 90 days prior to screening visit
Using insulin aspart or insulin lispro in Tandem 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

You may not qualify if…

Use of inhaled insulin within one week prior to screening visit
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
Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study
History or current diagnosis of lung cancer
Forced expiratory volume in 1 second (FEV1) measurement of <70% of predicted Global Lung Function Initiative value
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.
An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit
An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit
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
Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit
Exposure to any investigational drug in the 90 days prior to the screening visit
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)
Current use of Hydroxyurea medication
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
Current treatment for diabetic retinopathy
Known stage 4/5 chronic kidney disease or on dialysis
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

Where it is running

University of Louisville — Louisville, Kentucky, United States (enrolling)
University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
University of Washington — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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