Actively Recruiting
Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery
Led by Jaeb Center for Health Research · Updated on 2025-09-23
30
Participants Needed
3
Research Sites
51 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
M
Mannkind Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Age 18 to 65 years
- Clinical diagnosis of type 1 diabetes
- Using Tandem t:slim X2 or Tandem Mobi insulin pump with Control-IQ for at least 90 days before screening
- Using insulin aspart or insulin lispro in the insulin pump
- Total daily insulin dose between 20 and 80 units
- Usual rapid acting analogue insulin bolus for a 50 gram carbohydrate lunch meal is 12 units or less
- Physically active with at least three moderate or vigorous exercise sessions of 30 minutes each per week
- No medical, psychiatric, or other conditions or medications that pose safety concerns for study participation
- No electrocardiogram abnormalities increasing exercise risk, as judged by the investigator
- Investigator believes participant can safely follow the study protocol
- Able to read and understand written and spoken English or Spanish
You will not qualify if you...
- Use of inhaled insulin within one week before screening
- History of asthma, COPD, or other significant lung or cardiopulmonary diseases
- Smoking (cigarettes, cigars, pipes, marijuana, vaping) within 90 days before screening or plans to smoke during the study
- History or current diagnosis of lung cancer
- Forced expiratory volume in 1 second (FEV1) less than 70% of predicted value
- Pregnant, lactating, planning pregnancy, or childbearing potential without acceptable birth control
- Severe hypoglycemia event within 90 days before screening
- Diabetic ketoacidosis episode within 90 days before screening
- Any disease or medication (e.g., beta blockers) impacting glucose metabolism
- Use of non-insulin glucose-lowering or weight-reduction medication with glucose effect within 4 weeks before screening
- Exposure to investigational drugs within 90 days before screening
- Current or planned acute use of oral, inhaled, or injectable glucocorticoids (topical or intranasal allowed)
- Current use of Hydroxyurea medication
- Current or planned low carbohydrate diet (<50 grams/day) or low calorie diet (<800 kcal/day)
- Current treatment for diabetic retinopathy
- Known stage 4 or 5 chronic kidney disease or on dialysis
- Having a direct supervisor or first-degree relative involved in the clinical trial conduct
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
R
Robin Gal, MSPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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