Could a puff of inhaled insulin stop Exercise-Induced lows in type 1 diabetes?
NCT ID NCT06880835
First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study tests whether inhaled insulin (Afrezza) given with a meal is safer than a standard pump insulin bolus for preventing low blood sugar during exercise afterward. About 30 adults with type 1 diabetes who use automated insulin pumps will complete three exercise sessions in a clinic. The goal is to see if the inhaled insulin leads to fewer episodes of low blood sugar within 90 minutes of starting exercise.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inhaled technosphere insulin (Afrezza)
- What this could lead to
- If it works, this could offer a safer way to manage mealtime insulin before exercise, reducing the risk of dangerously low blood sugar.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to everyone. Inhaled insulin can cause cough or lung irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Louisville
RECRUITINGLouisville, Kentucky, 40202, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Washington
RECRUITINGSeattle, Washington, 98195, United States
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