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Diabetes Mellitus, Type 1INHALE-AIDExNCT06880835

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

A study of Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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+). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
5 Jun 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Robin Gal, MSPH contact

813-975-8690

rgal@jaeb.org

United States3 sites, 3 recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Taylor Hendryx, 502-861-4608, taylor.hendryx@nortonhealthcare.org

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Cornelia (Ginger) Bakes, 215-746-8136, T1D@pennmedicine.upenn.edu

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Dori Khakpour, 206-945-4965, dorik@uw.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

The study is a 3-period randomized crossover trial, each with a structured afternoon exercise session following a standard lunch meal.

9 participants completed Phase 1 sessions which included (1) TI for meal bolus with pump in sleep mode, (2) RAA for meal bolus with pump in sleep mode, and (3) RAA for meal bolus with pump in standard mode with transition to exercise mode one hour before start of exercise.

21 participants will complete the Phase 2 sessions which will include: (1) TI for meal bolus with pump in exercies mode, (2) TI for meal air bolus (i.e., the infusion set is disconnected from the pump and the TI bolus and carbohydrates are reported in the system but no pump insulin is administered) with pump in exercise mode, and (3) RAA for meal bolus with pump in exercise mode.

The study is being done to compare the efficacy and safety of TI versus RAA given as bolus for meal prior to initiating aerobic exercise in adults ≥18 to ≤ 65 years of age with T1D using Control-IQ.

All participants will complete 3 exercise sessions, with the order determined through randomization. Participants who complete Phase 1 may also participate in Phase 2 if they choose to.

Being tested
Control IQ + sleep or exercise activity with TI
Keywords
Diabetes Mellitus, Type 1, Exercise, Technosphere Insulin, Automated Insulin Delivery
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control IQ + sleep or exercise activity with TIDevice

    PHASE 1: TI for meal bolus with Control IQ + sleep activity pump setting PHASE 2: TI for meal bolus with Control IQ + exercise activity pump setting

Study groups in NCT06880835
Study groupRoleWhat they receive
Control IQ + sleep or exercise activity with TIExperimentalPHASE 1: TI for meal bolus with Control IQ + sleep activity pump setting. PHASE 2: TI for meal bolus with Control IQ+ exercise activity pump setting.
Receives: Device: Control IQ + sleep or exercise activity with TI
Control IQ + sleep or exercise activity with Rapid-Acting Analogue (RAA) ComparatorNo interventionPHASE 1: RAA for meal bolus with the Control IQ + sleep activity pump setting. PHASE 2: RAA for meal bolus with Control IQ + exercise activity pump setting.
Control IQ + exercise activity with Rapid-Acting Analogue (RAA) or TI air bolus ControlNo interventionPHASE 1: RAA for meal bolus with Control IQ pump setting with transition to Control IQ + exercise activity pump setting one hour before start of exercise. PHASE 2: TI for meal air bolus where the infusion set is disconnected and the bolus is entered into the pump with meal carbohydrates (no subcutaneous insulin is delivered from the pump), with Control IQ + exercise activity pump setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PHASE 1: Blood glucose <70 mg/dL

    Blood glucose <70 mg/dL within 90 minutes from the start of exercise

    Measured: 90 minutes

  2. PHASE 2: Blood glucose <70 mg/dL

    Blood glucose <70 mg/dL within 90 minutes from the start of exercise

    Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2025
  2. Study start5 Jun 2025
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880835
Sponsor's protocol ID
INHALE-AIDEx
Acronym
INHALE-AIDEx
Status last verified
Jul 2026
First submitted
12 Mar 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: A limited dataset is expected to be made available.

Questions about this trial

What is this clinical trial studying?

A study of Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robin Gal, MSPH (813-975-8690, rgal@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PHASE 1: Blood glucose <70 mg/dL (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06880835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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