Recruiting

Inhaled Insulin

Sponsor:

Jaeb Center for Health Research

Code:

NCT06880835

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Control IQ + sleep or exercise activity with TI

Study Details

Brief 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+). 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

Diabetes Mellitus, Type 1

Study ID

NCT06880835

Start date

Jun 5, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Control IQ + sleep or exercise activity with TI

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.

no intervention: Control IQ + sleep or exercise activity with Rapid-Acting Analogue (RAA) Comparator

PHASE 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.

no intervention: Control IQ + exercise activity with Rapid-Acting Analogue (RAA) or TI air bolus Control

PHASE 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

Interventions

Control IQ + sleep or exercise activity with TI

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

Primary outcome measure

  • PHASE 1: Blood glucose <70 mg/dL [ Time Frame: 90 minutes ]
  • PHASE 2: Blood glucose <70 mg/dL [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Diabetes Mellitus, Type 1
  • Exercise
  • Technosphere Insulin
  • Automated Insulin Delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-07-16.