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

NCT ID: NCT06880835

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2026-05-31

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.

Detailed Description

The study is a 3-period randomized crossover trial, each with a structured afternoon exercise session following a standard lunch meal. The 3 sessions are as follows: (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. 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control IQ + sleep activity with TI

TI for meal bolus with Control IQ + sleep activity pump setting

Group Type: EXPERIMENTAL

Control IQ + sleep activity with TI

Intervention Type: DEVICE

TI for meal bolus with Control IQ + sleep activity pump setting

Control IQ + sleep activity with Rapid-Acting Analogue (RAA) Comparator

RAA for meal bolus with with Control IQ + sleep activity pump setting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control IQ + exercise activity with Rapid-acting analogue (RAA) Control

RAA for meal bolus with Control IQ pump setting with transition to Control IQ + exercise activity pump setting one hour before start of exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Control IQ + sleep activity with TI

TI for meal bolus with Control IQ + sleep activity pump setting

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: collaborator

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael R Rickels, MD, MA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Michael Ridell, PhD

Role: STUDY_CHAIR

York University

Locations

University of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robin Gal, MSPH

Role: CONTACT

rgal@jaeb.org

813-975-8690

Facility Contacts

Taylor Hendryx

Role: primary

taylor.hendryx@nortonhealthcare.org

502-861-4608

Wendy Yang

Role: primary

T1D@pennmedicine.upenn.edu

215-746-8136

Dori Khakpour

Role: primary

dorik@uw.edu

206-945-4965

Other Identifiers

INHALE-AIDEx

Identifier Type: -

Identifier Source: org_study_id