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

NCT06880835 | Recruiting FDA Device

• 1 other identifier: INHALE-AIDEx
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Blood glucose <70 mg/dL

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

  90 minutes

Other Outcomes (14)

• Exploratory Efficacy Outcome: Change in blood glucose from exercise start to nadir glucose

  90 minutes

• Exploratory Efficacy Outcome: Change in CGM glucose from exercise start to nadir glucose

  90 minutes

• Exploratory Efficacy Outcome: Time in range 70-180 mg/dL

  90 minutes

Study Arms (3)

Control IQ + sleep activity with TI

EXPERIMENTAL

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

Device: Control IQ + sleep activity with TI

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

NO INTERVENTION

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

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

NO INTERVENTION

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

Interventions

Control IQ + sleep activity with TI DEVICE

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

Control IQ + sleep activity with TI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Mannkind Corporation: collaborator
• Tandem Diabetes Care, Inc.: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (3)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Michael R Rickels, MD, MA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Michael Ridell, PhD

  York University

  STUDY CHAIR

Central Study Contacts

Robin Gal, MSPH

CONTACT

813-975-8690; rgal@jaeb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (3)