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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJaeb Center for Health Research

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Control IQ + sleep activity with TI

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Jaeb Center for Health Research

Lead sponsor

Mannkind Corporation

Collaborator

Tandem Diabetes Care, Inc.

Collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator