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.
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
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
Crossover
Control IQ + sleep or exercise activity with TI
DevicePHASE 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
PHASE 1: Blood glucose <70 mg/dL
Blood glucose \<70 mg/dL within 90 minutes from the start of exercise
PHASE 2: Blood glucose <70 mg/dL
Blood glucose \<70 mg/dL within 90 minutes from the start of exercise
PHASE 1: Exploratory Efficacy Outcome: Change in blood glucose from exercise start to nadir glucose
Change in blood glucose from exercise start to nadir glucose within 90 minutes from start of exercise
PHASE 1: Exploratory Efficacy Outcome: Change in CGM glucose from exercise start to nadir glucose
Change in CGM glucose from exercise start to nadir glucose within 90 minutes from start of exercise
PHASE 1: Exploratory Efficacy Outcome: Time in range 70-180 mg/dL
Time in range 70-180 mg/dL within 90 minutes from start of exercise
PHASE 1: Exploratory Efficacy Outcome: Time in tight range 70-140 mg/dL
Time in tight range 70-140 mg/dL within 90 minutes from start of exercise
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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
