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.
The study is a 3-period randomized crossover trial, each with a structured afternoon exercise session following a standard lunch meal. 9 participants completed Phase 1 sessions which included (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. 21 participants will complete the Phase 2 sessions which will include: (1) TI for meal bolus with pump in exercies mode, (2) TI for meal air bolus (i.e., the infusion set is disconnected from the pump and the TI bolus and carbohydrates are reported in the system but no pump insulin is administered) with pump in exercise mode, and (3) RAA for meal bolus with pump in exercise mode. 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. Participants who complete Phase 1 may also participate in Phase 2 if they choose to.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
University of Louisville
Louisville, Kentucky, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGPHASE 1: Blood glucose <70 mg/dL
Blood glucose \<70 mg/dL within 90 minutes from the start of exercise
Time frame: 90 minutes
PHASE 2: Blood glucose <70 mg/dL
Blood glucose \<70 mg/dL within 90 minutes from the start of exercise
Time frame: 90 minutes
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