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

Study acronym: INHALE-AIDEx
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: 1 to 2v7 Show 5 more changesShow less
    • Primary completion date: May 31, 2026 to Oct 31, 2026
    • Study completion date: May 31, 2026 to Dec 31, 2026
    • Interventions: Control IQ + sleep activity with TI (Device) to Control IQ + sleep or exercise activity with TI (Device)
    • Study description expanded, about 86 words
    • Site contacts updated at 1 of 3 sites
  2. Study description revised
    • Eligibility criteria expanded, about 1 word
    v6
  3. Study sites: 2 to 3v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 15, 2025 to Jun 5, 2025
    v4
  5. Start date: Apr 15, 2025 to Jun 15, 2025
    • Primary and study completion dates: Mar 31, 2026 to May 31, 2026
    v3
  6. Study title shortened, about 6 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06880835
Lead Sponsor Jaeb Center for Health Research
Collaborators: Mannkind Corporation, Tandem Diabetes Care, Inc., The Leona M. and Harry B. Helmsley Charitable Trust
Conditions
(from sponsor)		 Diabetes Mellitus, Type 1
Related terms Diabetes Mellitus, Type 1, Motor Activity
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov