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

NCT06880835 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-23

No results posted yet for this study

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

Interventions

DEVICE

Control IQ + sleep activity with TI

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

Sponsors & Collaborators

  • Mannkind Corporation

    collaborator INDUSTRY

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Michael R Rickels, MD, MA · University of Pennsylvania

  • Michael Ridell, PhD · York University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880835 on ClinicalTrials.gov