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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Jaeb Center for Health Research
Study ID
NCT06880835
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Control IQ + sleep or exercise activity with TI — DEVICE
    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

Study Details

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.

Key Dates

First listed
Mar 18, 2025
Start date
Jun 5, 2025
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Control IQ + sleep or exercise activity with TI
    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.
  • No Intervention: Control IQ + sleep or exercise activity with Rapid-Acting Analogue (RAA) Comparator
    PHASE 1: RAA for meal bolus with the Control IQ + sleep activity pump setting. PHASE 2: RAA for meal bolus with Control IQ + exercise activity pump setting.
  • No Intervention: Control IQ + exercise activity with Rapid-Acting Analogue (RAA) or TI air bolus Control
    PHASE 1: RAA for meal bolus with Control IQ pump setting with transition to Control IQ + exercise activity pump setting one hour before start of exercise. PHASE 2: TI for meal air bolus where the infusion set is disconnected and the bolus is entered into the pump with meal carbohydrates (no subcutaneous insulin is delivered from the pump), with Control IQ + exercise activity pump setting

Primary Outcome Measure

PHASE 1: Blood glucose <70 mg/dL [ Time Frame: 90 minutes ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Taylor Hendryx
[email protected]
502-861-4608
University of PennsylvaniaPhiladelphiaPennsylvania19104
Cornelia (Ginger) Bakes
[email protected]
215-746-8136
University of WashingtonSeattleWashington98195
Dori Khakpour
[email protected]
206-945-4965

Find similar trials in Louisville, KY

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Louisville· Louisville, KYUniversity of Pennsylvania· Philadelphia, PAUniversity of Washington· Seattle, WA

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