The Pediatric Artificial Pancreas Automated Initialization Trial

Part of paid clinical trials in Stanford, California.

Sponsor
Marc Breton
Study ID
NCT06017089
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • AI-based Advisor system — DEVICE
    Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.

Study Details

The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.

Key Dates

Start date
Nov 10, 2023
Status verified
Aug 2025
Primary completion
Jun 17, 2024
Completion
Jun 17, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AI Advisor-driven at-home closed loop system initiation and parameter adaptation
    In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system.

Primary Outcome Measure

Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) [ Time Frame: Baseline and Weeks 1-8 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Barbara Davis Center, University of ColoradoAuroraColorado80045-
University of VirginiaCharlottesvilleVirginia22903-

Find similar trials in Stanford, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Stanford University· Stanford, CABarbara Davis Center, University of Colorado· Aurora, COUniversity of Virginia· Charlottesville, VA

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