CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
AI-based Advisor systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06017089
NCT06017089N/ACompleted
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The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaptation in Young Children With Type 1 Diabetes

Marc Breton·interventional·Posted Aug 30, 2023·Updated Sep 15, 2025

In Brief

A clinical study evaluating AI-based Advisor system for Type 1 Diabetes. Completed, enrolled 33 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, University of Colorado, Denver, Stanford University

Timeline

N/ACompletedFinished
202420252026
First PostedAug 30, 2023
Enrollment StartNov 10, 2023
Primary CompletionJun 17, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.8 years ago

Interventions

AI-based Advisor systemdevice

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.