The Pediatric Artificial Pancreas Automated Initialization Trial

NCT06017089 | Completed Results DMC FDA Device

• 2 other identifiers: 230262U01DK127551-03
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Continuous Glucose Monitor (CGM); Tandem t:slim Insulin Pump with Control-IQ Technology; Control-IQ Technology (CIQ); Artificial Pancreas (AP); Artificial Intelligence (AI); Closed loop control (CLC); Diabetes Assistant (DiAs)

Outcome Measures

Primary Outcomes (7)

• Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a)

  % of time below 54 mg/dL

  Baseline and Weeks 1-8

• Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b)

  % of time above 250 mg/dL

  Baseline and Weeks 1-8

• Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a)

  % of time in range 70-180 mg/dL

  Baseline and Weeks 1-8

• Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b)

  Mean glucose

  Baseline and Weeks 1-8

• Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c)

  % of time \>250 mg/dL

  Baseline and Weeks 1-8

• Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d)

  % of time \<70 mg/dL

  Baseline and Weeks 1-8

• Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)

  % of time \<54 mg/dL

  Baseline and Weeks 1-8

Secondary Outcomes (15)

• CGM Measured Time in Range

  Baseline and Weeks 1-8

• CGM Measured (a)

  Baseline and Weeks 1-8

• CGM Measured (b)

  Baseline and Weeks 1-8

• CGM Measured (c)

  Baseline and Weeks 1-8

• CGM Measured (d)

  Baseline and Weeks 1-8

Study Arms (1)

AI Advisor-driven at-home closed loop system initiation and parameter adaptation

EXPERIMENTAL

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.

Device: AI-based Advisor system

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.

AI Advisor-driven at-home closed loop system initiation and parameter adaptation

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month
• Familiarity and use of a carbohydrate ratio for meal boluses
• Age ≥2 and \<6 years old
• Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days
• Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
• Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above)
• Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day
• Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
• Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study162 provided Tandem pump during the study
• Total daily insulin dose (TDD) at least 5 Units/day
• Body weight at least 20 pounds (lbs)
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
• Parent/guardian proficient in reading and writing English
• Live in the United States, with no plans to move outside the United States during the study period

You may not qualify if:

• Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
• Hemophilia or any other bleeding disorder
• History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
• History of \>1 diabetic ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
• History of chronic renal disease or currently on hemodialysis
• History of adrenal insufficiency
• Hypothyroidism that is not adequately treated in the opinion of the investigator
• Use of oral or injectable steroids within the last 8 weeks
• Known, ongoing adhesive intolerance
• Plans to receive blood transfusions or erythropoietin injections during the course of the study
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Sponsors & Collaborators

• Marc Breton: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Jaeb Center for Health Research: collaborator
• University of Colorado, Denver: collaborator
• Stanford University: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Pavan J, Cobry E, Reed ZW, Villa-Tamayo MF, Diaz C JL, DeBoer MD, Schoelwer M, Jost E, Kingman R, Holmes V, Lum JW, Koravi CLK, Buckingham B, Beck R, Wadwa RP, Breton MD; PEDAP-AI Trial Study Group. Algorithm-Driven Initiation and Adaptation of Hybrid Closed-Loop in Young Children with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 2025 Aug;27(8):587-596. doi: 10.1089/dia.2024.0650. Epub 2025 Mar 28.

  PMID: 40152109 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: University of Virginia Center for Diabetes Technology

marc.breton@virginia.edu

434-982-6484

Study Officials

• John Lum, MS

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Raj P Wadwa, MD

  Barbara Davis Center, University of Colorado

  PRINCIPAL INVESTIGATOR

• Marc D Breton, Ph.D.

  University of Virginia Center for Diabetes Technology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 30, 2023
• Study Start: November 10, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after the primary publications of each study site.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team.

Locations

US (3)