The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI)

August 25, 2025 updated by: Marc Breton

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to <6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home.The key safety outcomes are adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center, University of Colorado
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month
  2. Familiarity and use of a carbohydrate ratio for meal boluses
  3. Age ≥2 and <6 years old
  4. Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days
  5. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
  6. 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)
  7. 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
  8. Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
  9. 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
  10. Total daily insulin dose (TDD) at least 5 Units/day
  11. Body weight at least 20 pounds (lbs)
  12. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
  13. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
  14. Parent/guardian proficient in reading and writing English
  15. Live in the United States, with no plans to move outside the United States during the study period

Exclusion Criteria:

  1. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
  2. Hemophilia or any other bleeding disorder
  3. History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
  4. History of >1 diabetic ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
  5. History of chronic renal disease or currently on hemodialysis
  6. History of adrenal insufficiency
  7. Hypothyroidism that is not adequately treated in the opinion of the investigator
  8. Use of oral or injectable steroids within the last 8 weeks
  9. Known, ongoing adhesive intolerance
  10. Plans to receive blood transfusions or erythropoietin injections during the course of the study
  11. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  12. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  13. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: AI-based Advisor system
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a)
Time Frame: Baseline and Weeks 1-8
% of time below 54 mg/dL
Baseline and Weeks 1-8
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b)
Time Frame: Baseline and Weeks 1-8
% of time above 250 mg/dL
Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a)
Time Frame: Baseline and Weeks 1-8
% 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)
Time Frame: Baseline and Weeks 1-8
Mean glucose
Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c)
Time Frame: Baseline and Weeks 1-8
% of time >250 mg/dL
Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d)
Time Frame: Baseline and Weeks 1-8
% of time <70 mg/dL
Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)
Time Frame: Baseline and Weeks 1-8
% of time <54 mg/dL
Baseline and Weeks 1-8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CGM Measured Time in Range
Time Frame: Baseline and Weeks 1-8
% of time spent within range 70 mg/dL-140 mg/dL.
Baseline and Weeks 1-8
CGM Measured (a)
Time Frame: Baseline and Weeks 1-8
% of time >180 mg/dL
Baseline and Weeks 1-8
CGM Measured (b)
Time Frame: Baseline and Weeks 1-8
% of time >300 mg/dL
Baseline and Weeks 1-8
CGM Measured (c)
Time Frame: Baseline and Weeks 1-8
% of time <60 mg/dL
Baseline and Weeks 1-8
CGM Measured (d)
Time Frame: Baseline and Weeks 1-8
Glucose standard deviation
Baseline and Weeks 1-8
CGM Measured (e)
Time Frame: Baseline and Weeks 1-8
Glucose coefficient of variation
Baseline and Weeks 1-8
CGM Measured (f)
Time Frame: Baseline and Weeks 1-8
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Baseline and Weeks 1-8
CGM Measured (g)
Time Frame: Baseline and Weeks 1-8
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia.
Baseline and Weeks 1-8
CGM Measured (h)
Time Frame: Baseline and Weeks 1-8
Weekly hyperglycemic event rate
Baseline and Weeks 1-8
CGM Measured (i)
Time Frame: Baseline and Weeks 1-8
Weekly hypoglycemic event rate
Baseline and Weeks 1-8
Binary Outcome 1
Time Frame: Baseline and Weeks 1-8
Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks.
Baseline and Weeks 1-8
Binary Outcome 2
Time Frame: Baseline and Weeks 1-8
Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks.
Baseline and Weeks 1-8
Binary Outcome 3
Time Frame: Baseline and Weeks 1-8
Participants with % of time in range 70-180 mg/dL >70% and % of time <70 mg/dL <4%
Baseline and Weeks 1-8
Total Daily Insulin
Time Frame: Baseline and Weeks 1-8
Total daily insulin (units/kg)
Baseline and Weeks 1-8
Basal Insulin
Time Frame: Baseline and Weeks 1-8
Percentage of total insulin delivered via basal administration.
Baseline and Weeks 1-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marc Breton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Jaeb Center for Health Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: John Lum, MS, Jaeb Center for Health Research
  • Study Chair: Marc D Breton, Ph.D., University of Virginia Center for Diabetes Technology
  • Principal Investigator: Raj P Wadwa, MD, Barbara Davis Center, University of Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 230262
  • U01DK127551-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community

IPD Sharing Time Frame

Data will be made available after the primary publications of each study site.

IPD Sharing Access Criteria

The Data Sharing Agreements will be formulated by the study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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