The Pediatric Artificial Pancreas Automated Initialization Trial

NCT ID: NCT06017089

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2024-06-17

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AI-based Advisor system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Marc Breton

OTHER

Sponsor Role: lead

Responsible Party

Marc Breton

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Lum, MS

Role: STUDY_DIRECTOR

Jaeb Center for Health Research

Raj P Wadwa, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Davis Center, University of Colorado

Marc D Breton, Ph.D.

Role: STUDY_CHAIR

University of Virginia Center for Diabetes Technology

Locations

Stanford University

Stanford, California, United States

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 40152109 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01DK127551-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

230262

Identifier Type: -

Identifier Source: org_study_id