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

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: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: AI-based Advisor system

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 time spent below 54mg/dL and time spent above 250mg/dL compared with baseline and with a matched historical control population over the same time period from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Severe hypoglycemia and diabetic ketoacidosis episodes will also be reported. 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 compared with baseline and the PEDAP historical control mentioned above. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc D Breton, Ph.D.; Phone Number: 4349826484; Email: mb6nt@virginia.edu
• Study Contact Backup: Name: Emma G Emory, RN; Phone Number: 4342433992; Email: ee9m@uvahealth.org

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Bruce Buckingham, MD; Phone Number: 650-804-0476; Email: buckingham@stanford.edu
      • Contact: Ryan Kingman; Phone Number: 650-736-4417; Email: rkingman@stanford.edu
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Barbara Davis Center, University of Colorado
      • Principal Investigator: Raj Paul Wadwa, MD
      • Contact: Raj Paul Wadwa, MD; Phone Number: 720-891-7123; Email: paul.wadwa@cuanschutz.edu
      • Contact: Emily Jost, MPH RD CDCES CSSD; Phone Number: 303-724-7313; Email: emily.jost@cuanschutz.edu
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Marc D Breton, Ph.D.; Phone Number: 434-982-6484; Email: mb6nt@virginia.edu
      • Principal Investigator: Marc D Breton, Ph.D.
      • Sub-Investigator: Mark D DeBoer, MD
      • Sub-Investigator: Melissa J Schoelwer, MD
      • Contact: Viola Holmes, RD, CDCES; Phone Number: 434-249-6251; Email: vjf7j@uvahealth.org

Participation Criteria

Eligibility Criteria

• 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 3 months
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. Currently using an insulin pump
2. Concurrent use of any non-insulin glucose-lowering agent (including glucagon- like peptide (GLP)-1 agonists, Symlin, dipeptidyl peptidase (DPP)-4 inhibitors, sodium-glucose cotransporter (SGLT)-2 inhibitors, sulfonylureas)
3. Hemophilia or any other bleeding disorder
4. History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
5. History of >1 Diabetic Ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
6. History of chronic renal disease or currently on hemodialysis
7. History of adrenal insufficiency
8. Hypothyroidism that is not adequately treated in the opinion of the investigator
9. Use of oral or injectable steroids within the last 8 weeks
10. Known, ongoing adhesive intolerance
11. Plans to receive blood transfusions or erythropoietin injections during the course of the study
12. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
13. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
14. 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint (Hyperglycemia)	The percent of time spent above 250 mg/dL between the 8 weeks follow-up and baseline	8 weeks
Primary Safety Endpoint (Hypoglycemia)	The percent of time spent below 54 mg/dL between the 8 weeks follow-up and baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Measured Time in Range	The percent of time spent within range, 70 mg/dL-180 mg/dL.	8 weeks
CGM Measured Mean Glucose	The average of the CGM values measured and collected within the 8-week data collection period.	8 weeks
CGM Measured Hypoglycemia	The percent of time spent below 70 mg/dL.	8 weeks
CGM Measured Glucose Coefficient of Variation	Observed glucose variability ((standard deviation/mean)x100)	8 weeks
Binary outcome 1	% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥5%	8 weeks
Binary outcome 2	% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥10%	8 weeks
Binary outcome 3	% Time in range 70-180 mg/dL >70% and % time <70 mg/dL <4%	8 weeks
Total daily insulin	Total daily insulin (units/kg)	8 weeks
Basal Insulin	Percentage of total insulin delivered via basal administration.	8 weeks

Collaborators and Investigators

• Sponsor: Marc Breton
• Collaborators: University of Colorado, Denver; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford University; Jaeb Center for Health Research
• Investigators: Study Director: John Lum, MS, Jaeb Center for Health Research; Principal Investigator: Raj Paul Wadwa, MD, Barbara Davis Center, University of Colorado; Study Chair: Marc D Breton, Ph.D., University of Virginia Center for Diabetes Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 14, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Tandem t:slim Insulin Pump with Control-IQ Technology; Diabetes Assistant (DiAs); Artificial Intelligence (AI); Control-IQ Technology (CIQ); Closed loop control (CLC)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID 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