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
Trial ID: NCT06017089
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-11-10
Completion date: 2024-06-17
Sponsor: Marc Breton
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Jaeb Center for Health Research; University of Colorado, Denver; Stanford University
Conditions: Type 1 Diabetes
Interventions: AI-based Advisor system
Locations: Stanford University; Barbara Davis Center, University of Colorado; University of Virginia
Countries: United States; United States; United States
Enrollment: 33
Age range: 2 Years - 5 Years
Sex: ALL

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.

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

Outcomes:
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a); Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b); Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a); Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b); Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c); Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d); Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)