The Pediatric Artificial Pancreas Automated Initialization Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: AI-based Advisor system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months 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 Exclusion Criteria: Currently using an insulin pump 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) 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI Advisor-driven at-home closed loop system initiation and parameter adaptation<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)