The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to learn whether an investigational automated insulin delivery system (study system) for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.

Detailed Description
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Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a closed-loop system. This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic. A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.

Official Title
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The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Tandem t:slim X2 with Control-IQ Technology Pro
* Device: Standard Care (SC)
* Device: Tandem t:slim X2 with Control-IQ Technology V1.5


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 6 months and using insulin for at least 6 months Familiarity and use of a carbohydrate ratio for meal boluses. Age ≥2 and <6 years old Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff. 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 study-provided Tandem pump during the study. • Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart Total daily insulin dose (TDD) at least 5 U/day Body weight at least 20 lbs. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3) 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. Exclusion Criteria: Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 [GLP-1] agonists, Symlin, Dipeptidyl peptidase-4 [DPP-4] inhibitors, Sodium-glucose Cotransporter-2 (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 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 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 (specified in the study procedure manual) Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM Participation in another pharmaceutical or device trial at the time of enrollment or during the study Employed by, or having immediate family members employed by Tandem Diabetes Care, 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: 24 Months
Maximum Age: 71 Months

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLC Group<br>Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26). | Device: Tandem t:slim X2 with Control-IQ Technology Pro<br>* The Tandem t:slim X2 with Control-IQ Technology Pro is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.<br>Device: Tandem t:slim X2 with Control-IQ Technology V1.5<br>* The Tandem t:slim X2 with Control-IQ Technology V1.5 is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.<br>|
| Active Comparator: SC Group<br>Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26). | Device: Standard Care (SC)<br>* Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).<br>Device: Tandem t:slim X2 with Control-IQ Technology V1.5<br>* The Tandem t:slim X2 with Control-IQ Technology V1.5 is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range | Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM-measured Percent Above 250 mg/dL | Percentage of time with a glucose above 250 mg/dL as measured by CGM | 13 weeks | 
| CGM-measured Mean Glucose | Average glucose value measured by CGM | 13 weeks | 
| HbA1c at 13 Weeks | HbA1c at 13 weeks | 13 weeks | 
| CGM-measured Percent Below 70 mg/dL | Percentage of time with glucose below 70 mg/dL as measured by CGM | 13 weeks | 
| CGM-measured Percent Below 54 mg/dL | Percentage of time with glucose below 54 mg/dL as measured by CGM | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Control-IQ Technology, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI)