Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

Study Overview
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Brief Summary
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A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition

Detailed Description
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This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).

Official Title
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Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 2 and < 6 years old at the time of consent Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment Use of an insulin pump in the past 3 months Use of Dexcom G6 for at least 11 out of the last 14 days Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team Investigator has confidence that the parent/guardian(s) 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 already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Total daily insulin dose (TDD) of at least 5 U/day Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study Willingness to wear a Dexcom G6 sensor during the entire study An understanding and willingness to follow the protocol and sign informed consent Exclusion Criteria: Hypoglycemia induced seizure or loss of consciousness in the past 3 months Diabetes Ketoacidosis in the past 3 months Use of diluted insulin Concurrent use of any non-insulin glucose-lowering agent Hemophilia or any other bleeding disorder A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include: Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea) Addison's disease Diagnosed at less than 1 year of age without positive antibodies Decreased renal function Cystic fibrosis Other chronic conditions, such as an underlying seizure disorder Participation in another pharmaceutical or device trial at the time of enrollment or during the study. Having a family member(s) 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: 2 Years
Maximum Age: 6 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Pancreas Therapy<br>Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. | Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6<br>* Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].<br>* Other names: Automated Insulin Delivery Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Below 70 mg/dl. | Percent of time spent below 70 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Below 60 mg/dl. | Percent of time spent below 60mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Below 54 mg/dl. | Percent of time spent below 54mg/dL. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Below 50mg/dl. | Percent of time spent below 50mg/dL. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Above 180 mg/dl. | Percent of time spent above 180mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Above 250mg/dl. | Percent of time spent above 250mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Above 300 mg/dl. | Percent of time spent above 300 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Between 70-140mg/dl. | Percent of time spent between 70 mg/dl and 140mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Between 70-180mg/dl | Percent of time spent between 70 mg/dl and 180mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Number of Hypoglycemia Below 70 mg/dL | Number of hypoglycemia events (below 70 mg/dL). | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 
| Average Number of Treatments. | Average number of carbohydrate treatments per day. Participants were treated with  16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after  20min. Hypoglycemic treatments could occur at any time per study physician request | The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring. | 
| Average of Carbohydrate Treatments (g). | Average amount of carbohydrates (grams) used as a treatment. Participants were treated with  16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after  20min. Hypoglycemic treatments could occur at any time per study physician request | The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring. | 
| Percent of Time Spent in Closed Loop | Percentage of the amount of time spent with the Control-IQ system running in closed loop mode. | The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring. | 
| CGM Consensus Goal | Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump