Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

Study Overview
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Brief Summary
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The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.

Detailed Description
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This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes. Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.

Official Title
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Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Hybrid Closed Loop (HCL)
* Device: Control-IQ with MyTDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria for documented hyperglycemia (at least 1 must be met): Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required) Diagnosis of type 1 diabetes is based on the investigator's judgement Criteria for requiring insulin at diagnosis (both criteria must be met): Daily insulin therapy for ≥ 6 months Insulin pump therapy for ≥ 3 months Age 12-18 years Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart. Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study. For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study. Total daily insulin dose (TDD) at least 10 U/day. Exclusion Criteria: Diabetic ketoacidosis in the past 6 months Hypoglycemic seizure or loss of consciousness in the past 6 months History of seizure disorder History of any heart disease including coronary artery disease, heart failure, or arrhythmias History of altitude sickness Chronic pulmonary conditions that could impair oxygenation Cystic fibrosis Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study. History of ongoing renal disease (other than microalbuminuria). Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine). Pregnancy Presence of a febrile illness within 24 hours of the Ski Admission Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as: Inpatient psychiatric treatment in the past 6 months Uncontrolled adrenal insufficiency Alcohol abuse

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hybrid Closed Loop (HCL)<br>Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. | Device: Hybrid Closed Loop (HCL)<br>* Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.<br>|
| Experimental: Control-IQ with MyTDI<br>Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home: A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day A single correction factor (CF) of 1650/TDI will be implemented across the whole day Carbohydrate ratios (CR) will be set at: 00:00-04:00 CR=450/TDI 04:00-11:00 CR=360/TDI 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used. | Device: Control-IQ with MyTDI<br>* Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change between Percent Time in Range at home pre/post intervention at home | The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average CGM at home | number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame. | 5 days | 
| Change in average CGM at camp | number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame. | 2 days | 
| Change in Percent CGM below 50mg/dL at home | the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent CGM below 50mg/dL at camp | the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent CGM below 54mg/dL at camp | the number of CGM values falling below 54mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days | 
| Change in Percent below 60mg/dL at home | the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent below 60mg/dL at camp | the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days | 
| Change in Percent CGM below 70mg/dL at home | the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent CGM below 70mg/dL at camp | the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days | 
| Change in Percent CGM between 70mg/dL and 180mg/dL at camp | the number of CGM values falling between 70mg/dL and 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days | 
| Change in Percent CGM above 180mg/dL at home | the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent CGM above 180mg/dL at camp | the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days | 
| Change in Percent CGM above 250mg/dL at home | the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent CGM above 250mg/dL at camp | the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days2 | 
| Change in Percent CGM above 300mg/dL at home | the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days | 
| Change in Percent CGM above 300mg/dL at camp | the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days | 
| Change in Total daily insulin at home | sum of the recorded insulin injection over the time frame in units | 5 days | 
| Change in Total daily insulin at camp | sum of the recorded insulin injection over the time frame in units | 2 days | 
| Change in Total meal carbohydrates at home | sum of the meal sized recorded over the time frame | 5 days | 
| Change in Total meal carbohydrates at camp | sum of the meal sized recorded over the time frame | 2 days | 
| Change in Number of hypoglycemic events at home | Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL) | 5 days | 
| Change in Number of hypoglycemic events at camp | Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL) | 2 days | 
| Change in number of Hypoglycemia treatment at home | Sum of the number of CHO treatments recorded over the time frame | 5 days | 
| Change in number of Hypoglycemia treatment at camp | Sum of the number of CHO treatments recorded over the time frame | 2 days | 
| Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at home | Sum of the amount of carbohydrates used for treatments recorded over the time frame | 5 days | 
| Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at camp | Sum of the amount of carbohydrates used for treatments recorded over the time frame | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Pancreas (AP), Insulin Pump, Continuous Glucose Monitor (CGM), MyTDI, Hybrid Closed Loop (HCL), Total Daily Insulin (TDI)