Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

Study Overview
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Brief Summary
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Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.

Detailed Description
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This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80 years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump. After a run-in period, participants will use the study pump with Control-IQ technology 1.5 and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be enrolled so at least 160 complete the study.

Official Title
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Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: t:slim X2 insulin pump with Control-IQ technology 1.5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 to <81 years Diagnosis of type 1 diabetes for at least 1 year Currently using Control-IQ technology for at least 3 months, with CGM data recorded indicative of system use (active closed loop) for at least 85% of the possible time in 14 days prior to enrollment Total daily insulin dose (TDD) at least 2 U/day HbA1c < 10.5% Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation. For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If >18 years old, participant has someone who lives within 30 minutes of them who is willing to be contacted if the study team can't reach the participant in case of a suspected medical emergency. Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF) and assent, if applicable; and has agreed to follow all study procedures, including: suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use switching to or continuing to use Humalog during the lead-in period switching to Lyumjev for the main study period. willing and able to perform the study exercise and meal challenges. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management. Participant and/or parent/legal guardian have the ability to read and understand English Exclusion Criteria: More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months Inpatient psychiatric treatment in the past 6 months History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study. For Female: Currently pregnant or planning to become pregnant during the time period of study participation A negative pregnancy test will be required for all females of child-bearing potential (menarchal) Counseling on appropriate birth control options will be provided to females with child-bearing potential in the event the participant does not have an acceptable plan. Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). Hemophilia or any other bleeding disorder Hemoglobinopathy History of heart, liver, lung or kidney disease determined by investigator to interfere with the study History of allergic reaction to Humalog or Lyumjev Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (>450 ms) (Screening ECG only required for participants age > 50 years, duration of diabetes > 20 years, or history of coronary artery disease) Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis History of adrenal insufficiency History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated History of gastroparesis 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 anticipated for during the time period of study participation Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Eli Lilly and Co., or TypeZero Technologies, LLC, 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: 6 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®<br>Current Control-IQ technology users with type 1 diabetes, age 6-80, will use the t:slim X2 insulin pump with Control-IQ technology 1.5 and Lyumjev insulin for 3-months of outpatient use. | Device: t:slim X2 insulin pump with Control-IQ technology 1.5<br>* t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe hypoglycemia | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry | 3 months | 
| Diabetic ketoacidosis | Number of diabetic ketoacidosis events | 3 months | 
| Unanticipated adverse device effects | Number of unanticipated adverse device effects (UADE) events | 3 months | 
| Other serious adverse events | Number of other serious adverse events | 3 months | 
| Adverse drug reactions | Number of adverse drug reactions | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All reportable adverse events | Number of reportable adverse events during the course of the study | 3 months | 
| CGM hypoglycemia outcomes: Overall % time <54 mg/dL | CGM overall percent time < 54 mg/dL | 3 months | 
| CGM hypoglycemia outcomes: Postprandial % time <54 mg/dL | CGM postprandial percent time < 54 mg/dL | 3 months | 
| CGM hypoglycemia outcomes: Overall % time <70 mg/dL | CGM overall percent time < 70 mg/dL | 3 months | 
| CGM hypoglycemia outcomes: Postprandial % time <70 mg/dL | CGM postprandial percent time < 70 mg/dL | 3 months | 
| CGM hypoglycemia outcomes: Rate of hypoglycemia events | Rate of hypoglycemia events defined as 15 or more consecutive minutes <54 mg/dL | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, Control-IQ Technology, lyumjev