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

1. More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months

2. More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months

3. Inpatient psychiatric treatment in the past 6 months

4. 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.

5. For Female: Currently pregnant or planning to become pregnant during the time period of study participation

1. A negative pregnancy test will be required for all females of child-bearing potential (menarchal)

2. 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.

6. Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator

7. 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).

8. Hemophilia or any other bleeding disorder

9. Hemoglobinopathy

10. History of heart, liver, lung or kidney disease determined by investigator to interfere with the study

11. History of allergic reaction to Humalog or Lyumjev

12. Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study

13. 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)

14. Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis

15. History of adrenal insufficiency

16. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated

17. History of gastroparesis

18. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk

19. Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation

20. 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

What this study is about