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

Exclusion Criteria

• •1. 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).
• •2. Hemophilia or any other bleeding disorder
• •3. History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
• •4. History of \>1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
• •5. History of chronic renal disease or currently on hemodialysis
• •6. History of adrenal insufficiency
• •7. Hypothyroidism that is not adequately treated
• •8. Use of oral or injectable steroids within the last 8 weeks
• •9. Known, ongoing adhesive intolerance
• •10. Plans to receive blood transfusions or erythropoietin injections during the course of the study
• •11. 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)
• •12. Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM
• •13. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• •14. 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