The Pediatric Artificial Pancreas Automated Initialization Trial

Inclusion Criteria

• •1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month
• •2. Familiarity and use of a carbohydrate ratio for meal boluses
• •3. Age ≥2 and \<6 years old
• •4. Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days
• •5. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
• •6. Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above)
• •7. Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day
• •8. Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
• •9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study162 provided Tandem pump during the study
• •10. Total daily insulin dose (TDD) at least 5 Units/day
• •11. Body weight at least 20 pounds (lbs)
• •12. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• •13. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
• •14. Parent/guardian proficient in reading and writing English
• •15. Live in the United States, with no plans to move outside the United States during the study period