A Study of t:Slim X2 With Control-IQ Technology

Inclusion Criteria

• •1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months
• •2. Familiarity and use of a carbohydrate ratio for meal boluses.
• •3. Age ≥ 6 and ≤ 13 years old
• •4. Weight ≥25 kg and ≤140 kg
• •5. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• •6. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
• •7. Willingness to suspend use of any personal closed loop system that they use at home for the duration of the clinical trial once the study CGM is in use
• •8. Investigator has confidence that the participant 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 to t:slim X2. This includes:
• •* Participants randomized to Control IQ
• •* Participants on the SAP group on MDI treatment that will be provided a Tandem pump to switch to CSII
• •* Participates that are already in Continuous Subcutaneous Insulin Infusion (CSII) randomized to SAP during the extension phase when transition to Control IQ
• •10. Total daily insulin dose (TDD) at least 10 U/day
• •11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• •12. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.