Artificial Pancreas - Adolescent Physiology & Psychology Longitudinal Evaluation

Prior treatment

• History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
• Planned surgery during study duration
• (Randomized substudy only) Current use of an automated insulin delivery system (besides LGS and PLGS) such as Medtronic 670G, Control-IQ or DIY system (or unwillingness to discontinue automated insulin delivery for three months before enrollment and the duration of the trial).

Other illness

• Currently being treated for a seizure disorder
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
• Having a family member(s) employed by Tandem Diabetes Care, Inc. or Dexcom, Inc.

Lab values

• Hemoglobin A1c \>10% clinically obtained within the past 6 weeks
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
  • Severe renal impairment, end-stage renal disease, or dialysis
  • Inpatient psychiatric treatment in the past six months
  • Presence of a known adrenal disorder
  • Abnormal liver function test results (Transaminase\>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
  • Uncontrolled thyroid disease
  • Concurrent use of any non-insulin glucose-lowering agent.
  • Hemophilia or any other bleeding disorder.
• Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)

Other

• Pregnancy or intent to become pregnant during the trial
• Use of an insulin delivery mechanism that is not downloadable by the subject or study team
• Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial.

• Age 11 to \<13 years (at time of enrollment) with a parent/guardian (18+ yo) who is willing to participate with the child
• At least Tanner 2 pubic hair (boys), Tanner 2 breast development (girls)
• HbA1c \<10 clinically obtained within the last 6 weeks; if the participant is unable to go to the laboratory or clinic because of stay-at-home orders, the entry hemoglobin A1c level can be assessed via outside laboratory (e.g. LabCorp), home HbA1c device, recent clinically-obtained HbA1c in past month..
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Currently using insulin for at least six months
• Both prior pump and MDI users will use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
• Access to internet and willingness to upload data during the study as needed
• For females, not currently known to be pregnant or breastfeeding
• 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 childbearing 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.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• 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, if randomized to the Control-IQ group.
• Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/day
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• An understanding and willingness to follow the protocol and signed informed consent
• Participants must have Internet access and a computer system that meets the requirements for uploading the study equipment.
• Contact with primary diabetes physician to discuss study details and the participant's care, with study team continuing to feel that the participant is appropriate for study inclusion.