Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ
 system, MyTDI.
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin
 parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with
 Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1
 diabetes.

 Once deemed eligible, participants and their parent(s) will be trained on the use of the
 Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system.
 Participants will then use the this study equipment with their home insulin parameters at
 home for at home for 5 days. Participants will then come to the ski resort to participate in
 a 72-hour ski admission. Upon arrival, each participant will be randomized to either the
 using the Control-IQ system with their usual insulin parameters during the ski study and the
 at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and
 the at-home 5 days at home study. Study duration for each participant will require 5 study
 visits over about 2 weeks.
Inclusion Criteria:

 -  Criteria for documented hyperglycemia (at least 1 must be met):

 -  Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody
 determinations are not required)

 -  Diagnosis of type 1 diabetes is based on the investigator's judgement

 -  Criteria for requiring insulin at diagnosis (both criteria must be met):

 -  Daily insulin therapy for ≥ 6 months

 -  Insulin pump therapy for ≥ 3 months

 -  Age 12-18 years

 -  Currently using no insulins other than one of the following rapid-acting insulins at
 the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin
 glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or
 aspart.

 -  Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists,
 Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and
 naturaceuticals) is permitted if stable on current dose for at least 1 month.

 -  Willingness to wear a continuous glucose sensor and physiological monitor for the
 duration of the study.

 -  For females, not pregnant or breastfeeding. Female subjects who are sexually active
 should agree to use birth control during the study.

 -  Total daily insulin dose (TDD) at least 10 U/day.

 Exclusion Criteria:

 -  Diabetic ketoacidosis in the past 6 months

 -  Hypoglycemic seizure or loss of consciousness in the past 6 months

 -  History of seizure disorder

 -  History of any heart disease including coronary artery disease, heart failure, or
 arrhythmias

 -  History of altitude sickness

 -  Chronic pulmonary conditions that could impair oxygenation

 -  Cystic fibrosis

 -  Current use of oral glucocorticoids, beta-blockers or other medications, which in the
 judgement of the investigator, would be a contraindication to participation in the
 study.

 -  History of ongoing renal disease (other than microalbuminuria).

 -  Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or
 Glargine).

 -  Pregnancy

 -  Presence of a febrile illness within 24 hours of the Ski Admission

 -  Medical or psychiatric conditions that in the judgement of the investigator might
 interfere with the completion of the protocol such as:

 -  Inpatient psychiatric treatment in the past 6 months

 -  Uncontrolled adrenal insufficiency

 -  Alcohol abuse