safety and efficacy of initializing the control-iq artificial pancreas system using total daily insulin

Conditions: Type 1 Diabetes Mellitus

Summary: 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.

Eligibility criteria:
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

Keywords: artificial pancreas (ap) insulin pump continuous glucose monitor (cgm) mytdi hybrid closed loop (hcl) total daily insulin (tdi)