Type 1 Diabetes Mellitus Clinical Trial
Official title:
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.
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