Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

Type 1 Diabetes Mellitus Clinical Trial

Official title: Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

Status Completed

Clinical Trial Summary

The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT03804983
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Completion date: February 16, 2019