NCT03804983

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Hybrid Closed Loop (HCL)	Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
DEVICE	Control-IQ with MyTDI	Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Timeline

• Start date: 2019-01-15
• Primary completion: 2019-02-16
• Completion: 2019-02-16
• First posted: 2019-01-15
• Last updated: 2024-08-01
• Results posted: 2024-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study