NCT05204134

Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

Detailed description

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Automated Insulin Delivery Settings Initialization and Adaptation Algorithm	All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Timeline

• Start date: 2022-03-24
• Primary completion: 2022-09-09
• Completion: 2022-09-29
• First posted: 2022-01-24
• Last updated: 2024-04-05
• Results posted: 2024-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study