NCT05973422

Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes

Sigi Insulin Management System - First-in-Human Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early feasibility first-in-human study is a prospective single-arm single-center study of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.

Detailed description

Sigi Insulin Management System (Sigi) is a novel insulin patch pump intended for subcutaneous delivery if insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Sigi is offering superior delivery accuracy and precision, accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and smartphone control. Glycemia is CGM controlled and for safety purposes, CGM data are shared with study medical team during the whole study. Sigi FIH Study is conducted in a single clinical site in Lausanne University Hospital (CHUV) in Switzerland.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	SIGI Insulin Management System	Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.

Timeline

• Start date: 2024-05-31
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-08-02
• Last updated: 2024-01-11