NCT02877771

Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.

Detailed description

This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.

Conditions

• Diabetes Mellitus
• Type 1 Diabetes
• Insulin Pump

Interventions

Type	Name	Description
DEVICE	t:slim insulin pump with predictive low glucose suspend	To assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-08-24
• Last updated: 2016-09-01

Locations

2 sites across 1 country: United States