Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study

Status Completed

Clinical Trial Summary

Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.

Clinical Trial Description

The study schedule consists of two outpatient phases: 1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by; 2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2) Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study. Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator. After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04320069
Study type	Interventional
Source	Insulet Corporation
Contact
Status	Completed
Phase	N/A
Start date	June 9, 2020
Completion date	September 29, 2020

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