Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-06 @ 2:57 AM
Study NCT ID:
NCT02897557
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulet Artificial Pancreas Early Feasibility Study
Sponsor:
Insulet Corporation
Organization:
Study Overview
Official Title:
A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: