Ignite Creation Date:
2025-12-18 @ 8:49 AM
Ignite Modification Date:
2025-12-23 @ 10:14 PM
Study NCT ID:
NCT02877771
Status:
None
Last Update Posted:
2016-09-01 00:00:00
First Post:
2016-08-09 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study
Sponsor:
None
Organization:
Study Overview
Official Title:
None
Status:
None
Status Verified Date:
2016-08
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:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: