Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-29 @ 12:14 AM
Study NCT ID:
NCT02419859
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2015-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Sponsor:
CeQur Corporation
Organization:
Study Overview
Official Title:
A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2016-07
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 of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
Detailed Description:
This is a prospective, single center, open-label, uncontrolled study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (T2DM) who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of three phases: screening/baseline evaluation, transition to PaQ use and optimization, and PaQ treatment period. The use of these phases will allow an orderly transition to PaQ treatment as well as a reliable construct from which to interpret the final data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: