Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-01 @ 9:45 AM
Study NCT ID:
NCT01073566
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
Sponsor:
Calibra Medical, Inc.
Organization:
Study Overview
Official Title:
The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device
Status:
COMPLETED
Status Verified Date:
2025-01
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 this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.
Detailed Description:
The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.
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?: