Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073566
• Other study ID #: VP-00007
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2010
• Last updated: March 13, 2012
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2012
• Source: Calibra Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus on intensive insulin therapy

Exclusion Criteria:

• Insulin pump therapy

• Current use of NPH or regular insulin

• Severe hypoglycemic episodes in prior 6 months

• Unstable cardiac disease, hepatic, or renal function

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Finesse
Finesse Insulin Delivery Patch
• Pen/Syringe (Usual injection device)
Pen/Syringe

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	International Diabetes Center at Park Nicollet	Minneapolis	Minnesota
United States	California Pacific Medical Center	San Francisco	California

Sponsors (6)

Lead Sponsor	Collaborator
Calibra Medical, Inc.	Henry Ford Health System, International Diabetes Center at Park Nicollet, Nancy Bohannon, MD, Med. Corp., Northwestern University, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bohannon N, Bergenstal R, Cuddihy R, Kruger D, List S, Massaro E, Molitch M, Raskin P, Remtema H, Strowig S, Whitehouse F, Brunelle RL, Dreon D, Tan M. Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver mealtime insulin for ef — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Daily Blood Glucose	Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose	6 weeks	No
Secondary	Glucose Profiles Per Day	Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days	6 weeks	No
Secondary	Insulin Delivery System Rating	Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.	6 weeks	No
Secondary	Self-reported Hypoglycemic Episodes	Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.	6 weeks	Yes